This article is more than 5 years old. Information may no longer be current.
Avelumab plus axitinib improves PFS in advanced renal cell carcinoma
Click Here to Manage Email Alerts
Treatment with avelumab and axitinib improved PFS among patients with advanced renal cell carcinoma compared with sunitinib monotherapy, according to interim analysis results from the phase 3, multicenter, randomized JAVELIN Renal 101 trial.
The FDA previously granted breakthrough therapy designation to avelumab (Bavencio; EMD Serono, Pfizer), a PD-L1 monoclonal antibody, and axitinib (Inlyta, Pfizer), a tyrosine kinase inhibitor.
Researchers randomly assigned 886 patients 1:1 to avelumab plus axitinib or sunitinib (Sutent, Pfizer).
Results from an independent data monitoring committee analysis showed superior PFS with the avelumab-axitinib regimen among patients whose tumors had PD-L1 expression of greater than 1%, meeting the study’s primary objective.
The trial will continue to assess OS and PFS among all enrolled patients, regardless of PD-L1 expression.
“JAVELIN Renal 101 is the first positive phase 3 study combining an immune checkpoint blocker with a TKI, supporting the potential of Bavencio and Inlyta as a new cancer treatment approach for patients with advanced renal cell carcinoma,” Chris Boshoff, MD, PhD, senior vice president and head of immuno-oncology, early development and translational oncology at Pfizer, said in a company-issued press release. “These positive results reinforce Pfizer’s long-standing heritage in advancing standards of care for people with renal cell carcinoma, and we look forward to discussing these data in greater detail with health authorities.”
Researchers observed no new safety signals. Treatment-related adverse events for each drug in the trial appeared consistent with their known safety profiles.
“We are encouraged by these data, which illustrate the impact of Bavencio in combination with Inlyta as a potential first-line treatment for people with advanced renal cell carcinoma, a serious and life-threatening cancer,” Luciano Rossetti, MD, executive vice president and global head of research and development at Biopharma of Merck KGaA, said in the release. “They also support our firm belief in the promise of combining Bavencio with currently approved therapies and novel agents, a strong focus of the overall JAVELIN clinical development program.”