Clovis up as Rubraca shows survival benefit in late-stage ovarian cancer study

 

• Clovis Oncology (NASDAQ:CLVS) gains 10% in premarket, after announcing topline data from Phase 3 ARIEL4 study, evaluating Rubraca (rucaparib). The study in 349 women met its primary endpoint of improved progression-free survival (PFS) compared to chemotherapy, in relapsed ovarian cancer patients with a tumor mutation of BRCA who have received two or more prior lines of chemotherapy.
• Rucaparib arm (n=220) achieved statistical significance over the chemotherapy arm (n=105), with median PFS of 7.4 months vs. 5.7 months.
• An interim analysis showed a trend toward an overall survival  advantage in the chemotherapy arm, but was confounded by the high rate (64%) of per-protocol crossover to Rubraca following progression on chemotherapy. An analysis of intent-to-treat group showed a trend toward an overall survival advantage for those patients who received Rubraca at any point in the trial versus those who did not.
• Most common treatment-emergent severe adverse events with rucaparib were anemia/decreased hemoglobin (22%), neutropenia/decreased absolute neutrophil count (10%), asthenia/fatigue (8%), thrombocytopenia/decreased platelets (8%), and increased ALT/AST (8%).
• https://seekingalpha.com/news/3646142-clovis-stock-rises-rubraca-shows-survival-benefit-in-late-stage-ovarian-cancer-study