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Kuwait Times
05-07-2025
- Sport
- Kuwait Times
International Skating Union grants Kuwait full membership
LUSANNE: Salem Al-Ajmi, director of figure skating at the Kuwait Winter Sports Club, Yousef Al-Kandari, director of speed skating,ِ pose for a photo with ISU President Jae Yeol Kim. KUWAIT: The International Skating Union (ISU) granted the country full membership in its figure skating division, officially recognizing the Kuwait Figure Skating Federation. The decision, which was announced during the ISU's 2025 Congress currently being held in Switzerland, marks a major step forward for Kuwait's winter sports scene. In a statement to Kuwait News Agency (KUNA) on Thursday, President of the Kuwait Winter Sports Club, Fahid Al-Ajmi, hailed the development as a major milestone in the country's growing involvement on the global winter sports stage. The Kuwaiti delegation attending the ISU Congress included Salem Al-Ajmi, director of figure skating at the club, Yousef Al-Kandari, director of speed skating, and club administrator Farah Al-Qallaf. Al-Ajmi said Kuwait exercised its full voting rights at the Congress for the first time following the approval, taking part in key decisions aimed at developing the sport internationally. He expressed deep gratitude to the ISU and its president, South Korea's Jae Yeol Kim, for their confidence in Kuwait's skating program and their continued support. He explained that full membership was granted after Kuwait successfully met the ISU's eligibility requirements, including consistent participation in regional and international figure skating competitions and compliance with development standards. 'This recognition will boost the sport's development in Kuwait by creating more opportunities for our athletes to compete and gain valuable experience on the international stage,' Al-Ajmi said. He also extended congratulations to all club members and supporters who contributed to the achievement. Al-Ajmi credited the Kuwait Olympic Committee, led by Sheikh Fahad Nasser Al-Sabah, and Secretary-General Hussein Al-Musallam, for playing a key role in facilitating Kuwait's entry into the international skating community. He emphasized that the club remains committed to supporting all five winter sports under its umbrella. — KUNA
Business Wire
15-06-2025
- Health
- Business Wire
Genmab Announces Epcoritamab Investigational Combination Therapy Demonstrates High Response Rates in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT)
COPENHAGEN, Denmark--(BUSINESS WIRE)-- Genmab A/S (Nasdaq: GMAB) today announced new results from the Phase 1b/2 EPCORE ® NHL-2 trial Arm 10 (NCT04663347), evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who are eligible for autologous stem cell transplantation (ASCT). Results demonstrated an overall response rate (ORR) of 87 percent, a complete response (CR) rate of 65 percent and a partial response (PR) of 23 percent. The majority of patients (65 percent) proceeded to ASCT. At six months, an estimated 81 percent of responses were ongoing, 74 percent of patients were progression free, and 100 percent of patients were alive. These results were shared today during an oral presentation at the 30 th European Hematology Association (EHA) 2025 Congress. The safety profile of this combination therapy showed cytokine release syndrome (CRS) being low grade and no discontinuations due to treatment-emergent adverse events (TEAEs). The most common TEAEs were neutropenia (74 percent), anemia (68 percent), and thrombocytopenia (68 percent). CRS occurred in 52 percent; all were low grade (1/2) and resolved. One patient had immune effector cell-associated neurotoxicity syndrome (ICANS; grade 1), which resolved. No clinical tumor lysis syndrome was observed. Infections occurred in 18 patients (58 percent); five (16 percent) had serious infections. There were no Grade 5 TEAEs. 'These results are particularly encouraging because many of the patients in this study had high-risk disease, having progressed rapidly after initial treatment,' said Raul Cordoba, MD, PhD, Head of the Lymphoma Unit at the Fundacion Jimenez Diaz University Hospital, Madrid, Spain. 'This combination therapy of epcoritamab plus rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) offers a potential new treatment option for patients with relapsed/refractory diffuse large B-cell lymphoma, providing high response rates and a bridge to potentially curative autologous stem cell transplantation." Among patients in the study who progressed within 12 months after first-line treatment (n=20), epcoritamab in combination with R-ICE demonstrated an 85 percent ORR and 55 percent CR. Patients in the study who progressed after 12 months from first-line therapy experienced a 91 percent ORR and 82 percent CR. Additionally, patients with one prior line of therapy experienced an 88 percent ORR and 68 percent CR, and patients who were treated with more than one prior line of therapy experienced an 83 percent ORR and 50 percent CR. 