The planned trial will evaluate neoadjuvant ruxotemitide in combination with pembrolizumab against pembrolizumab monotherapy, with event-free survival (EFS) as the primary endpoint. The FDA confirmed that a single well-controlled trial may be sufficient to support a New Drug Application, pending the totality of the data.

The feedback follows encouraging interim results from the investigator-initiated Phase II NeoLIPA study, in which the ruxotemitide-pembrolizumab combination was tested in the same neoadjuvant melanoma setting. Among nine evaluable patients, 88 percent achieved an overall pathological response, 55 percent a major pathological response and 44 percent a complete pathological response, with no relapses reported at the time of analysis. Top-line results from NeoLIPA are expected in the second half of 2026.

Ruxotemitide is Lytix’s first-in-class oncolytic peptide, given by intratumoural injection to disrupt tumour cells, release antigens and trigger a systemic antitumour immune response — designed to convert immunologically “cold” tumours into “hot” ones and enhance the effect of checkpoint inhibitors such as pembrolizumab.

With the regulatory pathway now defined, Lytix says it is focused on partnership discussions to fund and execute the Phase III trial. The company recently appointed Timothy F. Herpin, Ph.D., M.B.A., as Chief Business Officer on a fractional basis to support that effort.

“This constructive feedback from the FDA on our registrational study design removes a key source of uncertainty as we look toward a registrational trial. With a defined regulatory pathway and a well-supported combination approach with pembrolizumab now in hand, we are well positioned to actively pursue partnerships…”, says CEO Øystein Rekdal