Novel Ovarian Cancer Drug Shows Efficacy in Phase 2 Trials
Efficacy and safety data shows encouraging results for rucaparib in BRCA-mutation ovarian cancer.
Efficacy and safety results from clinical trials of the investigational drug rucaparib show promise in patients with advanced ovarian cancer.
Rucaparib has previously received priority review designation among patients with ovarian cancer with both germline and somatic BRCA mutations, who have received prior chemotherapy treatment. Patients with repair deficiencies, such as high genomic loss of hetereozygosity known as BRCA-like, also benefit from the drug, according to a press release from Clovis.
The experimental drug is a small molecule inhibitor of PARP1, PARP2, and PARP3. The New Drug Application (NDA) submission seeks the approval of rucaparib in patients with BRCA mutated ovarian cancer.
Findings from these studies were presented at the European Society for Medical Oncology Annual Meeting.
“These results demonstrate that rucaparib may represent an important option for women with multiply relapsed BRCA-mutated ovarian cancer based on its encouraging efficacy and tolerability,” said Rebecca S. Kristeleit, MD, PhD, The University College London, Cancer Institute, London, UK. “In my opinion, rucaparib has the hallmarks of an important new therapeutic option for ovarian cancer patients.”
Clovis presented safety and efficacy data from the integrated phase 2 trials, Study 10 and ARIEL2. Included in the safety population for both trials were 377 patients, and 106 patients were included in the efficacy population.
The efficacy outcome measurement was objective response rate and duration of response, which were all confirmed, according to the press release. They also found that median progression-free survival was 10 months.
Scientists found that all patients included in the trial experienced a treatment-emergent adverse event with a 600-mg dose of rucaparib. Some adverse events were grade 3 or higher (47%), and some experienced an adverse event that caused a dose reduction.
The most common adverse events included nausea, fatigue, vomiting, anemia, increased aspartate and alanine, and constipation. Other common and serious adverse events included anemia, fatigue, and increased aspartate and alanine.
“If approved, rucaparib would be the first PARP inhibitor in the US indicated to treat ovarian cancer patients with germline or somatic BRCA mutations who have received 2 prior chemotherapies. Women with BRCA mutations represent about 25% of patients in the US living with ovarian cancer,” said Patrick J. Mahaffy, CEO and president of Clovis Oncology. “Our NDA review is ongoing with FDA, and in addition we are actively preparing for a European submission during the fourth quarter of 2016.”