RegulationOrphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Orphan Drug (Australia), Special Review Project (China)

Structure/Sequence

Sequence Code 9823266H

Source: *****

Sequence Code 9823293L

Source: *****

Clinical Trials associated with Bemarituzumab

NCT06978062

/ Not yet recruitingPhase 1IIT

An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)

This is an open-label,multi-centre, phase 1b safety and feasibility study aiming to assess the safey and feasibility of bemarituzumab plus chemiotherapy (FLOT) for the peri-operative treatment of resectable gastroesophageal cancer. Following this neo-adjuvant part, patients should undergo surgery. Following surgery, patients will receive FLOT chemotherapy in combination with bemarituzumab. Imaging will be performed every 3 months for the first 2 years and thereafter every 6 months as per standard of care.

Start Date20 Feb 2026

Sponsor / Collaborator

EORTC

NCT06967987

/ Not yet recruitingPhase 2IIT

Open-label Non-randomized Multicentric Phase 2 Study Evaluating the Combination of Bemarituzumab + FLOT Chemotherapy in Perioperative Setting for Resectable Stage cT2-T4a or N+ Gastric and GEJ Adenocarcinoma Overexpressing FGFR2b

Gastric and gastro-oesophageal junction (GEJ) adenocarcinomas rank as the fifth leading cause of cancer globally. The standard treatment for resectable non-metastatic cT2-T4NX gastric or GEJ adenocarcinoma is perioperative FLOT chemotherapy. In the FLOT4 trial, which included 55% of GEJ and 45% of gastric tumours, the FLOT chemotherapy regimen improved both disease-free survival and overall survival compared to the ECF/ECX regimen. The median overall survival was 50 months, and median disease-free survival was 30 months for the FLOT experimental arm. About 16% of patients achieved a pathological complete regression (TRG1a) in the modified ITT population treated by FLOT. For GEJ adenocarcinoma, the ESOPEC trial has recently demonstrated the superiority of FLOT regimen compared to radiochemotherapy (CROSS regimen) [ median overall survival 66 months for FLOT regimen vs 37months [HR 0.7 95% IC (0.53-0.92) p= 0.012].
Genomic analyses of gastric and GEJ adenocarcinomas conducted by the Cancer Genome Network Atlas have identified four distinct subtypes of tumours based on their gene expression profile. These subtypes include tumours positive for Epstein-Barr virus, microsatellite unstable tumours, genomically stable tumours, and tumours with chromosomal instability. This research has identified oncogenic driver alterations, leading to new targeted therapies and therapeutic strategies.
HER2 amplification and MSI status are current targets for targeted therapies with anti-HER2 antibodies and Immune Checkpoint Inhibitors (ICI), respectively. Trials using these therapies in perioperative settings are ongoing with promising preliminary results. However, targeted therapies are not currently available in the non-metastatic setting.
The overexpression of Fibroblast Growth Factor Receptor 2 (FGFR2) is a frequent molecular alteration in gastric and GEJ tumours, presenting a potential new therapeutic target. FGFR2b overexpression is associated with poor prognosis and can be detected through pre-screening by immunohistochemistry. Bemarituzumab, a monoclonal antibody specific to the splice-variant FGFR2b, has shown promising results in combination with chemotherapy in phase 2 trials.
Based on the frequency of FGFR2b overexpression, the tolerability of combination therapy with chemotherapy, and the need to improve survival rates for gastric and GEJ cancer patients, it is proposed to test the efficacy of the combination of FLOT chemotherapy and bemarituzumab in the perioperative setting for c T2-T4a or N+ gastric or GEJ adenocarcinoma MSS and overexpressing FGFR2b.

