eFfector sees no ‘obvious’ path forward for tomivosertib development in NSCLC

eFFECTOR Therapeutics announced topline results from the primary analysis of the randomized Phase 2 KICKSTART trial which tested tomivosertib or placebo, each combined with pembrolizumab, as frontline treatment for patients with non-small cell lung cancer NSCLC with PD-L1 greater than or equal to50%. Based on 36 events, the hazard ratio for progression free survival with PFS, the primary endpoint of the study, using a stratified Cox proportional hazards model was 0.62 in favor of tomivosertib. The two-sided p value for PFS, based on a stratified log rank test, was 0.21, which did not meet the pre-specified threshold of pless than or equal to0.2. The median PFS was 13.0 weeks in the tomivosertib plus pembrolizumab arm and 11.7 weeks in the placebo plus pembrolizumab arm, respectively. Overall survival results remain immature, however no trend favoring tomivosertib was observed. There were 67% Grade 3 or higher treatment emergent adverse events in the tomivosertib plus pembrolizumab arm versus 37% in the placebo plus pembrolizumab arm. “While there was evidence of modest tomivosertib activity in the trial, based on the totality of the data currently available we do not see an obvious path forward to continue developing tomivosertib in frontline NSCLC,” said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. “We sincerely appreciate the contributions of all the patients, their families, and trial site professionals who contributed to the execution of the trial. We will continue to analyze trial data and hope to present our findings at a future medical conference.” r