Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination with anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation and PD-L1 expression ≥50%, as confirmed by FDA-approved tests.
Olomorasib is a highly selective, second-generation KRAS G12C inhibitor with preliminary evidence of central nervous system (CNS) activity.
The Breakthrough Therapy designation is intended to accelerate the development and review of therapies that show substantial improvement over existing FDA-approved treatments based on early clinical evidence.
The Breakthrough Therapy designation recognizes the potential for olomorasib to be a meaningful treatment advance and highlights the continued unmet need for improved options for patients with KRAS G12C-mutant NSCLC, particularly in the first-line setting in combination with standard-of-care immunotherapy," said David Hyman, M.D., Lilly chief medical officer. "We look forward to presenting updated data from the olomorasib development program in significantly more patients and with longer follow-up at WCLC and continuing to investigate olomorasib in combination with immunotherapy-based regimens in a variety of treatment settings across the Phase 3 SUNRAY-01 and SUNRAY-02 studies."
Lilly will present updated results from its olomorasib clinical program—including the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 dose optimization study—at the 2025 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC), September 6–9 in Barcelona, Spain.
The company is also investigating olomorasib in combination with immunotherapy-based regimens across multiple treatment settings in its ongoing SUNRAY-01 and SUNRAY-02 Phase 3 studies.