- The Food and Drug Administration has granted approval to Pfizer and Merck KGaA's PD-L1 inhibitor avelumab, which will be marketed under the name Bavencio.
- While the drug will be the fourth checkpoint inhibitor to market, it was approved for the treatment of adults and children over 12 with metastatic Merkel cell carcinoma (MCC), a rare skin cancer, that currently has no other approved therapies.
- The drug was approved under the accelerated approval process, which means that the partners have to conduct further clinical trials to confirm the benefit of the drug. The FDA uses this accelerated pathway to get drugs to market for indications that have extremely limited treatment options.
Bavencio will enter the market behind blockbusters from Merck & Co. and Bristol-Myers Squibb, as well as a contender from Roche. Merck’s Keytruda (pembrolizumab) and Bristol-Myers' Opdivo (nivolumab) have been duking it out over the last two years, racking up indications and topping each other with clinical data.
A setback for Opdivo last summer in first-line lung cancer gave Merck a leg up in that market, allowing it to grab approval in that highly sought-after setting. But Opdivo still leads the market by revenues for now.
Other players like Pfizer, Roche and AstraZeneca have been battling to catch up and bring their own checkpoint inhibitors to market.
All of these drugs target the PD-1/L1 pathway, and allow a patient's own immune system to help attack the cancer cells. Yet, trials from Merck & Co and Bristol-Myers have shown that these treatments are more effective in patients that express higher levels of the PD-L1 biomarker — fractioning the market that could benefit from these highly effective therapies.
For that reason, all of these big pharmas have been partnering their checkpoint inhibitors with other targeted cancer therapies to find drug combinations that could be effective in larger patient populations.
The approval — while only for a small patient population of about 1,600 people in the U.S. — gives Pfizer and partner German Merck an entrance into this market. The approval was based on a trial of only 88 patients with metastatic MCC who had been previously treated with one prior chemotherapy. The trial showed an overall response rate of 33%, meaning those patients experienced a complete or partial shrinkage to their tumors. That response lasted more than six months in 86% of responders and more than a year in 45% of responders.
Merck and Bristol-Myers took similar strategies to get their checkpoint inhibitors approved, gaining approval in the smaller market of melanoma first before pursing approval in other indications.
Avelumab is being tested in a number of other cancer types under the JAVELIN clinical trial program, including non-small cell lung, bladder, gastric, ovarian and renal cancers.
Pfizer and Merck KGaA first linked up on avelumab in November 2014 when Pfizer agreed to pay $850 million upfront, as well as $2 billion in potential milestones. All development was funded jointly and commercialization will be shared.