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BAY1841788/ darolutamide · 1 trial · 1 indication
Overall survival (OS) was defined as the time from the date of randomization until death from any cause. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.
Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study. Median, percentile and other 95% CIs were computed using Kaplan-Meier estimates. NA = Value cannot be estimated due to censored data
| Arm | Type | Description |
|---|---|---|
| BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel | EXPERIMENTAL | Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel |
| Placebo + standard ADT + Docetaxel | PLACEBO_COMPARATOR | Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel |
| Name | Type | Description |
|---|---|---|
| BAY1841788 / darolutamide (ODM-201) | DRUG | 600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel |
| Standard ADT (androgen deprivation therapy) | DRUG | As prescribed by the treating physician. |
| Docetaxel | DRUG | As prescribed by the treating physician. |
| Placebo | DRUG | Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel. |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of prostate. * Metastatic disease * Candidates for ADT and docetaxel. * Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization * An Eastern Cooperative Oncology Group...
BAY 1841788 is an investigational small molecule being studied for prostate cancer, specifically metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer. It has also been evaluated in healthy volunteers for pharmacokinetic and drug interaction studies. The drug is still in clinical development and has not been approved by the FDA.
BAY 1841788 is an androgen receptor antagonist, meaning it blocks the action of androgens like testosterone, which can drive prostate cancer growth. By inhibiting the androgen receptor, the drug aims to slow or stop cancer progression. This mechanism is being tested in combination with standard therapies for metastatic prostate cancer.
BAY 1841788 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker BAYRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in prostate cancer patients.
BAY 1841788 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a dose escalation study in Japanese patients with metastatic castration-resistant prostate cancer and a drug interaction study in healthy volunteers. The drug remains investigational and is not yet approved.
BAY 1841788 has been studied in several completed trials. NCT02363855 was a Phase 1 dose escalation study in Japanese patients with metastatic castration-resistant prostate cancer. NCT02671097 and NCT03237416 were drug interaction studies in healthy volunteers. NCT02799602 was a Phase 3 trial combining darolutamide with standard therapy in metastatic hormone-sensitive prostate cancer.
Yes, BAY 1841788 is also known as darolutamide. Clinical trials listed under both names refer to the same drug. Darolutamide is the generic name used in later-stage studies, including the Phase 3 trial NCT02799602 for metastatic hormone-sensitive prostate cancer.