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Business Wire
01-07-2025
- Business
- Business Wire
Novocure to Present Final Secondary Endpoint Data from the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) in Pancreatic Cancer at the ESMO Gastrointestinal Cancers Congress 2025
BAAR, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) announced today that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer. These data from PANOVA-3 were accepted as a late-breaking abstract for oral presentation at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025, taking place July 2 to July 5 in Barcelona, Spain. 'In the PANOVA-3 trial, there was a significant improvement in overall survival and a significant delay in the progression of pain as well as delayed opioid medication use in patients treated with Tumor Treating Fields and chemotherapy compared to chemotherapy alone. Pancreatic cancer is associated with debilitating pain. Delaying these symptoms can preserve a patient's overall quality of life, a promising outcome we observed in this trial,' said Teresa Macarulla, MD, PhD, Medical Oncologist at Hospital Universitari Vall d'Hebron and Head of the Gastrointestinal and Endocrine Tumors Group at the Vall d'Hebron Institute of Oncology (VHIO). 'The overall survival and quality of life results in PANOVA-3 support Tumor Treating Fields therapy with gemcitabine and nab-paclitaxel as a potential standard of care for unresectable, locally advanced pancreatic cancer.' The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. 'The PANOVA-3 results illustrate that Tumor Treating Fields therapy can significantly improve clinical outcomes for patients, including overall survival, in unresectable, locally advanced pancreatic cancer,' said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. 'These new data show that Tumor Treating Fields therapy can also have a meaningful impact preserving patients' quality of life by delaying worsening symptoms of pancreatic cancer. We look forward to submitting a premarket application for Tumor Treating Fields therapy to the FDA in the second half of 2025.' Results from PANOVA-3 The primary endpoint of overall survival and several secondary endpoints, including pain-free survival, from PANOVA-3 were previously reported at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The additional secondary endpoint data to be presented at the ESMO Gastrointestinal Cancers Congress 2025 are the full quality of life outcomes as well as a post-hoc analysis of the time to first opioid use. The quality of life outcomes were measured using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum scales. The EORTC QLQ-C30 and the PAN26 measure global health status and function as well as symptoms including pain (irrespective of cause), pancreatic pain, and gastrointestinal symptoms. There was a statistically significant delay in the time to deterioration in global health status for patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.7 months, respectively, p=0.023. The delay in time to deterioration due to pain (irrespective of cause) was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median 10.1 months compared to 7.4 months, respectively, p=0.003. Similarly, the delay in time to deterioration due to pancreatic pain was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 14.7 months compared to 10.2 months, respectively, p=0.006. These results complement the statistically significant extension in pain-free survival reported at the 2025 ASCO Annual Meeting, which was defined as the time between randomization until a ≥20-point increase of pain using a visual analog scale (VAS) from baseline or death. Patients treated with TTFields concomitant with GnP had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with GnP alone; HR 0.74 (95% CI: 0.56–0.97) p=0.027. All gastrointestinal symptom scales included in the EORTC QLQ-C30 and PAN26, except for indigestion and altered bowel habit, significantly favored patients treated with TTFields concomitant with GnP. In a post-hoc analysis, time to first opioid use was significantly longer with TTFields and GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.4 months, respectively, p=0.046. TTFields therapy was well-tolerated, no new safety signals were observed, and device related safety outcomes were consistent with prior clinical studies using TTFields. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. The company will also present two posters of preclinical data from its pancreatic cancer development program. Data Presentation Details Oral Presentation: Late Breaking Abstract #LBA3: PANOVA-3: Pain and quality of life (QoL) outcomes with Tumor Treating Fields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LAPC) Presenting Author: Teresa Macarulla, MD, PhD, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Spain Time and Location: July 3, 2:10 PM CEST / 8:10 AM EDT, Barcelona Room Poster #311P: Effectiveness of tumor treating fields (TTFields) together with gemcitabine and nab-paclitaxel in pancreatic ductal adenocarcinoma (PDAC) preclinical models Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area Poster #316P: Pancreatic cancer cells are sensitized to FOLFIRINOX treatment by co-application with tumor treating fields (TTFields) Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area About PANOVA-3 PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity. The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months. About Pancreatic Cancer Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. i and the fifth most frequent cause in Europe. ii While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing. iii It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S. iv and the global incidence is more than 500,000. v Pancreatic cancer has a five-year relative survival rate of just 13%. vi Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation. Unfortunately, most locally advanced cases are diagnosed when the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option. About Tumor Treating Fields Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit and follow @Novocure on LinkedIn and Twitter. Forward-Looking Statements In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as 'anticipate,' 'estimate,' 'expect,' 'project,' 'intend,' 'plan,' 'believe' or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. ii International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. Accessed June 24, 2025. v International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. Accessed June 24, 2025. vi American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025
