by NCI Staff
On April 19, 2019, the Food and Drug Administration approved pembrolizumab (Keytruda) in combination with axitinib (Inlyta) for the initial treatment of people with advanced kidney cancer. The approval was based on the results of the KEYNOTE-426 clinical trial, which found that the combination improved how long patients lived overall and without their disease progressing. Further details on the trial results are discussed in the article below.
Results from two large clinical trials are expected to change the initial treatment for many people with newly diagnosed advanced kidney cancer.
In both studies, combination treatments that included a type of immunotherapy called an immune checkpoint inhibitor and the targeted therapy axitinib (Inlyta) led to better outcomes for patients with advanced kidney cancer than treatment with sunitinib (Sutent) alone, the standard of care for first-line therapy.
Results for the two phase 3 trials were reported last month at the American Society of Clinical Oncology Genitourinary Cancers Symposium (GU ASCO) in San Francisco and simultaneously published in the New England Journal of Medicine (NEJM).
The Food and Drug Administration (FDA) has already approved one immunotherapy combinationalready approved one immunotherapy combination as an initial, or first-line, treatment for people with advanced kidney cancer. And, based on these new data, several experts on the disease said further approvals for these patients are likely to be forthcoming.
“There’s a lot of exciting data. The treatment landscape is changing quickly,” said David McDermott, M.D., chief of medical oncology at Beth Israel Deaconess Medical Center, who has been involved in kidney cancer immunotherapy studies.
Evolving Treatment Strategies for Advanced Renal-Cell Cancer
In the last 12 years,