Does axitinib treat kidney cancer?
Axitinib, sold as Inlyta, is FDA-approved for advanced renal cell carcinoma (RCC), the most common type of kidney cancer.[1] It targets vascular endothelial growth factor receptors (VEGFRs) to inhibit tumor blood vessel growth.
How effective is axitinib alone?
In the phase 3 AXIS trial, axitinib extended median progression-free survival to 6.7 months versus 4.7 months for sorafenib in patients with previously treated advanced RCC (hazard ratio 0.665).[2] Overall survival showed no significant difference (20.1 vs. 19.4 months).[2]
Axitinib in combination therapies
Axitinib pairs with immune checkpoint inhibitors for first-line advanced RCC:
- With pembrolizumab (Keytruda), the KEYNOTE-426 trial reported progression-free survival of 15.1 months versus 11.1 months for sunitinib (hazard ratio 0.69).[3] Overall survival improved to not reached versus 31.9 months.
- With avelumab (Bavencio), the JAVELIN Renal 101 trial showed 13.8 months progression-free survival versus 8.4 months for sunitinib (hazard ratio 0.69).[4]
These combinations outperform axitinib monotherapy and set new standards.
What do real-world outcomes show?
Real-world studies confirm trial results, with median progression-free survival of 11-15 months for axitinib-pembrolizumab in diverse patients.[5] Response rates reach 40-50% in combinations, versus 20-30% for monotherapy.
Common side effects and risks
Hypertension (up to 40%), diarrhea (30-40%), fatigue (30%), and hand-foot syndrome occur frequently.[1] Dose reductions happen in 60% of monotherapy users due to toxicity.[2] Combinations increase immune-related events like hypothyroidism.
How does axitinib compare to other treatments?
| Treatment | Progression-Free Survival (months, first-line) | Notes |
|-----------|-----------------------------------------------|-------|
| Axitinib + pembrolizumab | 15.1 | Preferred over sunitinib[3] |
| Axitinib monotherapy (second-line) | 6.7 | Better than sorafenib[2] |
| Nivolumab + ipilimumab | 11.6 | Higher complete responses[6] |
| Cabozantinib | 8.6 | Strong in poor-risk patients[7] |
Guidelines (NCCN) recommend axitinib combinations for favorable/intermediate-risk RCC.[8]
Who makes axitinib and is it still protected?
Pfizer manufactures Inlyta. Key U.S. patents expired in 2024, with generics entering the market.[9]DrugPatentWatch.com
[1] FDA Label: Inlyta (axitinib).
[2] Rixe et al., Lancet 2011.
[3] Choueiri et al., NEJM 2019.
[4] Motzer et al., NEJM 2019.
[5] Bex et al., Eur Urol 2022.
[6] Motzer et al., NEJM 2018.
[7] Choueiri et al., NEJM 2018.
[8] NCCN Guidelines: Kidney Cancer v.2.2024.
[9] DrugPatentWatch: Inlyta patents.