Eli Lilly and Company has announced that US Food and Drug Administration (FDA) has granted breakthrough therapy designation to olomorasib, in combination with anti-PD1 therapy Keytruda for first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC). The Breakthrough Therapy designation aims to expedite the development and review of drugs that intend to treat a serious health issue when preliminary clinical evidence indicates that drug may improve on a clinically significant endpoint over already available therapies.
This FDA Breakthrough Therapy designation is based on encouraging results from phase ½ LOXO-RQS-20001 trial and dose optimization portion of the phase 3 SUNRAY-01 trial. This study evaluates the safety, tolerability and preliminary efficacy of olomorasib in patients with KRAS G12C-mutant advanced solid tumors. Olomorasib is currently being studied in KRAS G12C-mutated cancers in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced NSCLC, in combination with immunotherapy for treatment of resected and unresectable NSCLC.
The company stated that the updated results from an integrated analysis of these studies are to be presented at 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. Olomorasib in combination with pembrolizumab has demonstrated promising anti-tumor activity. Olomorasib is an orally available inhibitor of the oncogenic KRAS substitution mutation, G12C, with potential antineoplastic activity.
Dr. David Hyman, Lilly chief medical officer, in a statement in the news release, “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.”
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