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Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
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Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for olomorasib in combination with KEYTRUDA (pembrolizumab), a well-established anti-PD-1 therapy.

This designation is for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a high level of PD-L1 expression (≥ 50%).

The Breakthrough Therapy designation is designed to accelerate the development and review process for drugs that show a potential for substantial improvement over existing treatments for serious conditions. Olomorasib is an investigational, oral, and highly selective second-generation inhibitor of the KRAS G12C protein, and it has shown preliminary evidence of activity in the central nervous system.

According to Dr. David Hyman, Lilly’s chief medical officer, the designation recognizes olomorasib's potential to be a significant advancement for patients with KRAS G12C-mutant NSCLC, a population with a continued unmet medical need. The designation is supported by encouraging data 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 of these studies will be presented at the 2025 World Conference on Lung Cancer (WCLC). Specifically, data on olomorasib plus pembrolizumab as a first-line treatment will be presented, as will results from a combination of olomorasib with chemoimmunotherapy (pembrolizumab, pemetrexed, and platinum). These presentations will include a more extensive patient population and longer follow-up period compared to previously released data.

Lilly's development program for olomorasib is ongoing, with two Phase 3 studies, SUNRAY-01 and SUNRAY-02, investigating the drug in various treatment settings for KRAS G12C-mutant NSCLC. The SUNRAY-01 study, for example, is a randomized, double-blind, placebo-controlled trial evaluating olomorasib in combination with standard-of-care therapies to see if it can improve clinical outcomes. Olomorasib is a highly potent inhibitor with a high target occupancy rate, which may allow for safer combinations with less toxicity. The KRAS G12C mutation is one of the most common oncogenes across all tumor types and is present in approximately 13% of patients with NSCLC. Overall, this Breakthrough Therapy designation highlights the promising potential of olomorasib to transform the treatment landscape for a specific and challenging form of lung cancer.

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