'The results from this trial highlight the potential of this investigational epcoritamab containing regimen, especially in patients who progress quickly after initial treatment, and reinforce our joint efforts with AbbVie to develop epcoritamab as a core therapy for B-cell lymphomas, especially as we develop epcoritamab in earlier lines of therapy and a broader patient population,' said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. 'Our comprehensive EPCORE clinical trial program is dedicated to advancing epcoritamab as both monotherapy and in combination to address the significant unmet need in relapsed/refractory diffuse large B-cell lymphoma and other hematologic malignancies." Use of epcoritamab + R-ICE in patients with R/R DLBCL eligible for ASCT is not approved and the safety and efficacy of epcoritamab for use as a combination therapy in DLBCL have not been established. About Diffuse Large B-Cell Lymphoma DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases. In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men. DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge. About the EPCORE ® NHL-2 Trial EPCORE NHL-2 is a Phase 1b/2 open-label interventional trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and in combination with other standard of care agents in patients with B-cell non-Hodgkin's lymphoma (B-NHL). The trial consists of two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The primary objective of Part 1 is safety, and the primary goal of Part 2 is preliminary efficacy. The primary endpoint was overall response rate (ORR) based on best overall response per Lugano criteria. MRD negativity was assessed as a secondary endpoint. Arm 10 of the EPCORE NHL-2 study enrolled 31 patients with R/R DLBCL, who were eligible for R-ICE and ASCT, and had received ≥1 prior line of treatment. At the time of data cutoff (December 18, 2024), median follow-up was 11 months (range, 6−15). Among the 31 patients treated with epcoritamab 48 mg + R-ICE, 61 percent were Ann Arbor stage III/IV, 42 percent had bulky disease ≥7 cm, 81 percent had one prior LOT (range, 1−3), and 65 percent had progressed within 12 months of first-line treatment. More information on this trial can be found at (NCT: 04663347). About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody ® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. i Epcoritamab (approved under the brand name EPKINLY ® in the U.S. and Japan, and TEPKINLY ® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Where approved, epcoritamab is available as a readily accessible therapy without the need for reducing tumor burden ('debulking'). Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with R2 compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit for more information. EPKINLY ® (epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Full Prescribing Information and Medication Guide, including Important Warnings. Globally, prescribing information varies; refer to the individual country product label for complete information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO ®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. This Media Release contains forward looking statements. The words 'believe,' 'expect,' 'anticipate,' 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ®; the Y-shaped Genmab logo ®; Genmab in combination with the Y-shaped Genmab logo ®; HuMax ®; DuoBody ®; HexaBody ®; DuoHexaBody ®, HexElect ® and KYSO™. EPCORE ®, EPKINLY ®, TEPKINLY ® and their designs are trademarks of AbbVie Biotechnology Ltd. i Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine
Yahoo
13-06-2025
- Business
- Yahoo
Biomea Fusion Presents Updated Preliminary Clinical Data for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia at EHA 2025
