Eleni Efstathiou, MD, PhD, spoke about the treatment combination of niraparib plus abiraterone acetate and prednisone for the treatmeant of men with metastatic castration-resistant prostate cancer in the phase 3 MAGNITUDE trial.
In an interview with CancerNetwork® during the 2022 Genitourinary Cancer Symposium, Eleni Efstathiou, MD, PhD, section chief of Genitourinary Medical Oncology at Houston Methodist Oncology Partners in Texas, gave an overview of the phase 3 MAGNITUDE trial (NCT03748641). Patients with metastatic castration-resistant prostate cancer with and without homologous recombination repair (HHR) gene alterations were treated with niraparib (Zejula) plus abiraterone (Zytiga) acetate and prednisone as first-line therapy.
This study looked at the population of patient with metastatic castration-resistant prostate cancer who had undergone prior treatment with what we know as medical castration [with treatment failure]. They were randomized to receive treatment with niraparib plus abiraterone versus abiraterone with placebo. Now, the interesting part about the trial design was, first, we designed a trial to focus on patients who harbored DNA-damage response gene mutations, but we also wanted to be inclusive of patients who may not harbor such mutations and test the efficacy of the combination in that setting. During the design, the statistics [indicated] early enough whether the combination was efficacious in this population that did not harbor such mutations. Importantly, part of the design of the trial was to allow inclusion of men who were already exposed for short periods of time to abiraterone acetate, so that niraparib vs placebo would be added on.
Chi K, Rathkopf D, Smith M, et al. Phase 3 MAGNITUDE study: first results of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration- resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. J Clin Oncol. 2022; 40(suppl_6):12. doi: 10.1200/JCO.2022.40.6_suppl.012