Abstract No : Presentation 910O
Indication : Head & Neck Cancer
Intervention : Avelumab + ChemoRT
Company : Pfizer
Technology : PD-L1 inhibitor + ChemoRT
697 patients were randomized (avelumab arm, n=350; placebo arm, n=347); baseline characteristics were similar in both arms. At interim analysis, the hazard ratios for PFS per modified RECIST v1.1 (based on 224 events) and overall survival (OS; based on 131 deaths) were 1.21 (95% CI: 0.93-1.57; p=0.920) and 1.31 (95% CI: 0.93-1.85; p=0.937), respectively, both in favor of placebo + CRT. Median PFS and OS were not reached in either arm. Grade ≥3 adverse events (AEs) were more frequent with avelumab + CRT vs placebo + CRT (88% vs 82%); fatal AEs occurred in 6% and 5%, respectively. Rates of AEs leading to discontinuation of any study drug were similar in both arms (33% vs 32% in the avelumab vs placebo arms).
Tolerability was similar in both arms; however, the study did not demonstrate statistically significant improvement in PFS with avelumab + CRT vs placebo + CRT. These results may inform future trial design.