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Phase II study of maintenance rucaparib in patients with platinum-sensitive advanced pancreatic cancer and a pathogenic germline or somatic variant in BRCA1, BRCA2, or PALB2

Journal of Clinical Oncology May 14, 2021

Reiss KA, Mick R, O'Hara MH, et al. - Researchers investigated the role of the poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi) rucaparib as maintenance therapy in advanced pancreatic cancer (PC) with germline or somatic pathogenic variant (PV) in BRCA1, BRCA2, or PALB2, in this investigator-initiated, single-arm phase II study. For at least 16 weeks, platinum-based chemotherapy was administered to eligible patients, and there was no evidence of platinum resistance. Chemotherapy was stopped and patients were given rucaparib 600 mg orally twice a day until progression. Progression-free survival (PFS) rate at 6 months was estimated to be 59.5%, a median PFS of 13.1 months and median overall survival of 23.5 months was reported. At 12 months, estimated PFS was 54.8%. In 36 patients with measurable disease, ORR was found to be 41.7% (3 complete responses; 12 partial responses). Disease control rate was 66.7%. There were no new safety signals. Overall, findings demonstrate the safety as well as the effectiveness of maintenance rucaparib for platinum-sensitive, advanced PC with a PV in BRCA1, BRCA2, or PALB2. In cases with gPALB2 and sBRCA2 PVs, efficacy was evident, thus, expanding the population likely to benefit from PARPi beyond gBRCA1/2 PV carriers.

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