FDA approves combination of Merck & Co.'s Keytruda, Pfizer's Inlyta for first-line kidney cancer

Merck & Co. announced Monday that the FDA has expanded the label for Keytruda (pembrolizumab) to include use in combination with Pfizer's tyrosine kinase inhibitor Inlyta (axitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC). Merck noted that the approval, the first for Keytruda in advanced RCC, also makes it the first anti-PD-1 immunotherapy cleared by the FDA "as part of a combination regimen that significantly improved overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) versus [Pfizer's Sutent] sunitinib in patients with advanced RCC." 

The decision is based on findings from the randomised Phase III KEYNOTE-426 trial of 861 patients who had not received systemic therapy for advanced RCC. Patients were enrolled regardless of PD-L1 tumour expression status. 

For the main efficacy measures, an interim analysis unveiled in February showed that compared to Sutent monotherapy, the combination of Keytruda plus Inlyta cut the risk of death by 47 percent, while the risk of disease progression or death was reduced by 31 percent. KEYNOTE-426 also found that ORR was 59 percent for patients who received the combination therapy versus 36 percent for those treated with Sutent. "Consistent results were observed across pre-specified subgroups, [International Metastatic RCC Database Consortium] risk categories and PD-L1 tumour expression status," Merck noted.

The company also reported that estimated survival rates at 12 months were 89.9 percent in the Keytruda combination arm, compared with 78.3 percent for Sutent, while the 18-month survival estimates were 82.3 percent and 72.1 percent, respectively. Median survival was not reached in either group. 

Cowen analyst Yaron Werber said the approval, which comes two months ahead of expectations, allows the combination therapy to get an early launch ahead of other rival products. Bristol-Myers Squibb's immunotherapy combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) is currently considered a gold standard for previously untreated patients with advanced kidney cancer. Analysts anticipate that Keytruda will generate more than $10 billion for Merck this year

For related analysis, see ViewPoints: Keytruda’s road to riches in RCC not yet written in the stars. See also, ViewPoints: Keytruda gives no quarter, as well as KOL Views Results: Leading oncologist says 'not so fast' on anointing Keytruda king in RCC.

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