US biotech company Mirati Therapeutics announced positive Phase II results for its investigational treatment adagrasib as a treatment for KRAS-mutated lung cancer.

The Phase II KRYSTAL-1 study is evaluating adagrasib in patients with advanced non-small-cell lung cancer (NSCLC) with the KRAS G12C mutation, prior to systemic therapy.

Adagrasib is an investigational oral small-molecule inhibitor of KRAS G12C that is optimised to sustain target inhibition.

The analysis, which was completed in the intent-to-treat population, showed adagrasib demonstrated an objective response rate (ORR) of 43% and a disease control rate of 80%.

“The KRAS mutation has historically been challenging to target, leaving patients with limited treatment options,” said Charles Baum, president and chief executive officer, Mirati Therapeutics.

“These positive topline data further strengthen our belief in adagrasib as a potentially differentiated therapy for patients with non-small cell lung cancer harbouring the KRASG12C mutation. We look forward to submitting our New Drug Application to the US Food and Drug Administration in the fourth quarter of 2021 and advancing our expanding adagrasib development program, which includes numerous monotherapy and combination studies in KRASG12C-mutated solid tumours,” he added.

Mirati is also planning to submit the detailed results from the ongoing Phase II registration-enabling cohort of the KRYSTAL-1 study for presentation at a medical congress in early 2022.

In addition to NSCLC, adagrasib is being evaluated as a monotherapy and in combination with other anti-cancer therapies in patients with advanced KRAS G12C-mutated solid tumours, including colorectal cancer and pancreatic cancer.