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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

 
• By Mandy Jackson

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.

lung cancer with cancer cell on the lung and magnifying glass
Responses to Lumakras came sooner and lasted longer than with docetaxel • Source: Shutterstock

Amgen, Inc.’s Lumakras (sotorasib) did not perform as well in detailed results from the Phase III CodeBreaK 200 clinical trial in previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC) presented at the European Society for Medical Oncology (ESMO) meeting on 12 September as it did in a Phase II pivotal trial. It still significantly bested docetaxel on progression-free survival (PFS), but overall survival (OS) was better for the comparator.

Although the trial also showed some signs of the risk of potential liver damage, an issue noted in labeling, it may be a palatable trade-off for patients with KRAS G12C-mutated NSCLC who might be able to avoid chemotherapy with an oral drug that provides an additional month of PFS. Lumakras won accelerated approval from the US Food and Drug Administration in May 2021, with a safety warning about hepatoxicity on its label

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