bemarituzumab (AMG 552) / ZAI Lab, Amgen - LARVOL DELTA

Bemarituzumab (BEMA) plus chemotherapy for advanced or metastatic FGFR2b-overexpressing gastric or gastroesophageal junction cancer (G/GEJC): FORTITUDE-101 phase III study results (ESMO 2025) - P3 | "†All pts who received ≥1 dose of investigational product or mFOLFOX6 were analyzed according to treatment received. TRAE, treatment-related adverse event."

Late-breaking abstract • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

FORTITUDE-301: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov) - P1/2 | N=260 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Monotherapy • Pan tumor • Trial completion • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

The pharma has stopped the Fortitude-103 trial, a phase 1b/2 study of the candidate in first-line gastric cancer, and will no longer pursue the asset in that indication. (FierceBiotech) - "That decision was made based on bemarituzumab’s documented struggles in the earlier Fortitude-101 and Fortitude-102 trials....The company is now weighing its options for bemarituzumab moving forward, an Amgen spokesperson confirmed to Fierce Biotech."

Discontinued • Trial termination • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

BEMAFLOT: Study Evaluating the Combination of Bemarituzumab + FLOT Chemotherapy in Perioperative Setting for Resectable Stage cT2-T4a or N+ Gastric and GEJ Adenocarcinoma Overexpressing FGFR2b (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Institut Cancerologie de l'Ouest | N=49 ➔ 0 | Trial completion date: Jun 2034 ➔ Jan 2026 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jun 2029 ➔ Jan 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): a randomised, double-blind, placebo-controlled, phase 2 study. (PubMed, Lancet Oncol) - P2 | "In this exploratory phase 2 study, despite no statistically significant improvement in progression-free survival, treatment with bemarituzumab showed promising clinical efficacy. Confirmatory phase 3 trials of bemarituzumab plus mFOLFOX6 powered to demonstrate statistical significance are being investigated in patients with previously untreated, FGFR2b-overexpressing, advanced gastric or gastro-oesophageal junction adenocarcinoma."

Journal • P2 data • Dental Disorders • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Solid Tumor • Stomatitis • FGFR2 • HER-2

Bemarituzumab for treatment of previously untreated advanced and/or metastatic gastric and gastroesophageal cancer (GC): Final analysis of a randomized phase 2 trial (FIGHT) (ESMO-GI 2023) - P2 | "After 24 months of follow-up, patients with FGFR2b overexpression treated with bemarituzumab + mFOLFOX6 continued to show clinically meaningful outcomes over patients treated with placebo + mFOLFOX6; more pronounced efficacy was observed in patients with ≥10% of tumor cells with 2+/3+ FGFR2b IHC staining intensity. Randomized phase 3 trials focused on patients with ≥10% of tumor cells to confirm the observed clinical benefit of bemarituzumab are ongoing."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • HER-2

Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy (clinicaltrials.gov) - P2 | N=126 | Active, not recruiting | Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

FORTITUDE-102: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer. (clinicaltrials.gov) - P3 | N=515 | Active, not recruiting | Sponsor: Amgen | Trial primary completion date: Jan 2026 ➔ Oct 2025

Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • FGFR2

Ocular Safety Evaluation of Bemarituzumab in FGFR2b-Overexpressing Gastroesophageal Adenocarcinoma: A 42-Week Follow-Up Study. (PubMed, Ocul Immunol Inflamm) - "The ocular AEs occurred frequently in patients receiving bemarituzumab, requiring close ophthalmic monitoring and prophylactic administration of FGF-based eye drops. Collaboration between oncologists and ophthalmologists is critical for the timely management of treatment-related AEs, which could ultimately improve overall clinical outcomes."

