After Back To Back Failure For Keytruda Plus Lenvima, Merck Touts Durable Clinical Benefit For The Combo In Advanced Kidney Cancer

Merck & Co Inc MRK announced data from the final pre-specified overall survival (OS) analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial investigating Keytruda (pembrolizumab) plus Eisai Co Ltd's ESALY Lenvima (lenvatinib) for the first-line treatment of advanced renal cell carcinoma (RCC).
These data will be presented at the upcoming American Society of Clinical Oncology Annual Meeting.
Also Read: Merck, Eisai Shelve Keytruda Plus Lenvima Combo Trial In Skin Cancer Setting, Disappoints In Certain Type Of Colorectal Cancer.
After four years of follow-up, Keytruda plus Lenvima maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21%.
The 24- and 36-month estimated OS rates were 80.4% and 66.4% for Keytruda plus Lenvima versus 69.6% and 60.2% for Pfizer Inc's PFE Sutent (sunitinib), respectively.
Keytruda plus Lenvima reduced the risk of disease progression or death by 53%, with a median progression-free survival (PFS) of 23.9 months versus 9.2 months for sunitinib.
The objective response rate (ORR) was 71.3%, with a complete response (CR) rate of 18.3% for Keytruda plus Lenvima versus an ORR of 36.7% 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.
Price Action: MRK shares closed at $112.30 on Thursday.