The U.S. Food and Drug Administration (FDA) on Thursday granted Breakthrough Therapy designation to Eli Lilly and Co.’s (NYSE:LLY) olomorasib, in combination with Merck & Co. Inc.’s (NYSE:MRK) anti-PD-1 therapy Keytruda (pembrolizumab), for the first-line treatment of unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%.
Olomorasib is a potent and highly selective second-generation inhibitor of KRAS G12C with preliminary evidence of central nervous system (CNS) activity.
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The Breakthrough Therapy designation aims to expedite the development and review of drugs intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.
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The FDA Breakthrough Therapy designation is based on results from the Phase 1/2 LOXO-RAS-20001 trial and the dose optimization portion of the Phase 3 SUNRAY-01 trial.
Updated results from an integrated analysis from these studies will be presented at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer.
In an oral presentation (Abstract #MA02.06), Lilly will report on an integrated analysis of efficacy and safety results in patients with KRAS G12C-mutant NSCLC who received olomorasib plus pembrolizumab as first-line treatment in the dose optimization cohorts of the Phase 1/2 LOXO-RAS-20001 study and Phase 3 SUNRAY-01 study.
In a second oral presentation, Lilly will report results of an integrated analysis in patients with KRAS G12C-mutant advanced or metastatic NSCLC who received olomorasib in combination with chemoimmunotherapy (pembrolizumab, pemetrexed, and platinum) as a first-line treatment in the Phase 1/2 LOXO-RAS-20001 trial and safety lead-in for the Phase 3 SUNRAY-01 trial.
As of Jan. 15, 2025, 85 patients received olomorasib plus pembrolizumab.
With a median follow-up of 7.6 months, the ORR was 71% in all patients (n=82) regardless of PD-L1 expression and 85% in patients with PD-L1 ≥50% who received olomorasib 100 mg BID (n=26).
Responses were durable across all patients, as the median DOR was not yet reached, and the six-month PFS rate was 77%.
LLY, MRK Price Action: Eli Lilly stock is up 1.21% at $746.54 and Merck is down 0.52% at $83.74 at publication on Thursday.
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