Sotorasib’s Confirmatory Data in NSCLC Unreliable, Says FDA Panel
An FDA advisory committee on Thursday said the confirmatory trial data for the KRAS inhibitor sotorasib (Lumakras) in previously treated non-small cell lung cancer (NSCLC) cannot be reliably interpreted in the CodeBreaK 200 study. Most members of the Oncologic Drugs Advisory Committee (ODAC) agreed with FDA staff that multiple sources of systemic bias during the […]
KRAS Mutations in Metastatic CRC Predict Survival Benefit of Chemo Combo
Codon-specific KRAS mutations are predictive of an overall survival (OS) benefit for metastatic colorectal cancer (mCRC) patients treated with trifluridine-tipiracil (FTD/TPI; Lonsurf), according to a genomics-based analysis. After identifying biomarkers of resistance and validating the findings in a real-world dataset, researchers showed that patients with KRAS G12-mutant tumors in the phase III RECOURSE trial achieved […]
Adagrasib Shows Anti-Tumor Activity in Heavily Pretreated KRAS-Mutant CRC
Adagrasib (Krazati) demonstrated antitumor activity in heavily pretreated patients with KRAS G12C-mutated, metastatic colorectal cancer (CRC), according to phase I/II study results. Monotherapy with the oral KRAS inhibitor led to responses in 19% (95% CI 8-33) of 43 evaluable patients with CRC, with a median duration of response of 4.3 months (95% CI 2.3-8.3) and […]
KRAS Inhibitor Shrinks Tumors in Over 40% of NSCLC Patients
CHICAGO — More than 40% of patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) responded to treatment with adagrasib, findings from a phase II trial showed. Among 112 evaluable patients in the KRYSTAL-1 study, all of whom were previously treated, the confirmed objective response rate (ORR) was 42.9% with the investigational KRAS G12C inhibitor, […]