The study, led by Oslo University Hospital, is investigator-initiated, single-arm, and non-randomized. It was designed to show a pCR rate of at least 40%, against a historical benchmark of 20% for pembrolizumab alone. A pCR means that no viable cancer cells are found in the tumor tissue removed at surgery. Ruxotemitide is injected directly into the tumor. The data available so far show no new safety signals.

“We are encouraged that NeoLIPA has met its primary endpoint. We thank the patients and the clinical teams who have contributed to the study and look forward to sharing the detailed findings with the oncology community,” says Henrik Jespersen, Principal Investigator of NeoLIPA at Oslo University Hospital.

The Oslo-based company now plans a randomized Phase III study. It will compare ruxotemitide plus pembrolizumab with pembrolizumab alone, using event-free survival as the primary endpoint. Full data, including the exact pCR rate, will be presented at an upcoming international oncology conference.

“Meeting the primary endpoint confirms NeoLIPA as a successful study and a meaningful step in the development of ruxotemitide in resectable melanoma. This result strengthens our rationale for advancing ruxotemitide in combination with pembrolizumab into a randomized Phase III study,” says Øystein Rekdal, CEO, Lytix Biopharma.