Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ORIC-944
Rinzimetostat · 2 trials · 2 indications
Radiographic Progression Free Survival is defined as the time from the date of randomization to first evidence of radiographic progression as assessed in soft tissue by RECIST 1.1 or in bone per PCWG3 guideline by BICR, or death, whichever occurs first
RP2D as determined by interval 3+3 dose escalation design
PK of ORIC-944 single agent and in combination with an ARPI
PK of ORIC-944 single agent and in combination with an ARPI
PK of ORIC-944 single agent and in combination with an ARPI
PK of ORIC-944 single agent and in combination with an ARPI
| Arm | Type | Description |
|---|---|---|
| Investigational Arm | ACTIVE_COMPARATOR | Rinzimetostat + darolutamide |
| Physician's Choice | ACTIVE_COMPARATOR | Control Arm |
| Single Agent Dose Escalation | EXPERIMENTAL | ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles |
| Combination Dose Escalation | EXPERIMENTAL | ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combinations with abiraterone, apalutamide, darolutamide, or enzalutamide |
| Combination Dose Optimization | EXPERIMENTAL | Cohort A and C: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with apalutamide Cohort B and D: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with darolutamide Combinations with abiraterone or enzalutamide may be conducted in the future |
| Name | Type | Description |
|---|---|---|
| Rinzimetostat | DRUG | 400 mg once daily (QD) |
| Darolutamide | DRUG | 600 mg twice daily (BID) |
| Enzalutamide | DRUG | 160 mg once daily (QD) |
| Docetaxel | DRUG | 75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles |
| ORIC-944 | DRUG | Oral, once daily, continuous |
| Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets | DRUG | Oral, 1000 mg once daily, continuous |
| Apalutamide (Erleada™) 60 mg or 240 mg tablets | DRUG | Oral, 240 mg once daily, continuous |
| Darolutamide (Nubeqa®) 300 mg tablets | DRUG | Oral, 600 mg twice daily, continuous |
| Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets | DRUG | Oral, 160 mg once daily, continuous |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features * Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first ...
Rinzimetostat is an investigational small molecule being studied for metastatic castration resistant prostate cancer and metastatic prostate cancer. It is being evaluated in patients whose disease has progressed after treatment with abiraterone acetate. It is not approved for any indication and remains in clinical development.
Rinzimetostat targets EED, the embryonic ectoderm development protein, which is a component of the Polycomb repressive complex 2. EED is an enzyme, and Rinzimetostat belongs to the small molecule enzyme inhibitor class. By binding EED, the drug is designed to interfere with PRC2-mediated gene repression in prostate cancer cells.
Rinzimetostat is being developed by Oric Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ORIC. The company is running the clinical program for the drug in prostate cancer, including a Phase 3 study in metastatic castration resistant prostate cancer and a Phase 1 study in metastatic prostate cancer.
Rinzimetostat is in Phase 3 development. The Phase 3 trial is the most advanced study of the drug, and a Phase 1 trial is also ongoing. Rinzimetostat is investigational and has not been approved by the FDA for any indication.
Rinzimetostat is being studied in two recruiting trials. The Phase 3 Himalayas-1 study, NCT07723248, enrolls about 600 men with metastatic castration resistant prostate cancer previously treated with abiraterone acetate in the United States and Puerto Rico. The Phase 1 study, NCT05413421, enrolls about 275 men with metastatic prostate cancer in the United States, Australia, Spain, and the United Kingdom.
Yes, Rinzimetostat and ORIC-944 are two names for the same investigational drug. ORIC-944 is the earlier code name used by the developer, Oric Pharmaceuticals, while Rinzimetostat is the current name. Searches for either name refer to the same EED-targeting small molecule in prostate cancer trials.