ESMO 2025 | Phase I study of SVV-001 with nivolumab and ipilimumab in high-grade NETs

Neuroendocrine cancer is not one disease, but a spectrum of diseases. On one end of the spectrum, we have very treatable neuroendocrine tumors with very good prognosis, a lot of new drug development happening. But unfortunately, on the more aggressive end of the spectrum is neuroendocrine carcinomas or high-grade neuroendocrine cancers, which have very poor prognosis, very limited treatment options. In fact, five-year survival is less than 15%. So that was a big motivation for me to research this rarer, unmet medical need of an issue. And there was some data from SWOG-DARTS-1602 suggesting that ipilimumab and nivolumab can help some patients, not the majority, but a minority of patients. The beauty of ipilimumab and nivolumab in this setting was that there were deep, durable responders. We wanted to expand that benefit to the majority of patients and do something to make these cold or immunologically inert tumors into hot tumors that the majority may respond to immune checkpoint inhibitors. So we added an oncolytic virus called Seneca Valley virus to the immune checkpoint inhibitors in our preclinical models and saw significant improvement in efficacy and we later translated this work into an ongoing first-in-human investigative initiative clinical trial. The study is ongoing and has now completed two dose-escalation cohorts, but my hope is that we would be able to convert these cold tumors into hot tumors and the majority of these patients or NEC patients will respond to immune checkpoint inhibitors with the help of the oncolytic virus.

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