Eli Lilly (LLY) has announced a Phase 3 trial win for its targeted cancer therapy Retevmo (selpercatinib) in patients with a specific type of lung cancer who have previously undergone initial therapy such as surgery.
Citing topline data from its LIBRETTO-432 study, the Indiana-based drugmaker said on Monday that Retevmo reached the trial’s primary endpoint, leading to a statistically significant and clinically meaningful benefit in event-free survival.
The global trial, designed to test selpercatinib versus placebo as adjuvant therapy, enrolled 151 patients with early-stage non-small cell lung cancer whose tumors were positive for a genetic variation called rearranged during transfection (RET) fusion.
Retevmo is currently available in the U.S. for adults with RET fusion-positive NSCLC. While initial data from LIBRETTO-432 indicated a trend favoring Retevmo in terms of overall survival, one of the secondary endpoints, the findings were too immature to reach a definitive conclusion.
Regarding tolerability, Lilly (LLY) said that the twice-daily oral medication indicated a safety profile consistent with prior data from its development program.
The company intends to discuss the results with global health regulators. It also plans to release full data at a future medical event and submit the results for publication in a peer-reviewed journal.