Tuesday April 2, 2019 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced interim results from an investigator-initiated Phase 2 trial of Rubraca® (rucaparib) in platinum-sensitive patients with advanced pancreatic cancer at the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta.
Clovis said early data from the study are encouraging and suggest that first-line maintenance therapy with Rubraca following induction with platinum-based chemotherapy provides disease control with no new safety signals among patients with a pathogenic mutation in BRCA1, BRCA2 or PALB2.
“PARP inhibitors have demonstrated activity in multiple cancers that are associated with BRCA mutations,” said Kim A. Reiss Binder, assistant professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania and primary investigator for the rucaparib study.
“Given the seemingly intractable challenge presented by pancreatic cancer, we are very pleased that early results from this study support the mounting evidence suggesting PARP inhibitors may have a beneficial role in this disease.”
The University of Pennsylvania-based study is an ongoing, single-arm phase 2 trial investigating monotherapy Rubraca (600 mg twice daily) in the first-line maintenance setting.
The study will enroll a total of 42 patients with advanced pancreatic cancer and a pathogenic germline or somatic BRCA1, BRCA2 or PALB2 mutation, whose cancer has not progressed following at least four months of platinum-based chemotherapy.
Overall, Rubraca treatment in this study was well tolerated without dose-limiting toxicities, the company said.
“It is becoming clear that PARP inhibitors may offer a much-needed new treatment option for the physicians and patients who are facing the challenge of pancreatic cancer,” said Patrick J. Mahaffy, Clovis president and CEO.
“Based on the encouraging early findings from this investigator-initiated study, as well as the findings from our own RUCAPANC trial of Rubraca in pancreatic cancer, we are evaluating a potential clinical and regulatory path forward for Rubraca in the treatment of pancreatic cancer and hope to have more details later in 2019.
“In addition, at AACR we are presenting nonclinical data that continue to expand our understanding of both rucaparib and lucitanib to enhance our development strategies.”
Pancreatic cancer is the third leading cause of cancer deaths in the U.S. though it is a relatively rare cancer as the 11th most common cancer. In 2019 in the U.S., an estimated 56,770 new cases will be diagnosed and 45,750 deaths due to the disease will occur.