Clovis Oncology Announces Data Presentations at 2016 ASCO Annual Meeting
- New rucaparib data to be highlighted in poster presentations
- Rolling New Drug Application (NDA) submission for rucaparib for the treatment of patients with advanced ovarian cancer expected to complete during Q2 2016
- European Marketing Authorization Application (MAA) planned in Q4 2016
“We look forward to providing updates on rucaparib data in ovarian
cancer, including in patients with mutations beyond BRCA, as well as the
first presentation of our pancreatic cancer data,” said Patrick J.
Mahaffy, CEO and President of
Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1-3 currently being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) commonly referred to as “BRCA-like." Data from rucaparib studies are the subject of three poster presentations at the conference:
Abstract 4110 – RUCAPANC: An open-label, phase 2 trial of the PARP inhibitor rucaparib in patients (pts) with pancreatic cancer (PC) and a known deleterious germline or somatic BRCA mutation.
Susan M. Domchek, MD, University of Pennsylvania, Philadelphia, PA
Saturday, June 4from 8:00am-11:30am CDT
- Location: Hall A, Poster Board #102
Abstract 5540 – Refinement of prespecified cutoff for genomic loss of heterozygosity (LOH) in ARIEL2 part 1: A phase II study of rucaparib in patients (pts) with high grade ovarian carcinoma (HGOC).
Robert L. Coleman, MD, The University of Texas MD Anderson Cancer Center, Houston, TX
Monday, June 6from 1:00pm-4:30pm CDT
- Location: Hall A, Poster Board #363
Abstract 5549 – Feasibility of monitoring response to the PARP inhibitor rucaparib with targeted deep sequencing of circulating tumor DNA (ctDNA) in women with high grade serous carcinoma on the ARIEL2 trial.
Anna Piskorz, PhD, Cancer Research UK Cambridge Institute, University of Cambridge
Monday, June 6from 1:00pm-4:30pm CDT
- Location: Hall A, Poster Board #372
Rucaparib is an oral, potent small molecule inhibitor of PARP1-3 being
developed for the treatment of ovarian cancer, specifically in patients
with tumors with BRCA mutations and other DNA repair deficiencies beyond
BRCA, including those with high genomic loss of heterozygosity (LOH)
commonly referred to as “BRCA-like." Clovis is also exploring rucaparib
in other solid tumor types with significant BRCA and BRCA-like
populations, including prostate, breast and gastroesophageal cancers.
Rucaparib was granted Breakthrough Therapy designation by the U.S.
About Clovis Oncology
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates, the corresponding development pathways of our companion diagnostics, actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions regarding drug labeling, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics, including competitive developments. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.