75MO - Health-related quality of life (HRQoL) in FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer (G/GEJC): Results from the FIGHT trial comparing bemarituzumab (BEMA) + modified FOLFOX6 (mFOLFOX6) to placebo (PBO) + mFOLFOX6

Background

In the randomized, double-blind phase 2 FIGHT study (NCT03694522), median progression-free survival (PFS) at primary analysis (data cutoff [DCO] September 2020) was 9.5 months (m) with BEMA + mFOLFOX6 vs 7.4m with PBO + mFOLFOX6 (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.44–1.04). At DCO in February 2021, median overall survival (OS) was 19.2m vs 13.5m, respectively (HR: 0.60; 95% CI: 0.38–0.94). This analysis assessed the impact of adding BEMA to mFOLFOX6 on HRQoL in FIGHT.

Methods

Post-hoc HRQoL analyses (DCO February 2021) were based on the EORTC QLQ-C30 and EQ-5D-5L questionnaires, administered before/on study day 1, after 6 weeks (wks) from day 1, then every 8 wks while on treatment, and at the end of treatment visit. Changes from baseline in QLQ-C30 scales and EQ-5D (visual analogue scale [VAS]) and Utility Index) were analysed using mixed models for repeated measures. Time to first deterioration (of 10 points or more) or death (TTD) in the QLQ-C30 scales were assessed using Kaplan-Meier estimates and Cox models.

Results

155 patients were randomized in FIGHT (77 to the BEMA arm, 78 to the PBO arm). Per protocol completion rates for QLQ-C30 and EQ-5D questionnaires remained high (>90%) in the two arms while on treatment. Least squares (LS) mean differences (MD) from baseline in QLQ-C30 and EQ-5D were similar between the treatment arms (Table), numerically favouring the BEMA arm in several scales (including social, role, cognitive and emotional functioning [fct], and VAS) after 6 wks. Study arms were also comparable with respect to TTD, with no meaningful difference in any of the scales (95% CIs of the HRs included 1). Table: 75MO

Conclusions

In FIGHT, the addition of BEMA to mFOLFOX6 improved clinical outcomes, with no deterioration in HRQoL. HRQoL will be further evaluated in the ongoing confirmatory phase 3 FORTITUDE-101 trial.

Clinical trial identification

NCT03694522.

Editorial acknowledgement

Shawn Lee (Amgen Inc.) provided medical writing assistance in the preparation of this abstract.

Legal entity responsible for the study

Amgen Inc.

Funding

Amgen Inc.

Disclosure

Z.A. Wainberg: Financial Interests, Personal, Advisory Role, Advisor/consultant for and received honoraria: Amgen Inc; Financial Interests, Personal, Invited Speaker, Advisor/consultant for and received honoraria: Astra Zeneca, Daiichi, Bayer, BMS, Merck, Ipsen, Five Prime, Gilead, Arcus, Astellas, Molecular Templates, Array; Financial Interests, Institutional, Research Grant, Research grant/funding (institution): Amgen, AstraZeneca, Daiichi, Bayer, BMS, Merck, Ipsen, Five Prime, Gilead, Arcus, Astellas, Molecular Templates, Roche/Genentech, Array/Pfizer. P.C. Enzinger: Financial Interests, Personal, Advisory Role, Consulting or advisory role: ALX Oncology, Arcus Bioscence, Astellas, AstraZeneca, Blueprint Medicines, Chimeric Therapeutics, Celgene, Coherus, Daiichi Sankyo, Five Prime, Ideava, Istari, Legend, Lilly, Loxo, Merck, Novartis, Ono, Servier, Taiho, Takeda, Turning Point Therapeutics, Xencor, Zymeworks. K. Yamaguchi: Financial Interests, Personal, Advisory Role, Consulting or advisory role: Bristol Myers Squibb Japan, Daiichi Sankyo; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb Japan, Daiichi Sankyo, Chugai Pharma, Lilly, Merck, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharma, Daiichi Sankyo, Eisai, Gilead Sciences, Lilly, MSD Oncology, Sanofi, Taiho Pharmaceutical, Yakult Honsha. A. Gnanasakthy: Financial Interests, Personal, Full or part-time Employment, Employment with RTI Health Solutions who has contracts with multiple pharma companies, including Amgen; Ari receives no compensation from these pharma companies directly: RTI Health Solutions. K. Taylor: Financial Interests, Personal, Full or part-time Employment: Amgen Inc.; Financial Interests, Personal, Stocks/Shares: Amgen Inc. A. Jamotte: Financial Interests, Personal, Full or part-time Employment: Amgen Inc.; Financial Interests, Personal, Stocks/Shares: Amgen Inc. I. Majer: Financial Interests, Personal, Full or part-time Employment: Amgen Inc; Financial Interests, Personal, Stocks/Shares: Amgen Inc. Y. Kang: Financial Interests, Personal, Advisory Role, Consulting or advisory role: ALX Oncology, Amgen, Bristol Myers Squibb, DAEHWA Pharmaceutical, Macrogenics, Merck, Roche, Surface Oncology, Zymeworks. All other authors have declared no conflicts of interest.