Start Date30 Dec 2025

Sponsor / Collaborator

Institut de Cancerologie de L Ouest

[+1]

NCT06680622

/ RecruitingPhase 2

Bemarituzumab in Patients With FGFR2b-positive Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy - The IKF-AIO Phase IIa BEMARA Trial

The goal of this clinical trial is to evaluate if bemarituzumab in combination with different standard of care chemotherapies enhance tumor response in patients with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. The main questions are:
How do patients respond to these treatments? How is the overall and the progression-free survival rate with these treatments? How is the disease control rate with these treatments? How long is the duration of response and disease stabilization with these treatments? How is the safety with these treatments? How is the quality of life with these treatments?
Patients will be allocated to one of three possible treatment cohorts according to investigator's decision and current standard of care:
Bemarituzumab with cohort 1: irinotecan cohort 2: paclitaxel plus ramucirumab cohort 3: trifluridine/tipiracil

Start Date03 Mar 2025

Sponsor / Collaborator

Amgen, Inc.

[+2]

100 Clinical Results associated with Bemarituzumab

100 Translational Medicine associated with Bemarituzumab

100 Patents (Medical) associated with Bemarituzumab

Literatures (Medical) associated with Bemarituzumab

01 Sep 2025·CANCER TREATMENT REVIEWS

FGFR2b protein overexpression: An emerging biomarker in gastric and gastroesophageal junction adenocarcinoma

Review

Author: Wainberg, Zev A ; Rha, Sun Young ; Sommermann, Erica ; Honeycutt, Hayden ; Ochiai, Atsushi ; Smyth, Elizabeth C ; Kim, Kyoung-Mee

Gastric and gastroesophageal junction cancer (G/GEJC) is a heterogeneous and complex disease characterized by histologic and molecular subtypes. Although a growing number of treatments have improved survival outcomes in the advanced setting, the greatest therapeutic benefits are observed among patient populations eligible for biomarker-directed therapies. Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) is an emerging biomarker under phase 3 clinical investigation for G/GEJC with the novel monoclonal antibody bemarituzumab. FGFR2b protein overexpression in gastric cancer, together with its function in various oncogenic signaling pathways, makes it an attractive target for precision medicine and thereby has gained clinical interest for its potential prognostic role in G/GEJC. Thus, to explore the potential role of FGFR2b, this narrative review summarizes the role and mechanism of FGFR2b in advanced G/GEJC, describes appropriate detection methodology for FGFR2b protein overexpression, and discusses future considerations for precision treatment in advanced G/GEJC with respect to FGFR2b protein overexpression and the emergence of other biomarkers.

01 Jul 2025·Gastric Cancer

Low positivity rate of fibroblast growth factor receptor 2b is associated with heterogeneous expression in gastric cancer

Article

Author: Ahn, Ji Yong ; Lee, In-Seob ; Lee, Hyungeun ; Kim, Hyung-Don ; Lee, Heonwoo ; Ryu, Min-Hee ; Park, Young Soo ; Lee, Jeong Hoon

BACKGROUND:

Bemarituzumab, a monoclonal antibody targeting fibroblast growth factor receptor 2b (FGFR2b), is under evaluation in phase 3 trials of gastric cancer (GC) trials. However, data on the characteristics, prognostic significance, and heterogenous expression patterns of FGFR2b overexpression in GC remain limited. Therefore, this study aims to investigate the clinicopathologic characteristics and survival outcomes of FGFR2b-positive GC, along with the expression concordance across biopsy, surgical, and metastatic specimens.

METHODS:

This retrospective study included 466 patients with stages I-IV GC. Biopsy-surgical and primary-metastatic specimen pairs were available for 163 and 135 patients, respectively. FGFR2b overexpression was defined as moderate-to-strong membranous and/or cytoplasmic expression in ≥ 10% of tumor cells. FGFR2 amplification was evaluated using chromogenic in situ hybridization.

