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eFFECTOR Therapeutics | 8-K: Current report

SEC announcement ·  Apr 4 08:40
Summary by Moomoo AI
On April 4, 2024, eFFECTOR Therapeutics, Inc. reported the primary analysis results of its Phase 2 KICKSTART trial, which evaluated tomivosertib in combination with pembrolizumab as a frontline treatment for non-small cell lung cancer (NSCLC) with high PD-L1 expression. The study did not meet its primary endpoint of progression-free survival (PFS), with a hazard ratio of 0.62 and a p-value of 0.21, failing to reach the pre-specified threshold of p≤0.2. The median PFS was slightly higher in the tomivosertib arm compared to the placebo arm. However, the occurrence of Grade 3 or higher treatment emergent adverse events was significantly higher in the tomivosertib arm. Given these results, eFFECTOR Therapeutics has decided not to continue the development of tomivosertib for frontline NSCLC treatment...Show More
On April 4, 2024, eFFECTOR Therapeutics, Inc. reported the primary analysis results of its Phase 2 KICKSTART trial, which evaluated tomivosertib in combination with pembrolizumab as a frontline treatment for non-small cell lung cancer (NSCLC) with high PD-L1 expression. The study did not meet its primary endpoint of progression-free survival (PFS), with a hazard ratio of 0.62 and a p-value of 0.21, failing to reach the pre-specified threshold of p≤0.2. The median PFS was slightly higher in the tomivosertib arm compared to the placebo arm. However, the occurrence of Grade 3 or higher treatment emergent adverse events was significantly higher in the tomivosertib arm. Given these results, eFFECTOR Therapeutics has decided not to continue the development of tomivosertib for frontline NSCLC treatment. Instead, the company will shift its focus to advancing zotatifin for estrogen receptor-positive (ER+) breast cancer, with plans to enter a randomized, potentially registrational trial later in the year. The company also anticipates reporting additional data for zotatifin in the second half of 2024. An investigator-sponsored trial of tomivosertib in acute myeloid leukemia (AML) will proceed, based on a different mechanistic rationale than that for NSCLC.

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