Latest news with #DLBCL
Cision Canada
2 days ago
- Health
- Cision Canada
Roche Canada announces Polivy® (polatuzumab vedotin for injection) for the First-Line Treatment of Adults With Large B-Cell Lymphoma is now Publicly Reimbursed in Québec Français
This marks the first provincial listing of Polivy as a first-line treatment for DLBCL in Canada, highlighting Roche's ongoing commitment to meeting the diverse needs of healthcare systems and patients affected by lymphoma. MISSISSAUGA, ON, July 22, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that Polivy® (polatuzumab vedotin for injection) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL, is now publicly funded in Québec. 1 Roche Canada is fully committed to continuing to work with the other provincial and territorial jurisdictions to make Polivy available to patients as soon as possible through all public drug plans. Lymphoma refers to a group of blood cancers that develop in the lymphatic system. The lymphatic system works with other components of the immune system to help the body combat infections and disease. 3 There are two general categories of the different types of lymphoma: Hodgkin and non-Hodgkin lymphoma (NHL), with NHL being more common. 4 Diffuse large B-cell lymphoma (DLBCL) is a common, fast-growing and very aggressive type of non-Hodgkin lymphoma (NHL). 5 It was estimated that in 2024, 11,700 Canadians were diagnosed with NHL. 2 Despite generally positive responses to initial treatments, up to 40% of patients will experience relapse or refractory disease. 6 By effectively managing the disease from the outset, there could be a substantial reduction in the need for subsequent treatments and the associated patient and societal burden. Polivy received the first marketing authorization in Canada on July 9, 2020 from Health Canada, and on July 2, 2025, Québec approved it for public reimbursement for first-line treatment of DLBCL. 3,7 This represents a much-needed advance in treatment options as Polivy offers hope to first-line DLBCL patients by reducing the risk of disease progression, relapse, or death by 27% compared to the current standard of care. 1 With the availability of Polivy for newly diagnosed patients with DLBCL in Québec, Roche is continuing its commitment to develop innovative therapies for those affected by lymphoma. We are proud to have worked closely with key organizations in our Canadian healthcare systems to move Polivy from regulatory approval through to public access, and this work continues with the other provinces and territories. About Polivy® (polatuzumab vedotin for injection) 1 Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers an anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells. The monoclonal antibody binds to CD79b, a cell surface component of the B-cell receptor. CD79b expression is restricted to normal cells within the B cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in >95% of DLBCL. Upon binding CD79b, polatuzumab vedotin is rapidly internalized, aiding in the delivery of MMAE intracellularly. MMAE then works to kill dividing cells by inhibiting cell division and inducing apoptosis. About Diffuse Large B-cell Lymphoma (DLBCL) Lymphoma is the name for a group of blood cancers that develop in the lymphatic system and occur in two main types: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). In particular, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and the most common form of NHL. 5 About Roche in hematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs almost 2,000 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Québec. SOURCE Hoffmann-La Roche Limited (Roche Canada)
Yahoo
6 days ago
- Business
- Yahoo
Genentech Provides Update on Supplemental Biologics License Application for Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
SOUTH SAN FRANCISCO, Calif., July 18, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Genentech's supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant. Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the U.S. patient population. STARGLO was also intended as a postmarketing confirmatory study to convert the accelerated approval of Columvi in third-line or later DLBCL in the U.S. to full approval. Columvi remains under accelerated approval for people with third-line or later DLBCL. Discussions with the FDA are ongoing to confirm the Phase III SKYGLO study investigating Columvi in combination with Polivy® (polatuzumab vedotin-piiq), Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone for patients with previously untreated large B-cell lymphoma as the new postmarketing requirement. "While we are disappointed with this outcome, we remain confident in the data supporting the value of Columvi for U.S. patients who have relapsed following initial treatment, and its key role as monotherapy in the third-line setting," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We are committed to bringing Columvi to more people living with lymphoma and are actively exploring its potential in additional treatment settings, including as frontline therapy." "For patients with this aggressive form of lymphoma, effective treatment after relapse is paramount. The STARGLO study showed that Columvi-GemOx significantly improves overall survival and could have a positive impact for patients earlier in their treatment journey. This regimen is already approved in over 35 countries, which underscores the urgent need it addresses," said Jeremy Abramson, M.D., director, Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital Cancer Center, and principal investigator of the STARGLO study. Based on the STARGLO data, this Columvi combination is approved in more than 35 countries, including in the EU, and recommended in clinical practice guidelines including the U.S. