Cancer, Collaborations, Results

Bayer, Orion prostate cancer drug delays spread of disease in PhIII, but can it make a mark in a crowded market?

Bayer and Finland’s Orion (ORNBV: $FH) on Wednesday said their prostate cancer drug, darolutamide, met the main goal in a late-stage trial, lifting Orion’s shares up in Helsinki by nearly 10%. But the two drugmakers may be late to the party, with other such androgen receptor (AR) inhibitors such as Pfizer’s $PFE Xtandi as well as J&J’s $JNJ newer Erleada already on the market.

The trial tested darolutamide against a placebo in more than 1,500 patients with non-metastatic castration-resistant prostate cancer (nmCRPC) that were already on standard-of-care androgen deprivation therapy, and were at risk of the disease spreading.  Data showed the drug met the primary endpoint of metastasis-free survival, as it thwarted the cancer from spreading over the course of the study. Detailed results will be presented at an upcoming scientific meeting, the companies said.

The German drugmaker agreed to develop darolutamide with Orion in 2014, the same year the Phase III ARAMIS trial commenced.

Prostate cancer is the second most commonly diagnosed malignancy in men globally, and treatment options include surgery, radiation treatment and therapy using hormone-receptor antagonists. However, in nearly every case, the cancer grows resistant to conventional hormone therapy. Castration-resistant prostate cancer (CRPC) is an advanced form of the disease and is characterized by persistent, high level AR function and resistance to conventional anti-androgens.

AR inhibitors are a class of drugs designed to block the growth of cancer cells by binding to the androgen receptor and inhibiting its function. However, other biotechs such as Arvinas $ARVN are hoping to go one step further to help patients that progress despite AR inhibitor therapy by developing drugs to degrade the AR, potentially resulting in more profound anti-cancer effects and differential biology, versus inhibition.

Bayer, which already sells Xofigo for metastatic prostate cancer, said it plans to discuss ARAMIS data with health regulators regarding marketing authorization. The drug has already secured fast-track status with FDA as a treatment for nmCRPC. If approved, Orion will be in charge of manufacturing and Bayer will have the right to sell the drug globally, although Orion has the option of co-promoting the product in Europe. Upon the first sale in the United States, Orion is eligible to receive €45 million; the numbers are €20 million in Europe and €8 million in Japan.

Another trial evaluating darolutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC) is ongoing, and is expected to be completed in 2022.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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