TESARO Inc. announced the achievement of development milestones that trigger an $18 million payment from Janssen Biotech Inc.
The milestones are related to Janssen’s ongoing GALAHAD trial, which is assessing niraparib monotherapy for the treatment of men with metastatic castration-resistant prostate cancer and DNA-repair anomalies. Data from the trial are anticipated to support global regulatory filings in 2019.
In addition, data from the phase Ib BEDIVERE trial were recently presented at the European Society of Clinical Oncology and demonstrated the safety and tolerability of combining niraparib with abiraterone acetate + prednisone in men with mCRPC.
Data from the BEDIVERE trial will be used to inform the dosing regimen in a future phase III trial that will assess the clinical benefit of niraparib in combination with AA-P in mCRPC patients.
TESARO entered into a global prostate collaboration and license agreement with Janssen in 2016, through which Janssen received rights to develop and commercialize niraparib for patients with prostate cancer worldwide, except Japan. Under the terms of the agreement, TESARO is eligible to receive development, regulatory and commercial milestones, in addition to royalty payments.
GALAHAD is an ongoing phase II, open-label, single arm trial designed to evaluate the safety and efficacy of niraparib monotherapy (300mg daily) in men with metastatic castration-resistant prostate cancer and DNA-repair anomalies progressing on/after taxane-based chemotherapy and androgen receptor targeted therapy. Patients are enrolled in the study based on their DNA-repair deficiency status.
BEDIVERE is an ongoing phase Ib, open-label, dose-selection study with dose expansion designed to evaluate the safety of niraparib in combination with AA-P in men with metastatic castration-resistant prostate cancer who may or may not have had DNA-repair anomalies.
Niraparib is marketed in the U.S. and Europe under trade name Zejula.
