Invited discussant Lisa Pickering, PhD, FRCP, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, considered belzutifan to be a major advance in renal cell carcinoma (RCC).

“LITESPARK-005 met both its primary endpoints of progression-free survival and overall response rate. Overall survival has not been met at this time point; we need longer follow-up for that. Belzutifan was safe and quite well tolerated in this heavily pretreated population,” she said.

Lisa Pickering, PhD, FRCP

“This is a large, positive study. Belzutifan is meaningfully active in heavily pretreated patients with clear cell RCC. Putting the data together, I believe this is a practice-changing study, and I want belzutifan to be made available for patients,” Dr. Pickering stated.

Looking at combinations with belzutifan is the next logical step, she continued. “We saw a signal of benefit in both cohorts—treatment-naive patients and patients treated with prior immune checkpoint inhibition and a prior [vascular endothelial growth factor] tyrosine kinase inhibitor in the open-label phase II trial reported by Dr. Choueiri. The duration of response was impressive in both cohorts. We need randomized trials to determine the value of combinations, but the data support ongoing studies of belzutifan in combination with other therapies,” she said. 

DISCLOSURE: Dr. Pickering reported financial relationships with Bristol Myers Squibb, Eisai, EUSA, Ipsen, MSC Biomedical, and Pfizer.