Journal • Dry Eye Disease • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Keratitis • Ocular Inflammation • Oncology • Ophthalmology • Solid Tumor

Invited Discussant – Asian perspectives on Bemarituzumab (BEMA) plus chemotherapy for advanced or metastatic FGFR2b-overexpressing gastric or gastroesophageal junction cancer (G/GEJC): FORTITUDE-101 phase III study results (ESMO Asia 2025) - No abstract available

Metastases • P3 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Bemarituzumab (BEMA) plus chemotherapy for advanced or metastatic FGFR2b-overexpressing gastric or gastroesophageal junction cancer (G/GEJC): FORTITUDE-101 phase III study results (ESMO Asia 2025) - No abstract available

Metastases • P3 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

FORTITUDE-103: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (clinicaltrials.gov) - P1/2 | N=72 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Mar 2028 ➔ Aug 2026

Trial completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

Zai Lab Announces Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Updates (Businesswire) - "Tisotumab Vedotin (Tissue Factor ADC): BLA submission in recurrent or metastatic cervical cancer following progression on or after chemotherapy in the first quarter of 2025. Bemarituzumab (FGFR2b): BLA submission in first-line gastric cancer in the first half of 2025. Repotrectinib (ROS1/TRK): supplementary NDA submission in NTRK+ solid tumors in the first half of 2025. Tumor Treating Fields (TTFields): Marketing Authorization Application submissions in second-line+ NSCLC following progression on or after platinum-based chemotherapy and in first-line pancreatic cancer...Second-Line+ Extensive-Stage SCLC (ES-SCLC): Zai Lab to present updated data at a major medical conference in the first half of 2025. Zai Lab plans to initiate a pivotal study in 2025...Other neuroendocrine tumors: Zai Lab to initiate a global Phase 1 study in the first half of 2025...ZL-6201 (LRRC15 ADC): Zai Lab to provide preclinical data update and initiate a global Phase 1 study in sarcoma."

China filing • Clinical data • New P1 trial • Preclinical • Cervical Cancer • Gastric Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor

Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "Upcoming Potential NMPA Submissions: Bemarituzumab (FGFR2b) in first-line gastric cancer in the second half of 2025. Upcoming Potential NMPA Approvals: Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy; Repotrectinib (ROS1/TRK) in NTRK+ solid tumors."

China approval • China filing • Cervical Cancer • Gastric Cancer • Solid Tumor

Precision Antibody Therapy in Gastric and Gastroesophageal Cancer: Targeting FGFR2b, CLDN18.2, and VEGFR2. (PubMed, Cells) - "This review examines the mechanisms, safety profiles, and clinical trial outcomes of three targeted agents-bemarituzumab, zolbetuximab, and ramucirumab-which inhibit tumor growth through the FGFR2b, CLDN18.2, and VEGFR2 pathways, respectively. We also compare traditional versus adaptive clinical trial designs, explore emerging challenges such as therapeutic resistance and treatment-related toxicities, and consider implications for personalized medicine. Collectively, these agents represent a paradigm shift from empiric chemotherapy toward biomarker-driven immunotherapy, with the potential to significantly improve survival and quality of life in patients with advanced G/GEJ cancers."

IO biomarker • Journal • Review • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • KDR

Following a middling phase 3 readout for gastric cancer candidate bemarituzumab, Amgen has now stopped another phase 1b/3 trial of the molecule… (FierceBiotech) - "The Fortitude-102 trial was testing bemarituzumab, a monoclonal antibody, in combination with chemotherapy and Bristol Myers Squibb’s oncology drug Opdivo in 515 patients with untreated advanced gastric and gastroesophageal junction cancer with FGFR2b overexpression. The trial was halted due to inadequate efficacy....Phase 3 data from the trial had been expected in the second half of 2025 or first half of 2026..."

P3 data • Trial termination • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A single-arm, exploratory, phase II clinical trial of bemarituzumab combined with anlotinib, etoposide and carboplatin followed by thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. (ChiCTR) - P2 | N=39 | Not yet recruiting | Sponsor: Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Evaluating the Impact of Monoclonal Antibodies on Survival Outcomes in Advanced Gastric Cancer: A Systematic Review of RCTs (ACG 2025) - "Pembrolizumab plus chemotherapy also significantly enhances survival outcomes. In Boku et al., 2021, nivolumab demonstrated a significant OS benefit over placebo (5.3 vs 4.1 months) and a modest PFS benefit (1.61 vs 1.45 months). In Kong et al., 2024, inetetamab improved PFS compared to trastuzumab (8.5 vs 7.3 months, P = 0.046), but OS (15.4 vs 14.3 months) was not significantly different. Kang et al., 2024 reported that bemarituzumab plus mFOLFOX6 significantly improved both PFS (12.9 vs 8.2 months) and OS (24.7 vs 12.9 months) compared to placebo."