RESULTS:

FGFR2b overexpression was observed in 4.1% of patients, with 14/341 surgical specimens (4.1%), 3/284 gastric biopsies (1.1%), and 4/135 metastatic specimens (3.0%). FGFR2b overexpression correlated with deeper invasion and perineural invasion in resectable GC. However, it did not influence survival outcomes in resectable or metastatic GC. Among 163 biopsy-surgical pairs, FGFR2b overexpression was observed in only one pair (0.6%). Similarly, among 135 paired primary-metastatic specimens, FGFR2b overexpression was observed in one (0.7%). FGFR2 gene amplification occurred in 16/17 (94.1%) cases with FGFR2b overexpression.

CONCLUSION:

Significant intratumoral and intrapatient heterogeneity is observed in FGFR2b overexpression. Given this variability in expression levels, a single endoscopic biopsy may not accurately assess FGFR2b overexpression. The FGFR2b positivity rate in gastric cancers was 4.1%, likely due to the substantial heterogeneity in its expression.

01 Jul 2025·Ophthalmology and Therapy

Advancing Ocular Safety Profile Assessment: A Novel Grading Scale for Ocular Adverse Reactions Associated with Bemarituzumab

Article

Author: Li, Zhezhen ; Huang, Xiaojun Jacqueline ; Colby, Kathryn ; Raoof, Sumera ; Farooq, Asim V ; Hundal, Pradeep ; Murias Dos Santos, Telma ; Burke, Maureen ; Sulaiman, Rosilin ; Kaur, Savreet ; Zahlten-Kümeli, Anita

Targeted cancer therapies have transformed the landscape of cancer treatments but are often associated with off-target adverse drug reactions due to overlapping molecular pathways in healthy tissues, including those in the eye. Fibroblast growth factor receptors (FGFRs), expressed across various parts of the eye, can become unintended targets of FGFR inhibitors such as erdafitinib, infigratinib, and pemigatinib, leading to ocular adverse events (AEs) affecting the ocular surface and retina. AEs across clinical trials are graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), which may not completely capture the ocular sequelae resulting from the use of emerging therapies. As CTCAE grading is mainly through the description of symptoms and their impact on visual acuity, it is imperative to use a tool that relies more on objective findings from ophthalmologic evaluations. The novel ocular adverse reaction severity grading scale developed by Amgen in collaboration with expert ophthalmologists, accounts for the anatomical regions impacted by ocular adverse reactions and anchors each severity grade to objective observable criteria from ophthalmologic evaluations. This grading scale is being used across the clinical development program for bemarituzumab to precisely characterize the ocular safety profile, enabling cross-specialty collaboration between oncologists and eye care providers to implement appropriate management strategies. This commentary article highlights the efforts led by Amgen in collaboration with regulatory, medical, and academic fields to develop tools that facilitate early recognition of adverse reactions and appropriate interventions for patient care.