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®).† Data has been submitted to other health authorities around the world for approval consideration. Columvi monotherapy has been approved for use in R/R DLBCL after two or more prior lines of therapy in more than 60 countries worldwide. The sBLA is based on results from the Phase III STARGLO study which showed a statistically significant and clinically meaningful 41% reduction in the risk of death (hazard ratio=0.59, 95% confidence interval: 0.40–0.89, p=0.011) in patients treated with Columvi in combination with GemOx. Results were published in The Lancet and two-year follow-up data from the study were presented at the 61st American Society of Clinical Oncology Annual Meeting from May 30 – June 3, 2025, where improvements in primary and secondary endpoints were sustained. †NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. About the STARGLO study The STARGLO study [GO41944; NCT04408638] is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Columvi® (glofitamab-gxbm) in combination with gemcitabine plus oxaliplatin (GemOx) versus Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumor effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. About Columvi® (glofitamab-gxbm) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Genentech's broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development program, which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Genentech is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. As part of Genentech's efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with other medicines in previously untreated DLBCL in the Phase III SKYGLO study [GO44145; NCT06047080]. About diffuse large B-cell lymphoma (DLBCL) Diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and is the most common form of non-Hodgkin's lymphoma in the U.S. Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions. Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Improving treatments earlier in the course of the disease and providing much-needed alternative options could help to improve long-term outcomes. Columvi U.S. Indication Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer. It is not known if Columvi is safe and effective in children. The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works. What is the most important information I should know about Columvi? Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death. Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher chills or shaking fast or irregular heartbeat dizziness or light-headedness trouble breathing shortness of breath Due to the risk of CRS, you will receive Columvi on a "step-up dosing schedule". A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1). You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller "step-up" doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose. You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2). If your dose of Columvi is delayed for any reason, you may need to repeat the "step-up dosing schedule". If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi. Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions. Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects. Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away. What are the possible side effects of Columvi? Columvi may cause serious side effects, including: Cytokine Release Syndrome. Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: headache confusion and disorientation difficulty paying attention or understanding things trouble speaking sleepiness memory problems numbness, tingling, or weakness of the hands or feet dizziness shaking (tremors) Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat. Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare: tender or swollen lymph nodes pain or swelling at the site of the tumor chest pain cough trouble breathing The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness. The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting). Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects. Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you: have an infection have kidney problems are pregnant or plan to become pregnant. Columvi may harm your unborn baby Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Columvi. You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi. are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving Columvi? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems. These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects, as well as the Columvi full Prescribing Information and Medication Guide or visit About Polivy® (polatuzumab vedotin-piiq) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL. Polivy U.S. Indication Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL). Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies. Important Safety Information Possible serious side effects Everyone reacts differently to Polivy therapy, so it's important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects. Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication Side effects seen most often The most common side effects during treatment were Nerve problems in arms and legs Nausea Tiredness or lack of energy Diarrhea Constipation Hair loss Redness and sores of the lining of the mouth, lips, throat, and digestive tract Polivy may lower your red or white blood cell counts and increase uric acid levels. Polivy may not be for everyone. Talk to your doctor if you are Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see the full Prescribing Information and visit for additional Important Safety Information. About Genentech in hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Genentech Group, has headquarters in South San Francisco, California. For additional information about the company, please visit View source version on Contacts Media Contact:Kristen Ingram, (650) 467-6800 Advocacy Contact:Catherine Creme Henry, (202) 258-8228 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41 61 687 5284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-07-2025
- Business
- Yahoo
Imugene Announces Outstanding Response Rates from the Phase 1b Trial of the Azer-cel Allogeneic CAR T in 3L+ DLBCL
Since the February update, an additional 5 patients have been dosed, resulting in 2 Complete Responses (CR) and 3 Partial Responses (PR) 75% Overall Response rate (ORR): 6 total CR and 3 PR in Phase 1b trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T therapy in relapsed diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer First patient remains cancer free at 15 months and ongoing with additional patients having durable responses at 2, 5, and 11 months+ and durability data continuing to mature Patients in the trial have previously failed at least 3 lines of therapy with many patients failing 4-6 lines of therapy, including autologous CAR-T, reinforcing the potential of azer-cel in this high-unmet-need population Based on these positive results, Imugene expects to meet with the US FDA in Q4 2025 regarding a pivotal / registrational study for azer-cel Trial now open to enrol into CAR T naïve niche indications in other lymphomas Additional update expected in coming months SYDNEY, July 14, 2025 /PRNewswire/ -- Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, is pleased to announce exciting new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappearance of all signs of cancer in response to treatment. Since then, two additional patients have also achieved a Complete Response, and three patients have achieved Partial Response (cancer reduction by at least 50%) bringing the best overall response rate to 75% and the CR rate to 55%. The duration of response continues to mature. These patients are being treated with azer-cel and interleukin 2 (IL -2). Evaluable patients Treatment N Overall Response Rate (ORR) Complete Response (CR) At Day 60 Best Durability (Time of response) DLBCL Lymphodepletion (LD)1 +azer-cel +Interleukin-2 (IL-2) 12 9/12 (75%) 6/11 (55%) >450 days on going For approved, autologous CD19 CART products, the average time to best response is 2-3 months with some patients taking up to 6 months to achieve their best response. Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand). Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, Imugene will request a Type B (End of Phase 1) Meeting in Q4 2025, with the US FDA to present the data and to discuss designs for a pivotal / registrational trial for azer-cel. Leslie Chong, Managing Director and CEO of Imugene, said: "We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for DLBCL patients who have failed several previous lines of therapy. The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the FDA. Additionally, given the positive results, we are opening the trial to other niche blood cancer indications, such as PCNSL and other subtypes of B Cell Lymphoma, for CAR T naïve patients. This is a high unmet need with potential to expedite and expand the scope of azer-cel." Dr John Byon, Chief Medical Officer of Imugene, said: "DLBCL remains one of the most aggressive forms of lymphoma, and despite the existing therapies, there are a large number of patients that still face relapse or resistance. We are seeing significant potential from azer-cel to date in its ability to provide a critical step forward for these patients who have relapsed on multiple therapies, offering deep and durable responses with a one-time treatment. We remain deeply committed to transforming the standard of care in difficult-to-treat blood cancers, where significant unmet medical need still exists." The FDA Fast Track Designation for DLBCL received for azer-cel is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Benefits of the designation include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria. Imugene continues to actively enrol patients into the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response. About the Phase 1b azer-cel trial The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated. About diffuse large B cell lymphoma (DLBCL) DLBCL is an aggressive and fast-growing type of non-Hodgkin's lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000[1] global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse. [1]Science Direct Volume 60, Issue 5, November 2023 About primary central nervous system lymphoma (PCNSL) PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients. About other types of B Cell Lymphoma Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments. About Interleukin 2 (IL-2) IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells. For more information please contact: Leslie ChongManaging Director and Chief Executive Officerinfo@ General Investor Enquiriesshareholderenquiries@ Media EnquiriesMatt Wrightmatt@ Connect with us on LinkedIn @Imugene LimitedFollow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited About Imugene (ASX:IMU) Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body's immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T's for solid tumours and B-cell vaccine candidates. We are supported by a leading team of international cancer experts with extensive experience in developing novel cancer therapies that are currently marketed globally. