A phase 3 trial of Bayer and Orion’s darolutamide in patients with nonmetastatic castration-resistant prostate cancer (CRPC) has met its primary endpoint. The data could tee Bayer up to compete with Johnson & Johnson and Pfizer for a previously underserved population of prostate cancer patients.
Bayer licensed darolutamide from Finland's Orion in 2014 in return for €50 million ($57 million) upfront plus milestone commitments, and moved the oral androgen receptor antagonist into phase 3 later that year. Now, Bayer has data from the 1,500-patient phase 3 trial it hopes will serve as the basis for regulatory approval filings.
The release disclosing the top-line result of the trial is very light on details. Bayer revealed the drug significantly extended metastasis-free survival compared to placebo, resulting in the study meeting its primary endpoint. Beyond that, Bayer only disclosed that the safety and tolerability of the drug were consistent with previously published data. No numbers were provided in the statement.
In the recent past, any success in men with nonmetastatic CRPC and fast-rising prostate-specific antigen levels would have been enough for Bayer to make some money from darolutamide, as there were no drugs approved in these patients. However, J&J won approval for Erleada in the setting in February. Five months later, the FDA expanded the label for Astellas and Pfizer’s Xtandi to permit use in the same patient population. Astellas and Pfizer shortened their phase 3 program to cut J&J’s lead.
Assuming the data are good enough, Bayer’s darolutamide will come to market well after Erleada and Xtandi. That means Bayer will need to come armed with impressive data to carve out a piece of the market. The lack of any actual data in Bayer’s release makes it impossible to ascertain the strength of its hand.
The situation will become clearer when Bayer presents the full results at an as-yet-undisclosed upcoming scientific meeting. While preparing for the meeting, Bayer will also gear up to discuss the data and planned approval filings with regulatory agencies.
Bayer is leading these efforts, but the work has implications for Orion. The Finnish drug developer has an option to co-promote darolutamide in Europe and is in line to receive €73 million across three milestones tied to the first commercial sales in the U.S., Europe and Japan.
Shares in Orion rose 7% following publication of the results.