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

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

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

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

A Phase II Clinical Trial Evaluating the Efficacy and Safety of Bemarituzumab in Combination with Anlotinib as Consolidation Therapy in Limited-Stage Small Cell Lung Cancer (LS-SCLC) Patients Without Progression After Definitive Treatment (L-STAR Study) (ChiCTR) - P2 | N=35 | Not yet recruiting | Sponsor: Shandong First Medical University Affiliated Cancer Hospital; Shandong First Medical University Affiliated Cancer Hospital

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • 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=70 | Recruiting | Sponsor: Amgen | Trial completion date: Apr 2028 ➔ Aug 2028 | Trial primary completion date: Mar 2026 ➔ Jun 2026

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

Bemarituzumab: Data readout from P3 FORTITUDE-102 trial (NCT05111626) for 1L gastric/GEJ cancer in H2 2025/H1 2026 (Amgen) - Q2 2025 Results

P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

FORTITUDE-301: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov) - P1/2 | N=260 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Sep 2027 ➔ Feb 2026

Monotherapy • Pan tumor • Platinum resistant • Trial completion date • 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

FORTITUDE-101: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov) - P3 | N=547 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Aug 2025 ➔ Jun 2026

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

FGFR2b protein overexpression: An emerging biomarker in gastric and gastroesophageal junction adenocarcinoma. (PubMed, Cancer Treat Rev) - "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."

Biomarker • Journal • Review • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • FGFR2

AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR BEMARITUZUMAB IN FIBROBLAST GROWTH FACTOR RECEPTOR 2b (FGFR2b) POSITIVE FIRST-LINE GASTRIC CANCER (Amgen Press Release) - P3 | N=547 | FORTITUDE-101 (NCT05052801) | Sponsor: Amgen | "Amgen...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....Detailed results from the trial will be shared at a future medical meeting....A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with a data readout anticipated in H2 2025."

P3 data: top line • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Clinical characterization of FGFR2b expression in patients with advanced gastric or gastroesophageal junction adenocarcinoma. (PubMed, ESMO Open) - "This study revealed limited overlap of FGFR2b overexpression with currently actionable biomarkers, suggesting FGFR2b is a novel biomarker that identifies a distinct GC/GEJC patient population who may benefit most from an FGFR2b-targeting therapy."

IO biomarker • Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • FGFR2 • HER-2 • PD-L1