Conference Proceedings
Niraparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): Correlative measures of tumor response in phase II GALAHAD study
Matthew Raymond Smith, Karim Fizazi, Shahneen Kaur Sandhu, William Kevin Kelly, Eleni Efstathiou, Primo Lara, Evan Y Yu, Daniel J George, Kim N Chi, Fred Saad, Jason Summa, Jamie M Freedman, Gary Mason, Byron M Espina, Eugene Zhu, Deborah S Ricci, Linda A Snyder, Jason S Simon, Shinta Cheng, Howard I Scher
JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2020
Abstract
118 Background: Niraparib, a highly potent and selective poly (ADP-ribose) polymerase inhibitor (PARPi) received breakthrough designation by US FDA for treatment of pts with BRCA1,2 mutant mCRPC who progressed on taxane and androgen receptor-targeted therapy. Circulating tumor cells (CTC) detection associates with poor outcomes, with declining counts consistent with improved survival [1,2]. Methods: GALAHAD study assessed niraparib (300 mg daily) in pts with mCRPC+DRD (NCT02854436). Patients with non-measurable soft tissue disease by RECIST 1.1 were required to have a baseline CTC count ≥1 cell/7.5 mL blood. CTC response was defined as CTC conversion to <5 for pts with baseline CTC≥5 and CT..
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Funding Acknowledgements
Janssen Research & Development, LLC, USA