Merck, Eisai Report Yet Another Failure For Keytruda Plus Lenvima Combo Trial, This Time In Endometrial Cancer

Merck & Co Inc MRK and Eisai Co Ltd ESALY ESALF announced that the Phase 3 LEAP-001 trial of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as first-line treatment for patients with advanced or recurrent endometrial carcinoma.

The trial included patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.

Also Read: Double Flops For Merck's Lung Cancer Studies.

At the final analysis, Keytruda plus Lenvima did not improve OS or PFS sufficiently to meet the study's prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel). 

In September, the Phase 3 LEAP-006 trial of Keytuda plus Lenvima in combination with Alimta (pemetrexed) and platinum-containing chemotherapy did not meet its dual primary endpoints of OS and (PFS) versus Keytruda with pemetrexed and platinum-containing chemotherapy in certain types of lung cancer.

In April this year, after disappointing data, Merck and Eisai discontinued the Phase 3 LEAP-003 trial of Keytruda plus Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma.

In May, OS analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial for the first-line treatment of advanced renal cell carcinoma showed that after four years of follow-up, Keytruda plus Lenvima maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21%. 

Price Action: MRK shares are up 0.36% at $104.25 during the premarket session on the last check Friday.