Amgen Inc. remains committed to obtaining full approval from the Food and Drug Administration (FDA) for its Lumakras cancer drug. This comes after an advisory panel voted against the drug during a meeting held on Thursday.
Lumakras was initially granted approval in 2021 under an accelerated program that required further confirmatory trials. The recent panel meeting revolved around reviewing data from a Phase 3 trial known as CodeBreak 200, which assessed Lumakras as a treatment for patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC).
Despite the panel’s 10 to 2 vote against full approval, it’s important to note that the FDA is not obligated to follow their recommendations. However, in many cases, the FDA does take these recommendations into consideration.
Amgen emphasized its commitment to advancing its comprehensive global KRASG12C inhibitor development program. This includes exploring multiple LUMAKRAS combination regimens, such as its potential use in colorectal cancer. The company also expressed its intention to work closely with the FDA to pursue the full approval pathway for this important medicine.
The panel’s vote stemmed from their determination that the trial did not meet its primary endpoint of progression-free survival for patients with advanced lung cancer. The presence of “multiple sources of systemic bias” was highlighted in documents published earlier in the week.
Experts identified various issues with the trial, including an excessive number of patients switching between control and treatment groups, as well as a significant rate of consent withdrawal that affected the reliability of the data.
As stated in the documents, “The trial results are confounded by multiple sources of systemic bias, raising concerns about whether CodeBreaK 200 can be considered an adequate and well-controlled trial.” There were also doubts cast on the reliability of the primary endpoint of progression-free survival by BICR, given the difference in imaging intervals.
Amgen revealed that Lumakras has been administered to over 15,000 patients worldwide up to this point.
In terms of stock performance, Amgen’s shares remained stable in premarket trading. Year-to-date, the stock has gained 0.3%, while the SPDR S&P Biotech ETF XBI has experienced a 13% decline, and the S&P 500 SPX has shown an 11% gain.