Latest news with #FGFR2b
Yahoo
8 hours ago
- Business
- Yahoo
Amgen (AMGN) Announces Positive Results for Phase 3 Study of Bemarituzumab
Amgen Inc. (NASDAQ:AMGN) is one of the . On June 30, Amgen Inc. (NASDAQ:AMGN) announced positive topline results for an important phase 3 study of Bemarituzumab for certain stomach cancers. The company announced that the Phase 3 FORTITUDE-101 trial met its primary endpoint. The Bemarituzumab plus chemotherapy significantly improved overall survival in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer with FGFR2b overexpression and who are non-HER2 positive. A pharmacist filling a prescription for a complex drug developed by the company. Gastric cancer is the fifth leading cause of cancer-related death globally, with nearly 1 million new cases and over 650,000 deaths each year. Bemarituzumab is a first-in-class, Fc-optimized monoclonal antibody that targets FGFR2b, a protein overexpressed in a subset of gastric cancers. Management noted that detailed results will be presented in future meetings, and a separate Phase 3 trial of Bemarituzumab plus chemotherapy and nivolumab is ongoing, with results expected in the second half of 2025. Amgen Inc. (NASDAQ:AMGN) is a biotechnology company that develops innovative medicines for serious diseases with limited treatments. While we acknowledge the potential of AMGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
6 days ago
- Business
- Yahoo
Amgen and Zai Lab's trial of gastric cancer therapy meets primary endpoint
Amgen and Zai Lab have reported that the Phase III FORTITUDE-101 trial, assessing bemarituzumab in combination with chemotherapy (mFOLFOX6), achieved its primary goal of overall survival (OS) in individuals with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer. The combo showed OS improvement against placebo with chemotherapy in G/GEJ patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression, defined as 2+/3+ staining in at least 10% of tumour cells, as well as those who are non-human epidermal growth factor receptor 2 (HER2) positive. The placebo-controlled, randomised, double-blind trial involved 547 subjects across 300 sites in 37 nations. It was designed to assess the combo as a first-line treatment for this patient group. Its primary outcome measure is OS in those with FGFR2b ≥10% 2+/3+ tumour cell staining. Key secondary outcome measures are overall response rate (ORR) and progression-free survival (PFS). Notably, the trial incorporated more extensive ocular-related monitoring than earlier bemarituzumab trials. Zai Lab, which holds joint development and commercialisation rights for the therapy in mainland China, Macau, Taiwan, and Hong Kong, supported the conduct of the FORTITUDE-101 trial. Bemarituzumab has also received breakthrough therapy designation from the China Center for Drug Evaluation for treating FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma. In addition to FORTITUDE-101, a Phase III trial of bemarituzumab with chemotherapy and nivolumab is underway for the first-line gastric cancer treatment, with data readout expected in the second half of 2025. Amgen research and development executive vice-president Jay Bradner said: "Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates, and limited therapeutic options. "These first positive top-line results of an FGFR2b targeted monoclonal antibody from our Phase III FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer." "Amgen and Zai Lab's trial of gastric cancer therapy meets primary endpoint" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
6 days ago
- Business
- Yahoo
Amgen and Zai Lab's trial of gastric cancer therapy meets primary endpoint
Amgen and Zai Lab have reported that the Phase III FORTITUDE-101 trial, assessing bemarituzumab in combination with chemotherapy (mFOLFOX6), achieved its primary goal of overall survival (OS) in individuals with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer. The combo showed OS improvement against placebo with chemotherapy in G/GEJ patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression, defined as 2+/3+ staining in at least 10% of tumour cells, as well as those who are non-human epidermal growth factor receptor 2 (HER2) positive. The placebo-controlled, randomised, double-blind trial involved 547 subjects across 300 sites in 37 nations. It was designed to assess the combo as a first-line treatment for this patient group. Its primary outcome measure is OS in those with FGFR2b ≥10% 2+/3+ tumour cell staining. Key secondary outcome measures are overall response rate (ORR) and progression-free survival (PFS). Notably, the trial incorporated more extensive ocular-related monitoring than earlier bemarituzumab trials. Zai Lab, which holds joint development and commercialisation rights for the therapy in mainland China, Macau, Taiwan, and Hong Kong, supported the conduct of the FORTITUDE-101 trial. Bemarituzumab has also received breakthrough therapy designation from the China Center for Drug Evaluation for treating FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma. In addition to FORTITUDE-101, a Phase III trial of bemarituzumab with chemotherapy and nivolumab is underway for the first-line gastric cancer treatment, with data readout expected in the second half of 2025. Amgen research and development executive vice-president Jay Bradner said: "Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates, and limited therapeutic options. "These first positive top-line results of an FGFR2b targeted monoclonal antibody from our Phase III FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer." "Amgen and Zai Lab's trial of gastric cancer therapy meets primary endpoint" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
7 days ago
- Business
- Yahoo
Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass., June 30, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing. Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year 1, highlighting a critical unmet medical need. In China, there are over 350,000 new cases each year. The disease is associated with a poor prognosis, particularly in advanced stages where the five-year survival rate is less than 10%. There are currently no approved therapies specifically targeting FGFR2b overexpression in gastric cancer in China. "Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible." The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm. Detailed results from the trial will be shared at a future medical meeting. Zai Lab holds the development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan. Bemarituzumab has been granted Breakthrough Therapy designation by the China Center for Drug Evaluation of the National Medical Products Administration for the treatment of FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma. A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with data readout anticipated in H2 2025. About FGFR2b The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation.2 The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC.3 About FORTITUDE-101 FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled. The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining. Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab. About Gastric Cancer in China Gastric cancer is the fifth most common cancer worldwide, while China bears one of the highest gastric cancer burdens in the world with an estimated 358,700 new cases and 260,400 deaths annually.4 In China, approximately 80% of gastric cancer patients are diagnosed at an advanced or metastatic stage5. For those diagnosed with Stage IV gastric cancer, the overall 5-year survival rate is less than 10%6. Patients with advanced gastric and GEJ cancer that overexpress the FGFR2b protein may be associated with poor prognosis7-10. About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding the prospects and plans for developing and commercializing bemarituzumab, the potential benefits of bemarituzumab, and the potential treatment of gastric and gastroesophageal junction cancer. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at REFERENCES Bray F, et al. CA Cancer J Clin. 2024;74(3);229-263 Wainberg ZA, et al. Lancet Oncol. 2022;23(11):1430-40 Rha SY, et al. JCO Precis Oncol. 2025; 9 (e2400710). DOI:10.1200/PO-24-00710 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. Health Commission of The People's Republic Of China N. National guidelines for diagnosis and treatment of gastric cancer 2022 in China (English version). Chin J Cancer Res. 2022;34(3):207-237. Li HQ, Zhang H, Zhang HJ, Wang YX, Wang XB, Hou HF. Survival of gastric cancer in China from 2000 to 2022: A nationwide systematic review of hospital-based studies. J Glob Health 2022;12:11014. Catenacci D, et al. Presented at American Society of Clinical Oncology; June 4-8, 2021; Online Virtual Scientific Program. Abstract 4010. Ahn S, et al. Mod Pathol. 2016;29:1095-1103. Ishiwata T. Front Biosci (Landmark Ed). 2018;23:626-639. Wainberg ZA, et al. Lancet Oncol. 2022;23:1430-1440. View source version on Contacts For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 / Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 / 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
7 days ago
- Business
- Yahoo
Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass., June 30, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing. Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year 1, highlighting a critical unmet medical need. In China, there are over 350,000 new cases each year. The disease is associated with a poor prognosis, particularly in advanced stages where the five-year survival rate is less than 10%. There are currently no approved therapies specifically targeting FGFR2b overexpression in gastric cancer in China. "Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible." The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm. Detailed results from the trial will be shared at a future medical meeting. Zai Lab holds the development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan. Bemarituzumab has been granted Breakthrough Therapy designation by the China Center for Drug Evaluation of the National Medical Products Administration for the treatment of FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma. A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with data readout anticipated in H2 2025. About FGFR2b The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation.2 The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC.3 About FORTITUDE-101 FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled. The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining. Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab. About Gastric Cancer in China Gastric cancer is the fifth most common cancer worldwide, while China bears one of the highest gastric cancer burdens in the world with an estimated 358,700 new cases and 260,400 deaths annually.4 In China, approximately 80% of gastric cancer patients are diagnosed at an advanced or metastatic stage5. For those diagnosed with Stage IV gastric cancer, the overall 5-year survival rate is less than 10%6. Patients with advanced gastric and GEJ cancer that overexpress the FGFR2b protein may be associated with poor prognosis7-10. About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding the prospects and plans for developing and commercializing bemarituzumab, the potential benefits of bemarituzumab, and the potential treatment of gastric and gastroesophageal junction cancer. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at REFERENCES Bray F, et al. CA Cancer J Clin. 2024;74(3);229-263 Wainberg ZA, et al. Lancet Oncol. 2022;23(11):1430-40 Rha SY, et al. JCO Precis Oncol. 2025; 9 (e2400710). DOI:10.1200/PO-24-00710 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. Health Commission of The People's Republic Of China N. National guidelines for diagnosis and treatment of gastric cancer 2022 in China (English version). Chin J Cancer Res. 2022;34(3):207-237. Li HQ, Zhang H, Zhang HJ, Wang YX, Wang XB, Hou HF. Survival of gastric cancer in China from 2000 to 2022: A nationwide systematic review of hospital-based studies. J Glob Health 2022;12:11014. Catenacci D, et al. Presented at American Society of Clinical Oncology; June 4-8, 2021; Online Virtual Scientific Program. Abstract 4010. Ahn S, et al. Mod Pathol. 2016;29:1095-1103. Ishiwata T. Front Biosci (Landmark Ed). 2018;23:626-639. Wainberg ZA, et al. Lancet Oncol. 2022;23:1430-1440. View source version on Contacts For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 / Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 / 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
