The Absolute Effect / Renal Cell Carcinoma / Medical
In metastatic RCC progressing after prior systemic therapy, does axitinib improve disease control compared with sorafenib?
723 patients randomized 1:1 in a phase III trial; previous treatment included cytokines, sunitinib, bevacizumab plus interferon, or temsirolimus.
Axitinib 5 mg twice daily, with protocol-allowed escalation to 7 and 10 mg twice daily, versus sorafenib 400 mg twice daily.
Median PFS was 6.7 vs 4.7 months; HR 0.665 (95% CI 0.544–0.812), p<0.0001. Objective response was 19.4% versus 9.4%, an absolute increase of 10 percentage points (NNT ≈ 10 for one additional response).
In the prespecified prior-sunitinib subgroup, PFS was approximately 4.8 vs 3.4 months. Final OS analyses did not show a significant OS difference.
Treatment discontinuation for toxicity occurred in 4% with axitinib versus 8% with sorafenib. Hypertension, diarrhoea and fatigue were prominent with axitinib; palmar-plantar erythrodysaesthesia and alopecia were more characteristic of sorafenib.
AXIS established a PFS advantage for axitinib over sorafenib in previously treated metastatic RCC, without demonstrating a corresponding OS advantage.
AXIS enrolled patients previously treated with sunitinib or cytokines, and the PFS benefit of axitinib over sorafenib was seen after both prior treatment categories. In the overall population, median PFS was 6.7 vs 4.7 months (HR 0.665); in the prior-sunitinib subgroup it was 4.8 vs 3.4 months (HR 0.741), and in the prior-cytokine subgroup 12.1 vs 6.5 months (HR 0.464). Overall response was 19.4% vs 9.4%. Overall survival was not significantly different in the final analysis.
Clinical message: Lack of response to the previous therapy did not preclude benefit from another VEGFR-targeted agent. However, AXIS predates current first-line ICI combinations; these data are historical evidence for sequencing after sunitinib/cytokines, not direct evidence for every post-ICI sequence.
Prior-treatment subgroup analysis ↗ · EAU RCC guidance ↗
Targeted freshness note added 14 October 2026; full guideline reconciliation remains pending.