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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.

Mirati’s Adagrasib Appears To Maintain CRC Edge In KRAS Race

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

Can Amgen Balance Efficacy, Safety With KRAS/PD-1 Combination?

Data presented during the weekend at WCLC for Lumakras with Keytruda or Tecentriq raised questions about elevated liver toxicity and a lackluster response rate.

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