The PARP space continues to generate positive data. Clovis Oncology just released positive rucaparib topline data in the maintenance treatment of Ovarian Cancer. The ARIEL-3 study achieved its endpoints of improved progression-free survival in BRCA-mutant, HDR+ as well as overall intent-to-Treat populations. Median progression-free survival improved from 5.4 months (Placebo) to 16.6 months in BRCA-mutant, 13.6 months in HDR+ and 10.8 in Intent-to-Treat. Most common AEs were anemia (19%) and AST/ALT (11%). Clovis indicated that the latter were generally transient and occurred in the first treatment cycle.
The ARIEL-3 trial had enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
“Based on these encouraging data, it is clear that rucaparib demonstrates a clinically meaningful impact in delaying disease recurrence in women in this trial with advanced ovarian cancer,” said Robert L. Coleman, M.D., professor and vice chair, clinical research, in the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center in Houston and the U.S. Principal Investigator for the ARIEL3 study. “The PFS and safety results achieved in this study are particularly promising, because they suggest women are able to stay on rucaparib for a prolonged period of time while gaining benefit. It is also clinically significant that rucaparib not only sustained the most recent response to platinum, but in some patients also enhanced that response, including the elimination of residual tumor.”
Clovis will present the full ARIEL3 data set at ESMO in September.