- Pfizer and Merck in Germany are kicking off a phase 3 study testing the combination of Merck's PD-L1 inhibitor avelumab with Pfizer's existing tyrosine kinase inhibitor (TKI) Inlyta, the companies said on Tuesday. The study will look at whether the combination of the two drugs is more effective in treating advanced renal cell carcinoma than Pfizer's monotherapy Sutent.
- The first patient out of a planned 583 began treatment on Tuesday. Renal cell carcinoma has particularly severe five-year survival rates.
- The success of the first PD1/PD-L1 checkpoint inhibitors on the market has prompted many companies to pursue combination studies matching PD1 agents with small molecules, chemotherapies, and immuno-oncology drugs.
Bristol-Myers Squibb's Opdivo and Merck's Keytruda have led the way in the anti-PD1 space and are forecast for billions in annual sales by 2020. Their clinical and commercial success is spurring a flood of combination studies. EP Vantage estimates roughly a third of these studies combine PD1/PD-L1 inhibitors with small molecules like Inlyta.
"The first patient receiving treatment in this pivotal trial marks an important milestone in the strategic immuno-oncology alliance between Merck and Pfizer,” said Alise Reicin, Head of Global Clinical Development at Merck.
“We are exploring the potential of innovative, rational combination therapies, which combine avelumab with other treatment modalities to address significant unmet needs that exist in challenging cancers, such as advanced renal cell carcinoma," she said.
This development program for avelumab includes over 1,600 patients being treated across over 15 tumor types. Merck and Pfizer agreed to co-develop and co-commercialize the compound in November 2014.
Inlyta, on the other hand, is designed to be a successor to Pfizer's Sutent. Last year, Inlyta earned $430 million in global sales, a 5% increase from 2014. It is currently indicated in the U.S. and E.U for second-line treatment of advanced renal cell carcinoma.