By RTT News, September 29, 2013, 04:52:00 AM EDT
(RTTNews.com) - Clovis Oncology ( CLVS ) announced updated results from an ongoing Phase I/II monotherapy study of rucaparib, the Company's oral, potent, small molecule poly (ADP-ribose) polymerase or PARP inhibitor being developed for the treatment of ovarian cancer.
"We've seen significant clinical activity with one complete response in breast cancer and six partial responses in ovarian, breast and pancreatic cancers to date, and a disease control rate in patients with germline BRCA mutant ovarian (platinum-sensitive and platinum-resistant) cancer of 100% and 63% at 12 and 24 weeks, respectively," said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist UCLH and UCL Cancer Institute in London.
According to the company, these data demonstrate that rucaparib is both well-tolerated and predictably absorbed, and provides meaningful clinical benefit to certain ovarian cancer patients. Now that the company has identified the recommended Phase II dose, it plans to commence its late-stage development program in platinum-sensitive ovarian cancer. This includes a now-open biomarker study known as ARIEL2 or the Assessment of Rucaparib in Ovarian Cancer Phase 2 Trial which will refine the definition of patients beyond those with BRCA mutations who may benefit from rucaparib.
By the end of 2013, the company expects to initiate a Phase III pivotal trial known as ARIEL3 in a broad set of ovarian cancer patients with a stratified efficacy analysis in genetically-defined groups, including somatic and germline BRCA mutations as well as a population with mutations beyond BRCA, utilizing insights from the ARIEL2 study.
The company noted that Fifty-three patients have been treated with rucaparib monotherapy in this study as of September 2013, in once-daily or QD and twice-daily or BID dosing cohorts, up to 500 mg QD and 840 mg BID. A dose of 600 mg BID has been selected as the recommended Phase 2 dose based on maximum exposure, manageable toxicity and activity. Rucaparib is well tolerated up to 600 mg BID with minimal Grade 3 and no Grade 4 adverse events. No patients have discontinued rucaparib due to a treatment-related adverse event.
The company stated that patients have received a median of four previous anticancer regimens and 40 percent have received five or more previous therapies. Twenty-six patients (50%) have breast tumors, 19 patients (37%) have ovarian/peritoneal tumors and seven patients (13%) have other solid tumors.
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