Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or enzalutamide) or docetaxel for treating patients with metastatic castration resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate.
The primary objective of this study is to demonstrate superiority in radiographic progression free survival (rPFS) of the investigational arm of rinzimetostat + darolutamide combination versus physician's choice of control: ARPI (darolutamide or enzalutamide) or docetaxel.
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 line mCRPC setting is required
Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication
Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of treatment completion
Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer) prior to randomization
Known or suspected brain metastasis or active leptomeningeal disease
Parallel
Rinzimetostat
Drug400 mg once daily (QD)
Darolutamide
Drug600 mg twice daily (BID)
Enzalutamide
Drug160 mg once daily (QD)
Docetaxel
Drug75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles
Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
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
Overall Survival (OS)
OS is defined as time from date of randomization to date of death due to any cause
Objective response rate (ORR)
ORR is defined as proportion of patients with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR)
Duration of Response (DoR)
DOR is defined as time of first response to first documentation of radiographic progression or death, whichever occurs first
Prostate Specific Antigen (PSA) response
Defined as the proportion of patients with a confirmed ≥50% and ≥90% decline in PSA from baseline as per the PCWG3 criteria, along with the maximum decline in PSA occurring at any point on study
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ORIC Pharmaceuticals
Lead sponsor
Bayer
Collaborator
