GU CANCERSKidney CancerRenal Cancer

Keytruda plus Lenvima Combo Received FDA Approval for Advanced Kidney Cancer

August 20, 2021

Frontline Keytruda plus Lenvima for advanced renal cell carcinoma is an effective treatment with life-prolonging benefits, although patients should be monitored for side effects that can be easily managed.

  • The FDA  approved a combination of Merck & Co. and Eisai drugs (Keytruda and Lenvima) 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.
  • 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.

“It is a great time for the field of (renal cell carcinoma). What an honor and privilege to see these advances impacting the lives of patients. This combo did have though the longest (progression-free survival), and highest response rate and complete response rates as compared to other combinations, though not through a direct head-to-head comparison.” says Dr. Toni K. Choueiri, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston. “Keytruda plus Lenvima is another option,” Dr. Choueiri mentioned,

The latest approval was based on a three-arm study called CLEAR. which demonstrated a 61% reduced risk of disease progression or death in patients treated with the combination therapy. The regimen also contributed to a progression-free survival of 23.9 months compared with 9.3 months in patients treated with Sutent (sunitinib). 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.

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