- Custirsen fails to boost survival in patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed after treatment with docetaxel.
Why this matters
- Custirsen blocks protein clusterin, which is associated with treatment resistance.
- Post hoc analysis of the SYNERGY trial reported survival benefits with first-line docetaxel plus custirsen.
- Phase 3 AFFINITY study of 635 patients with mCRPC randomly assigned to receive either cabazitaxel plus prednisone plus custirsen (n=317) or cabazitaxel plus prednisone (control group, n=318).
- Funding: OncoGenex Pharmaceuticals.
- Overall OS did not differ between the 2 groups (P=.53).
- In patients with poor prognosis, OS was similar in both the groups (P=.80).
- 76% of patients in the custirsen group vs 66% in the control group experienced grade ≥3 adverse events; most common were neutropenia (22% vs 20%), anemia (22% vs 16%), and fatigue (7% vs 6%).
- Open-label study.