New clinical results show sustained CRi, deep bone marrow responses, and encouraging survival in FLT3-mutant AML patients, including those previously treated with gilteritinib REDWOOD CITY, Calif., June 13, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ('Biomea' or the 'Company') (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced updated preliminary clinical data from the ongoing Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory ('R/R') acute leukemia ('AL'). The results will be presented in a poster presentation at the European Hematology Association ('EHA') 2025 Congress in Milan, Italy. The presentation by Dr. Farhad Ravandi of The University of Texas MD Anderson Cancer Center will highlight emerging safety, pharmacokinetics/pharmacodynamics, and early clinical activity data for BMF-500, a highly selective covalent FMS-like tyrosine kinase 3 ('FLT3') inhibitor, in heavily pretreated patients with R/R AL. Key Results from the EHA 2025 Poster Presentation27 patients were enrolled across two study arms, Arm A (no CYP3A4 inhibitor; n=10) and Arm B (CYP3A4 inhibitor; n=17). All patients had R/R AL, with a median of 4 prior lines of therapy. 18 of the 27 patients were FLT3 mutations ('FLT3m') while the other 9 patients had FLT3 wild-type AL. Frequent co-mutations included WT1, TP53, IDH1/2, and NRAS. All 18 FLT3m patients had failed gilteritinib in the R/R setting and 9 of the 18 had received at least two FLT3 inhibitors prior to study entry. 26 of 27 (96%) enrolled patients had also received and failed the BCL2 inhibitor venetoclax. Key findings include: Clinical Activity Observed: 9 of 11 efficacy-evaluable FLT3m patients, defined as all patients enrolled who received at least one dose and had at least one disease assessment, showed bone marrow (BM) blast reduction; 5 of 11 achieved >50% BM blast reduction. 1 FLT3m patient achieved complete remission with incomplete hematologic recovery (CRi), sustained for 6 cycles. 1 FLT3m patient achieved morphologic leukemia-free state (MLFS); response is ongoing. 1 FLT3m patient met all criteria for partial response (PR) except platelet recovery; categorized as near PR. 2 of 4 efficacy-evaluable FLT3 wild-type patients achieved durable disease control ≥120 days, with treatment ongoing for one patient. Additional clinical improvements include reductions in peripheral blasts, transfusion dependency, and frequency of hydroxyurea use. Pharmacokinetics/Pharmacodynamics: FLT3 inhibition correlated with BMF-500 systemic exposures. Bone marrow and plasma concentrations of BMF-500 and its metabolites were comparable, suggesting good compartmental penetration. Survival: Median overall survival (mOS) among all treated FLT3m patients (n=18) was 3.8 months (Arm A) and 3.5 months (Arm B) during dose escalation. For the efficacy-evaluable FLT3m patients (n=12), the mOS for Arms A and B was 3.8 and 3.6 months, respectively during dose escalation. These survival durations compare favorably to historical mOS of 2.1 months in patients with R/R FLT3m acute myeloid leukemia ('AML') post-failure with both gilteritinib and venetoclax. 1 Ongoing Dose Escalation: Dose escalation continues at 200 mg BID (Arm A) and 75 mg BID (Arm B). Based on observed activity and tolerability, further evaluation is underway to determine optimal biologic dose ('OBD') and recommended Phase II dose ('RP2D'). Safety and Tolerability BMF-500 was generally well-tolerated across dose levels. No dose-limiting toxicities (DLTs), QT prolongation, or discontinuations due to treatment-related adverse events were reported. Escalation is ongoing without safety restrictions. 'The updated COVALENT-103 results continue to support the potential of BMF-500 as a selective, covalent FLT3 inhibitor,' said Mick Hitchcock, Ph.D., Interim Chief Executive Officer of Biomea Fusion. 'We are encouraged by the depth of bone marrow responses, the achievement of MLFS and CRi, and the early survival benefit in heavily pretreated patients with FLT3 mutations who had progressed following prior FLT3 inhibitor therapy. These data speak to BMF-500's potential to meaningfully improve outcomes in a high-risk AML population with no currently available treatment options.' Following completion of the COVALENT-103 dose escalation phase in R/R AL patients with FLT3m, Biomea plans to conclude its internal development of BMF-500 in oncology and is actively exploring strategic partnerships to advance the program. Poster Presentation Details Date/Time: Saturday, June 14 (18:30-19:30 CEST) Title: Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory (R/R) Acute Leukemia (AL): Preliminary Phase 1 Data from the COVALENT-103 Study (NCT05918692) Poster Number: PS1520 Presenter: Farhad Ravandi, M.D., University of Texas MD Anderson Cancer Center About COVALENT-103 COVALENT-103 is a multicenter, open-label, non-randomized trial seeking to evaluate the safety and efficacy of BMF-500, a twice daily oral treatment, in adult patients with R/R AL with FLT3 wild-type or FLT3m. The Phase I COVALENT-103 study aims to evaluate the safety and tolerability of BMF-500, determine the optimal biologic dose and recommended Phase II dose, and identify initial efficacy signals. Additional information about the Phase I clinical trial of BMF-500 can be found at using the identifier, NCT05918692. About BMF-500 BMF-500 is an investigational, orally bioavailable, covalent small molecule