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

Efficacy Of Bemarituzumab In Patients With Advanced Gastric and Gastroesophageal Junction Cancer (GC/GEJ) by FGFR2 Amplification Status: Exploratory Biomarker Analysis from FORTITUDE-101 (F101) and FORTITUDE-102 (F102) (ESMO 2026) - No abstract available

Biomarker • Clinical • Metastases • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • FGFR2

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

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

Deciphering the prognostic value of FGFR2b/2c isoform expression levels in advanced esophagogastric cancer through whole-transcriptome sequencing. (ASCOBT 2024) - "Background: Fibroblast growth factor receptor (FGFR) isoform switching from FGFR2b to FGFR2c has been implicated in epithelial-to-mesenchymal transition and enhanced invasive potential in various malignancies and potentially be involved in resistance mechanisms to FGFR2b targeted therapy (e.g., bemarituzumab)... Our findings underscore the substantial concordance between IHC and WTS analysis of FGFR2, the feasibility of distinguishing FGFR2 isoforms using WTS, and the prognostic implications of FGFR2c isoform in patients with advanced G/GEJ cancer. Further analysis is warranted in patients receiving FGFR2b targeted treatment."

Biomarker • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

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 | Terminated | Sponsor: Amgen | Trial completion date: Aug 2026 ➔ Nov 2025 | Active, not recruiting ➔ Terminated; Sponsor Decision

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

Fruquintinib combined with bemozumab versus fruquintinib as third-line treatment for advanced metastatic colorectal cancer: A randomized, open-label, single-center Phase II clinical study (RCTS) (ChiCTR) - P2 | N=40 | Not yet recruiting | Sponsor: Taian Central Hospital; Taian Central Hospital

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

FGFR2 amplification and fusion identified by NGS align with FGFR2b overexpression. (PubMed, Virchows Arch) - "In conclusion, adequate surgical tissue enables strong concordance between FGFR2b IHC and NGS. FGFR2b IHC is an effective frontline screen, while NGS is essential for detecting rare FGFR2 fusions that define an aggressive, poor‑prognosis subtype."

Journal • Next-generation sequencing • Gastric Cancer • Oncology • Solid Tumor • FGFR2 • FPR2 • HER-2

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 | Terminated | Sponsor: Amgen | Trial completion date: Jan 2027 ➔ Oct 2025 | Active, not recruiting ➔ Terminated; Study was terminated by sponsor

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

Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Terminated; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Trial termination • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

FORTITUDE-301: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov) - P1/2 | N=260 | Terminated | Sponsor: Amgen | Completed ➔ Terminated; Sponsor Decision

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

FGFR-targeted therapies in advanced esophagogastric cancer: A systematic review and meta-analysis. (ASCO 2026) - "In HER2-negative disease, chemotherapy ± nivolumab is standard, but yields limited survival...40 (34.2%) patients had prior trastuzumab therapy...Bemarituzumab significantly improved overall survival compared with placebo (HR 0.58), while median OS in single-arm cohorts was 8.2 months with pemigatinib and 14.2 months with nintedanib... FGFR-targeted therapies show activity in FGFR-altered esophagogastric cancers, especially with FGFR2b-directed monoclonal antibodies. Toxicities are manageable, but responses vary, highlighting the need for molecular selection. Larger trials are needed to identify patients most likely to benefit and optimal treatment sequencing."

Metastases • Retrospective data • Review • Dental Disorders • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hypertension • Neutropenia • Oncology • Ophthalmology • Solid Tumor • Stomatitis • FGFR • HER-2

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

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

Global prevalence of FGFR2b protein overexpression in advanced gastric cancer and gastroesophageal junction cancers: pooled analysis of two bemarituzumab phase III studies. (PubMed, ESMO Open) - P3 | "This study represents the largest prevalence assessment of FGFR2b overexpression in G/GEJC using a validated IHC assay. The observed estimates of 36.5% (any 2+/3+) and 16.6% (FGFR2b ≥10% 2+/3+) suggest that FGFR2b is prevalent in a meaningful proportion of patients with advanced G/GEJC."

Journal • P3 data • Retrospective data • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • FGFR2

Bemarituzumab Suppresses Choroidal Neovascularization in Mice by Downregulating Melanoma Cell Adhesion Molecule and Yes-Associated Protein 1. (PubMed, ACS Pharmacol Transl Sci) - "Experiments on HUVECs further verify the inhibitory effect of FPA144 on vascular endothelial cells. Our findings demonstrate that FPA144 can efficiently inhibit the development of choroidal neovascularization in mice by downregulating CD146 and Yap1."

Journal • Preclinical • Age-related Macular Degeneration • Macular Degeneration • Melanoma • Oncology • Ophthalmology • Retinal Disorders • Solid Tumor • Wet Age-related Macular Degeneration • MCAM • YAP1

Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=134 ➔ 40 | Trial completion date: Apr 2027 ➔ Apr 2026 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2026 ➔ Apr 2026; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ANGELICA: AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Centre Leon Berard | N=87 ➔ 0 | Not yet recruiting ➔ Withdrawn

dMMR • Enrollment change • Platinum resistant • pMMR • Trial withdrawal • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • FOLR1

Preclinical evaluation of a novel and highly differentiated FGFR2b-targeting ADC with low risk of ocular toxicity (AACR 2026) - "Bemarituzumab, an ADCC-enhanced FGFR2b antagonist, has demonstrated efficacy in patients with FGFR2b-overexpressing G/GEJ cancer. Together, these data demonstrate preclinical efficacy and low risk of ocular toxicity of a FGFR2-targeting ADC utilizing ALX007 as a highly differentiated antibody backbone. Further development for the treatment of FGFR2b-expressing tumors is warranted."

