Summary

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• Rubraca (rucaparib) is indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is also indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.
• This summary is based on the review of 12 systematic review(s)/meta-analysis(es). ^[1-12]
• In metastatic castration-resistant prostate cancer (mCRPC), 43% of the overall population achieved a PSA decline of ≥ 50% (95% CI 0.32-0.54), with BRCA2 patients showing a higher response rate of 66% (95% CI 0.57-0.7). Overall survival was 15.9 months (95% CI 12.9-19.0) in the general population and 23.4 months (95% CI 22.8-24.1) in BRCA2 patients.
• In recurrent ovarian cancer treated with PARP inhibitors (PARPi) for maintenance therapy, the progression-free survival (PFS) was significantly improved, with a hazard ratio (HR) of 0.34 (CI 0.29-0.40) in the overall population and 0.24 (CI 0.18-0.31) in BRCA-mutant patients.
• Newly diagnosed ovarian cancer patients receiving PARPi showed a PFS benefit, with an HR of 0.46 (CI 0.30-0.71) for the overall population and 0.36 (CI 0.29-0.44) for the BRCAm population.
• BRCA-mutant ovarian cancer patients demonstrated significant PFS improvements with PARPi, with no statistically significant differences observed between Olaparib, Niraparib, and Rucaparib in terms of PFS or overall survival across different subpopulations.
• The incidence of any grade adverse events (AEs) in mCRPC was 50% (95% CI 0.39-0.60), with 50% (95% CI 0.39-0.60) of patients experiencing grade 3 or 4 AEs. Hematological adverse events, particularly anemia, were the most common (21.5%).
• In ovarian cancer, there was an increased risk of severe adverse events with PARPi compared to placebo, notably hematological AEs such as thrombocytopenia and neutropenia. Niraparib was associated with a higher risk of grade 3 and 4 thrombocytopenia and any grade neutropenia compared to other PARPi, while Olaparib may present fewer grade 3 or higher AEs compared to Niraparib and Rucaparib.
• Rucaparib and Niraparib had higher incidences of grade 3 or 4 adverse events compared to Olaparib, specifically in hematological outcomes such as thrombocytopenia and neutropenia.
• In mCRPC, BRCA2 patients exhibited higher PSA decline rates (66%, 95% CI 0.57-0.7) and overall survival (23.4 months, 95% CI 22.8-24.1) compared to the overall mCRPC population. In ovarian cancer, PARPi treatment significantly improved PFS in BRCA mutant subgroups, with both germline (HR 0.23, 95% CI 0.18-0.30) and somatic mutations showing similar benefits. Homologous recombination deficient (HRD) patients also showed substantial PFS improvement, albeit less pronounced than BRCA mutants, while homologous recombination proficient (HRP) patients benefited to a lesser extent.