inhibitor of FLT3, discovered in-house using Biomea's proprietary FUSION™ System. Designed to be highly potent and selective, BMF-500 has demonstrated encouraging potential in extensive preclinical studies. Its kinase inhibitory profile indicates strong target selectivity, which may translate to a reduced risk of off-target effects. About Biomea FusionBiomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecules, icovamenib and BMF-650, both designed to significantly improve the lives of patients with diabetes, obesity, and other metabolic diseases. We aim to cure. Visit us at and follow us on LinkedIn, X, and Facebook. Forward-Looking Statements Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the 'Securities Act'), and Section 21E of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'). These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will,' and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including BMF-500, the potential of BMF-500 as a treatment for patients with FLT3m R/R AL, our research, development, partnership and regulatory plans, and the timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea's business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (SEC), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Reference: 1. Corley et al. (P1798) HemaSphere 2024;8(S1), 3339-3340. Contact: Meichiel Jennifer Weiss Sr. Director, Investor Relations and Corporate DevelopmentIR@
Yahoo
13-06-2025
- Business
- Yahoo
Data of InnoCare's Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress
BEIJING, June 13, 2025--(BUSINESS WIRE)--Latest data of InnoCare's (HKEX: 09969; SSE: 688428) robust oncology pipelines were presented at the ongoing European Hematology Association (EHA) 2025 Congress. Poster Presentation: 1. First Presentation of Efficacy and Safety Data for First-Line Treatment of CLL/SLL with BCL2 Inhibitor Mesutoclax in Combination with BTK Inhibitor Orelabrutinib (Abstract No.: PS1567) The study showed that mesutoclax (100 and 125 mg) in combination with orelabrutinib was safe and well tolerated in patients with treatment naïve (TN) CLL/SLL. Substantial efficacy was observed, with early high undetectable MRD (uMRD) rate. 42 patients with TN CLL/SLL were enrolled (mesutoclax 100 mg, n=21; 125 mg, n=21). The fixed-duration treatment of mesutoclax in combination with orelabrutinib is expected to deliver deeper remissions for TN CLL/SLL patients. In all patients, the overall response rate (ORR) was 97.6%. At week 24 of the combination therapy, in the 125 mg dose cohort, the overall response rate (ORR) was 100%, the complete remission rate (CRR) was 23.8%, the CRR in target lesions was 57.1%, and the peripheral blood (PB) uMRD rate was 48%. In the 100 mg mesutoclax dose cohort, the ORR was 95.2%, the CRR was 19.0%, the CRR in target lesions was 42.9%, and the PB uMRD rate was 19%. With the extension of the duration of treatment, the therapeutic efficacy is expected to be further improved. All patients are still on treatment. No disease progression or death occurred, and no adverse events leading to discontinuation of treatment were reported. Due to its favorable efficacy and safety profile, a registrational Phase III clinical study of mesutoclax (125 mg once daily) in combination with orelabrutinib for the treatment of TN CLL/SLL patients has been initiated, with patient enrollment being accelerated. 2. Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (Abstract No.: PF898) The absence of a standard first-line treatment for marginal zone lymphoma (MZL) have inspired the exploration of novel regimens. In recent years, Bruton's tyrosine kinase inhibitors (BTKis) have demonstrated durable responses with a favorable benefit-risk profile across all MZL subtypes in the relapsed/refractory setting. Orelabrutinib is a novel BTK inhibitor with higher selectivity and fewer off-target than other BTK inhibitors. Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance was effective and well-tolerated in untreated patients with MZL. The majority of patients presented with MALT lymphoma and had Ann Arbor stage II-IV disease. At the end of induction treatment, the overall response rate (ORR) was 100.0% among all enrolled patients. At the data cutoff, the median progression-free survival (PFS) and overall survival (OS) remained immature. No BTK inhibitor-related adverse events (AEs), such as atrial fibrillation or bleeding, were observed. 3. The Rationality, Efficacy and Safety of Orelabrutinib plus Obinutuzumab (O2) in Systemic Treatment-naïve Marginal Zone Lymphoma: A Prospective Cohort Study (Abstract No.: PS1902) The Orelabrutinib plus Obinutuzumab regimen had well rationality and demonstrated promising efficacy. Across the entire study and during the period of induction therapy, the best objective response rate (ORR) was 100%. 