Rucaparib resulted in longer progression free survival compared with standard of care chemotherapy among patients with relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a deleterious BRCA mutation, according to data from a recent phase 3 clinical trial.
Results of the ARIEL4 trial were presented at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer.
Patients enrolled were randomized to received either 600 mg twice daily of oral rucaparib or the standard of care and chemotherapy and stratified based on progression-free interval:
1 to 6 months = platinum-resistant;
6 to 12 months = partially platinum-sensitive;
12 months or greater = fully platinum-sensitive.
Patients in the chemotherapy arm with platinum-resistant or partially platinum-sensitive disease also received weekly paclitaxel doses, while patients with fully platinum-sensitive disease received an investigator’s choice of platinum-based chemotherapy including single-agent carboplatin or cisplatin or a platinum doublet of either carboplatin and paclitaxel, carboplatin and gemcitabine or cisplatin and gemcitabine.
The primary endpoint was investigator-assessed progression-free survival, while secondary endpoints included objective response rate and safety.
The researchers reported that the median progression-free survival was “significantly longer” with rucaparib compared to chemotherapy in the efficacy and intent to treat populations. For patients with BRCA reversion mutations, the authors noted an exploratory analysis showed the progression-free survival was shorter with rucaparib vs. chemotherapy (2.9 vs. 5.5 months, HR = 2.769; 95% CI, 0.909-7.755). The overall response rate was determined to not be significantly different between the two groups in both populations. Safety was similar between the two groups.
“Patients with BRCA-mutated advanced, relapsed OC who received rucaparib had a significant improvement in PFS vs. SCO CT,” the authors said. “This is the first prospective report from a randomized trial demonstrating that the presence of a BRCA reversion mutation predicts for primary resistance to rucaparib.”