SOLANA BEACH, Calif. - eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a biopharmaceutical company focused on developing treatments for cancer, disclosed the primary analysis from the Phase 2 KICKSTART trial of tomivosertib in non-small cell lung cancer (NSCLC) patients.
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 trial evaluated tomivosertib combined with pembrolizumab against a placebo with pembrolizumab in patients with a high expression of PD-L1. The median PFS was 13.0 weeks for the tomivosertib group, marginally higher than 11.7 weeks for the placebo group.
However, no significant trend favoring tomivosertib was observed in overall survival rates, which remain immature. The tomivosertib arm also reported a higher incidence of Grade 3 or higher treatment-emergent adverse events compared to the placebo arm (67% vs. 37%).
Steve Worland, Ph.D., president and CEO of eFFECTOR, expressed disappointment in the results and indicated that there seems to be no clear path forward for tomivosertib in frontline NSCLC treatment. He thanked the patients, families, and trial site professionals for their contributions to the trial.
Despite these results, eFFECTOR's focus shifts to zotatifin, another drug candidate from its pipeline with a different mechanism, which is expected to enter a potentially registrational trial for estrogen receptor-positive (ER+) breast cancer later in the year.
Preliminary positive median PFS and safety data were presented at the previous year's San Antonio Breast Cancer Symposium. Further data on zotatifin, including the recommended phase 2 dose, is anticipated in the second half of 2024.
Additionally, an investigator-sponsored trial of tomivosertib in acute myeloid leukemia (AML) will continue, based on a distinct mechanistic rationale from NSCLC.
eFFECTOR Therapeutics specializes in selective translation regulator inhibitors (STRIs), targeting the eIF4F complex and its activating kinase, mitogen-activated protein kinase interacting kinase (MNK), to control tumor growth and immune evasion.
The information reported is based on a press release statement from eFFECTOR Therapeutics.
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