3 patients who achieved partial response (PR) after the induction therapy subsequently achieved complete response (CR) in the maintenance period. The 18-month progression-free survival (PFS) and overall survival (OS) rates were both 100%. 4. Ultra-low Dose Radiotherapy Combined with Orelabrutinib Improves the Complete Response Rate of Treatment for Localized Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma (Abstract No.: PS1901) The combination of ultra-low dose radiotherapy and orelabrutinib in the treatment of ocular adnexal extranodal marginal zone lymphoma (OA-EMZL) not only improves the effectiveness of treatment but also significantly reduces the toxic effects of radiotherapy, providing a new approach for the treatment of localized OA-EMZL. Of all the 17 patients who completed treatment, 16 patients achieved complete response (CR) and one patient achieved a partial response. Additionally, the lesions in the patients still undergoing treatment have shrunk compared to before treatment. 5. Orelabrutinib plus Bendamustine-Rituximab (OBR) versus Bendamustine-Rituximab (BR) in Transplant-ineligible, Intermediate- to High-risk Mantle Cell Lymphoma (MCL) (Abstract No.: PS1969) This open-label, randomized, multi-center study aims to compare the efficacy and safety of Orelabrutinib plus Bendamustine-Rituximab versus Bendamustine-Rituximab in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma (MCL) patients. Early data suggest that Orelabrutinib plus Bendamustine-Rituximab could reduce disease progression events compared to Bendamustine-Rituximab in high-risk MCL. Updated outcomes on efficacy, safety, and biomarker analysis will be reported. 6. Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma: Updated Results from a Phase II Study (Abstract No.: PF950) The results further support Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) as a potential treatment option for elderly patients with diffuse large B-cell lymphoma (DLBCL), demonstrating promising efficacy and acceptable safety, especially for those who responded to the Pomalidomide-Rituximab-Orelabrutinib (PRO) induction therapy. A total of 32 patients were enrolled in this study, of whom 26 patients completed ≥3 cycles of the PRO-miniCHOP, resulting in a complete response rate (CRR) of 65.4% and overall response rate (ORR) of 100.0%. Among the 21 patients who completed the full 6-cycle therapy with PRO-miniCHOP, both the CRR and ORR were 95.2%. At a median follow-up of 15.6 months, the median progression-free survival (PFS) and overall survival (OS) had not yet been reached, with the 2-year PFS and OS rates being 94.7% and 100.0%, respectively. 7. Orelabrutinib Addition to R-CHOP-like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL: Update Results of Orient Study (Abstract No.: PS1943) In non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL) patients who responded to orelabrutinib plus rituximab (OR) induction, orelabrutinib plus R-CHOP-like (OR-CHOP) exhibited favorable antitumor activity and manageable safety. Update results further support the orelabrutinib plus R-CHOP-like therapy as an option in this disease. At end of 6-cycle orelabrutinib plus R-CHOP-like, response (all 100%) was independent of double-expressing lymphoma (DEL), extranodal involvement (EI), and Lymphgen subtypes. No off-target-related cardiac toxicities occurred. 8. Primary Efficacy and Safety of First-line R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) followed by Autologous Hematopoietic Stem Cell Transplantation in PCNSL (Abstract No.: PF966) The Rituximab, Methotrexate, Thiotepa, and Orelabrutinib (R-MTO) induction treatment has demonstrated notable efficacy in achieving higher response rate among patients with newly diagnosed primary central nervous system lymphoma (PCNSL), with a manageable safety profile. At the data cutoff, all patients had completed four cycles of induction therapy, and the complete response (CR) rate and overall response rate (ORR) were 93.34% and 96.67%, respectively. The 12-month progression-free survival (PFS) and overall survival (OS) rates were 82.26% and 85.33%, respectively. 9. Orelabrutinib, Rituximab Combined with High-Dose Methotrexate as Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: PS1917) This study demonstrated the promising efficacy of the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate induction regimen in newly diagnosed primary central nervous system lymphoma (PCNSL), with encouraging response rates and durable progression-free survival (PFS). The regimen also showed promising overall survival (OS) trends, highlighting its potential as an effective treatment. Treatment-related adverse events (TRAEs) were manageable, and no severe BTK inhibitor-related off-target toxicities (e.g., atrial fibrillation/flutter) were observed. These findings suggest that the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate regimen is a well-tolerated and effective therapeutic option for PCNSL. Except the above poster presentations, more than 10 studies were also selected as poster presentations or online publications at the meeting. For more detailed clinical data, please refer to EHA website. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. View source version on Contacts Media Chunhua Investors 86-10-66609999ir@ 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