Yahoo
15-05-2025
- Business
- Yahoo
Agenus Announces New Data from Expanded MSS Metastatic Colorectal Cancer Cohort to be Presented at ESMO GI 2025
Presenting new data in the most mature readout to date, with 60% more patients and reported median and 2-year overall survival. LEXINGTON, Mass., May 15, 2025--(BUSINESS WIRE)--Agenus Inc. ("Agenus" or the Company") (NASDAQ: AGEN), a leader in immuno-oncology, today announced new data from its ongoing Phase 1 trial evaluating botensilimab and balstilimab (BOT/BAL) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) at the 2025 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress in Barcelona, Spain. A poster presentation will feature updated findings from an expanded cohort of 123 patients, incorporating additional participants and extended follow-up to further assess clinical activity of the combination, including durability of response and overall survival (NCT03860272). Presentation Details: Presentation: Botensilimab plus balstilimab in an expanded cohort of 123 patients with metastatic microsatellite stable colorectal cancer and no active liver metastases Presenting Author: Dr. Benjamin Schlechter, Dana Farber Cancer Institute Poster Number: 8P Session Date and Time: 7/4/2025, 3:30 PM – 4:30 PM CEST (9:30 AM – 10:30 AM EDT) About Botensilimab (BOT) Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," "establish," "potential," "superiority," "best in class," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. View source version on Contacts Investors 917-362-1370investor@ Media 781-674-4422communications@ 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
13-05-2025
- Business
- Yahoo
Ten-Year APHINITY Data Show Genentech's Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer
– Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy – – 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease – – Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress – SOUTH SAN FRANCISCO, Calif., May 13, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. "Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "These long-term data reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting." "After ten years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY study chair, chair of the German Breast Group (GBG) and the chief executive officer of the GBG Forschungs GmbH. "Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence." After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044). A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97). The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses. No benefit was seen in the node negative subgroup. The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified. Full results will be presented as a late-breaking abstract on Thursday, May 15 at the 2025 European Society for Medical Oncology Breast Cancer Congress. "The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings," said Liz Frank, independent research advocate. "Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring." The collaborative efforts of Genentech, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer. About the APHINITY study APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer. The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment. Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life. What is Perjeta? Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and chemotherapy for: Use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer Use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer. Important Safety Information What are the possible side effects of Perjeta? Perjeta may cause serious side effects, including: Perjeta can cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure) Your doctor will run tests to monitor your heart function before and during treatment Based on these tests, your treatment may be interrupted or discontinued Contact a health care professional immediately if you experience any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects. Your doctor will verify your pregnancy status before treatment begins Birth control should be used while receiving Perjeta and for 7 months after your last dose of Perjeta. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping Perjeta If you think you may be pregnant, you should contact your healthcare provider immediately If you are exposed to Perjeta during pregnancy, or become pregnant while receiving Perjeta or within 7 months following the last dose of Perjeta with Herceptin, you are encouraged to report Perjeta exposure to Genentech at 1-888-835-2555 Who should not take Perjeta? Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta. What are other possible serious side effects of Perjeta? Serious side effects of Perjeta may also include: Infusion-related reactions: Perjeta is given as an infusion. Perjeta can cause serious infusion-related reactions, some fatal. When given alone, the most common infusion-related reactions were fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting. When given with Herceptin and docetaxel, the most common infusion-related reactions were fatigue, altered taste, hypersensitivity, muscle pain, and vomiting Severe allergic reactions: Perjeta can cause hypersensitivity reactions, including anaphylaxis and fatal events. Contact a health care professional immediately if you experience any of the following symptoms: swelling of the face, lips or tongue, trouble breathing, or chest pains The most common side effects of Perjeta include: The most common side effects of Perjeta when given with Herceptin and chemotherapy prior to surgery for early breast cancer include: Constipation Damage to the nerves (numbness, tingling, pain in hands/feet) Diarrhea Fatigue Hair loss Headache Decreased red blood cell counts, white blood cell counts, and platelet counts Mouth sores or blisters Nausea Muscle pain Vomiting Weakness The most common side effects of Perjeta when given with Herceptin and chemotherapy after surgery for early breast cancer include: Diarrhea Nausea Hair loss Fatigue Damage to the nerves (numbness, tingling, pain in hands/feet) Vomiting The most common side effects of Perjeta when given with Herceptin and docetaxel for metastatic breast cancer include: Diarrhea Hair loss Low levels of white blood cells with or without fever Nausea Fatigue Rash Damage to the nerves (numbness, tingling, pain in hands/feet) Side effects may vary based on chemotherapy regimen. These are not all the possible side effects of Perjeta. