Mirati Therapeutics reports updated results from the KRYSTAL-7 Phase 2 study

Mirati Therapeutics announced updated results from the KRYSTAL-7 Phase 2 study evaluating adagrasib combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation at the European Society of Medical Oncology Congress, or ESMO, 2023. These data demonstrate a manageable safety profile and early signs of durability of adagrasib in combination with a checkpoint inhibitor in the first-line NSCLC setting. Summary of clinical results included: In patients with PD-L1 TPS greater than or equal to50%, adagrasib and pembrolizumab demonstrated an overall response rate, or ORR, of 63% and disease control rate, or DCR, of 84% and promising early signs of durability. The 63% confirmed response rate compares favorably to pembrolizumab monotherapy which has demonstrated an ORR of 39-45%. A median progression free survival has not been reached at 10.1 months median follow up. The safety profile of the adagrasib and pembrolizumab combination was consistent with either agent as monotherapy, with a low rate of treatment related adverse events leading to discontinuation of both drugs in only 4% of patients.Treatment related hepatic events occurred in less than10% of patients and were predominantly low grade. No patients discontinued both adagrasib and pembrolizumab due to ALT/AST increase or hepatic-related TRAEs. Mirati plans to initiate a Phase 3 clinical study to evaluate adagrasib in combination with pembrolizumab in the first line setting for KRASG12C-mutated NSCLC with PD-L1 TPS greater than or equal to50%. Initial patient enrollment is expected by year-end 2023.