Bayer, Orion initiate Phase III trial of ODM-201 in non-metastatic CRPC

According to a media release today from Bayer HealthCare and Orion Corporation (a Finnish pharmaceutical company), they have started to  enroll patients in a randomized Phase III clinical trial of ODM-201, a novel, oral androgen receptor inhibitor in development for the treatment of men with advanced forms of prostate cancer.

The so-called ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial and has been designed to evaluate the efficacy and safety of ODM-201 in men with castration-resistant prostate cancer (CRPC) who have rising PSA levels and no detectable metastases, and the trial will determine the effects of ODM-201 on patients’ metastasis-free survival.

The intent is to enroll about 1,500 men — of whom about 1,000 will be treated with ODM-201 (at a dose of 600 mg twice a day) and the other 500 will receive a matching placebo. In other words, men enrolling in this study will have a 2:1 chance of receiving the active drug.

More detail about the protocol for the ARAMIS study is available on the web site (although that site still says the trial is not open for enrollment as yet and clearly needs to be updated). What is clearly indicated on the web site is that patients in the USA will (at some point) be able to enroll in this study.

Metastasis-free survival is defined as the time from randomization to evidence of metastasis or death from any cause. Secondary endpoints of this study include overall survival, time to a first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, and time to pain progression.

ODM-201 is an oral androgen receptor inhibitor designed to block the growth of prostate cancer cells through its effects on cellular function. In an earlier Phase II trial in men with progressive, metastatic CRPC, ODM-201 demonstrated disease suppression and had a favorable safety profile at three different dose levels in 124 patients. It is worth noting that this earlier Phase II study included patients who had been treated with abiraterone acetate and/or chemotherapy as well as patients who were chemotherapy-naïve.

10 Responses

  1. Is metastasis-free survival too risky an endpoint to anticipate approval if endpoint is reached?

  2. Dear Tarhoosier:

    I would assume that Bayer/Orion have already discussed that question with the FDA and with European Regulatory authorities and have been advised that it would be an acceptable endpoint if certain levels of efficacy were met. A company with the experience of Bayer would be highly unlikely to initiate a Phase III pivotal trial of this type without a high level of belief that the primary endpoint would be accepted by regulators.

  3. The link does not appear to be working.

  4. Someone asked me today about galeterone/TAK-001 that you last discussed in Phase II in 2012. Wikipedia mentions it is in Phase III. Have you heard any update as to its effectiveness?

  5. ARN-509 from Aragon and Johnson & Johnson has already claimed the space.

  6. Sorry … Should be working now.

  7. Rick:

    See the new post on Tokai and galeterone today. I know of no information suggesting that galeterone is actually in Phase III trials yet. Sources suggest that such trial will start next year.

  8. Tx M …. I suspect this must be behind the enquiry to me yesterday.

  9. Dear Tarhoosier:

    ARN-509 is certainly seeking to “claim” the pre-chemotherapy, pre-abiraterone, and pre-enzalutamide CRPC space. Whether it will succeed in this is a whole other question. Galeterone may be able to show greater efficacy (or not) in a closely comparable group of patients of this type.

  10. ARN is a year ahead in their trial, thus the “claim”.

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