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Together with leading specialists and medical professionals, we believe Imugene's immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited. View original content to download multimedia: SOURCE Imugene Ltd Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
08-07-2025
- Business
- Malaysian Reserve
Bispecifics/BiTE Market Anticipates Impressive Growth Trajectory During the Forecast Period (2025-2034) Across 7MM Due to Their Expansion Beyond Oncology
The bispecific antibody and BiTE market is witnessing robust growth driven by advances in immuno-oncology and rising demand for targeted cancer therapies. Key factors include increasing clinical success, regulatory approvals, and the ability of these therapies to engage immune cells directly against tumors. Partnerships and investments from major pharmaceutical players are accelerating pipeline development. The bispecific antibody and BiTE market is also expanding beyond oncology into autoimmune and infectious diseases. LAS VEGAS, July 8, 2025 /PRNewswire/ — DelveInsight's Bispecifics/BiTE Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Acute Lymphocytic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma, Multiple Myeloma, Non-small-cell Lung Cancer (NSCLC), Small-cell Lung Cancer (SCLC), Biliary Tract Cancer (BTC), Psoriasis, Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus (SLE), Wet Age-related Macular Degeneration (AMD), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging bispecifics/BiTE, market share of individual therapies, and current and forecasted bispecifics/BiTE market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the Bispecifics/BiTE Market Report As per DelveInsight's analysis, the total market size of bispecifics/BiTE in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Acute Lymphocytic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma, Multiple Myeloma, Non-small-cell Lung Cancer (NSCLC), Small-cell Lung Cancer (SCLC), Biliary Tract Cancer (BTC), Psoriasis, Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus (SLE), Wet Age-related Macular Degeneration (AMD), and others. Leading bispecifics/BiTE companies, such as Aurigene Oncology, Curis, Zenas BioPharma, I-MAB Biopharma, ABL Bio, Bristol Myers Squibb, IMBiologics, Y-Biologics, HK Innoen, Sanofi, Regeneron Pharmaceuticals, and others, are developing novel bispecifics/BiTE that can be available in the bispecifics/BiTE market in the coming years. Some of the key bispecifics/BiTE therapies in the pipeline include CA-170, Obexelimab, Givastomig, IMB-101, SAR446422, Linvoseltamab, and others. Based on pipeline activities, most of the bispecific antibodies are developed in multiple myeloma, followed by NSCLC. In June 2025, BioNTech and Bristol Myers Squibb agreed on the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate. According to Zenas BioPharma's Q1 2025 report published in May 2025, the company anticipates reporting topline Phase III results for Obexelimab in IgG4-related disease by the end of 2025, 12-week primary endpoint data in RMS in the third quarter of 2025, and 24-week primary endpoint data in SLE in the first half of 2026. In February 2025, Regeneron Pharmaceuticals announced that the US FDA the resubmission of the Biologics License Application (BLA) for linvoseltamab accepted for review for the treatment of adult patients with Relapsed/Refractory multiple myeloma who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy. The target action date for the FDA decision is July 10, 2025. According to I-MAB Biopharma's Q1 2025 report published in May 2025, the company anticipates presenting data from the givastomig dose expansion cohorts (n = 40) in the first half of 2026, with further development initiatives and data readouts from the Phase Ib study expected through 2027. Additionally, new data from the givastomig dose escalation combination study in US patients will be presented at the European Society of Medical Oncology Gastrointestinal (ESMO GI) Cancers Congress 2025, scheduled for July 2–5 in Barcelona, Spain. In May 2025, Genentech announced two-year follow-up data from the Phase III STARGLO study. The updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit of this off-the-shelf, fixed-duration Columvi combination for people with R/ DLBCL who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT). Discover which indication is expected to grab the major bispecifics/BiTE market share @ Bispecifics/BiTE Market Report Bispecifics/BiTE Market Dynamics The bispecific antibody and BiTE market is experiencing strong momentum, driven by rapid advancements in immuno-oncology and increasing demand for precision biologics. These modalities are designed to simultaneously bind two different antigens or epitopes, commonly