Phase II study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): Preliminary results of GALAHAD.
Matthew Raymond Smith, Shahneen Kaur Sandhu, William Kevin Kelly, Howard I Scher, Eleni Efstathiou, Primo Lara, Evan Y Yu, Daniel J George, Kim N Chi, Jason Summa, Nishi Kothari, Xin Zhao, Byron M Espina, Deborah S Ricci, Jason S Simon, Namphuong Tran, Karim Fizazi
Journal of Clinical Oncology | AMER SOC CLINICAL ONCOLOGY | Published : 2019
202 Background: New therapies are needed for patients (pts) with mCRPC progressing after androgen-receptor signaling inhibitors (ARSIs) and taxane therapies. Niraparib is a once daily highly selective inhibitor of poly (ADP-ribose) polymerase (PARP-1 and 2). Methods: GALAHAD is an ongoing open label Ph 2 study assessing niraparib (300 mg daily) in pts with DRD progressing on/after ARSIs and taxane chemotherapy. Using a validated plasma assay, DRD status was defined as pathogenic mutations (including homozygous deletions) of BRCA1/2, ATM, FANCA, PALB2, CHEK2, BRIP1 or HDAC2. Composite response rate (RR) was defined as an objective response by RECIST 1.1 for measurable disease, circulating tu..View full abstract