FDA Grants Breakthrough Therapy Designation to Lilly-Merck Combo Drug for Advanced Lung Cancer

The US FDA has granted Breakthrough Therapy designation to Eli Lilly's olomorasib in combination with Merck's Keytruda for the treatment of unresectable advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation and PD-L1 expression ≥ 50%. The Breakthrough Therapy designation aims to expedite the development and review of drugs with preliminary clinical evidence indicating substantial improvement over already available therapies. The FDA 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.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Eli Lilly's olomorasib in combination with Merck's Keytruda (pembrolizumab) for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%. The Breakthrough Therapy designation aims to expedite the development and review of drugs that show substantial improvement over existing therapies for serious conditions [1].

The FDA's decision is based on encouraging results from the Phase 1/2 LOXO-RAS-20001 trial and the dose optimization portion of the Phase 3 SUNRAY-01 trial. Updated efficacy and safety data for olomorasib will be presented at the 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC), taking place September 6-9 in Barcelona, Spain [1].

Olomorasib is a potent and highly selective second-generation inhibitor of KRAS G12C, with preliminary evidence of central nervous system (CNS) activity. 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 [1].

Eli Lilly's chief medical officer, David Hyman, M.D., commented, "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." Lilly will present updated data from the olomorasib development program at WCLC, including results from the Phase 1/2 LOXO-RAS-20001 study and Phase 3 SUNRAY-01 trial [1].

Olomorasib is currently being studied in various clinical trials, including the Phase 3 SUNRAY-01 and SUNRAY-02 studies, which are evaluating its efficacy and safety in combination with pembrolizumab and chemotherapy as first-line treatment for KRAS G12C-mutant metastatic NSCLC [1].

References:
[1] https://www.biospace.com/press-releases/lillys-olomorasib-receives-u-s-fdas-breakthrough-therapy-designation-for-the-treatment-of-certain-newly-diagnosed-metastatic-kras-g12c-mutant-lung-cancers