eFFECTOR Therapeutics, Inc. declared preliminary results from the first analysis of the KICKSTART Phase 2 clinical trial on Thursday. The trial studied whether tomivosertib or placebo, when used with pembrolizumab, could effectively treat patients diagnosed with non-small cell lung cancer showing PD-L1 equal to or more than 50%.
Upon analyzing 36 incidents, tomivosertib proved beneficial when gauging progression free survival (PFS), the study's primary indicator. Researchers used a stratified Cox proportional hazards model to determine this and found the hazard ratio was 0.62 in favor of tomivosertib.
However, when the PFS findings were subjected to a stratified log rank test, the resulting p-value was 0.21, unable to match the preset threshold of p=0.2. Regardless, the median PFS for patients treated with both tomivosertib and pembrolizumab stood at 13.0 weeks, showing a slight edge over the 11.7 weeks recorded in the treatment group that used the placebo and pembrolizumab.
The final results on overall survival are yet to mature, and no inclination towards tomivosertib has been noticeable thus far. The treatment group that received tomivosertib alongside pembrolizumab reported 67% instances of grade 3 or higher treatment emergent adverse incidents, which is significantly higher than the 37% reported in the placebo arm.