Renal cancer: titrated axitinib feasible after checkpoint inhibitors

  • Ornstein MC & al.
  • Lancet Oncol
  • 16 Aug 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Single-arm study.