Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage research and development, biotechnology company, today presented two-year follow-up data from a pooled analysis of the Phase 1/1b Cohort and Phase 2 Cohort A for the KRYSTAL-1 study evaluating adagrasib (KRAZATI®) in patients with non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation.
In the pooled analysis, adagrasib demonstrated durable efficacy with a median overall survival (OS) of 14.1 months and a 2-year OS rate of 31% in patients with previously treated KRASG12C-mutated NSCLC. Exploratory analyses suggested clinical benefit in patients with treated, stable central nervous system (CNS) metastases at baseline with clinical benefit noted across most baseline co-mutations.
In the study, adagrasib demonstrated a manageable long-term safety profile with low grade treatment-related adverse events (TRAEs). Hepatotoxicity was not observed in any patients who received adagrasib within 30 days of prior immunotherapy and, overall, there was a low rate of grade >3 hepatoxicity.
A confirmatory Phase 3 study, KRYSTAL-12, is ongoing, evaluating adagrasib vs. docetaxel in previously treated patients with KRASG12C-mutated NSCLC.
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