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Before you take Perjeta, tell your healthcare provider about all of your medical conditions, including if you: Have a history of heart disease Are pregnant or plan to become pregnant. Perjeta can harm your unborn baby Are breastfeeding or plan to breastfeed. It is not known if Perjeta passes into your breastmilk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see the full Prescribing Information for additional Important Safety Information, including most serious side effects. What is Herceptin? Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways: As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→ TH." With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH." Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy). Patients are selected for therapy based on an FDA-approved test for Herceptin. *High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3. Important Safety Information Possible serious side effects with Herceptin Not all people have serious side effects, but side effects with Herceptin therapy are common. Although some people may have a life-threatening side effect, most do not. A patient's doctor will stop treatment if any serious side effects occur. Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following: HEART PROBLEMS These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient's doctor will check for signs of heart problems before, during, and after treatment with Herceptin. INFUSION REACTIONS, including: Fever and chills Feeling sick to your stomach (nausea) Throwing up (vomiting) Pain (in some cases at tumor sites) Headache Dizziness Shortness of breath These signs usually happen within 24 hours after receiving Herceptin. A patient should be sure to contact their doctor if they: Are a woman who could become pregnant, or may be pregnant Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for 7 months after your last dose of Herceptin. If you are or become pregnant while receiving Herceptin or within 7 months after your last dose of Herceptin, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555. Have any signs of SEVERE LUNG PROBLEMS, including: Severe shortness of breath Fluid in or around the lungs Weakening of the valve between the heart and the lungs Not enough oxygen in the body Swelling of the lungs Scarring of the lungs A patient's doctor may check for signs of severe lung problems when he or she examines the patient. Have LOW WHITE BLOOD CELL COUNTS Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone. A patient's doctor may check for signs of low white blood cell counts when he or she examines the patient. Side effects seen most often with Herceptin Some patients receiving Herceptin for breast cancer had the following side effects: Fever Feeling sick to your stomach (nausea) Throwing up (vomiting) Infusion reactions Diarrhea Infections Increased cough Headache Feeling tired Shortness of breath Rash Low white and red blood cell counts Muscle pain A patient should contact their doctor immediately if they have any of the side effects listed above. Patients are encouraged to report side effects to Genentech and the FDA. You may report side effects to FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Please see the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. 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 Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit All trademarks used or mentioned in this release are protected by law. View source version on Contacts Media Contact:Nicole Burkart, (650) 467-6800 Advocacy Contact:Julie Burns, (860) 881-6594 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41616875284 Sign in to access your portfolio
Yahoo
13-05-2025
- Business
- Yahoo
Ten-year APHINITY data show Roche's Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer
Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy1 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease1 Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress Basel, 13 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer.1 After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.1 'Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen,' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'These long-term data reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting.' "After 10 years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY Study Chair, Chair of the German Breast Group (GBG) and the Chief Executive Officer of the GBG Forschungs GmbH. 'Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph-node positive disease who are at high risk of recurrence.' After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044).1 A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97).1 The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses.1,2 No benefit was seen in the node negative subgroup.1 The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified.1,2 Full results will be presented as a late-breaking abstract on Thursday, 15 May at the 2025 European Society for Medical Oncology Breast Cancer Congress. 