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news.Merck has secured approval from the US Food and Drug Administration (FDA) for Keytruda in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma (RCC).
Image: Merck’s Keytruda anti-PD-1 therapy. Photo: courtesy of Merck Sharp & Dohme Corp.
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Keytruda is an anti-PD-1 therapy, while Inlyta is a tyrosine kinase inhibitor. Keytruda will help enhance the ability of the body’s immune system to detect and combat tumor cells.
Keytruda is a humanized monoclonal antibody, which restricts the interaction between PD-1 and its ligands PD-L1 and PD-L2 to activate T lymphocytes that may affect both tumor cells and healthy cells.
The FDA approval was based on data from the pre-specified interim analysis of the phase 3 Keynote-426 trial that showed significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda in combination with axitinib compared to sunitinib.
Keynote-426 is a randomized, multi-center and open-label trial carried out in 861 patients who had not received systemic therapy for advanced RCC. Patients have been enrolled disregarding of PD-L1 tumor expression status.
Patients were randomized in 1:1 ratio to one of the following treatment arms, including Keytruda 200mg intravenously every three weeks up to 24 months in combination with axitinib 5mg orally and twice daily, and sunitinib 50mg orally and once daily for four weeks and then off treatment for two weeks.
Merck Research Laboratories clinical research vice president Dr Scot Ebbinghaus said: “This represents a new treatment option for patients with advanced renal cell carcinoma, who will now have access to KEYTRUDA as part of a first-line combination regimen.
“Today’s approval reflects Merck’s commitment to patients with cancer and further supports the use of KEYTRUDA to help improve survival outcomes for patients with advanced renal cell carcinoma.”
At present, more than 950 trials are being carried out to assess the potential of Keytruda across a wide variety of cancers and treatment settings.
Keytruda, in combination with pemetrexed and platinum chemotherapy, was approved as the first-line treatment forpatients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