News (Medical) associated with Bemarituzumab

16 Jul 2025

·www.prnewswire.com

Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER. BC, July 16, 2025 /PRNewswire/ -- As lawmakers weigh potential cuts to scientific research funding, the outlook for developing cancer cures faces growing uncertainty. The situation is further complicated by renewed regulatory scrutiny of mRNA vaccines at both federal and state levels, casting a shadow over ongoing cancer research efforts. Meanwhile, the incidence of cancers—especially gastrointestinal and colorectal cancers among younger populations—is on the rise, heightening the need for new therapeutic approaches. In response, a new generation of biotech companies is stepping forward with promising clinical milestones on the horizon, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zai Lab Limited (NASDAQ: ZLAB), GeoVax Labs, Inc. (NASDAQ: GOVX), OS Therapies (NYSE-American: OSTX), and SELLAS Life Sciences Group, Inc. (NASDAQ: SLS). Industry forecasts suggest the global oncology drug market could climb past US$900 billion by 2034. Within that, next-generation cancer treatments—powered by advances in personalized and precision medicine—are expected to reach US$175.2 billion, according to Precedence Research, growing at a compound annual rate of 7.35%. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just rolled out an expanded translational data review package that tightens the scientific case for pelareorep, its intravenously delivered oncolytic virus. Fresh analyses from the GOBLET gastrointestinal‑cancer study and the AWARE‑1 breast‑cancer study shows pelareorep actively replicating inside tumors, switching on interferon signaling in the immune system, and drawing tumor‑infiltrating lymphocytes into the cancer microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded a clear increase in PD‑L1 expression, a checkpoint marker that helps immune cells recognize tumors, and tracked newly expanded T‑cell clones in the blood that matched those inside shrinking lesions. Together, these findings suggest pelareorep can convert "cold" tumors into "hot" ones that respond better to modern immunotherapies. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Two GOBLET cohorts—metastatic pancreatic ductal adenocarcinoma (mPDAC) and anal cancer—remain open. Management plans to outline the next clinical milestones before the end of the third quarter. Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a two‑year overall‑survival rate of 21.9%, compared with the historical benchmark of 9.2%. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective response rate. No immune checkpoint therapy is approved in this cancer today, which makes the signal especially noteworthy. Progress extends to hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC). Across two randomized trials, pelareorep added more than ten months of median overall survival. In BRACELET‑1, the drug nearly doubled median progression‑free survival to 12.1 months versus 6.4 months in the control arm, suggesting durable disease control. Next week, Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes. To steer these data toward value‑creating deals and late‑stage trials, Oncolytics Biotech strengthened its leadership earlier this year. The board tapped industry veteran Jared Kelly for the CEO seat and named Andrew Aromando Chief Business Officer. Both executives helped guide Ambrx Biopharma into a $2‑billion sale to Johnson & Johnson, giving them a playbook for capital‑efficient development and strategic partnering. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Zai Lab Limited (NASDAQ: ZLAB) recently reported that its Phase 3 FORTITUDE‑101 study found bemarituzumab plus mFOLFOX6 significantly improved overall survival over chemotherapy alone in first‑line fibroblast growth factor receptor 2b (FGFR2b)‑positive gastric and gastroesophageal junction cancers. The antibody becomes the first FGFR2b inhibitor to post a statistically and clinically meaningful survival benefit, and the company plans a rapid regulatory filing in China under its Breakthrough Therapy designation. "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." GeoVax Labs, Inc. (NASDAQ: GOVX) recently stated that the FDA's curative‑intent approval of Keytruda for head and neck cancer strengthens the rationale for its planned Phase 2 trial combining Gedeptin and pembrolizumab. "We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed," added Dr. Kelly McKee, GeoVax's Chief Medical Officer. "We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease." The study, expected to launch in 2026, will give Gedeptin intratumorally before surgery to trigger local cytotoxicity, then add checkpoint inhibition to boost systemic immunity. Endpoints include pathologic response, recurrence rates, and immune biomarkers, aligning with guidance in a recent New England Journal of Medicine editorial. OS Therapies (NYSE-American: OSTX) has locked in an End‑of‑Phase 2 FDA meeting for 27 August 2025 to discuss a rolling Biologics License Application for OST‑HER2 in recurrent, lung‑metastatic osteosarcoma, while parallel regulatory consultations are set with the EMA and the UK MHRA. "We are making significant progress towards our primary objective of obtaining regulatory approval for OST-HER2 in recurrent, pulmonary metastatic osteosarcoma prior to the sunsetting of the rare pediatric disease priority review voucher ("PRV") program," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "We strongly believe in the promise of the listeria immunotherapy platform to help prevent and treat cancer, and intend to judiciously deploy our capital to focus on the OST-HER2 approval while advancing our other clinical programs without deploying significant capital or running other clinical studies while we wait for the OST-HER2 approval and related PRV sale." The company is also advancing a Phase 1 prostate‑cancer immunotherapy, OST‑504, with full data expected later in 2025. OST‑HER2 already carries Rare Pediatric Disease, Fast Track, and Orphan Drug designations, positioning the program for a potential Priority Review Voucher and accelerated approvals in multiple markets. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) met every primary endpoint in its Phase 2 trial of SLS009 in relapsed/refractory acute myeloid leukemia-myelodysplasia-related changes (AML MR), delivering a 44% overall response rate at the optimal 30 mg twice‑weekly dose and a median overall survival of 8.9 months—far above the 2.4 month historical benchmark. The CDK9 inhibitor also showed a 50% response rate in high‑risk ASXL1‑mutated and M4/M5 subgroups, with no dose‑limiting toxicities reported. "We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks," said Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS. "AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes." Following FDA guidance, the company will launch an 80‑patient randomized study in newly diagnosed first‑line AML by Q1 2026 to support a potential New Drug Application. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo - SOURCE Equity Insider WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 2Phase 3Fast Track