'The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings,' said Liz Frank, Independent Research Advocate. 'Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring.' The collaborative efforts of Roche, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer.3 About the APHINITY studyAPHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer.4 The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment.4 Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life.4 About the Perjeta-based regimen (intravenous (IV) Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy)The Perjeta-based regimen is approved in more than 120 countries/regions for the treatment of both early-stage and metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In the neoadjuvant (before surgery) early-stage breast cancer setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy.5 Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) early-stage breast cancer setting.6 In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.7 Phesgo® – a subcutaneous fixed-dose combination of Perjeta and Herceptin – is also approved in more than 120 countries/regions and provides faster and more flexible administration of Perjeta and Herceptin under the skin in approximately eight minutes, compared to hours with standard IV administration.8,9 The European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended updating Phesgo's label in the European Union to allow administration outside of a clinical setting (such as in a person's home) by a healthcare professional, which can help to alleviate treatment burden and free up cancer care capacity in clinics.10 About Roche's medicines for human epidermal growth factor receptor 2 (HER2)-positive breast cancerRoche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early-stage and advanced HER2-positive disease. HER2-positive breast cancer affects approximately 15-20% of people with breast cancer.11 Survival outcomes for people with HER2-positive breast cancer, once seen as an aggressive type of the disease, have been transformed through the development of targeted therapies, including Roche molecules Herceptin® (trastuzumab), Perjeta® (pertuzumab), Kadcyla® (trastuzumab emtansine) and Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous).12,13 Long-term survival is now a possibility for many people, which also contributes to societal and economic benefits.14 Eligibility for treatment with Roche's HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease. About Roche in breast cancerOur medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by Loibl S, et al. Adjuvant pertuzumab or placebo + trastuzumab + chemotherapy (P or Pla + T + CT) in patients (pts) with early HER2-positive operable breast cancer in APHINITY: Final analysis at 11.3 years' median follow-up. Presented at: ESMO Breast Cancer; 2025 May 14-17; Munich, Germany. Abstract #LBA1.[2] Loibl S, et al. VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up. Annals of Oncology. 2022;33(9):986-987.[3] National Comprehensive Cancer Network (NCCN). NCNN Guidelines Insights [Internet; cited 2025 May]. Available from: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY) [Internet; cited May 2025]. Available from: Gianni L, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25-32.[6] Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377(2):122-131.[7] Swain M, et al. Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2015;372(8):724-734.[8] PHESGO pertuzumab/trastuzumab/hyaluronidase-zzxf. Recommended dosing and administration for PHESGO [Internet; cited 2025 May]. Available from: Perjeta pertuzumab. Early Breast Cancer Treatment. The infusion process [Internet; cited 2025 May]. Available from: O'Shaughnessy J, et al. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. Eur J Cancer. 2021;152:223-232.[11] Ban M, et al. Early HER2-positive breast cancer: current treatment and novel approaches. Breast Care. 2020;15(6):560-569.[12] Ligorio F, et al. Prognostic impact of body mass index (BMI) in HER2+ breast cancer treated with anti-HER2 therapies: from preclinical rationale to clinical implications. Ther Adv Med Oncol. 2022;14(1):17588359221079123.[13] Mendes D, et al. The benefit of HER2-targeted therapies on overall survival of patients with metastatic HER2-positive breast cancer–a systematic review. Breast Cancer Research. 2015;17:140.[14] WifOR Institute. The Value of Investing in Innovative Medicines: Socioeconomic Burden and Annual Social Impact of Roche Treatments for HER2+ Breast Cancer, Multiple Sclerosis and Retinal Disease [Internet; cited 2025 May]. Available from: Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: Attachment 13052025_APHINITY Perjeta_enError 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
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Ten-Year APHINITY Data Show Genentech's Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer
– Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy – – 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease – – Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress – SOUTH SAN FRANCISCO, Calif., May 13, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. "Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "These long-term data reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting." "After ten years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY study chair, chair of the German Breast Group (GBG) and the chief executive officer of the GBG Forschungs GmbH. "Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence." After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044). A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97). The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses. No benefit was seen in the node negative subgroup. The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified. Full results will be presented as a late-breaking abstract on Thursday, May 15 at the 2025 European Society for Medical Oncology Breast Cancer Congress. "The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings," said Liz Frank, independent research advocate. "Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring." The collaborative efforts of Genentech, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer. About the APHINITY study APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer. The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment. Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life. What is Perjeta? Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and chemotherapy for: Use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer Use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back Perjeta® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer. Important Safety Information What are the possible side effects of Perjeta? Perjeta may cause serious side effects, including: Perjeta can cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure) Your doctor will run tests to monitor your heart function before and during treatment Based on these tests, your treatment may be interrupted or discontinued Contact a health care professional immediately if you experience any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects. Your doctor will verify your pregnancy status before treatment begins Birth control should be used while receiving Perjeta and for 7 months after your last dose of Perjeta. