Mirati Therapeutics Presents Two-Year Follow-Up Data from KRYSTAL-1 Study

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Mirati Therapeutics Presents Two-Year Follow-Up Data from KRYSTAL-1 Study

Mirati Therapeutics, Inc.® (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.

"This data reinforces the ability of adagrasib to positively impact patients as a potential best in class option," said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "Adagrasib offers a differentiated option for KRASG12C-mutated NSCLC as evidenced by its clinical activity in the CNS and ability to sequence adagrasib immediately after prior immunotherapy. We look forward to continuing to advance adagrasib across lines of therapy in a range of tumor types for the benefit of patients living with KRASG12C-mutated cancer."

"These data continue to reinforce the benefit of adagrasib for patients living with KRASG12C-mutated NSCLC who are in need for better options than the historical standard of care chemotherapy," Shirish M. Gadgeel, MD, head, the Division of Hematology/Oncology, associate director, Patient Experience and Clinical Care, the Henry Ford Cancer Institute. "The long term overall survival for adagrasib is meaningful for patients."

In December of 2022, adagrasib was added to the National Comprehensive Center Network (NCCN) Guidelines for patients living with previously treated KRASG12C-mutant NSCLC. Following, adagrasib was added the NCCN guidelines for CNS Cancers for patients living with previously treated KRASG12C-mutant NSCLC and CNS metastases.

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