Median time from onset to an increase in ALT and AST was 26 and 37 days, respectively and only 1 patient experienced new onset treatment-related ALT/AST increase after 3 months. Increases in alanine transaminase (ALT)/ aspartate transaminase (AST) were consistent with either agent as a monotherapy with Grade 3 TRAEs being highest grade and total incidence of Grade 3 liver function test (LFT) increases of 9%.TRAEs led to discontinuation of both adagrasib and pembrolizumab in 2 patients and only pembrolizumab in 2 patients there were no patients who discontinued only adagrasib due to a TRAE. Treatment-related adverse events (TRAEs) were Grade 1-2 (39%), Grade 3 (40%) and Grade 4 (4%) there were no Grade 5 TRAEs observed. 75 patients were enrolled and evaluable for safety with a median follow-up of 3.5 months (duration of treatment: 2 months).The KRYSTAL-7 and KRYSTAL-1 trials represent the largest dataset evaluating a KRAS G12C inhibitor in combination with a PD-1/L1 checkpoint inhibitor as a first-line treatment for patients with NSCLC harboring a KRAS G12C mutation.These data are the first to demonstrate the tolerability and feasibility of a concurrent combination regimen of a KRAS G12C inhibitor and a PD-1/L1 checkpoint inhibitor. (NASDAQ: MRTX), a clinical-stage oncology company today announced preliminary results from the KRYSTAL-7 Phase 2 trial and KRYSTAL-1 Phase 1b cohort evaluating adagrasib (400mg twice daily) concurrently combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRAS G12C mutation across all PD-L1 subgroups. 5, 2022 /PRNewswire/ - Mirati Therapeutics, Inc. ET (Presentation #LBA4) during the "Proffered Paper session 1" session. Findings will be presented on December 7 at the 2022 ESMO Immuno-Oncology Annual Congress, as an oral presentation from 2:05 p.m.-2:15 p.m.Adagrasib in combination with pembrolizumab demonstrates favorable tolerability and promising preliminary efficacy in patients with first-line advanced/metastatic NSCLC harboring a KRAS G12C mutation.
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