one on a tumor cell and the other on an immune effector cell, such as a T-cell, thereby redirecting immune activity toward malignant cells. Their ability to provide targeted immune activation while minimizing systemic toxicity positions them as highly attractive therapeutic options, particularly for difficult-to-treat cancers and hematological malignancies. Market growth is being fueled by a combination of technological innovation and clinical validation. Companies are investing heavily in next-generation bispecific platforms that offer improved stability, manufacturability, and half-life extension. Major pharmaceutical players, as well as emerging biotech firms, are advancing robust pipelines of bispecifics and BiTEs, with several candidates achieving regulatory approvals in recent years. The entry of these agents has set a precedent, increasing investor confidence and accelerating deal-making activity, including strategic collaborations and licensing agreements. Despite the enthusiasm, the bispecifics/BiTE market faces key challenges. Manufacturing complexities, immunogenicity risks, and potential for cytokine release syndrome remain technical and clinical hurdles. Additionally, the crowded competitive landscape necessitates differentiation, either through novel targets (e.g., B7-H3, DLL3, CLDN6) or superior clinical outcomes. Pricing pressures and reimbursement considerations also loom large, particularly as more therapies enter the market and stakeholders demand cost-effective value delivery. In summary, the bispecific and BiTE market represents one of the most dynamic frontiers in biologics. With many candidates in preclinical and clinical development globally, the next decade is likely to see continued maturation of the field, consolidation among players, and deeper integration of bispecifics into standard-of-care treatment paradigms. Strategic investments, patient-centric development, and continuous innovation will be critical to sustaining long-term growth. Bispecifics/BiTE Treatment Market Bispecific antibodies are designed to address complex, multifactorial diseases by simultaneously targeting two distinct disease-related molecules with a single therapeutic agent. Most approved bispecifics are used in oncology, particularly for conditions like multiple myeloma and diffuse large B-cell lymphoma (DLBCL). Outside of oncology, only two, HEMLIBRA and VABYSMO, have been approved for treating hemophilia A, neovascular (wet) age-related macular degeneration, and diabetic macular edema. Additionally, KIMMTRAK, a bispecific molecule, has received approval specifically for uveal melanoma. REMOVAB, the world's first approved bispecific antibody, was developed to treat malignant ascites associated with solid tumors and received approval from the EMA. However, it was withdrawn from the market in 2017 due to commercial considerations. ZIIHERA is a bispecific antibody that targets HER2 by binding to two distinct extracellular domains on the receptor. In November 2024, the U.S. FDA granted accelerated approval for ZIIHERA (50 mg/mL for IV injection) for use in adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). Zanidatamab, the molecule behind ZIIHERA, is also under evaluation in various clinical trials as a targeted therapy for solid tumors. These include Phase III studies for gastroesophageal adenocarcinoma (GEA) and metastatic breast cancer (mBC), as well as Phase II trials for colorectal and breast cancers. The drug was originally developed by Zymeworks and is now being advanced by Jazz Pharmaceuticals and BeiGene through licensing agreements. Jazz holds commercialization rights for the U.S., Europe, Japan, and all regions except Asia-Pacific territories already licensed by Zymeworks to BeiGene (excluding Japan, but including the rest of Asia, Australia, and New Zealand). In April 2025, Jazz announced its participation at the ASCO annual meeting, where three abstracts related to zanidatamab were accepted for presentation. Furthermore, the European Medicines Agency's CHMP issued a positive opinion recommending conditional marketing authorization of zanidatamab monotherapy for adults with previously treated, unresectable, locally advanced or metastatic HER2-positive (IHC 3+) BTC. COLUMVI is a bispecific antibody designed to engage CD20 and CD3, featuring a unique 2:1 structural configuration. It brings T cells into proximity with malignant B cells, making it effective in targeting cancers such as diffuse large B-cell lymphoma (DLBCL). In June 2023, the FDA granted accelerated approval to COLUMVI for use in patients with relapsed or refractory DLBCL (not otherwise specified) or large B-cell lymphoma (LBCL) that has transformed from follicular lymphoma, following at least two prior systemic treatments. Learn more about the FDA-approved bispecifics/BiTE therapies @ Bispecifics/BiTE Drugs Key Emerging Bispecifics/BiTE and Companies Several key players, including Aurigene Oncology/Curis (CA-170), I-MAB Biopharma/ABL Bio/Bristol Myers Squibb (Givastomig), IMBiologics/Y-Biologics/HK Innoen (IMB-101), Regeneron Pharmaceuticals (Linvoseltamab), Sanofi (SAR446422), Zenas BioPharma (Obexelimab), and others, are involved in developing drugs for Bispecifics/BiTE for various indications such as NSCLC, Bladder and Kidney Cancers, IgG4-RD, RMS, SLE, multiple sclerosis, and others. CA-170 is an orally administered, first-in-class small molecule with strong activity. It selectively inhibits PD-L1 and