11 Jul 2025

·pmlive.com

Amgen’s bemarituzumab shows promise in phase 3 gastric cancer study

Amgen has shared positive results from a late-stage study of its investigational fibroblast growth factor receptor 2b (FGFR2b)-targeted monoclonal antibody bemarituzumab in gastric cancer. The phase 3 FORTITUDE-101 trial, conducted with the support of Zai Lab, has been evaluating bemarituzumab plus mFOLFOX6 chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric or gastro-oesophageal junction (G/GEJ) cancer in patients with FGFR2b protein overexpression. Patients were excluded if they were known to be human epidermal growth factor receptor 2 (HER2) positive. Results from a pre-specified interim analysis showed that the study met its primary endpoint, with bemarituzumab plus chemotherapy demonstrating a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy. Gastric cancer is the fifth leading cause of cancer-related deaths globally, with almost one million new cases diagnosed every year. Approximately 38% of patients with advanced G/GEJ cancer have FGFR2b overexpression, which can play a significant role in tumour development and progression. Jay Bradner, executive vice president of research and development at Amgen, 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 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer.” A late-stage study evaluating bemarituzumab plus chemotherapy and Bristol Myers Squibb’s Opdivo (nivolumab) in patients with first-line gastric cancer is also ongoing, with data from the trial expected to be announced later this year. Amgen gained access to bemarituzumab in 2021 through its $1.9bn acquisition of Five Prime Therapeutics. Zai Lab holds co-development and commercialisation rights for the drug in mainland China, Hong Kong, Macau and Taiwan. Robert Bradway, chairman and chief executive officer at Amgen, said at the time of the March 2021 acquisition announcement: “We look forward to welcoming the Five Prime team to Amgen and working with them to leverage our best-in-class monoclonal antibody manufacturing capabilities to supply additional clinical materials, as well as expanded production quantities, to realise the full potential of bemarituzumab for even more patients around the world as quickly as possible.”

Phase 3AcquisitionClinical ResultADC

01 Jul 2025

·pharma.economictimes.indiatimes.com

Amgen says gastric cancer drug meets main goal in late-stage trial

Bengaluru: Amgen said on Monday its experimental therapy helped patients with advanced gastric cancer live longer when combined with chemotherapy, according to interim data from a late-stage study. The antibody drug, bemarituzumab , was acquired as part of Amgen's $1.9 billion purchase of Five Prime Therapeutics in 2021, aiming to gain a foothold in the Asian market where gastric cancer is more prevalent than the U.S. Amgen did not disclose how much the therapy when provided with chemotherapy helped improve overall survival in patients compared with those who received chemotherapy alone. The company said the most common side effects linked to bemarituzumab included vision problems, eye irritation, anemia and nausea. Eye-related problems occurred more frequently and were more severe in patients taking the drug, it said. The data is "clearly good news" for bemarituzumab given the cancer's difficult-to-treat nature, Guggenheim analyst Vamil Divan said, adding that further details on the magnitude of the benefits and side effects will be keenly watched. Eye-related problems and related discontinuations will be important data points to evaluate the potential market opportunity, William Blair analyst Matt Phipps said. Amgen said it plans to present further details from the study at a future medical meeting. The study enrolled 547 patients with a type of gastric or gastroesophageal junction cancer that had spread to other parts of the body and had excessive amounts of the FGFR2b protein. The drug targets FGFR2b, which is associated with tumor growth in about 38% of patients with the cancer, according to Amgen. Treatment options for advanced gastric cancer include chemotherapy alone or with immunotherapy drugs such as Bristol Myers Squibb's Opdivo for some patient groups or Roche's Herceptin for tumors with specific genetic markers. Divan projects potential U.S. peak sales of about $550 million for the drug, when adjusted for a 60% probability of success. Amgen partners with Zai Lab to develop and commercialize bemarituzumab in mainland China, Hong Kong, Macau and Taiwan. (Reporting by Kamal Choudhury and Mariam Sunny in Bengaluru; Editing by Shreya Biswas)

