Eli Lilly's Retevmo Helps Non-Small Cell Lung Cancer Patients

Eli Lilly & Company recently announced updates on the Phase 2 clinical trial studying its kinase inhibitor, Retevmo, in RET fusion-positive non-small cell lung cancer (NSCLC). 

The updated analysis of the Phase 1/2 LIBRETTO-001 trial included 355 patients. About 247 of these patients were previously treated with at least one line of platinum chemotherapy, and 69 were treatment-naïve. About 58% of patients received anti-PD-1 or anti-PD-L1 therapy before the study. 

In the trial, Retevmo elicited an objective response rate of 61.1% in patients previously treated with platinum chemotherapy. In contrast, treatment-naïve patients saw an objective response rate of 84.1%, and 26 patients had a central nervous system response rate of 84.6%. 

At a median follow-up of two years in both treatment-naïve patients and platinum-chemotherapy pretreated populations, the median duration of response was 55.2% and 60.9%, respectively. 

Notably, the safety profile of Retevmo was consistent with the known safety profile of the drug in previous trials. The most common adverse events were mild. Nearly 34 patients discontinued treatment, 11 of which were related to Retevmo. 

"The LIBRETTO trial provides the largest set of clinical data for a RET inhibitor, and these results continue to demonstrate evidence of meaningful clinical outcomes for patients with metastatic RET fusion-positive NSCLC treated with Retevmo, including those with difficult-to-treat brain metastases," David Hyman, MD, chief medical officer of oncology at Eli Lilly & Company, said in the announcement. 

"We are continuing to build on the robust body of evidence supporting Retevmo, including through an ongoing randomized Phase 3 confirmatory study, with a planned readout in 2023," Hyman continued. 

In May 2020, FDA approved Retevmo to treat NSCLC, medullary thyroid cancer, and other types of thyroid cancers in patients whose tumors have an alteration in a specific gene. 

Retevmo was the first therapy approved specifically for cancer patients with RET gene alterations. FDA based its approval on a study, which found that the overall response rate for 55 previously treated patients was 69% and 73% for the 88 patients who were not previously treated. 

Currently, a global, randomized, Phase 3 trial is recruiting patients to compare Retevmo to the current standard of care in the first-line treatment of advanced or metastatic RET fusion-positive NSCLC.