Study to evaluate PARP inhibitor rucaparib as treatment for locally advanced or metastatic pancreatic cancer with a deleterious BRCA mutation
BOULDER, Colo.--(BUSINESS WIRE)--June 16, 2014--
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the RUCAPANC (Rucaparib Assessment in BRCA-mutated Pancreatic Cancer) study has commenced with the dosing of the first patient at a U.S. study site. Rucaparib is the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of pancreatic cancer and platinum-sensitive ovarian cancer.
“I am very enthusiastic about starting this important trial,” said Susan Domchek, MD, Director of the Basser Research Center for BRCA in the Abramson Cancer Center of the University of Pennsylvania, Professor of Medicine at Penn’s Perelman School of Medicine, and Principal Investigator of the RUCAPANC study. “Clinical data demonstrate that patients with a BRCA mutation may benefit from PARP inhibitor therapy. While most PARP inhibitor development is underway in ovarian and breast cancers, BRCA mutations exist in other cancers as well. Pancreatic cancer represents a very difficult-to-treat disease, with very limited options following disease progression, and I’m pleased to have the opportunity to explore rucaparib in the treatment of BRCA-mutant-driven pancreatic cancer.”
“We are pleased to move forward with the RUCAPANC Phase 2 study, as the data in pancreatic cancer patients treated with rucaparib to date have been very encouraging,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “New options for the treatment of advanced pancreatic cancer are needed, and we believe there is potential for an accelerated submission path should the data from this study support it.”
Several pancreatic cancer patients have been treated with rucaparib, with a few notable responses in patients with BRCA mutations. A pancreatic cancer patient with a BRCA2 mutation experienced a robust partial response to rucaparib therapy following failed first-line FOLFIRINOX treatment, with a best response of 52 percent target lesion shrinkage at cycle 6. In addition, a pancreatic cancer patient with a BRCA2 mutation who failed first-line gemcitabine therapy achieved a best response of 43 percent target lesion shrinkage at cycle 4. The progression-free survival (PFS) for these patients was 7.5 and 5.9 months, respectively, with no significant toxicity.
RUCAPANC is a Phase 2 open-label study exploring rucaparib monotherapy in patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation (germline or somatic) who have progressed on one to two prior therapies. Study sites are currently opening in the U.S. and Israel. For more information about the study, please visit www.rucapanc.com.
The RUCAPANC study is currently enrolling up to 100 pancreatic cancer patients who will receive rucaparib at the recommended Phase 2 dose (RP2D) of 600mg BID. The primary study endpoint is overall response rate; secondary endpoints include duration of response, progression-free survival, overall survival, and safety.
About Rucaparib
Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 being developed for the treatment of platinum-sensitive ovarian cancer, in patients with either BRCA mutations or other DNA repair deficiencies, as well as the RUCAPANC study in patients with BRCA-mutant pancreatic cancer. For information about rucaparib studies in ovarian cancer, please visit www.arielstudy.com.
About Pancreatic Cancer
According to the American Cancer Society, over 46,000 new cases of pancreatic cancer will be diagnosed in the United States in 2014. According to the National Cancer Institute’s SEER database, 81 percent of patients with pancreatic cancer present with unresectable, locally advanced, also referred to as Stage III, or metastatic, also referred to as Stage IV, disease. Even after surgical resection and adjuvant chemotherapy or radiotherapy for apparently localized disease, these patients often experience early recurrence and rapid disease progression. As a result, according to the American Cancer Society, pancreatic cancer has one of the highest mortality rates among all cancers, with an estimate for five-year overall survival of approximately six percent in the United States. Approximately five percent of unselected pancreatic cancer patients and up to ten percent of pancreatic cancer patients of Ashkenazi Jewish descent harbor a germline BRCA mutation, and somatic BRCA mutations also appear to play a role in pancreatic cancer.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado.
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.
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