Amgen’s cancer drug Lumakras outperformed chemotherapy in a closely watched late-stage clinical trial, the biotechnology company said Tuesday afternoon, helping validate a first-of-its-kind approval for the targeted therapy last year.
In a brief statement, Amgen said treatment with Lumakras extended progression-free survival — a measure of how long patients go without their cancer growing — versus the chemotherapy docetaxel in patients with a certain type of lung cancer who had previously received other drugs.
The drugmaker did not disclose any detailed data on how well its drug compared to docetaxel, indicating only that the results were statistically significant. "Further analyses of the data are ongoing, and we look forward to sharing detailed data at an upcoming medical meeting," said David Reese, Amgen’s head of research and development, in the statement.
Lumakras is the first drug approved to treat cancers caused by mutations in a gene called KRAS. Frequently mutated in lung, colon and pancreatic cancers, the KRAS gene has eluded drug developers for decades. But advances in research opened up new ways to target the gene and its related proteins, leading to Lumakras and, behind it, a growing pipeline of KRAS-targeting cancer medicines.
The Food and Drug Administration approved Lumakras in May 2021 based on clinical trial data that showed it could shrink tumors in a little more than a third of patients with advanced lung cancer that harbored a specific KRAS mutation called G12C. The clearance was conditional, meaning Amgen needs to confirm it through further testing that prove Lumakras’ benefit.
The Phase 3 trial that Amgen now says succeeded is the most direct path for the company to do so. The study enrolled 345 patients with KRAS G12C-mutated non-small cell lung cancer who previously received platinum-based chemotherapy as well as a type of immunotherapy known as a checkpoint inhibitor.
The study’s main goal is comparing Lumakras to docetaxel on progression-free survival, although it will also assess other metrics like tumor response rates and overall survival.
Amgen is also studying Lumakras in combination with other drugs, and in other tumor types outside of lung cancer. Earlier this month, anticipated data on a test of Lumakras alongside immunotherapy showed some effectiveness, but revealed substantial liver toxicity that could limit the potential of using the drugs together.
Amgen shares rose by as much as 2% in Wednesday morning trading.