Rucaparib (Rubraca®): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care.

Summary

• A detrimental effect in terms of overall survival (OS) has been observed for rucaparib compared to the chemotherapy-containing control arm (19.6 months and 27.1 months respectively with a Hazard Ratio (HR) of 1.550 (95% CI: 1.085, 2.214), p=0.0161) following a planned interim analysis (IA) in the post-approval randomized controlled study CO-338-043 (ARIEL4). 
• The European Medicines Agency (EMA) is performing a review of all available information to assess the impact of this information on the use of rucaparib as monotherapy for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. 
• While the review is ongoing, physicians are recommended not to start monotherapy treatment with rucaparib in in the above treatment indication. 
• The recommendation above does not apply to the indication of monotherapy for the maintenance treatment of adult patients with platinum- sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
• Safety data reported so far for rucaparib in the ARIEL4 study appear consistent with that reported in other clinical trials of rucaparib.