Cancer, Results

Bayer, Orion prostate cancer drug cuts risk of metastasis or death by more than 50% in key study

As Merck and Bristol-Myers look toward prostate cancer as the next battleground for immuno-oncology dominance, Bayer and partner Orion broke out the numbers that showed their drug, darolutamide, cut the risk of metastasis or death by 59% in a late-stage trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The companies first reported the drug had met the main goal in the ARAMIS trial last October. 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 high risk of the disease spreading.

Data showed the drug met the primary endpoint of inducing a statistically significant improvement in metastasis-free survival (MFS) (HR=0.41 and p value<0.001) compared to placebo, which translates to a 59% reduction in the risk of metastasis or death in nmCRPC patients, Bayer said, adding that median MFS was 40.4 months in the darolutamide arm versus 18.4 months for the placebo cohort.

The secondary endpoints in the trial included overall survival (OS), time to pain progression and time to initiation of first cytotoxic chemotherapy, and each metric suggested a trend favorable to darolutamide.

Karim Fizazi

“These data are exciting for the prostate cancer community, as they show darolutamide’s potential to treat asymptomatic nmCRPC patients and delay spread of the disease,” said Karim Fizazi, professor of medicine at the Institut Gustave Roussy at the University of Paris SudFrance in a statement

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.

The German drugmaker agreed to develop the AR inhibitor darolutamide with Finland’s Orion (ORNBV: $FH) in 2014, the same year the Phase III ARAMIS trial commenced. The class of drugs is designed to block the growth of cancer cells by binding to the androgen receptor and inhibiting its function.

Bayer, which already sells Xofigo for metastatic prostate cancer, said it plans to discuss ARAMIS data with health regulators regarding marketing applications. The drug has already secured fast-track status with the FDA as a treatment for nmCRPC. But Bayer may be late to the party, with other such androgen receptor inhibitors such as Pfizer’s $PFE Xtandi as well as J&J’s $JNJ newer Erleada already on the market.

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
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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