Lilly Introduces Breakthrough Olomorasib Therapy for Treating KRAS G12C-Mutant Advanced Pancreatic Cancer
Eli Lilly and Company has introduced olomorasib as a monotherapy for adults with previously treated advanced pancreatic cancer carrying a KRAS G12C mutation.
Olomorasib is an investigational oral, highly selective next-generation inhibitor of the KRAS G12C protein. The therapy is designed to specifically target KRAS G12C mutations, which occur in approximately 1% to 2% of patients with pancreatic cancer, and is being developed as a targeted treatment option for patients with limited therapeutic choices.
The designation is supported by preliminary results from the Phase 1/2 LOXO-RAS-20001 study, which is evaluating olomorasib in patients with KRAS G12C-mutant advanced solid tumours, including patients with advanced pancreatic cancer who have received at least one prior systemic therapy.
Pancreatic cancer is one of the most difficult cancers to treat, with approximately 60,000 cases diagnosed each year in the United States. Patients with metastatic disease have a five-year survival rate of less than 5%, while those with KRAS G12C-mutant pancreatic cancer may have poorer outcomes. There are currently no approved therapies specifically targeting KRAS G12C-mutant pancreatic cancer.
The FDA’s Breakthrough Therapy Designation is intended to accelerate the development and review of medicines for serious conditions where preliminary clinical evidence indicates the potential for substantial improvement over available treatments. Lilly is continuing to evaluate olomorasib across multiple KRAS G12C-mutant cancers, including pancreatic cancer and non-small cell lung cancer.
Olomorasib is currently being studied in the Phase 1/2 LOXO-RAS-20001 trial and in global Phase 3 studies evaluating its use in combination with other treatments for KRAS G12C-mutant non-small cell lung cancer. This is the second Breakthrough Therapy Designation granted to olomorasib, following an earlier designation for its use with pembrolizumab in certain patients with KRAS G12C-mutant non-small cell lung cancer.
