Abstract 1221P
Background
In the randomized, double-blind phase II 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 mean differences 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. Table: 1221P
| Instrument | Scale | Least squares mean difference (95% CI) vs baseline after 6 wks - BEMA vs PBO | Median TTD (in m) BEMA / PBO |
| QLQ-C30 fct scales (MD >0 favours BEMA) | Global health status/QoL | -0.3 (-7.9; 7.2) | 5.5 / 6.0 |
| Physical fct | 1.6 (-4.8; 8.0) | 5.5 / 5.9 | |
| Cognitive fct | 3.3 (-2.8; 9.3) | 5.1 / 3.9 | |
| Emotional fct | 5.4 (-0.9; 11.7) | 10.5 / 7.4 | |
| Role fct | 7.8 (-0.5; 16.1) | 5.7 / 3.9 | |
| Social fct | 10.1 (1.6; 18.7) | 5.3 / 5.1 | |
| QLQ-C30 symptom scales (MD < 0 favours BEMA) | Pain | -0.2 (-7.9; 7.5) | 5.7 / 5.2 |
| Fatigue | 1.8 (-5.2; 8.8) | 3.9 / 3.7 | |
| Appetite loss | 2.3 (-8.2; 12.9) | 5.5 / 6.8 | |
| Nausea/vomiting | 0.5 (-6.7; 7.7) | 5.3 / 6.0 | |
| Sleep disturbance | 0.9 (-8.7; 10.5) | 8.8 / 6.1 | |
| EQ-5D (MD >0 favours BEMA) | VAS | 4.0 (-2.1; 10.1) | - |
| Utility index | 0.020 (-0.047; 0.087) | - |
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 III FORTITUDE-101 trial (NCT05052801).
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: Non-Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Daiichi, Bayer, BMS, Merck, Ispen, Five Prime, Gilead, Arcus, Astellas, Molecular Templates, Array; Financial Interests, Institutional, Research Grant: Amgen, AstraZeneca, Daiichi, Bayer, BMS, Merck, Ispen, Five Prime, Gilead, Arcus, Astellas, Molecular Templates, Roche/Genentech, Array/Pfizer. P.C. Enzinger: Financial Interests, Institutional, Advisory Role: ALX Oncology, Arcus Bioscience, 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, Institutional, Advisory Role: Bristol-Myers Squibb Japan, Daiichi Sankyo; Financial Interests, Institutional, Speaker’s Bureau: Bristol-Myers Squibb Japan, Chugai Pharma, Daiichi Sankyo, Lilly, Merck, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda; Financial Interests, Institutional, Funding: Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharma, Daiichi Sankyo, Eisai, Gilead Sciences, Lilly, MSD Oncology, Ono Pharmaceutical, Sanofi, Taiho Pharmaceutical, Yakult Honsha. A. Gnanasakthy: Financial Interests, Institutional, Full or part-time Employment: RTI Health Solutions . A. Jamotte: Financial Interests, Institutional, Full or part-time Employment: Amgen Inc. I. Majer: Financial Interests, Institutional, Full or part-time Employment: Amgen Inc. Y. Kang: Financial Interests, Personal, Advisory Board: ALX Oncology, Zymeworks, Amgen, Novartis, Macrogenics, Daehwa, Blueprint, Surface Oncology, BMS, Merck, Roche. All other authors have declared no conflicts of interest.