Business Wire
13-06-2025
- Health
- Business Wire
Data of InnoCare's Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress
BEIJING--(BUSINESS WIRE)--Latest data of InnoCare's (HKEX: 09969; SSE: 688428) robust oncology pipelines were presented at the ongoing European Hematology Association (EHA) 2025 Congress. First presentation of the efficacy and safety data for first-line treatment of CLL/SLL with BCL2 inhibitor Mesutoclax in combination with BTK inhibitor orelabrutinib Poster Presentation: 1. First Presentation of Efficacy and Safety Data for First-Line Treatment of CLL/SLL with BCL2 Inhibitor Mesutoclax in Combination with BTK Inhibitor Orelabrutinib (Abstract No.: PS1567) The study showed that mesutoclax (100 and 125 mg) in combination with orelabrutinib was safe and well tolerated in patients with treatment naïve (TN) CLL/SLL. Substantial efficacy was observed, with early high undetectable MRD (uMRD) rate. 42 patients with TN CLL/SLL were enrolled (mesutoclax 100 mg, n=21; 125 mg, n=21). The fixed-duration treatment of mesutoclax in combination with orelabrutinib is expected to deliver deeper remissions for TN CLL/SLL patients. In all patients, the overall response rate (ORR) was 97.6%. At week 24 of the combination therapy, in the 125 mg dose cohort, the overall response rate (ORR) was 100%, the complete remission rate (CRR) was 23.8%, the CRR in target lesions was 57.1%, and the peripheral blood (PB) uMRD rate was 48%. In the 100 mg mesutoclax dose cohort, the ORR was 95.2%, the CRR was 19.0%, the CRR in target lesions was 42.9%, and the PB uMRD rate was 19%. With the extension of the duration of treatment, the therapeutic efficacy is expected to be further improved. All patients are still on treatment. No disease progression or death occurred, and no adverse events leading to discontinuation of treatment were reported. Due to its favorable efficacy and safety profile, a registrational Phase III clinical study of mesutoclax (125 mg once daily) in combination with orelabrutinib for the treatment of TN CLL/SLL patients has been initiated, with patient enrollment being accelerated. 2. Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (Abstract No.: PF898) The absence of a standard first-line treatment for marginal zone lymphoma (MZL) have inspired the exploration of novel regimens. In recent years, Bruton's tyrosine kinase inhibitors (BTKis) have demonstrated durable responses with a favorable benefit-risk profile across all MZL subtypes in the relapsed/refractory setting. Orelabrutinib is a novel BTK inhibitor with higher selectivity and fewer off-target than other BTK inhibitors. Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance was effective and well-tolerated in untreated patients with MZL. The majority of patients presented with MALT lymphoma and had Ann Arbor stage II-IV disease. At the end of induction treatment, the overall response rate (ORR) was 100.0% among all enrolled patients. At the data cutoff, the median progression-free survival (PFS) and overall survival (OS) remained immature. No BTK inhibitor-related adverse events (AEs), such as atrial fibrillation or bleeding, were observed. 3. The Rationality, Efficacy and Safety of Orelabrutinib plus Obinutuzumab (O2) in Systemic Treatment-naïve Marginal Zone Lymphoma: A Prospective Cohort Study (Abstract No.: PS1902) The Orelabrutinib plus Obinutuzumab regimen had well rationality and demonstrated promising efficacy. Across the entire study and during the period of induction therapy, the best objective response rate (ORR) was 100%. 3 patients who achieved partial response (PR) after the induction therapy subsequently achieved complete response (CR) in the maintenance period. The 18-month progression-free survival (PFS) and overall survival (OS) rates were both 100%. 