Date: 2016-06-06
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Clovis Oncology (USA - CO)
Product: rucaparib
Action
mechanism: enzyme inhibitor/PARP inhibitor. Rucaparib is an orally-available, small molecule PARP 1 (poly ADP-ribose polymerase) and PARP2 inhibitor being developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as “BRCA-like” or “BRCAness.” Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) that inhibits a specific DNA repair pathway known as base excision repair (BER). PARP inhibitors (PARPi) have been shown to effectively kill tumors with a defect in BRCA1 or BRCA2. Clinical benefit has been observed in patients with a gBRCA mutation as well as in those with a somatic BRCA (sBRCA) mutation. Clinical data have also shown that pancreatic cancer patients with a gBRCA mutation benefit from PARPi treatment. Clinical activity of PARP inhibitors in BRCA-mutated pancreatic cancer combined with the paucity of 2nd line therapies support evaluation of rucaparib in pancreatic cancer patients known to harbor a deleterious BRCA mutation.
Disease: pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: Israel, USA
Trial
details: The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation. (NCT02042378)
Latest
news: * On June 6, 2016, Clovis Oncology announced the final results of the RUCAPANC study of rucaparib in pancreatic cancer at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The open-label phase 2 RUCAPANC study investigated the safety and efficacy of rucaparib in patients with advanced pancreatic cancer and a known deleterious germline or somatic BRCA mutation and final results were presented in a poster session on June 4. A total of 19 patients were enrolled and received one or more doses of rucaparib, with a median of three cycles (range 1-18) of treatment started. The confirmed investigator-assessed ORR based on RECIST criteria was 16%, in which two partial responses (PR) and one complete response (CR) were observed. The disease control rate was 32% for all patients (6/19) and 50% for patients with one prior chemotherapy (3/6). All three patients with a confirmed response received only one prior line of therapy. Common treatment-emergent AEs included nausea (63%) and anemia (47%). These findings are expected to inform future rucaparib study designs in patients with advanced BRCAmut pancreatic cancer.
The poster presentation, titled “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” was presented Saturday by Robert Vonderheide, MD, D. Phil., University of Pennsylvania, Philadelphia, PA during the Poster Session titled “Gastrointestinal (Noncolorectal) Cancer” (Abstract 4110; Poster Board #102).
