These data are hypothesis-generating and will be confirmed in the phase III study. A positive result will usher in the first predictive biomarker for patients with advanced renal cell carcinoma….

— Eric Jonasch, MD

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Eric Jonasch, MD, Professor in the Department of Genitourinary Cancer at MD Anderson Cancer Center in Houston, commented on this phase II study. “This is an important study, since we have, for the first time, randomized, prospective data comparing the combination of a checkpoint antibody with an antivascular endothelial growth factor (VEGF) agent in the front-line setting to an established standard of care.”

He continued: “The study for the first time suggests that programmed cell death ligand 1 (PD-L1) tumor expression may be a predictive biomarker for benefit from PD-L1–targeting antibodies in renal cell carcinoma.”

Points of Concern

Dr. Jonasch mentioned two points of concern raised by the study: (1) In the overall study population, response rate and progression-free survival were generally lower than anticipated. (2) Although complete response rates were observed in the experimental arms, a higher-than-expected rate of complete responses was also seen in the comparator arm, making this result more difficult to interpret.

“These data are hypothesis-generating and will be confirmed in the phase III study,” predicted Dr. Jonasch. “A positive result will usher in the first predictive biomarker for patients with advanced renal cell carcinoma, provided the overall study meets its primary endpoints.” ■

Disclosure: Dr. Jonasch reported no potential conflicts of interest.