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The US Food and Drug Administration (FDA) has approved the combination of pembrolizumab, an anti-PD-1 immunotherapy, plus lenvatinib, an oral tyrosine kinase inhibitor, for the first-line treatment of people with advanced renal cell carcinoma (RCC).
The approval is based on the results from the phase 3 CLEAR/KEYNOTE-581 trial, in which the combination showed significant improvement in survival and response to treatment compared to the standard of care with sunitinib.
Pembrolizumab plus lenvatinib reduced the risk of the cancer getting worse by 61% and the time to when the cancer started growing again and the treatment stopped working (progression-free survival) was an average of 23.9 months compared to 9.2 months for sunitinib.
The combination reduced the risk of death by 34% versus sunitinib. 73% of patients responded to treatment and their cancer reduced in size versus 36% with sunitinib. 16% of people had a complete response and 55% had a partial response to treatment with pembrolizumab plus lenvatinib compared to 4% and 32% for those on sunitinib.
Pembrolizumab can cause immune-related side effects, which may be severe or fatal and can affect any organ or tissue in the body. However, if identified early they can be managed to ensure the safe use of pembrolizumab.