VISTA, both of which are immune checkpoint proteins that suppress immune responses. The compound is currently undergoing Phase III clinical trials for non-small cell lung cancer (NSCLC) as well as bladder and kidney cancers. In February 2020, Curis revised its collaboration and licensing agreement with Aurigene Discovery Technologies. The updated terms granted Aurigene development and commercialization rights for CA-170 across Asia, expanding on its original rights in India and Russia. Curis retained exclusive rights to the drug in the United States, Europe, and other global markets and is eligible to receive royalties from sales in Asia. The original partnership between Curis and Aurigene began in 2015. Givastomig (also referred to as TJ-CD4B/ABL111 or TJ033721) is a bispecific antibody engineered to target Claudin 18.2 (CLDN18.2) on tumor cells and activate T-cells through 4-1BB in a tumor-restricted manner. It is designed to engage tumor cells expressing varying levels of CLDN18.2, commonly found in gastric and pancreatic cancers, and locally stimulate T-cell activity within the tumor microenvironment. In September 2024, I-Mab Biopharma shared results from a Phase I trial of givastomig in patients with CLDN18.2-positive advanced gastroesophageal cancer. The therapy was well tolerated at doses up to 15 mg/kg administered biweekly and showed promising clinical activity in patients who had previously undergone multiple treatments. These patients exhibited a broad range of CLDN18.2 expression. Earlier, in March 2022, the FDA granted givastomig Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancers. The anticipated launch of these emerging therapies are poised to transform the bispecifics/BiTE market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the bispecifics/BiTE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about bispecifics/BiTE clinical trials, visit @ Bispecifics/BiTE Treatment Drugs Bispecifics/BiTE Overview Bispecific antibodies, including Bispecific T-cell Engagers (BiTEs), represent an innovative class of immunotherapies designed to harness the immune system to target and destroy cancer cells more precisely. Unlike conventional monoclonal antibodies, bispecifics are engineered to recognize and bind to two different antigens simultaneously. One arm typically targets a tumor-associated antigen on cancer cells, while the other engages a molecule on immune cells, most commonly CD3 on T cells. This dual targeting brings T cells into close proximity with tumor cells, triggering T-cell activation and cytotoxicity, even without the need for antigen presentation or co-stimulation. BiTEs are a specific subset of bispecifics characterized by their compact size and lack of an Fc region, enabling better tissue penetration and faster pharmacokinetics. The most well-known example is blinatumomab, approved for treating certain types of B-cell acute lymphoblastic leukemia. As research expands, next-generation BiTEs and bispecifics are being developed to improve half-life, reduce off-target effects, and address solid tumors, traditionally more challenging for immunotherapy. Their modular design also enables customization to different tumor types and immune targets, making them a versatile and rapidly advancing segment of oncology therapeutics. Bispecifics/BiTE Epidemiology Segmentation The bispecifics/BiTE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for Bispecifics/BiTE Total Eligible Patient Pool in Selected Indications for Bispecifics/BiTE Total Treated Cases in Selected Indications for Bispecifics/BiTE Bispecifics/BiTE Report Metrics Details Study Period 2020–2034 Bispecifics/BiTE Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report Acute Lymphocytic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma, Multiple Myeloma, Non-small-cell Lung Cancer (NSCLC), Small-cell Lung Cancer (SCLC), Biliary Tract Cancer (BTC), Psoriasis, Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus (SLE), Wet Age-related Macular Degeneration (AMD), and others Key Bispecifics/BiTE Companies Aurigene Oncology, Curis, Zenas BioPharma, I-MAB Biopharma, ABL Bio, Bristol Myers Squibb, IMBiologics, Y-Biologics, HK Innoen, Sanofi, Regeneron Pharmaceuticals, Zymeworks, Genentech, Genmab, Pfizer, Johnson & Johnson Innovative Medicine, AstraZeneca, and others Key Bispecifics/BiTE Therapies CA-170, Obexelimab, Givastomig, IMB-101, SAR446422, Linvoseltamab, ZIIHERA, COLUMVI, EPKINLY, LUNSUMIO, ELREXFIO, VABYSMO, TECVAYLI, SAPHNELO, OCREVUS, and others Scope of the Bispecifics/BiTE Market Report Bispecifics/BiTE Therapeutic Assessment: Bispecifics/BiTE current marketed and emerging therapies Bispecifics/BiTE Market Dynamics: Conjoint Analysis of Emerging Bispecifics/BiTE Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Bispecifics/BiTE Market Access and Reimbursement Discover more about bispecifics/BiTE therapies in development @ Bispecifics/BiTE Clinical Trials Table of Contents 1 Key Insights 2 Report Introduction 3 Key Highlights Of The Report 4 Executive Summary Of Bispecifics/BiTE 5 Key Events 6 Epidemiology And Market Forecast Methodology 7 Bispecific/BiTE Market Overview At A Glance 7.1 Market Share (%) Distribution of Bispecifics/BiTE by Therapies in 2024 7.2 Market Share (%) Distribution of Bispecifics/BiTE by Therapies in 2034 7.3 Market Share (%) Distribution of Bispecifics/BiTE by Indications in 2024 7.4 Market Share (%) Distribution of Bispecifics/BiTE by Indications in 2034 8 Background