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping Perjeta If you think you may be pregnant, you should contact your healthcare provider immediately If you are exposed to Perjeta during pregnancy, or become pregnant while receiving Perjeta or within 7 months following the last dose of Perjeta with Herceptin, you are encouraged to report Perjeta exposure to Genentech at 1-888-835-2555 Who should not take Perjeta? Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta. What are other possible serious side effects of Perjeta? Serious side effects of Perjeta may also include: Infusion-related reactions: Perjeta is given as an infusion. Perjeta can cause serious infusion-related reactions, some fatal. When given alone, the most common infusion-related reactions were fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting. When given with Herceptin and docetaxel, the most common infusion-related reactions were fatigue, altered taste, hypersensitivity, muscle pain, and vomiting Severe allergic reactions: Perjeta can cause hypersensitivity reactions, including anaphylaxis and fatal events. Contact a health care professional immediately if you experience any of the following symptoms: swelling of the face, lips or tongue, trouble breathing, or chest pains The most common side effects of Perjeta include: The most common side effects of Perjeta when given with Herceptin and chemotherapy prior to surgery for early breast cancer include: Constipation Damage to the nerves (numbness, tingling, pain in hands/feet) Diarrhea Fatigue Hair loss Headache Decreased red blood cell counts, white blood cell counts, and platelet counts Mouth sores or blisters Nausea Muscle pain Vomiting Weakness The most common side effects of Perjeta when given with Herceptin and chemotherapy after surgery for early breast cancer include: Diarrhea Nausea Hair loss Fatigue Damage to the nerves (numbness, tingling, pain in hands/feet) Vomiting The most common side effects of Perjeta when given with Herceptin and docetaxel for metastatic breast cancer include: Diarrhea Hair loss Low levels of white blood cells with or without fever Nausea Fatigue Rash Damage to the nerves (numbness, tingling, pain in hands/feet) Side effects may vary based on chemotherapy regimen. These are not all the possible side effects of Perjeta. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Before you take Perjeta, tell your healthcare provider about all of your medical conditions, including if you: Have a history of heart disease Are pregnant or plan to become pregnant. Perjeta can harm your unborn baby Are breastfeeding or plan to breastfeed. It is not known if Perjeta passes into your breastmilk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see the full Prescribing Information for additional Important Safety Information, including most serious side effects. What is Herceptin? Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways: As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→ TH." With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH." Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy). Patients are selected for therapy based on an FDA-approved test for Herceptin. *High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3. Important Safety Information Possible serious side effects with Herceptin Not all people have serious side effects, but side effects with Herceptin therapy are common. Although some people may have a life-threatening side effect, most do not. A patient's doctor will stop treatment if any serious side effects occur. Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following: HEART PROBLEMS These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient's doctor will check for signs of heart problems before, during, and after treatment with Herceptin. INFUSION REACTIONS, including: Fever and chills Feeling sick to your stomach (nausea) Throwing up (vomiting) Pain (in some cases at tumor sites) Headache Dizziness Shortness of breath These signs usually happen within 24 hours after receiving Herceptin. A patient should be sure to contact their doctor if they: Are a woman who could become pregnant, or may be pregnant Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for 7 months after your last dose of Herceptin. If you are or become pregnant while receiving Herceptin or within 7 months after your last dose of Herceptin, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555. Have any signs of SEVERE LUNG PROBLEMS, including: Severe shortness of breath Fluid in or around the lungs Weakening of the valve between the heart and the lungs Not enough oxygen in the body Swelling of the lungs Scarring of the lungs A patient's doctor may check for signs of severe lung problems when he or she examines the patient. Have LOW WHITE BLOOD CELL COUNTS Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone. A patient's doctor may check for signs of low white blood cell counts when he or she examines the patient. Side effects seen most often with Herceptin Some patients receiving Herceptin for breast cancer had the following side effects: Fever Feeling sick to your stomach (nausea) Throwing up (vomiting) Infusion reactions Diarrhea Infections Increased cough Headache Feeling tired Shortness of breath Rash Low white and red blood cell counts Muscle pain A patient should contact their doctor immediately if they have any of the side effects listed above. Patients are encouraged to report side effects to Genentech and the FDA. You may report side effects to FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-877-436-3683. Please see the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. 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 Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit All trademarks used or mentioned in this release are protected by law. View source version on Contacts Media Contact:Nicole Burkart, (650) 467-6800 Advocacy Contact:Julie Burns, (860) 881-6594 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41616875284
