An Amgen Inc. lung cancer drug, sotorasib, targets an aggressive genetic mutation called KRAS. In the Phase II trial, this drug has shown to provide durable clinical benefit with pretreated non-small cell lung cancer (NSCLC) who harbors KRAS p.G 12C mutations. Sotorasib is the first-in-class small molecule that specifically and irreversibly inhibits KRAS p.G 12C. This international study enrolled 120 cancer patients excluding those with untreated active brain metastases. About 80% of patients’ disease responded to treatment or remained stable.
In this trial, the enrolled patients were followed for a median period of 12.2 months and of these, 46 patients experienced a confirmed response. This results in an objective response rate of 37.1 percent. Dr Bob Li, who led the Phase II study said, “This is a historic milestone in lung cancer therapy. After four decades of scientific efforts in targeting KRAS, sotorasib has potential to be the first targeted treatment option for this patient population with a high unmet need.”
For the treatment of KRAS-mutated lung cancer, these findings are a significant advance in the field. Almost all the patients in the study had received prior treatment with either chemotherapy or with immunotherapy drugs, while 80% of them had received both. Amgen has filed for approvals with regulators in six countries. If approved, sotorasib will be the first direct inhibitor of the mutation. While Amgen is the first to reach regulators with KRAS-blocking drug, other companies are also following close behind.
More clinical trials of sotorasib alone as well as in combination with other type of cancer drugs are also ongoing with the purpose to benefit more patients.
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