Impressed by the potential of a combo featuring Keytruda with Eisai’s star cancer drug Lenvima (lenvatinib mesylate), Merck $MRK has stepped up with $300 million in cash and a commitment of more than $5 billion in milestones to kick off a full slate of trials for the duo.
An oral TKI already approved for thyroid cancer and in combination with everolimus for kidney cancer, Eisai noted a little more than a month ago that their drug scored well in a Phase III study for first-line liver cancer. And Merck sees a big future for this drug tied to Keytruda, which is now involved in more than 700 clinical trials.
In this pact, Eisai and Merck will develop Lenvima as a monotherapy and in combination with the checkpoint, with the two sharing development costs. Eisai will book global sales while the two companies share revenue. And they’ll work together now on a pipeline of their own targeting endometrial cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma, as well as a basket trial targeting multiple cancer types.
This deal follows Merck CEO Ken Frazier’s vow to follow up on his $8.5 billion partnership with AstraZeneca on Lynparza with more such revenue-generating pacts.
In a breakdown of the money at stake, Merck will be on the hook for $650 million for options through 2020 and will provide $450 million to reimburse Eisai on its share of the research costs. There’s another $385 million on the table in development milestones and close to $4 billion for sales goals.
What got them here?
In the RCC cohort of Study 111/KEYNOTE-146, researchers tracked an ORR after 24 weeks of treatment of 63%, with tumor regression observed in 93% (28/30) of RCC patients since the initiation of treatment.
From their statement:
The results of the interim analysis (n=23) of the endometrial cancer cohort in Study 111/KEYNOTE-146 as of December 1, 2016, indicated ORR Week 24 of 52.2 percent (95% CI, 30.6-73.2) based on independent radiologic review and 47.8 percent (95% CI, 26.8-69.4) based on investigator review. Additionally, tumor regression was observed regardless of the state of microsatellite instability (MSI). Anti-PD-1 antibodies are generally less effective in patients with low frequency of MSI, which is a biomarker for the inability to repair errors in the base sequence of DNA, or who are MSI negative.
“Together with Eisai, we aim to maximize the value of Lenvima for its current indications while jointly pursuing additional approvals in combination with Keytruda across a wide range of cancers,” said Merck R&D chief Roger Perlmutter. “There is strong scientific evidence supporting synergistic effects of Keytruda when used in combination with Lenvima, and the companies have already received Breakthrough Therapy Designation from the U.S. FDA for the Keytruda/Lenvima combination in renal cell carcinoma. Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world.”
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