And Overview 8.1 Introduction 8.2 Treatment 8.3 FDA-Approved Bispecifics/BiTE Antibodies 9 Epidemiology And Patient Population 9.1 Key Findings 9.2 Assumptions And Rationale 9.3 Total Cases of Selected Indication for Bispecifics/BiTE in the 7MM 9.4 The eligible pool of Indications for Bispecific/BiTE Antibodies in the 7MM 9.5 Treatable Cases by Indication for Bispecific/BiTE Antibodies in the 7MM 10 Marketed Drugs 10.1 Key Competitors 10.2 ZIIHERA (zanidatamab): Zymeworks 10.2.1 Product Description 10.2.2 Regulatory Milestones 10.2.3 Other Developmental Activities 10.2.4 Clinical Development 10.2.4.1 Clinical Trial Information 10.2.5 Safety and Efficacy 10.2.6 Analyst Views 10.3 COLUMVI (glofitamab): Roche 10.3.1 Product Description 10.3.2 Regulatory Milestones 10.3.3 Other Developmental Activities 10.3.4 Clinical Development 10.3.4.1 Clinical Trial Information 10.3.5 Safety and Efficacy 10.3.6 Analyst Views List to be continued… 11 Emerging Drugs 11.1 Key Competitors 11.2 CA-170: Aurigene Oncology and Curis 11.2.1 Product Description 11.2.2 Other Development Activities 11.2.3 Clinical Development 11.2.3.1 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analyst Views 11.3 Givastomig: I-MAB Biopharma, ABL Bio, and Bristol Myers Squibb 11.3.1 Product Description 11.3.2 Other Development Activities 11.3.3 Clinical Development 11.3.3.1 Clinical Trials Information 11.3.4 Safety and Efficacy 11.3.5 Analyst Views List to be continued… 12 Bispecifics/BiTE: The 7MM Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Conjoint Analysis 12.4 Key Market Forecast Assumptions 12.4.1 Cost Assumptions and Rebates 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Years and Therapy Uptake 12.5 Total Market Size of Bispecifics/BiTE in the 7MM 12.6 United States Market 12.6.1 Market Size of Bispecifics/BiTE By Indications in the United States 12.6.2 Market Size By Therapies in the United States 12.7 EU4 and the UK Market 12.7.1 Market Size of Bispecifics/BiTE By Indications in EU4 and the UK 12.7.2 Market Size By Therapies in EU4 and the UK 12.8 Japan Market 12.8.1 Market Size of Bispecifics/BiTE By Indications in Japan 12.8.2 Market Size By Therapies in Japan 13 Unmet Needs Of Bispecifics/BiTE 14 SWOT Analysis Of Bispecifics/BiTE 15 KOL Views Of Bispecifics/BiTE 16 Market Access and Reimbursement 16.1 United States 16.1.1 Centre for Medicare & Medicaid Services (CMS) 16.2 EU4 and the UK 16.2.1 Germany 16.2.2 France 16.2.3 Italy 16.2.4 Spain 16.2.5 United Kingdom 16.3 Japan 16.3.1 MHLW 17 Appendix 17.1 Bibliography 17.2 Report Methodology 18 DelveInsight Capabilities 19 Disclaimer 20 About DelveInsight Related Reports Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Pfizer, Takeda, Johnson & Johnson Innovative Medicine, Eli Lilly and Company, Merck, Bristol-Myers Squibb, Roche, Shanghai Henlius Biotech, AbbVie, Daiichi Sankyo, Nuvation Bio, PDC*line Pharma, Moderna Therapeutics, Pfizer, GSK, Gilead Sciences, BieGene, Nuvalent, among others. Small Cell Lung Cancer Market Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SCLC companies, including Ascentage Pharma, Merck & Co., AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences, IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content:
Medscape
08-07-2025
- Health
- Medscape
DLBCL Debate: Is Pola-R-CHP a Suitable Standard for All?
LUGANO, Switzerland — The advent of the Pola-R-CHP (polatuzumab plus R-CHOP) regimen has shaken up the long-held standard of R-CHOP in the treatment of diffuse large B-cell lymphoma (DLBCL) and should now be the standard for all patients who meet the inclusion criteria of the landmark POLARIX trial that established its efficacy — according to one side of a debate on the issue held at the 18th International Conference on Malignant Lymphoma (ICML) 2025. Conversely, the POLARIX trial had some notable caveats — including the lack of improvement in overall survival vs R-CHOP alone, and findings indicating that Pola-R-CHP benefits appear to favor patients with the activated B-cell (ABC)-like subtype — key limitations that suggest that R-CHOP is still 'good enough' and the right choice for some patients, the counterargument concluded. The phase 3 POLARIX trial moved to the center of the debate after becoming, in 2022, the first positive trial in 20 years to show benefit over the long-time standard of care of R-CHOP for treatment-naïve, high-risk patients with DLBCL. The trial showed that polatuzumab vedotin, a CD79b-directed antibody-drug conjugate, added to R-CHOP provided an absolute improvement of 6.5% in progression-free survival (PFS) after 2 years compared with R-CHOP alone (76.7% vs 70.2%), and the improvements have been further reported to be sustained at 5 years (66.7% vs 58.1%). 'It should be emphasized that this was a randomized, double-blind, placebo-controlled, phase 3 international trial,' asserted Sonali M. Smith, MD, the Elwood V. Jensen professor of medicine and chief of the Section of Hematology and Oncology at the University of Chicago, Chicago, in making the case in favor of Pola-R-CHP as a new standard of care for all patients meeting POLARIX trial inclusion criteria. 'This is the gold standard of clinical trials. If we don't listen to the gold standard, why are we even doing trials?' she emphasized. Overall Survival vs PFS Among the most prominent issues of debate is that despite the improvement in PFS, there was virtually no difference between Pola-R-CHP and R-CHOP in the trial in terms of overall survival (88.7% vs 88.6%). Smith argued that over the course of the study's follow-up period, the trajectories in each group do suggest a likely eventual greater improvement in survival with Pola-R-CHP. 