Eisai and Merck & Co Inc (MSD) will present data at the American Society of Clinical Oncology (ASCO) meeting from their Phase III trial for the combination therapy of Lenvima plus Keytruda as a first-line treatment for advanced renal cell carcinoma (RCC).

The preview data is positive, showing after four years of follow-up, Lenvima plus Keytruda maintained a clinically meaningful overall survival (OS) benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). The 24- and 36-month estimated OS rates were 80.4% and 66.4% for Lenvima plus Keytruda versus 69.6% and 60.2% for sunitinib, respectively.

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Results from the final pre-specified OS analysis were consistent with the results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial. Additionally, Lenvima plus Keytruda reduced the risk of disease progression or death by 53% (HR=0.47 [95% CI, 0.38-0.57]), with a median progression-free survival (PFS) of 23.9 months (95% CI, 20.8-27.7) for Lenvima plus Keytruda versus 9.2 months (95% CI, 6.0-11.0) for sunitinib.

The objective response rate (ORR) was 71.3% (95% CI, 66.6-76.0) with a complete response (CR) rate of 18.3% for Lenvima plus Keytruda versus an ORR of 36.7% (95% CI, 31.7-41.7) with a CR rate of 4.8% for sunitinib.

There were no new safety signals and the safety profile at the final OS analysis was consistent with the primary analysis.

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Sunitinib malate, an oral multi-targeted tyrosine kinase inhibitor, is currently marketed as Sutent by Pfizer.

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GlobalData analysts forecast the rise in sales for Merk’s Keytruda reaching US $30 billion by 2027. While Eisai’s Lenvima sales are predicted to peak in 2025 at US $3.7 billion, and Pfizer’s Sutent sales are expected to continue its downward trend and shrink to only US $306 million by 2027.

Lenvima plus Keytruda is approved in the US, the EU, Japan, and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma. Lenvima is marketed as Kisplyx for advanced RCC in the EU.

Eisai and Merck are studying the Lenvima plus Keytruda combination through the LEAP clinical program in various solid tumour indications.

The results come on the heels of the failure of Lenvima and Keytruda combination therapy’s Phase III trials LEAP-003 (NCT03820986) and LEAP-017 (NCT04776148) investigating it as a first-line treatment in patients with metastatic melanoma and relapsed/refractory colorectal cancer, respectively.