Eli Lilly’s olomorasib has been given Breakthrough Therapy designation by the US FDA as a monotherapy to treat adult patients with advanced pancreatic cancer.
The designation is based on preliminary results from the open-label, multicentre, phase 1/2 LOXO-RAS-20001 study of olomorasib in patients with KRAS G12C-mutant, advanced solid tumours, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.
Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C.
Pancreatic cancer is diagnosed in approximately 60,000 people in the United States each year, with an estimated 50,000 deaths projected annually. Outcomes for patients with metastatic pancreatic cancer are typically poor, with a five-year survival rate under 5%. Growing evidence suggests outcomes for patients with KRAS G12C-mutant pancreatic cancer are worse than those without the mutation, underscoring a persistent gap in treatment and an opportunity to address a significant unmet need. There currently are no approved therapies that specifically target KRAS G12C-mutant pancreatic cancer.
“Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumours harbour a KRAS G12C mutation face limited options once their disease progresses,” said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. “This Breakthrough Therapy designation reflects the early potential we’re seeing with olomorasib in this setting and the critical need for new treatment options.
Olomorasib was previously granted Breakthrough Therapy designation, in combination with Keytruda, for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation and PD-L1 expression ≥ 50%.