Mirati's KRAS Inhibitor Receives FDA Breakthrough Tag For Lung Cancer Harboring KRAS Mutation

The FDA has granted Breakthrough Therapy designation to Mirati Therapeutics Inc's MRTX adagrasib in non-small cell lung cancer (NSCLC) patients with the KRAS-G12C mutation.
The decision was based on preliminary results from the Phase 1/2 KRYSTAL-01 trial in patients with advanced NSCLC whose cancer had progressed following prior treatment with immunotherapy or chemotherapy.
According to data presented in October, 45% of patients saw an objective response.
Those numbers come from a pooled data set of 51 patients who received 600 mg doses in Mirati's Phase 1/1b and 2. 42% achieved a partial response, and 51% saw stable disease as of the August cut-off.
In a pooled set of 110 patients (including those with colorectal cancer and other tumors), 30% suffered severe/life-threatening treatment-related side effects, the most frequent being increased ALT and AST.
Two patients died due to treatment-related events, including one with pneumonitis and one with cardiac failure.
"We look forward to submitting a New Drug Application for adagrasib in the second half of this year and further advancing adagrasib across a broad development plan to improve clinical outcomes in patients with KRASG12C mutated cancers," CEO Charles Baum said in a statement.
Price Action: MRTX shares are up 3.75% at $168.55 in the premarket session on the last check Friday.