Is Amgen's Lung Cancer Drug Lumakras Up to the Mark? FDA Briefing Raises Concerns

The FDA released briefing documents ahead of Oncologic Drugs Advisory Committee meeting scheduled for October 5 to review Amgen Inc's AMGN supplemental application for complete approval of Lumakras (sotorasib) for previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC)

Staff reviewers said the company's late-stage trial might not be considered "adequate and well-controlled," according to briefing documents.

Amgen's drug, Lumakras, was approved by the FDA in May 2021 under an accelerated pathway for advanced lung cancer patients with KRAS mutations who have received at least one prior systemic therapy. 

The potential systemic bias in CodeBreaK 200 may be difficult to overcome to determine the superiority of sotorasib over docetaxel reliably, given the marginal progression-free survival benefit and no difference in overall survival, the FDA staff said.

Data from the confirmatory study showed that Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34%, compared with chemotherapy.

Amgen generated $285 million in Lumakras sales in 2022.

William Blair writes that the documents paint a rather unfavorable picture of Amgen, casting a shadow. 

The findings, while not necessarily indicating that Lumakras will be retracted from the market for its existing use, imply the potential need for an additional confirmatory trial. 

The commercial prospects for Lumakras in non-small cell lung cancer appear to be declining. However, the blow might be softened by encouraging outcomes in colorectal cancer treatments, as indicated by the forthcoming CodeBreaK 300 data scheduled for presentation at ESMO. 

Additional planned combination studies might also play a role in mitigating the impact of the less than stellar outcomes of CodeBreaK 200.

Price Action: AMGN shares are down 1.91% at $261.22 on the last check Tuesday.