2020-11-15| Trials & Approvals

Merck, Eisai’s Combo Therapy Registers Superiority against Pfizer’s Drug in Kidney Cancer Trial

by Tulip Chakraborty
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Renal cell carcinoma (RCC) is the most common type of kidney cancer, which is twice as common in men as in women. In the year 2020 alone, it is estimated that there will be approximately 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease.

On November 10th, Merck announced that their blockbuster drug Keytruda combined with Eisai’s Lenvima, had demonstrated superior results in a pivotal trial involving RCC patients compared to Pfizer’s Sutent (sunitinib). Detailed data from the Phase 3 trial is expected to be revealed soon to the regulatory authorities for approvals.

Keytruda, a PD-L1 inhibitor, has already been approved for several indications, including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck cancer, Hodgkin lymphoma, large B-cell lymphoma, bladder cancer, colorectal cancer, among others. Keytruda hit $11.12 billion in sales in 2019 and is poised to reach approximately $24.3 billion by 2026.


KEYNOTE-581 Trial

KEYNOTE-581 is a Phase 3, multicenter, randomized clinical trial which evaluated the combo therapy of Lenvima and Keytruda and Lenvima and everolimus in comparison to sunitinib in 1050 patients with RCC. Results showed that combination therapy with Keytruda met the primary endpoint of progression-free survival and secondary endpoints like overall survival and objective response rate compared to sunitinib. Though the Lenvima plus everolimus combo met the primary endpoint and overall response rate, the overall survival was not altered. The safety profile of both therapies is consistent with previous clinical trials. The detailed results would be presented in an upcoming medical meeting.

Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, of Merck, said, “The results for Keytruda plus Lenvima versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival, and objective response rate, build on the growing scientific evidence that supports the investigation of Keytruda-based combinations for the first-line treatment of advanced renal cell carcinoma. Eisai is committed to working together to continue to explore the potential of the Keytruda plus Lenvima combination, particularly in areas of great unmet need such as renal cell carcinoma”.

Dr. Takashi Owa, Vice President, at Eisai further noted, “The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of Keytruda plus Lenvima for the first-line treatment of advanced RCC. These data also support the potential first-line use of Lenvima plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy. These findings energize our efforts as we continue to advance our understanding and address the unmet needs of patients with difficult-to-treat cancers”.



This new clinical trial data may be key to capturing the already crowded kidney cancer treatment field. Both Keytruda and Lenvima are separately approved to treat kidney cancer, with the combination therapy showing better results than Pfizer’s long-standing standard kidney cancer treatment Sutent. Keytruda, in combination with Inlyta, has also been shown to be more beneficial than Sutent.

Bristol Myers Squibb also reported that combination therapy of their PD-1 inhibitor, Opdivo, and Exelixis’ tyrosine kinase inhibitor Cabometyx is significantly better than Sutent. Besides, its Opdivo plus Yervoy combo has also shown promising results by reducing the risk of death by 31% as compared to Sutent. With Merck and BMS demonstrating better efficacy with their combo therapies, Pfizer’s hold on the market is challenged.

By T. Chakraborty. Ph.D.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: FDA Accepts Opdivo, Cabometyx Combo’s Priority Review Applications



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