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Amgen Wins World-First Lumakras Approval, Faces Challenge Of COVID-Era Launch

US FDA Cleared KRAS G12C Inhibitor For Second-Line NSCLC

Executive Summary

Commercial EVP Murdo Gordon said launching sotorasib during the pandemic is a tougher challenge than encouraging doctors to screen lung cancer patients for KRAS G12C mutations and raising patient awareness.

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Amgen’s Lumakras Efficacy Confirmed In Phase III, But Not As Strong As Phase II

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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The company is reporting strong ORR, durability and PFS at ESMO in heavily pretreated colorectal cancer, an indication where Amgen’s Lumakras has struggled.

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