4. Ultra-low Dose Radiotherapy Combined with Orelabrutinib Improves the Complete Response Rate of Treatment for Localized Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma (Abstract No.: PS1901) The combination of ultra-low dose radiotherapy and orelabrutinib in the treatment of ocular adnexal extranodal marginal zone lymphoma (OA-EMZL) not only improves the effectiveness of treatment but also significantly reduces the toxic effects of radiotherapy, providing a new approach for the treatment of localized OA-EMZL. Of all the 17 patients who completed treatment, 16 patients achieved complete response (CR) and one patient achieved a partial response. Additionally, the lesions in the patients still undergoing treatment have shrunk compared to before treatment. 5. Orelabrutinib plus Bendamustine-Rituximab (OBR) versus Bendamustine-Rituximab (BR) in Transplant-ineligible, Intermediate- to High-risk Mantle Cell Lymphoma (MCL) (Abstract No.: PS1969) This open-label, randomized, multi-center study aims to compare the efficacy and safety of Orelabrutinib plus Bendamustine-Rituximab versus Bendamustine-Rituximab in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma (MCL) patients. Early data suggest that Orelabrutinib plus Bendamustine-Rituximab could reduce disease progression events compared to Bendamustine-Rituximab in high-risk MCL. Updated outcomes on efficacy, safety, and biomarker analysis will be reported. 6. Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma: Updated Results from a Phase II Study (Abstract No.: PF950) The results further support Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) as a potential treatment option for elderly patients with diffuse large B-cell lymphoma (DLBCL), demonstrating promising efficacy and acceptable safety, especially for those who responded to the Pomalidomide-Rituximab-Orelabrutinib (PRO) induction therapy. A total of 32 patients were enrolled in this study, of whom 26 patients completed ≥3 cycles of the PRO-miniCHOP, resulting in a complete response rate (CRR) of 65.4% and overall response rate (ORR) of 100.0%. Among the 21 patients who completed the full 6-cycle therapy with PRO-miniCHOP, both the CRR and ORR were 95.2%. At a median follow-up of 15.6 months, the median progression-free survival (PFS) and overall survival (OS) had not yet been reached, with the 2-year PFS and OS rates being 94.7% and 100.0%, respectively. 7. Orelabrutinib Addition to R-CHOP-like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL: Update Results of Orient Study (Abstract No.: PS1943) In non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL) patients who responded to orelabrutinib plus rituximab (OR) induction, orelabrutinib plus R-CHOP-like (OR-CHOP) exhibited favorable antitumor activity and manageable safety. Update results further support the orelabrutinib plus R-CHOP-like therapy as an option in this disease. At end of 6-cycle orelabrutinib plus R-CHOP-like, response (all 100%) was independent of double-expressing lymphoma (DEL), extranodal involvement (EI), and Lymphgen subtypes. No off-target-related cardiac toxicities occurred. 8. Primary Efficacy and Safety of First-line R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) followed by Autologous Hematopoietic Stem Cell Transplantation in PCNSL (Abstract No.: PF966) The Rituximab, Methotrexate, Thiotepa, and Orelabrutinib (R-MTO) induction treatment has demonstrated notable efficacy in achieving higher response rate among patients with newly diagnosed primary central nervous system lymphoma (PCNSL), with a manageable safety profile. At the data cutoff, all patients had completed four cycles of induction therapy, and the complete response (CR) rate and overall response rate (ORR) were 93.34% and 96.67%, respectively. The 12-month progression-free survival (PFS) and overall survival (OS) rates were 82.26% and 85.33%, respectively. 9. Orelabrutinib, Rituximab Combined with High-Dose Methotrexate as Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: PS1917) This study demonstrated the promising efficacy of the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate induction regimen in newly diagnosed primary central nervous system lymphoma (PCNSL), with encouraging response rates and durable progression-free survival (PFS). The regimen also showed promising overall survival (OS) trends, highlighting its potential as an effective treatment. Treatment-related adverse events (TRAEs) were manageable, and no severe BTK inhibitor-related off-target toxicities (e.g., atrial fibrillation/flutter) were observed. These findings suggest that the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate regimen is a well-tolerated and effective therapeutic option for PCNSL. Except the above poster presentations, more than 10 studies were also selected as poster presentations or online publications at the meeting. For more detailed clinical data, please refer to EHA website. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
