- Axitinib on an individualized titration scheme appears feasible and active but failed to achieve the prespecified threshold for PFS in patients with locally recurrent/metastatic renal cell carcinoma (RCC) previously treated with checkpoint inhibitors.
Why this matters
- There is a lack of standard treatment after immunotherapy in this setting.
- Retrospective data support use of vascular endothelial growth factor receptor tyrosine inhibitors, but prospective data were lacking.
- Phase 2 study evaluated axitinib in 40 patients with locally recurrent/metastatic clear cell RCC most recently treated with immune checkpoint inhibitors.
- Starting dose: 5 mg twice daily, followed by toxicity-based titration of dose escalations and reductions by 1 mg every 14 days.
- Primary outcome: PFS; the prespecified threshold for clinically meaningful activity was 9.5 months.
- Funding: Pfizer.
- Median follow-up was 8.7 months.
- Median PFS was 8.8 (95% CI, 5.7-16.6) months.
- 45% of patients achieved objective response; 67% of these had sustained response for >12 months.
- 45% of patients achieved stable disease.
- The most common any-grade and grade 3 toxicities were fatigue, hypertension, and hand-foot syndrome.
- No toxicity-related treatment discontinuations occurred.
- 20% of patients experienced treatment-related serious adverse events.
- Single-arm study.