'We start to see with follow-up that the curves continue to stay apart, and there is a suggestion perhaps that this may be permanent,' Smith noted. Supporting that, 'there are numerically more deaths in the R-CHOP arm,' she added. Smith cited important research derived from very large datasets of DLBCL in the Surrogate Endpoint for Aggressive Lymphoma Collaboration database concluding that 24 month PFS is indeed an indicator of excellent long-term survival. 'Patients treated with rituximab containing anthracycline-based immunochemotherapy on clinical trials who are alive without progression at 24 months from the onset of initial therapy [having] excellent outcomes with survival that is marginally lower but clinically indistinguishable from the age-, sex-, and country-matched background population for 7 years after achieving PFS [at 24 months],' the study concluded. Those findings underscore that 'PFS has now become an appropriate endpoint for the majority of trials that are designed,' Smith said. Furthermore, with an 'embarrassment of riches' in terms of new treatments in the relapsed/refractory DLBCL setting changing the treatment landscape, 'I think showing an overall survival advantage is going to be exceedingly difficult, and it does not mean that PFS advantages are not meaningful.' Counterpoint: PFS Difference 'Quite Small'; Curves Separate Late Making the counter-argument, Grzegorz (Greg) S. Nowakowski, MD, a professor of medicine and deputy director of the Mayo Clinic Comprehensive Cancer Center, in Rochester, Minnesota, noted first that the benefit of PFS overall in the POLARIX trial is 'quite small' — in terms of the number needed to treat, the 6.5% PFS difference with Pola-R-CHP equates to about 15 patients needed to receive the therapy to prevent one relapse, he said. Furthermore, the separation of the curves between Pola-R-CHP and R-CHOP occurs relatively late, he added. 'With R-CHOP alone, in multiple trials, we saw the separation of event-free survival or PFS curves occurring early,' Nowakowski said. But vs Pola-R-CHP in the POLARIX trial, 'the separation of these curves occurs relatively late, at 6 months, and by the time that happens, most of the patients who have primary refractory disease have already progressed,' he said. Nowakowski noted research showing that patients with LBCL who relapse early or fail to achieve a complete response after frontline treatment have poor outcomes. 'We know in the clinic that the worst [outcomes] are among patients who progress early,' Nowakowski said. ABC Subtype: 'Elephant in the Room' Lumbers in Overall survival aside, another key finding from POLARIX was that some of the highest responses appear limited to key subgroups including older patients, those with nonbulky disease, and most notably, those with the ABC cell-of-origin subtype compared with the germinal center B-cell-like (GCB) subtype. Smith argued that there is more to the story with that limitation as well. 'Other factors are important here — for example, older patients also had better responses — does that mean we should not offer this to younger patients who are otherwise eligible?' Additionally, 'we know that ABC increases with age, which raises the question, is ABC a surrogate for older patients who happen to do better with this treatment?' Smith pondered. Of note, only about a third of patients in the POLARIX study had the ABC subtype. However, 25% of the enrolled patients did not have any cell-of-origin that was assessed, and 15% could not be classified within one set or another, Smith said. 'So I think cell-of-origin is too blunt an instrument for us to consider as precision therapy.' Subgroup Differences Cannot Be Ignored Both speakers cited new data adding further complexity to the debate — a late-breaking subanalysis of POLARIX study, as reported by Medscape Medical News , showing that even within the ABC subgroup of patients, the majority of Pola-R-CHP benefit was limited to just one of five clusters, the C5, which is associated with poor outcomes. The trial further showed 'absolutely no difference [in responses] in the GCB subgroup, which, by the way, is more common than ABC,' Nowakowski noted. As a result of the collective data, some centers have policies in place of only using Pola-R-CHP among patients with the ABC subtype or non-GCB subtypes, he said. 'They are mindful that there is no overall survival difference in POLARIX, and that the ABC and non-GCB are the subgroups who can truly benefit.' Ultimately, Pola-R-CHP is clearly important — but still currently subject to too many caveats to be the standard of care for all, he argued. 'Right now, some centers are using it in all patients; some use it in some patients; some use it in ABC- or maybe non-GCB-defined patients only, as we do in our practice,' he said. 'And one could use it even more narrowly in the future based on these subtypes,' he added. 'I do think most of us would consider this an important option, but it is not a standard yet, and that is reflected by most of our regulatory agencies.' An informal polling of the audience following the debate showed agreement heavily weighing in favor of Nowakowski's argument — with an early separation of curves observed as the real-time display of voting results.
