- Merck & Co and partner Eisai won't be able to win a quick U.S. approval of their combination therapy for previously untreated liver cancer after another drug regimen beat them to market.
- The Food and Drug Administration issued a complete response letter to Merck's and Eisai's application for accelerated clearance of their respective drugs Keytruda and Lenvima in unresectable hepatocellular carcinoma, saying the companies didn't prove the combination offers a "meaningful advantage" over available treatment.
- While the accelerated approval path is now closed, the two companies already have a larger, Phase 3 study underway and said they plan to keep working with the FDA to win an OK.
It's a rare setback for Merck's market-leading cancer therapy Keytruda, which brought in sales of $3.3 billion in the first three months of this year alone.
In its first-quarter financial filing, Merck said the application for Keytruda and Lenvima was already under review at the FDA. But before the target review completion date, the FDA approved a combination therapy from Roche for the same set of patients.
Merck and Eisai's pitch was supported by data showing the two drugs helped to shrink tumors, a surrogate endpoint on which drugmakers can ask for accelerated approval. The FDA had also granted Keytruda and Lenvima a Breakthrough Therapy designation for the liver cancer indication, which requires the treatment in question offering a substantial improvement over available drugs.
The May 29 approval of Roche's Tecentriq and Avastin, however, was based on a trial that found the drugs extended survival compared to standard of care — raising the bar for an accelerated approval. Merck and Eisai will now have to submit data from a bigger, late-stage study to win clearance.
Merck said the Phase 3 study of Keytruda and Lenvima in hepatocellular carcinoma is already fully enrolled.
The New Jersey-based drugmaker partnered with Japan's Eisai in 2018 in a deal worth as much as $5.76 billion. Merck got the rights to 50% of gross profits from Lenvima and made plans to launch a series of studies to test the medicine in combination with Keytruda.
U.S., Australia and Canadian regulators all approved the combination of Keytruda and Lenvima for certain endometrial tumors the next year.