Viktor Grünwald, MD, PhD

Formal discussant Viktor Grünwald, MD, PhD, of the Hannover Medical School, Germany, agreed that the results of JAVELIN Renal 101 were impressive, but he was more cautious about accepting avelumab (Bavencio)/axitinib (Inlyta) as a new standard of care without longer follow-up and quality-of-life data.

“One of the beauties is that the combination of avelumab and axitinib is tolerable, with no liver toxicity. It was surprising that severe toxicities were in the same range for both arms. There is no issue about tolerability, but is this combination the right treatment for all patients?” he asked. “Is the combination better than sequencing? To answer that question, we need to see the overall survival benefit and quality-of-life data. The survival data are immature.”

“In the real-life setting, the great contender is ipilimumab (Yervoy)/nivolumab (Opdivo) for intermediate- and poor-risk patients. More recently, KEYNOTE-426 showed that pembrolizumab (Keytruda)/axitinib is an effective first-line therapy for advanced renal cell carcinoma. The story is not over, and we need longer follow-up,” Dr. Grünwald continued. “The combination strategy is not ready for prime time.” He said that for now the standard of care for intermediate/poor-risk patients is ipilimumab/nivolumab, which “delivers a clinically relevant overall survival benefit.”

“Favorable-risk patients represent a niche where avelumab plus axitinib could be a new standard of care. I don’t believe avelumab plus axitinib can compete with ipilimumab/nivolumab in intermediate/poor-risk patients today, but it may be able to replace sunitinib in favorable-risk patients,” he told listeners. ■

DISCLOSURE: Dr. Grünwald owns stock and has other ownership interests in MSD, Bristol-Myers Squibb, and AstraZeneca; has received honoraria from Bristol-Myers Squibb, Eisai, Merck Serono, AstraZeneca, Ipsen, Exelixis, Bayer, MSD Oncology, Pfizer, Novartis, Roche, Lilly, PharmaMar and Cerulean Pharma; is a consultant/advisor with Novartis, Lilly, Cerulean Pharma, EUSA Pharma, Merck Serono, MSD Oncology, ClinSol, Ipsen, Bristol-Myers Squibb, Janssen-Cilag, and Pfizer; has received research funding from Bristol-Myers Squibb, Pfizer, MSD Oncology, AstraZeneca, Roche, Ipsen, and EUSA Pharma, and institutional research funding from Novartis; and has received travel expenses from Bayer, Bristol-Myers Squibb, Pfizer, Novartis, MSD Oncology, Merck Serono, and Ipsen.