On May 23, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that abstracts highlighting progress in the rucaparib clinical development program will be presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6 in Chicago (Press release, Clovis Oncology, MAY 23, 2017, View Source [SID1234519267]). Schedule your 30 min Free 1stOncology Demo! Four abstracts highlighting ongoing rucaparib clinical trials will showcase some of the multiple cancer types in which the compound is being studied, including germline and somatic BRCA-mutated, relapsed, high-grade ovarian cancer; metastatic castration-resistant prostate cancer associated with homologous recombination deficiency; and HER2 negative metastatic breast cancer.
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"The abstracts being presented at ASCO (Free ASCO Whitepaper) 2017 highlight the depth of our clinical program exploring the potential of rucaparib as a precision medicine therapeutic for multiple cancer types," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The oncology community has taken great interest in PARP inhibitors and the role of these novel therapeutics within the cancer treatment paradigm. We are pleased to describe these current clinical studies evaluating rucaparib in various solid tumor settings at this prestigious meeting, and importantly, we look forward to announcing the top-line results from ARIEL3 in the ovarian cancer maintenance treatment setting by the end of June."
Rucaparib is Clovis Oncology’s oral, potent, small-molecule inhibitor of PARP1, PARP2 and PARP3. In December 2016, the FDA approved rucaparib (Rubraca) tablets as monotherapy for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a deleterious BRCA mutation (germline and/or somatic) as identified by an FDA-approved companion diagnostic test.
The ARIEL3 pivotal study of rucaparib is a randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period of time for which the disease is controlled after a response to platinum-based chemotherapy. Top-line results from ARIEL3 are anticipated by the end of June, and the Company plans to provide a more comprehensive presentation of the ARIEL3 results in a scientific session at a medical meeting later this year. Pending positive data, the Company intends to submit a supplemental New Drug Application (NDA) for a second line or later maintenance treatment indication within approximately four months of the database lock.
The three trials-in-progress abstracts accepted for presentation at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting comprise:
Abstract TPS5603 (Poster #423b) – ARIEL4: An International, Multicenter Randomized Phase 3 Study of the PARP Inhibitor Rucaparib vs Chemotherapy in Germline or Somatic BRCA1- or BRCA2-Mutated, Relapsed, High-Grade Ovarian Carcinoma
Presenter: Amit M. Oza, MD, Princess Margaret Cancer Centre, University Health Network
Session: Gynecologic Cancer
Date/Time: Saturday, June 3, 1:15-4:45 p.m. CDT
Location: Hall A
Abstract TPS1117 (Poster #103b) – An open-label, phase II study of rucaparib, a PARP inhibitor, in HER2 negative metastatic breast cancer patients with high genomic loss of heterozygosity: RUBY.
Presenter: Anne Patsouris, MD, Institute of West Cancerology Paul Papin
Session: Breast Cancer-Metastatic
Date/Time: Sunday, June 4, 8:00-11:30 a.m. CDT
Location: Hall A
Abstract TPS5087 (Poster #160b) – Trial of RucaparIb in ProsTate IndicatiONs 3 (TRITON3): An International, Multicenter, Randomized, Open-Label Phase 3 Study of Rucaparib vs Physician’s Choice of Therapy for Patients (Pts) with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Associated with Homologous Recombination Deficiency (HRD)
Presenter: Charles J. Ryan, MD, University of California San Francisco Helen Diller Family Comprehensive Cancer Center
Session: Genitourinary (Prostate) Cancer
Date/Time: Monday, June 5, 1:15-4:45 p.m. CDT
Location: Hall A
Additionally, Clovis’ companion diagnostics collaborator Foundation Medicine will present results from a genomic-profiling study:
Abstract 5512 (Oral #5512) – Comprehensive genomic profiling (CGP) with loss of heterozygosity (LOH) to identify therapeutically relevant subsets of ovarian cancer (OC)
Presenter: Julia Andrea Elvin, MD PhD, Foundation Medicine, Inc.
Session: Clinical Science Symposium
Date/Time: Monday, June 5, 8:48-9:00 a.m. CDT
Location: E450ab
Clovis’ rucaparib posters will be available online at View Source as of the time they are presented at the meeting.
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. The MAA submission in Europe for an ovarian cancer treatment indication was submitted and accepted during the fourth quarter of 2016. Additionally, rucaparib is being developed as maintenance treatment for ovarian cancer in the ARIEL3 trial for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, as well as biomarker negative patients. Topline results from ARIEL3 are expected by late June, which, pending positive data, is expected to be followed by the submission of a sNDA for a second line or later maintenance treatment indication. Rucaparib is also being developed in patients with mutant BRCA tumors and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies, or HRD. Studies open for enrollment or under consideration include prostate, breast, pancreatic, gastroesophageal, bladder and lung cancers. Clovis holds worldwide rights for rucaparib.