ADC • Preclinical • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • FGF10 • FGF7 • FGFR2

Engineering and development of a novel bispecific ADC targeting EGFR and FGFR2b (AACR 2026) - "Bemarituzumab, an afucosylated FGFR2b monoclonal antibody has shown efficacy in the clinical study for the treatment in patients with FGFR2b‑positive GC and GEJ cancer...Our EGFR×FGFR2b bsAb function as a partial FGFR2b ligand blocker, and only weakly inhibiting FGF7 while sparing FGF10‑mediated signaling, thus with the potential to reduce on‑target toxicity associated with FGF7/FGF10 blockade. Several bsAb ADC were generated with various cytotoxic payloads and are being tested in vitro and in vivo studies."

ADC • Bispecific • Gastric Cancer • Oncology • Solid Tumor • EGFR • FGF10 • FGF7 • FGFR2

Preclinical development of 3H-10000, a novel vedotin antibody-drug conjugate for treatment of FGFR2b-expressing cancers (AACR 2026) - "More important is that there existed significant synergy in tumor growth inhibition and regression in SNU-16 CDX study, when 3H-10000 was combined with a FGFR2 selective small molecule inhibitor 3HP-2827, which would strongly support clinic trail exploration of the combined therapy strategy of FGFR2b-ADC and 3HP-2827 to overcome drug resistance and perform persistent therapeutic efficacy. The safety study demonstrated that 3H-10000 spared corneal toxicity in mice compared with Bemarituzumab...Overall, 3H-10000, the novel FGFR2b ADC, is a highly potent targeted therapy candidate against cancers.Overall, this study is the first to our knowledge where the combinational treatment of FGFR2b ADC and FGFR2 selective kinase inhibitor demonstrated synergic inhibition of tumor cell growth. These results strongly support advancing 3H-10000 into clinical evaluation in treatment of unnormal FGFR2 expressing solid tumors, and a phase I study has (CTR20254555) is ongoing."

ADC • Late-breaking abstract • Preclinical • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FGFR2

20210096: Study Comparing Bemarituzumab plus Chemotherapy with Placebo and Chemotherapy in Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression (FORTITUDE-101) (clinicaltrialsregister.eu) - P2/3 | N=327 | Completed | Sponsor: Amgen Inc. | Active, not recruiting ➔ Completed

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

Characterization of novel humanized FGFR2b antibody-based ADCs site-specifically conjugated with topoisomerase I inhibitor payload in preclinical tumor models (AACR 2025) - "Anti-tumor efficacy was evaluated in FGFR2b-positive tumor cell line-derived xenograft (CDX) models in mice. 38D4 specifically binds to FGFR2b with a higher affinity than the Bemarituzumab-analog. FGFR2b ADC TST105 demonstrated the high potency, strong anti-tumor activity and bystander effect in the preclinical studies, which support further investigations of TST105 in FGFR2b positive solid tumors."

ADC • Preclinical • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • FGFR2

ALK201, a first-in-class FGFR2b-targeting antibody-drug conjugate for patients with FGFR2b+ gastric cancer and other solid tumors (AACR 2025) - P1/2 | "ALK201 blocked FGF7/10-FGFR2b interaction and inhibited downstream phospho-ERK activation, comparable to Bemarituzumab. In summary, preclinical results indicated that ALK201 is an effective candidate for the treatment of solid tumors expressing FGFR2b with a tolerable safety profile. The phase I/II clinical study including dose escalation and dose expansion to evaluate the safety, tolerability, PK and anti-tumor activity of ALK201 in adult participates with advanced solid tumor is ongoing (NCT06656390)."

ADC • Clinical • Late-breaking abstract • Gastric Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FGF7 • FGFR2

SCR-A002, a novel FGFR2b-targeting ADC for solid tumors (AACR 2025) - "Background: FGFR2b (fibroblast growth factor receptor 2 IIIb), an isoform of transmembrane tyrosine kinase FGFR family, is overexpressed in various cancers, including gastric, esophageal, breast, hepatocellular, pancreatic, ovary, uterine, cervical, endometrial, lung, colorectal cancers. SCR-A002 showed remarkable anti-tumor efficacy in preclinical data, suggesting that SCR-A002 is expected to provide a new treatment option as single agent or combo with SoC for patients with FGFR2b-overexpressing solid tumor."

ADC • Colorectal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • FGFR2

Preclinical evaluation of BG-C137, a potential first-in-class FGFR2b-targeting ADC, for the treatment of FGFR2b-expressing cancer (AACR 2025) - P1 | "Indeed, the clinical benefit of targeting FGFR2b has been demonstrated by Bemarituzumab, an Fc-enhanced monoclonal antibody in combination with chemotherapy in first-line FGFR2b-expressing gastric cancer. With its differentiated targeting strategy, BG-C137 is not only a first-in-class FGFR2b ADC but also holds the potential to pursue the best-in-class opportunity in FGFR2b targeting treatments. Together, these observations support the clinical development of BG-C137 for the treatment of FGFR2b-expressing tumors (ClinicalTrials.gov ID NCT06625593)."

ADC • Preclinical • Gastric Cancer • Oncology • Solid Tumor • FGFR2