Bayer's Nubeqa Posts Significant OS Data as it Fights for Market Share in Prostate Cancer
Six months after winning approval from the U.S. Food and Drug Administration, Bayer announced that Nubeqa (darolutamide) posted stunning overall survival results by delaying the growth of tumors in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
Late Thursday, Bayer said its preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial showed significant improvement in overall survival in patients who received a combination of Nubeqa and androgen deprivation therapy (ADT) in comparison to placebo and androgen deprivation therapy in nmCRPC. Bayer said previously published results from the ARAMIS trial showed a “statistically significant improvement in the primary efficacy endpoint of metastasis-free survival of darolutamide plus ADT compared to placebo plus ADT.” However, Bayer said at the time of that analysis, overall survival data was not yet available. The company intends to provide a detailed analysis, including the overall survival data at an upcoming scientific meeting.
Nubeqa is an oral androgen receptor inhibitor (ARI) that was jointly developed by Bayer and Finland-based Orion Corporation. Nubeqa was approved in July 2019 based on the results of the ARAMIS trial that, as noted above, showed highly significant improvement in metastasis-free survival, with a median of 40.4 months compared to 18.4 months for placebo plus ADT. The drug was approved under the FDA’s Priority Review designation.
The new data should give Bayer’s Nubeqa some energy to go after market share held by other drugs approved to treat prostate cancer, including Pfizer’s and Astellas' Xtandi, which won approval for a new indication in prostate cancer. In December, Xtandi was approved as a treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC). Xtandi won approval for non-metastatic Castration-Resistant Prostate Cancer in 2018. Xtandi was initially approved in 2012 for late-stage prostate cancer. Pfizer has yet to post overall survival data in nmCRPC.
Another prostate cancer drug that Nubeqa will challenge is Johnson & Johnson’s Erleada. In 2018, Erleada won approval from the U.S. Food and Drug Administration in 2018 for non-metastatic castration-resistant prostate cancer. In December, Janssen, J&J’s pharma division, published results that showed Erleada plus ADT therapy resulted in a 25% reduction in the risk of death compared to placebo.
Prostate cancer is the second most common cancer in men worldwide, with about 164,000 expected diagnoses in the United States this year. It is estimated that more than 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, the companies said in the announcement. Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.