Keytruda/Inlyta combo scores FDA approval in advanced kidney cancer

pharmafile | April 23, 2019 | News story | Manufacturing and Production, Sales and Marketing FDA, MSD, Pfizer, Sutent, inlyta, keytruda, pharma 

MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) has secured another approval from the FDA, this time as a first-line treatment in combination with Pfizer’s Inlyta (axitinib) in advanced renal cell carcinoma.

The FDA made the decision based on Phase 3 data which showed that the combo significantly improved overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to Pfizer’s Sutent (sunitinib).

Specifically, Keytruda plus Inlyta reduced the risk of death by 47% and improved PFS by 31% compared to Sutent, while the additional efficacy outcome measure of ORR stood at 59% compared to 36% with Sutent. The manufacturer noted that the findings remained consistent across pre-specified subgroups, IMDC risk categories and PD-L1 tumour expression status.

“Given the aggressive nature of the disease, many patients with advanced renal cell carcinoma need additional treatment options that can help improve survival outcomes,” explained Dr Brian Rini, Medical Oncologist at Cleveland Clinic Cancer Center and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. “Pembrolizumab in combination with axitinib offers an important new therapeutic option for physicians to consider when approaching initial treatment for patients newly diagnosed with advanced renal cell carcinoma.”

Dr Scot Ebbinghaus, Vice President, Clinical Research at MSD, also commented: “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 MSD’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.”

Matt Fellows

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