Eli Lilly and Company (Lilly) has received the US Food and Drug Administration’s (FDA) breakthrough therapy designation for olomorasib in combination with Keytruda (pembrolizumab) to treat a type of lung cancer.
The breakthrough status applies to using the regimen as a first-line treatment for patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) featuring a KRAS G12C mutation. It also requires a PD-L1 expression level of 50% or higher, as determined by FDA-approved tests.
Olomorasib is an investigational oral inhibitor targeting the KRAS G12C, a mutation of the KRAS protein, found in NSCLC and other solid tumours.
The drug candidate had shown preliminary evidence of central nervous system (CNS) activity.
Lilly chief medical officer David Hyman said: “The breakthrough therapy designation recognises 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.
“We look forward to presenting updated data from the olomorasib development programme 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.”
The FDA granted the breakthrough therapy status for olomorasib based on positive data from the LOXO-RAS-20001 and SUNRAY-01 clinical trials.
The LOXO-RAS-20001 trial is an open-label Phase 1/2 study assessing the safety and efficacy of olomorasib in KRAS G12C-mutant solid tumours.
SUNRAY-01 is a Phase 3 clinical trial evaluating olomorasib plus pembrolizumab, with or without chemotherapy, in KRAS G12C-mutant lung cancer.
Lilly said that olomorasib is currently being evaluated in various KRAS G12C-mutated cancers, both as monotherapy and in combination with other drugs.
In June this year, Lilly agreed to acquire Verve Therapeutics, a clinical-stage company focused on genetic medicines for cardiovascular disease, for up to $1.3bn.
