Bayer plans filings for prostate cancer drug darolutamide

Bayer is planning regulatory filings of darolutamide in prostate cancer following phase III trial results showing it helped prevent the disease from spreading, in a niche where Pfizer and Johnson & Johnson have already gained a foothold.

The German pharma developed darolutamide in partnership with Finland’s Orion Corporation, with the latter due a series of payments when the drug is filed in major markets.

The ARAMIS trial tested darolutamide in men with non-metastatic castration resistant prostate cancer (nmCRPC), to see if the drug could stop the disease from metastasising.

Pfizer’s Xtandi (enzalutamide) has been approved as a way of preventing the disease from spreading after the FDA expanded its label earlier this year, and J&J’s newer drug Erleada (apalutamide) was also approved in this indication earlier this year.

Results from ARAMIS showed darolutamide significantly extended metastasis-free survival (MFS) compared to placebo.

The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.

ARAMIS is a randomised, multi-centre, double-blind, placebo-controlled trial in more than 1,500 patients with nmCRPC treated with androgen deprivation therapy as standard of care and who are at risk of developing metastatic disease.

The primary endpoint of this trial is metastasis-free survival (MFS) defined as time between randomisation and evidence of metastasis or death from any cause.

The secondary objectives of this trial are overall survival (OS), time to first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, time to pain progression and characterisation of the safety and tolerability of darolutamide.

Scott Fields, head of oncology development at Bayer’s pharmaceutical division, said: “Despite recent advances in nmCRPC, there remains a high unmet need for additional treatment options that delay the time to metastases with a manageable safety profile.

“We are encouraged by the results of the ARAMIS trial and look forward to presenting the full data at an upcoming scientific meeting.”

Bayer plans to discuss the data from the ARAMIS trial with regulators, and the FDA has granted it a Fast Track designation, potentially setting up a faster six-month data review.

Under the terms of a deal announced in 2014 Orion is eligible to receive payments of 45 million euros, 20 million euros and 8 million euros upon the first commercial sale in the US, EU and Japan, respectively

Orion will also receive tiered royalties on the product sales, which will be approximately 20%, including production revenue. With sales increase, royalties may increase slightly. Orion may receive one-off payments from Bayer if certain sales targets are met.

Orion and Bayer have an ongoing phase 3 clinical trial (ARASENS) which evaluates the safety and efficacy of darolutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Expected to be completed in 2022, there are no separate milestone payments related to the ARASENS trial.


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