A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Summary
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
Timeline
- Start
- 2016-03-23
- Primary completion
- 2023-08-31
- Completion
- 2024-06-26
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Avelumab + Axitinib vs Sunitinib; p = 0.0001; Hazard Ratio (HR) 0.61 (95% CI 0.475 to 0.790) reads as mixed primary results NCT02684006 ↗
registry analysis (superiority test); Avelumab + Axitinib vs Sunitinib; p = 0.1509; Hazard Ratio (HR) 0.86 (95% CI 0.701 to 1.057) reads as mixed primary results NCT02684006 ↗
release “JAVELIN Renal 101 shows significant improvement in progression-free survival with a hazard ratio of 0.69 in patients regardless of PD-L1 expression” reads as met primary endpoint pfizer.com ↗
release “BAVENCIO+INLYTA significantly reduced the risk of disease progression or death by 39% in patients with PD-L1-positive (≥1%) tumors, a primary endpoint” reads as met primary endpoint pfizer.com ↗
release “Phase III JAVELIN Renal 101 study, which demonstrated a significant extension in median progression-free survival (PFS)” reads as met primary endpoint pfizer.com ↗
release “Phase III JAVELIN Renal 101 study, which demonstrated that BAVENCIO in combination with axitinib significantly lowered risk of disease progression or death by 31%” reads as met primary endpoint pfizer.com ↗
release “JAVELIN Renal 101 shows significant improvement in progression-free survival with a hazard ratio of 0.69 in patients regardless of PD-L1 expression” reads as met primary endpoint prnewswire.com ↗
release “BAVENCIO+INLYTA significantly reduced the risk of disease progression or death by 39% in patients with PD-L1-positive (≥1%) tumors, a primary endpoint” reads as met primary endpoint prnewswire.com ↗
release “JAVELIN Renal 101 shows significant improvement in progression-free survival” reads as met primary endpoint pfizer.com ↗
release “positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS)” reads as met primary endpoint pfizer.com ↗
release “The opinion was based on positive findings from the Phase III JAVELIN Renal 101 study, which demonstrated a significant extension in median progression-free survival (PFS)” reads as met primary endpoint pfizer.com ↗
release “EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with BAVENCIO in combination with axitinib compared with sunitinib” reads as met primary endpoint pfizer.com ↗
Publications
- Tucker M, Chen YW, Voss MH, McGregor BA, Bilen MA, Grimm MO, Nathan P, Kollmannsberger C, Tomita Y, Huang B, Amezquita R, Mariani M, di Pietro A, Rini B. Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial. BMJ Oncol. 2024 Jun 12;3(1):e000181. doi: 10.1136/bmjonc-2023-000181. eCollection 2024.
- Choueiri TK, Penkov K, Uemura H, Campbell MT, Pal S, Kollmannsberger C, Lee JL, Venugopal B, van den Eertwegh AJM, Negrier S, Gurney H, Albiges L, Berger R, Haanen JBAG, Oyervides Juarez V, Rini BI, Larkin J, Nole F, Schmidinger M, Atkins MB, Tomita Y, Ellers-Lenz B, Hoffman J, Sandner R, Wang J, di Pietro A, Motzer RJ. Avelumab + axitinib versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma: final analysis of the phase III JAVELIN Renal 101 trial. Ann Oncol. 2025 Apr;36(4):387-392. doi: 10.1016/j.annonc.2024.12.008. Epub 2024 Dec 18.
- Grimm MO, Oya M, Choueiri TK, Motzer RJ, Schmidinger M, Quinn DI, Gravis-Mescam G, Verzoni E, Van den Eertwegh AJM, di Pietro A, Mariani M, Wang J, Thomaidou D, Albiges L. Impact of Prior Cytoreductive Nephrectomy on Efficacy in Patients with Synchronous Metastatic Renal Cell Carcinoma Treated with Avelumab plus Axitinib or Sunitinib: Post Hoc Analysis from the JAVELIN Renal 101 Phase 3 Trial. Eur Urol. 2024 Jan;85(1):8-12. doi: 10.1016/j.eururo.2023.09.016. Epub 2023 Oct 16.
- Rini BI, Atkins MB, Choueiri TK, Teresi RE, Rosbrook B, Thakur M, Hutson TE. Plain language summary looking at how long side effects last after treatment with axitinib is stopped in people with advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2623-2629. doi: 10.2217/fon-2023-0233. Epub 2023 Aug 1.
- Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
- Haanen JBAG, Larkin J, Choueiri TK, Albiges L, Rini BI, Atkins MB, Schmidinger M, Penkov K, Michelon E, Wang J, Mariani M, di Pietro A, Motzer RJ. Extended follow-up from JAVELIN Renal 101: subgroup analysis of avelumab plus axitinib versus sunitinib by the International Metastatic Renal Cell Carcinoma Database Consortium risk group in patients with advanced renal cell carcinoma. ESMO Open. 2023 Jun;8(3):101210. doi: 10.1016/j.esmoop.2023.101210. Epub 2023 Apr 25.
- Rini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3.
- Masters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27.
- Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.
- Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23.
- Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7.
- Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25.
- Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Axitinib | Small molecule | 5 mg | Oral |
| Comparator | Sunitinib | Small molecule | 50 mg | Oral |