Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma
Mené sur 886 patients atteints d’un carcinome à cellules rénales de stade avancé, cet essai de phase III compare l’efficacité, du point de vue de la survie sans progression et de la survie globale, et la toxicité du sunitinib et d’un traitement de première ligne combinant avélumab et axitinib, selon l’expression tumorale de PD-L1 (durée minimale de suivi : 13 mois)
Résumé en anglais
Background : The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib vs sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis. Patients and methods : Treatment-naïve patients with aRCC were randomized (1:1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary endpoints were PFS and overall survival (OS) among patients with PD-L1+ tumors. Key secondary endpoints were OS and PFS in the overall population. Results : Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cutoff Jan 28, 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm (PD-L1+ population: hazard ratio [HR] 0.62 [95% CI, 0.490–0.777]; 1-sided P < 0.0001; median 13.8 [95% CI, 10.1–20.7] vs 7.0 months [95% CI, 5.7–9.6]; overall population: HR 0.69 [95% CI, 0.574–0.825]; 1-sided P < 0.0001; median 13.3 [95% CI, 11.1–15.3] vs 8.0 months [95% CI, 6.7–9.8]). OS data were immature (PD-L1+ population: HR 0.828 [95% CI, 0.596–1.151]; 1-sided P = 0.1301; overall population: HR 0.796 [95% CI, 0.616–1.027]; 1-sided P = 0.0392). Conclusion : Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS vs sunitinib; OS data were still immature.
