Amgen’s Lumakras Efficacy Confirmed In Phase III, But Not As Strong As Phase II
ORR 28% Versus 37% In Trial Prior To Accelerated Approval
Lumakras data at ESMO in KRAS G12C-mutated lung cancer bested docetaxel on PFS, and largely on safety. OS was better for chemotherapy, but the trial was not powered for statistical significance on OS.
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In this week's podcast edition of Five Must-Know Things: a big US approval for BMS; Roche touts its diverse R&D pipeline; Lumakras’s mixed Phase III results in lung cancer; Japan controversy over a COVID-19 antiviral; and GSK's vaccine strategy in India.
A planned Phase II trial for PLK1 inhibitor onvansertib in KRAS-mutant colorectal cancer may support accelerated approval, but results are two years off and the company cut its prostate cancer plans to conserve cash.
Remaining questions after ASCO include whether Lumakras (sotorasib) might work in first-line NSCLC with certain co-mutations and if ocular toxicities will hamper bemarituzumab in gastric cancer.