On September 28, 2016 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that data from its rucaparib program in ovarian cancer will be presented at the annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress. ESMO (Free ESMO Whitepaper) will take place October 7-11, 2016 in Copenhagen, Denmark. The data being presented comprise the primary efficacy and safety data included in the New Drug Application (NDA) currently under priority review with the FDA (Press release, Clovis Oncology, SEP 28, 2016, View Source;p=RssLanding&cat=news&id=2206462 [SID:SID1234515469]).
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Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1, PARP2 and PARP3 currently being developed for the treatment of advanced ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA (commonly referred to as homologous recombination deficiencies, or HRD). Data from rucaparib studies are the subject of one oral and one poster presentation at the conference:
Abstract 856O – Clinical activity of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients (pts) with high grade ovarian carcinoma (HGOC) and a BRCA mutation (BRCAmut): Analysis of pooled data from Study 10 (parts 1, 2a, and 3) and ARIEL2 (parts 1 and 2)
Rebecca S. Kristeleit, PhD, The University College London, Cancer Institute, London, United Kingdom
Friday, October 7 from 2:45pm-3:00pm CEST
Location: Oslo
Abstract 219TiP – Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)
Christy Toms, PhD, The Institute of Cancer Research, Sutton, United Kingdom
Monday, October 10 from 1:00pm-2:00pm CEST
Location: Hall E, Poster Board #219
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed for advanced ovarian cancer.
Specifically, Clovis is developing rucaparib as monotherapy treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test) who have been treated with two or more chemotherapies. Rucaparib was granted Breakthrough Therapy Designation for this proposed indication by the FDA in April 2015. In August 2016, the FDA accepted Clovis’ New Drug Application (NDA) submission for accelerated approval of rucaparib and granted priority review status to the application with a PDUFA date of February 23, 2017; and in September 2016, the FDA notified Clovis that the Agency is not planning to hold an advisory committee meeting to discuss the Company’s NDA for rucaparib. The Company’s Marketing Authorization Application (MAA) to the European Medicines Agency for the proposed treatment indication for rucaparib is planned for Q4 2016.
Additionally, Clovis is developing rucaparib as maintenance therapy in the ARIEL3 trial for ovarian cancer patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA (commonly referred to as homologous recombination deficiencies, or HRD). Data from ARIEL3 are expected in Q4 2017, which is expected to be followed by the submission of a supplemental NDA for a second-line or later maintenance indication.
Rucaparib is also being explored in other solid tumor types with BRCA and HRD populations, including breast, prostate and gastroesophageal cancers.
Clovis holds worldwide rights for rucaparib.