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ESMO 2025 | Cohort A2 of LITESPARK-015: belzutifan in advanced pancreatic NETs
Mauro Cives, MD, University of Bari Aldo Moro, Bari, Italy, discusses results from cohort A2 of the Phase II LITESPARK-015 trial (NCT04924075) evaluating the HIF-2α inhibitor belzutifan in patients with advanced pancreatic neuroendocrine tumors (NETs) that had progressed after prior targeted therapy. Belzutifan showed modest antitumor activity, with a small proportion of patients achieving objective responses and durable disease control. The treatment was generally well tolerated, with anemia being the most frequent adverse event, supporting its manageable safety profile in this pretreated population. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
I mean, the background of this study is very solid. The LITESPARK-015 study is built upon the results of the LITESPARK-004 study. The LITESPARK-004 study focused on patients with VHL disease. So all patients had germline mutations of the VHL gene, so they got the VHL disease. And if you look at the overall response rate in the subgroup of patients with pancreatic neuroendocrine tumors, well, that is the kind of waterfall plot that we will always like to see in medical oncology...
I mean, the background of this study is very solid. The LITESPARK-015 study is built upon the results of the LITESPARK-004 study. The LITESPARK-004 study focused on patients with VHL disease. So all patients had germline mutations of the VHL gene, so they got the VHL disease. And if you look at the overall response rate in the subgroup of patients with pancreatic neuroendocrine tumors, well, that is the kind of waterfall plot that we will always like to see in medical oncology. With a lot of complete responses, you can really see the tumors melting because of the treatment. So that was the background. That was the basis for this new trial that enrolled patients with the pancreatic neuroendocrine tumors. In this study, patients didn’t need to have a VHL mutation. VHL mutations were investigated only locally and only two patients out of 70 enrolled patients had a VHL mutation. The overall response rate is 10%. And in particular, it is worth mentioning that two patients with the VHL mutation got a response. The progression-free survival is 3.9 months, which is similar to the progression-free survival in the placebo arm of, for example, the cabozantinib trial. So my point is Belzutifan per se may not be an active treatment, at least alone, for the treatment of patients with pancreatic NETs. Perhaps in the future, we need to combine Belzutifan with other agents, in particular, in my opinion, multi-tyrosine kinase inhibitors.
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