A major deal between MSD and Eisai will see the two companies team-up globally to support the development and commercialisation of PBS-listed cancer therapy LENVIMA (lenvatinib mesylate).
LENVIMA, an oral tyrosine kinase inhibitor, was discovered and developed by Eisai. It was listed on the PBS in December 2016 for the treatment of radioactive iodine refractory differentiated thyroid cancer. It was considered for the treatment of advanced renal cell carcinoma at last week's PBAC meeting.
Under the agreement, the companies will jointly further develop and commercialise LENVIMA as monotherapy and in combination with MSD's PBS-listed anti-PD-L1 therapy KEYTRUDA (pembrolizumab).
Eisai will book LENVIMA product sales globally, as monotherapy and in combination, and the two companies will share gross profits equally.
MSD will Eisai an upfront payment of US$300 million, up to US$650 million for certain option rights through 2020, as well as US$450 million as reimbursement for R&D expenses.
Eisai is also eligible to receive a number of additional milestone payments, including in relation to sales, with the potential to provide the company up to almost US$5.8 billion.
Eisai is currently running a phase 3 study of LENVIMA in combination with KEYTRUDA, or with Novartis' AFINITOR (everolimus), compared to chemotherapy for the treatment of renal cell carcinoma.
The companies said interim results from an ongoing Phase 1b/2 trial (Study 111/KEYNOTE-146), evaluating the LENVIMA and KEYTRUDA combination in select solid tumours including renal cell carcinoma, "provided evidence for synergistic effects on the observed overall response rate, regardless of treatment experience or PD-L1 tumor expression."
They now plan to jointly initiate new clinical studies evaluating the combination in 11 potential indications across six types of cancer (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 cancers.
A basket trial tests the effect of one medicine on a single genetic mutation regardless of tumour type.
“Aiming to maximize the potential of LENVIMA and expedite the creation of innovative treatments in this age of 'Cancer Evolution,' we have entered into this collaboration with Merck [MSD] who developed the anti-PD-1 antibody KEYTRUDA,” said Haruo Naito, representative corporate officer and CEO of Eisai. “By providing new treatment options including for refractory cancers with no hopes for a cure to date, we are striving to further contribute to increasing the benefits provided to patients and their families.”
“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 Dr Roger Perlmutter, the head of MSD's global research organisation. “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.”