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EFFECTOR Reports Results Of Phase2 KICKSTART Trial Of Tomivosertib-Pembrolizumab In NSCLC
(RTTNews) - eFFECTOR Therapeutics, Inc. (EFTR) announced Thursday 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 =50%.
Based on 36 events, the hazard ratio for progression free survival (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 p=0.2. 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.
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