Avelumab plus axitinib versus sunitinib as first-line treatment in advanced renal cell carcinoma

In the phase 3 JAVELIN trial, recently published on Annals of Oncology, the first-line treatment with avelumab plus axitinib resulted in significantly longer progression-free survival and a higher objective response rate versus sunitinib in patients with advanced renal cell carcinoma, with more durable responses and a manageable long-term safety profile.

The JAVELLIN trial enrolled patients with untreated advanced renal cell carcinoma, randomized to receive  avelumab plus axitinib or sunitimib. The final results of the trial provide the longest follow-up to date for immune checkpoint inhibitor  plus tyrosine kinase inhibitor combination treatment from a phase 3 trial in advanced renal cell carcinoma: the minimum follow-up was 68 months in all patients. The median overall survival with avelumab plus axitinib versus sunitinib, respectively, was 43.2 months versus 36.2 months  in the PD-L1+ population and 44.8 months versus 38.9 months in the overall population; in both cases it didn’t reach statistical significance. Progression-free survival remained prolonged with avelumab plus axitinib versus sunitinib, with a 5-year event-free rate in the overall population of 12% versus 4.4%. Objective response rate in the overall population was 59.7%  with avelumab plus axitinib versus 32% with sunitinib; duration of response was more than 5 years in 16.4% versus 9.2%, respectively. The long-term safety profile was manageable, with no new safety signals. As authors conclude, «Patient reported outcomes during treatment were similar between arms, suggesting that adding avelumab to tyrosine kinase inhibitor treatment had no adverse impact on health-related quality of life. This final analysis results from JAVELIN Renal 101 showed long-term efficacy benefits, a manageable safety profile, and stable quality of life with first-line avelumab plus axitinib in patients with advanced renal cell carcinoma».