Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EPI-7386 · 1 trial · 3 indications
Defined as prostate-specific antigen (PSA) undetectable (\<0.2 ng/mL) at 6 months after treatment. The true BRR for the study population will be estimated based on the number of biochemical responses using a binomial distribution, and its confidence interval (CI) will be estimated using Wilson's method.
Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed
Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed
Objective response rate (ORR)
| Arm | Type | Description |
|---|---|---|
| EPI-7386 + Enzalutamide | EXPERIMENTAL | EPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles). |
| Name | Type | Description |
|---|---|---|
| EPI-7386 | DRUG | 600 mg orally administered twice daily |
| Enzalutamide | DRUG | 160 mg administered orally once daily, with or without food |
| Androgen Deprivation Therapy (ADT) | DRUG | LHRH agonist/antagonist or orchiectomy |
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed prostate adenocarcinoma without small cell or neuroendocrine features (please note: \>10% small cell or neuroendocrine differentiation will be excluded). * Subjects must have received no prior second-generation antia...
EPI-7386 is an investigational small molecule being studied for metastatic hormone-sensitive prostate cancer (mHSPC). It has been evaluated in a Phase 2 trial combining it with enzalutamide and androgen deprivation therapy. It is not approved for any indication and remains in clinical development.
EPI-7386 is being developed by ESSA Pharma Inc., which trades under the ticker EPIX. The company is the sponsor of the clinical program evaluating the drug in prostate cancer.
EPI-7386 is in Phase 2 clinical development. One Phase 2 trial has been completed. The drug is investigational and has not been approved by the FDA for any use.
EPI-7386 has been studied in the Phase 2 trial NCT06312670, titled Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer. The trial was completed, enrolled 13 participants, and was conducted in the United States.
No, EPI-7386 is not FDA approved. It is an investigational small molecule in Phase 2 clinical development for metastatic hormone-sensitive prostate cancer. Approval has not been granted for any indication.