On October 29, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported the achievement of development milestones that trigger an $18 million payment from Janssen Biotech Inc. (Janssen) (Press release, TESARO, OCT 29, 2018, View Source [SID1234530297]). 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 (mCRPC) and DNA-repair anomalies. Data from the trial are anticipated to support global regulatory filings in 2019.
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In addition, data from the Phase 1b BEDIVERE trial were recently presented at the European Society of Clinical Oncology (ESMO) (Free ESMO Whitepaper) and demonstrated the safety and tolerability of combining niraparib with abiraterone acetate + prednisone (AA-P) in men with mCRPC. Data from the BEDIVERE trial will be used to inform the dosing regimen in a future Phase 3 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.
About the Janssen GALAHAD Clinical Trial
GALAHAD is an ongoing Phase 2, 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 (mCRPC) 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.
About the Janssen BEDIVERE Clinical Trial
BEDIVERE is an ongoing Phase 1b, 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 (mCRPC) who may or may not have had DNA-repair anomalies.
About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.