AcquisitionImmunotherapyADCClinical Result

100 Deals associated with Bemarituzumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16105

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
FGFR2b positive gastroesophageal junction cancer	Phase 3	China	Amgen, Inc.	05 Jun 2023
FGFR2b positive gastroesophageal junction cancer	Phase 3	China	Zai Lab (Shanghai) Co., Ltd.	05 Jun 2023
Gastrooesophageal junction cancer	Phase 3	United States	Amgen, Inc.	14 Mar 2022
Gastrooesophageal junction cancer	Phase 3	China	Amgen, Inc.	14 Mar 2022
Gastrooesophageal junction cancer	Phase 3	Japan	Amgen, Inc.	14 Mar 2022
Gastrooesophageal junction cancer	Phase 3	Argentina	Amgen, Inc.	14 Mar 2022
Gastrooesophageal junction cancer	Phase 3	Australia	Amgen, Inc.	14 Mar 2022
Gastrooesophageal junction cancer	Phase 3	Austria	Amgen, Inc.	14 Mar 2022
Gastrooesophageal junction cancer	Phase 3	Belgium	Amgen, Inc.	14 Mar 2022
Gastrooesophageal junction cancer	Phase 3	Brazil	Amgen, Inc.	14 Mar 2022

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05052801 (FORTITUDE-101, NEWS) Manual	Phase 3	Stomach Cancer First line	547	bemarituzumab + mFOLFOX6	zbyanofean(kjiqyndpwl) = 联合治疗组在总生存期（OS）方面相比单纯化疗组，取得了具有统计学意义和临床意义的显著改善，达到了试验的主要终点。 wdyfsdmxct (qpqwizsfke ) Met View more	Positive	03 Jul 2025
				mFOLFOX6
NCT05267470 (FORTITUDE-201, CTgov)	Phase 1	Squamous non-small cell lung cancer	74	Docetaxel+Bemarituzumab (Part 1: Bemarituzumab Dose 1 With Docetaxel)	kziuhvqoxb = xxzivgbbxt uzhsynhrbb (kpxoayevga, wzgunismbz - yedwktlctl) View more	-	25 Mar 2025
				Docetaxel+Bemarituzumab (Part 1: Bemarituzumab Dose 2 With Docetaxel)	kziuhvqoxb = thdhaahtwe uzhsynhrbb (kpxoayevga, oorhwfrgse - pmetvwqzwc) View more
NCT03694522 (FIGHT, Pubmed) Manual	Phase 2	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line HER2 Negative	155	Bemarituzumab-mFOLFOX6	dehdlzezym(wieinqynmu) = sgzhhhqlvt fogjhownno (dzphfrfuta, 7.3 - 13.7) View more	Positive	03 Feb 2024
				Placebo-mFOLFOX6	dehdlzezym(wieinqynmu) = wcfthyjvta fogjhownno (dzphfrfuta, 5.7 - 8.4) View more
NCT03694522 (FIGHT, ESMO_ASIA2023)	Phase 2	FGFR2b positive gastroesophageal junction cancer First line FGFR2b+	89	Bemarituzumab (bema)+FOLFOX6	blwscrnovi(vlnboskdyl) = Corneal treatment-emergent adverse events (TEAEs) occurred in 68.2% (n=30) bema and 13.6% (n=6) pbo pts vaxdddntxs (gytcgjejgh ) View more	Positive	03 Dec 2023
