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Merck has clinical studies underway with drugs and drug combinations that could broaden its presence in prostate cancer. It just struck a $290 million deal to add another one.
The sum is an upfront payment to Orion, a Finland-based company with a small molecule designed to treat advanced prostate cancer by going after a novel target. The drug, ODM-208, is currently in Phase 2 testing and Orion has been looking ahead to Phase 3. Under the new partnership announced Wednesday, Orion and Merck will share in that late-stage clinical development, as well as the commercialization of the prostate cancer drug, if it’s approved.
Merck already has a piece of the market for drugs that treat advanced prostate cancer. The company has a commercialization agreement with AstraZeneca covering that company’s drug, Lynparza. In 2020, the drug added metastatic castration-resistant prostate cancer to its list of FDA-approved indications. Lynparza is part of a class of medicines called PARP inhibitors, which only address patients whose tumors have a particular genetic profile. The Orion deal gives Merck the opportunity to offer another approach.
The growth of some cancers, such as prostate cancer, is driven by hormones. Hormone therapies that block the production of these hormones are part of the current treatment regimens for these cancers. ODM-208 is designed to block CYP11A1, an enzyme that plays a key role in the production of steroid hormones. According to Orion, this drug is the first to work by this mechanism. In its 2021 financial statement, the company said ODM-208 has the potential to treat cancers that have become resistant to standard hormonal treatments.
Though Orion and Merck are now equal partners in the development of ODM-208, the agreement gives the pharma giant the option to gain an exclusive global license to the molecule. If Merck exercises that option, it takes on full responsibility for development and commercialization expenses. Orion would be eligible for milestone payments, plus royalties from the sales of an approved product. No financial details about the option or the milestones were disclosed, but Dean Li, president of Merck Research Laboratories, sees the Orion drug as a promising new approach to hormone therapy.
“Targeting CYP11A1 provides a compelling approach to suppressing the production of steroid hormones, a key driver of prostate cancer,” Li said in a prepared statement. “We believe ODM-208 has the potential to complement our existing program in prostate cancer and look forward to working with the team at Orion.”
Not all of Merck’s research efforts in prostate cancer have been successful. In March, the company stopped a Phase 3 study testing Lynparza in combination with its blockbuster cancer immunotherapy, Keytruda, in patients with metastatic castration-resistant prostate cancer. The decision to terminate the study was made after an interim analysis found that that the combination did not improve overall survival compared to the control arm.
A longstanding alliance with Eisai covers the development and commercialization of Lenvima, a small molecule designed to block enzymes called tyrosine kinases. A combination of Lenvima and Keytruda has reached Phase 3 testing in 14 tumor types, including prostate cancer. In yet another alliance, Merck is working with antibody drug conjugate specialist Seagen. The research spans tests of one of that company’s drugs, ladiratuzumab vedotin, by itself and in combination with Keytruda. One of the studies is a Phase 2 test evaluating the drug combination in solid tumors, including prostate cancer.
Photo: Christopher Occhicone/Bloomberg, via Getty Images
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