- The Food and Drug Administration on Wednesday approved a combination of Merck & Co. and Eisai drugs that were shown in clinical testing to delay the progression of advanced kidney cancer and extend survival for patients when used as first-line therapy.
- The new indication is the latest result from a broad research collaboration between the two companies around their respective drugs Keytruda and Lenvima. Last month, the FDA cleared the combination to treat certain types of endometrial cancer. In 2018, Merck and Eisai agreed to a potentially $5.76 billion deal that would test the drugs' benefits in 11 indications across six types of cancer.
- Merck and Eisai view the combination as a way to give patients and doctors more weapons against cancer. Keytruda, an infusion, works by revving up the immune system. Lenvima, a capsule, works by targeting proteins on cancer cells that help tumors spread.
Keytruda is already Merck's star drug, with sales jumping 23% year over year to total $4.2 billion in the second quarter. Combination studies with Lenvima offer the chance to wrest an even greater share of the oncology market. Overall, Merck is aiming for more than 90 new indications for its cancer medicines by 2028.
The latest approval was based on a three-arm study called CLEAR. The trial compared patients on the Keytruda-Lenvima regimen with a group that got Lenvima and a medicine called everolimus and a third group that received an older medication called sunitinib, approved in 2006 to treat advanced kidney cancer and sold by Pfizer as Sutent. The Keytruda-Lenvima group showed the biggest benefit.
When compared with Sutent, the Keytruda-Lenvima combination treatment reduced the risk of death or disease progression by 61%. Patients on the two-drug therapy had a median of 23.9 months of progression-free survival, compared with 9.2 months for Sutent.
Measured by overall survival, combination therapy reduced the risk of death by about a third compared to Sutent.
Still, the drugs do have side effects. Adverse reactions caused 37% of patients in the Keytruda-Lenvima arm to stop taking one or both of the medications.
Merck won a priority review from the FDA for the drug combination based on benefits seen in the CLEAR study. At the time Merck inked its larger deal with Eisai in 2018, the combination had already received an FDA Breakthrough Therapy Designation for advanced kidney cancer, allowing the company to move faster through the development and review process.