Metastases • Review • Gastric Cancer • Oncology • Solid Tumor

Advances in targeted treatment for gastric cancer (KINGCA Week 2025) - P3 | "The KEYNOTE‑811 trial demonstrated that adding pembrolizumab to trastuzumab–chemotherapy significantly improved OS in PD-L1 CPS ≥1 patients (20.0 vs. 16.8 months; HR 0.80), establishing this triplet as the global first-line standard—while ToGA remains preferred for CPS 75%, PFS >12 months), leading to the phase 3 HERIZON‑GEA‑01 trial...Two pivotal phase 3 trials have validated its relevance: - SPOTLIGHT (zolbetuximab + mFOLFOX6): median PFS 10.61 vs. 8.67 months (HR 0.75) and OS benefit (HR 0.75; p=0.0053)...Ongoing studies include LUCERNA (NCT06901531), evaluating zolbetuximab + pembrolizumab + chemotherapy in untreated, locally advanced or metastatic gastric/GEJ adenocarcinoma...The phase 2 FIGHT trial (bemarituzumab + mFOLFOX6) showed favorable PFS (9.5 vs. 7.4 months; HR 0.68) and OS trends despite not meeting statistical significance, with corneal toxicity as the main adverse event...Nivolumab (CheckMate 649), pembrolizumab (KEYNOTE-859), and tislelizumab..."

IO biomarker • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Early Overall Survival Advantage With Bemarituzumab in Gastric/GEJ Cancers Attenuated With Follow-up (Oncology News Central) - "At the prespecified interim analysis, bemarituzumab significantly improved OS in patients with FGFR2b at least 10% 2+/3+ TC staining. Median OS was 17.9 months with bemarituzumab compared with 12.5 months with placebo (hazard ratio [HR], 0.61; 95% CI, 0.43–0.86). This benefit was consistent across key prespecified subgroups...In addition, progression-free survival was also significantly improved with the addition of bemarituzumab to mFOLFOX6 (8.6 vs. 6.7 months; HR, 0.71; 95% CI, 0.53–0.95). There was no improvement in objective response, at 45.9% in the bemarituzumab group and 44.8% in the placebo group....Overall, corneal adverse events showed a delayed onset with a gradual resolution (median, 17 weeks)."

P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

WJOG18524G: A single-arm phase II study evaluating bemarituzumab combined with ramucirumab and paclitaxel in FGFR2b-positive advanced gastric or gastroesophageal junction cancer (RAINBIRD) (ESMO 2025) - "Translational research is planned to explore predictive biomarkers and mechanisms of resistance to bemarituzumab through tumor DNA sequencing (PleSSiSion-Neo) and circulating tumor DNA analysis (Guardant360), with samples collected at multiple time points. Legal entity responsible for the study West Japan Oncology Group."

Metastases • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • FGFR2

LNF2102: A novel FGFR2b-targeted monoclonal antibody with mitigated ocular toxicity in preclinical studies (ESMO 2025) - "Notably, in comparison with bemarituzumab, LNF2102 demonstrated a weaker ability to block FGF10. Legal entity responsible for the study Lunan Pharmaceutical Group Co., Ltd. Funding Lunan Pharmaceutical Group Co., Ltd."

Preclinical • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Gastric Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • FGF10 • FGF7 • HER-2

FORTITUDE-103: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (clinicaltrials.gov) - P1/2 | N=72 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2028 ➔ Mar 2028 | Trial primary completion date: Jun 2026 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

ANGELICA: AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer (clinicaltrials.gov) - P1/2 | N=87 | Not yet recruiting | Sponsor: Centre Leon Berard

dMMR • New P1/2 trial • pMMR • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Update on Amgen’s bemarituzumab Phase 3 FORTITUDE-101 Study (Zai Lab Press Release) - "At the pre-specified interim analysis, which was the primary analysis, the bemarituzumab plus chemotherapy regimen demonstrated a clinical and statistically significant improvement in overall survival (OS) compared to chemotherapy alone. However, at the final analysis, the magnitude of the previously observed survival benefit has attenuated. Amgen has indicated that the results from both the interim analysis and final analysis will be presented at an upcoming major medical meeting....Data readout from FORTITUDE-102 is anticipated by the end of 2025 or the first half of 2026."

P3 data • Gastric Cancer