				Placebo+mFOLFOX6
NCT03343301 (FIGHT, CTgov)	Phase 1	Gastrointestinal cancer metastatic \| Malignant neoplasm of gastro-oesophageal junction \| Stomach Cancer	12	Modified FOLFOX6+Bemarituzumab (Bemarituzumab 6 mg/kg + mFOLFOX6)	ecuhuriied = ilafdqorij jzkmtfngby (yytgfjfzlo, ivmojuxhnh - jrlntcgtyx) View more	-	27 Jan 2023
				Modified FOLFOX6+Bemarituzumab (Bemarituzumab 15 mg/kg + mFOLFOX6)	ecuhuriied = kfrzmcbokp jzkmtfngby (yytgfjfzlo, muwlbthqau - cflyrnrbct) View more
NCT03694522 (FIGHT, Pubmed) Manual	Phase 2	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line FGFR2b-selected \| HER2-negative	155	mFOLFOX6+Bemarituzumab	csztteelqs(qphfthbmfx) = bfjzblowyo trnpeoveji (lzcxncpooy, 7.3 - 12.9) View more	Positive	13 Oct 2022
				mFOLFOX6+Placebo	csztteelqs(qphfthbmfx) = cdhwqabicr trnpeoveji (lzcxncpooy, 5.8 - 8.4) View more
NCT03694522 (FIGHT, CTgov)	Phase 2	Gastrooesophageal junction cancer	155	l-leucovorin (l-LV)+oxaliplatin (L-OHP)+Bemarituzumab+5-fluorouracil (5-FU) (Bemarituzumab + mFOLFOX6)	pqhfwveusb(ztwtecsgte) = ynlxptamzg vqqkbhsinm (xkksfuukiw, jtkqxviles - mpelzsjqfr) View more	-	24 May 2022
				Placebo+l-leucovorin (l-LV)+oxaliplatin (L-OHP)+5-fluorouracil (5-FU) (Placebo + mFOLFOX6)	pqhfwveusb(ztwtecsgte) = pwyjvepwqb vqqkbhsinm (xkksfuukiw, crznenisud - cxueiuykdq) View more
NCT03694522 (FIGHT, AACR2021)	Phase 2	Metastatic gastroesophageal adenocarcinoma	721	bemarituzumab	vghceyiavq(xrcgkrxfet) = ozakysngmb bnmbbzhmjj (ebxokpomyx ) View more	-	01 Jul 2021
NCT03694522 (FIGHT, ASCO 12021 \| ASCO 22021) Manual	Phase 2	Advanced Gastric Adenocarcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma FGFR2b Positive	155	mFOLFOX6+Bemarituzumab	mhpobzojbg(ouhqcfvsty) = xowhuyifxb eaxcpmgdwd (tohhnjadfw ) View more	Positive	20 May 2021
				mFOLFOX6+placebo	zohntwyvzn(nigfxvlstp) = touivobkbk pribwwzkki (ycforshuqp, 8.4 - 13.8) View more
NCT03694522 (FIGHT, ASCO_GI2021)	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma First line	155	Bemarituzumab 15mg/kg + mFOLFOX6	qlxdoauvqr(tvgelwfcrf) = zuaakohvsi jpvlnipkjf (glnrldldwk ) View more	Positive	22 Jan 2021
				Placebo + mFOLFOX6	qlxdoauvqr(tvgelwfcrf) = uyxagyrxul jpvlnipkjf (glnrldldwk ) View more

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