A panel of experts will vote on whether Lumakras (sotorasib) should be approved for the treatment of adults with previously treated locally advanced or metastatic (spread to other parts of the body) KRAS G12C-mutated non-small cell lung cancer, according to an announcement from Amgen, the manufacturer of the drug.
The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the available data and vote on the drug’s potential FDA approval on Oct. 5, 2023.
Lumakras works by inhibiting the KRAS G12C mutation, which is found in approximately 13% of patients with lung cancer, according to a study published in The Journal of Molecular Diagnostics. This mutation amplifies pathways that lead to the creation of cancerous cells. In May 2021, Lumakras was granted an accelerated approval for patients with KRAS G12-mutant non-small cell lung cancer who were previously treated with at least one systemic therapy, marking the first targeted therapy to become available for this patient population.
ODAC will review data from the CodeBreaK trials, which are testing Lumakras in patients with advanced solid tumors that harbor a KRAS G12C mutation. According to the press release, studies have shown that Lumakras has a favorable benefit/risk profile — meaning that it benefits patients more than it poses risks to them — for patients with both lung and colorectal cancer. Researchers are also analyzing the use of Lumakras in combination with other drugs.
Serious side effects that have been observed with Lumakras include liver damage, which occurred in 1.7% of patients enrolled in the CodeBreaK 100 study; and interstitial lung disease (scarring of the lungs), which occurred in 0.8% of patients in CodeBreaK 100, all of which were moderate to severe.
The most common side effects that occurred in 20% or more of patients being treated with Lumakras were diarrhea, musculoskeletal pain, nausea, fatigue, liver toxicity and cough.
Despite these side effects, findings from the phase 3 CodeBreaK 200 trial that were presented at the 2022 European Society of medical Oncology Congress showed that Lumakras decreased the risk of disease progression or death and improved quality of life compared with docetaxel in patients with previously treated non-small cell lung cancer. Data showed that 40.4% of patients receiving docetaxel experienced side effects, compared with 33.1% for those receiving Lumakras. Additionally, 22.5% of patients given docetaxel experienced at least one serious side effect, compared to only 10.7% for those given Lumakras.
“We believe in the clinical value of Lumakras for prescribers and patients navigating KRAS G12C-mutated (non-small cell lung cancer), and we look forward to discussing the comprehensive data package for Lumakras with members of the Committee,” Dr. David M. Reese, executive vice president of Research and Development at Amgen, said in the press release.
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