(Prostate Cancer) Is Rucaparib Effective?
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- February 24, 2023
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On February 16–18, 2023, Alan Haruo Bryce et al. from Mayo Clinic presented the efficacy and safety results of rucaparib monotherapy in metastatic castration-resistant prostate cancer (mCRPC) from the TRITON3 Phase 3 trial at ASCO GU 2023 in San Francisco, California.
Trial Design
TRITON3 was a multicenter, randomized, open-label Phase 3 trial that randomized mCRPC patients in a 2:1 ratio to:
- Rucaparib group: 600 mg
- Physician's choice group: Enzalutamide, abiraterone, or docetaxel
Primary endpoint: Progression-free survival (PFS). Secondary endpoints: Overall survival (OS), objective response rate (ORR), duration of response, and PSA progression index.
Efficacy Results
Primary endpoint — Median PFS in BRCA-mutated patients:
- Rucaparib: 11.2 months
- Docetaxel: 8.3 months
- Enzalutamide/Abiraterone: 4.5 months
Median PFS in overall population:
- Rucaparib: 10.2 months
- Docetaxel: 8.3 months
- Enzalutamide/Abiraterone: 4.5 months
Secondary endpoint — Median OS in BRCA-mutated patients:
- Rucaparib: 24.3 months
- Docetaxel: 18.9 months
- Enzalutamide/Abiraterone: 22.1 months
Median OS in overall population:
- Rucaparib: 23.6 months
- Docetaxel: 19.1 months
- Enzalutamide/Abiraterone: 22.1 months
Safety Profile
Most common adverse event — asthenia/fatigue:
- Rucaparib: 61.1% | Docetaxel: 67.6% | Enzalutamide/Abiraterone: 57.6%
Most common Grade 3+ adverse events:
- Rucaparib: Anemia 61.1%
- Docetaxel: Neutropenia 14.1%
- Enzalutamide/Abiraterone: Hypertension 10.2%
Conclusions
Based on the TRITON3 trial results, Alan Haruo Bryce et al. concluded that rucaparib monotherapy improved progression-free survival compared to physician's choice (enzalutamide, abiraterone, or docetaxel) in mCRPC patients, with a safety profile consistent with previously known data.
Source: https://meetings.asco.org/abstracts-presentations/216883
- Clinical trial drug
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