- Clovis Oncology Inc CLVS announced topline data from the Phase 3 TRITON3 trial, demonstrating that Rubraca monotherapy treatment significantly improved radiographic progression-free survival (rPFS) compared with the control group.
- The control group consisted of the physician's choice of docetaxel, abiraterone acetate, or enzalutamide.
- The safety profile of Rubraca observed in the TRITON3 study was consistent with Rubraca labeling.
- Related: FDA's Recommendation Before Clovis Submits Rubraca Application For Ovarian Cancer.
- During the first quarter of 2023, the company plans to submit a supplemental marketing application to the FDA for the BRCA subgroup of patients. It intends to discuss with the FDA submitting for the broader ITT population.
- The Rubraca arm achieved statistical significance over the control arm for the primary endpoint of rPFS with a hazard ratio of 0.50. The median PFS for the population of patients with BRCA mutations treated with Rubraca was 11.2 months vs. 6.4 months among those who received a physician's choice.
- The median PFS for all patients enrolled in TRITON3 and treated with Rubraca was 10.2 months vs. 6.4 months.
- The hazard ratio for the interim analysis of the secondary endpoint of overall survival (OS) in the BRCA subgroup and ITT population, which are not yet mature, favored Rubraca. The hazard ratio for OS in the exploratory subgroup of ATM, which is mature, favored the control arm.
- Price Action: CLVS shares are up 0.50% at $1.20 on the last check Monday.
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