Biomarker-defined benefit from FLOT plus nivolumab in metastatic gastroesophageal cancer: Extended follow-up and immune-inflammatory markers of the phase II IKF-AIO-moonlight trial.

In 30 seconds

This extended follow-up and subgroup analysis of the multicentre phase II AIO-STO-0417 trial examined FLOT plus nivolumab in patients with advanced gastroesophageal adenocarcinoma. In Arm C, 52 patients received the combination; median progression-free survival was 7.0 months and median overall survival was 14.6 months, with median follow-up of 12.7 months. Positive PD-L1 CPS and low baseline monocyte-to-lymphocyte ratio (MLR) together identified a subgroup with longer overall survival than other patients receiving the regimen. Quality-of-life findings included reduced pain but worse physical functioning and greater fatigue.

Key findings

• With FLOT plus nivolumab, median progression-free survival was 7.0 months and median overall survival was 14.6 months.
• Patients with CPS≥ 1 and low MLR had median overall survival of 32.3 vs 7.4 months (p = 0.044).
• Low NLR was associated with median overall survival of 25.5 vs 6.8 months (p = 0.088); low MLR with 28.4 vs 8.3 months (p = 0.14).
• FLOT plus nivolumab reduced pain but was associated with decreased physical functioning and increased fatigue.

Why it matters

Triplet chemotherapy combined with immunotherapy may offer substantial benefit to selected patients, but its intensity makes patient selection important. These exploratory biomarker findings suggest that baseline MLR alongside PD-L1 CPS could help identify patients more likely to benefit, while the quality-of-life results highlight the need to weigh potential survival gains against treatment burden.

What to keep in mind

The biomarker findings come from subgroup analyses of a phase II trial and include numerically different outcomes that were not statistically significant for several comparisons; the combination arm included 52 patients.