TrialWatch: Bayer & Orion Discuss Potential Prostate Cancer Treatment from ARAMIS Trial Findings

Feb 18, 2019 | Oncology, Positive Results, Prostate Cancer

Prostate Cancer

A prostate cancer treatment shows considerable promise according to a full set of results from a recent ARAMIS clinical trial. Darolutadmide was developed by Orion Corporation in partnership with Bayer. Recent trial results exhibit good efficacy and tolerability for the treatment of prostate cancer. What is the ARAMIS study? Sponsored by Bayer in collaboration with Orion, the study’s purpose was to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer. ODM201 is also known as darolutadmide. Darolutamide is a chemically unique androgen receptor inhibitor developed to prevent cancer cell growth.  It binds strongly to the androgen receptor and inhibits androgen receptor function. In addition to the Phase III ARAMIS study, darramamide is also being studied in the treatment of hormone-sensitive prostate cancer (ARASENS)in the Phase III study.  The sponsors recently presented findings at the 2019 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium February 14-16 in San Francisco, California.

The ARAMIS trial is a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of Darolutadmide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) being treated with androgen deprivation therapy (ADT) and at high risk for developing metastatic disease.  Bayer is already planning discussions with regulatory agencies. The treatment has been granted Fast Track designation by the U.S. Food and Drug Administration.

  • The 1,509-patient trial reveals that darolutamide combined with ADT achieved a 59% reduction in the risk of metastasis or death vs. ADT plus placebo
  • The sponsors’ report that the investigational therapy was associated with a small number of side effects compared to placebo and to ADT. Some findings:
  • Non-metastatic life span was statistically significant—on average the median metastatic lifetime was 40.4 months in combination with darolutamide and the current conventional ADT
  • Positive direction was also observed in the lifetime: the risk of death for any reason was 29% lower
  • Adverse event incidents were comparable to current treatment
  • The quality of life for patients was like that of standard

TrialSite News provides a link to more granular trial information.

The European partnership seeks to take on treatments from Johnson & Johnson and Pfizer/Astellas.  The Bayer and Orion partnership believe that regulatory agency approval can lead to considerable market due to its benign side-effect profile which according to PMLive is “attributed to a novel structure that means that unlike enzalutamide and apalutamide it is unable to cross the blood-brain barrier and lacks activity at GABA type A receptors. Current androgen antagonists are associated with a range of side effects including fractures, falls, seizures, and weight loss, but in ARAMIS darolutamide seemed to exhibit placebo-like tolerability, with only fatigue occurring significantly more often than control.”

The non-metastatic CRPC market represents a largely untapped market segment and the Bayer and Orion team are banking on what some analysts project—that it could develop and unfold into a multibillion market. For this to happen the payers will need to buy in to the value proposition so actual performance will be required.