HRD CANCER TRIAL

In terms of prior treatment with new hormonal therapies, 60.6% of patients had received abiraterone monotherapy, 23.9% received enzalutamide monotherapy and 14.1% received a combination of those two. 1.4% of patients had an undetermined HRD status.50.7% of patients had HRD-negative tumors, and.47.9% of patients had HRD-positive tumors.HRD status was almost evenly split in the cohort: All other patients had an ECOG status of 0. More than half (57.7%) of the patient population in the cohort had an ECOG performance status of 1. Additional secondary endpoints included overall survival (OS), time to and duration of objective response, time to PSA progression, safety and radiographic progression-free survival (rPFS). The primary endpoints assessed in this cohort were overall response rate (ORR) and PSA response rate (PSA-RR). Of note, nivolumab dosing was limited to a maximum of 2 years. Treatment was given until a patientвЂ™s disease progressed or unacceptable toxicity was reached. Nivolumab was administered at a 480-mg dose every 4 weeks (Q4W) and rucaparib was given at a 600-mg dose twice per day (BID). Additionally, patients who made up the study population were ineligible for (or refused) immediate chemotherapy. Patients in this cohort also did not receive any prior treatments with PARP inhibitors. Here, Petrylak presented data from the final analysis of cohort A2 - which comprised 71 patients (median age, 73 years range, 51-87 years) who had received 1 to 2 prior new hormonal therapies in the pre-chemotherapy setting.

HRD CANCER TRIAL

Petrylak, MD, professor of medicine and urology at Yale School of Medicine and co-director of the Cancer Signaling Networks Research Program at Yale Cancer Center in New Haven, Connecticut, noted in his presentation of data, there was limited clinical activity with the combination in patients with HRD-negative tumors.ДЄmong all cohorts of the phase 2 CheckMate 9KD trial (NCT03338790), patients had to have mCRPC, documented disease progression, an ECOG performance status of 0-1, available tumor tissue for HRD testing and no prior treatment with drugs that targeted T-cell co-stimulation or immune checkpoint pathways. The findings from the CheckMate 9KD trial also showed noteworthy activity in individuals whose tumors harbored BRCA mutations. Combination therapy with the PARP inhibitor rucaparib (Rubraca) and the immunotherapy nivolumab (Opdivo) demonstrated clinical activity in patients with homologous recombination deficiencyвЂ“positive metastatic castration-resistant prostate cancer (mCRPC) who had no prior chemotherapy, according to findings shared during the 2021 ESMO Congress.