Calliditas announces positive initial results from its phase 2 head and neck cancer trial

The analysis showed statistically significant improvements in progression-free survival (PFS), as well as overall survival (OS), with notable changes in tumor biology consistent with setanaxib’s mechanism of action.

“This is a very promising result which provides clinical proof of the mode of action of setanaxib in line with our thesis on its anti-fibrotic effects, and with results beyond our expectations for a study of this wingspan. It is exciting that we now have positive clinical evidence supporting our first-in-class NOX platform,” said Renée Aguiar-Lucander, CEO of Calliditas.

In this study, researchers investigated the effects of combining setanaxib with pembrolizumab, a standard treatment.

The trial included 55 patients with moderate or high levels of cancer-associated fibroblasts (CAFs) in their tumors. Patients received either setanaxib or placebo in addition to pembrolizumab and were followed for at least 15 weeks.

Results showed that patients receiving both setanaxib and pembrolizumab experienced significant improvements compared to those receiving pembrolizumab alone.

These improvements included longer progression-free survival (median 5 months versus 2.9 months) and better overall survival rates at 6 and 9 months.

Additionally, more patients on setanaxib showed disease stabilization compared to those on placebo.

Although there was no significant difference in tumor size reduction between groups, analysis of tumor samples revealed an increase in CD8+ T cells in those treated with setanaxib, suggesting a enhanced immune response, consistent with the mechanism of action of setanaxib.

The combination treatment was well tolerated with no new safety concerns.

“It is very encouraging to see statistical significance on important clinical outcomes in this relatively small study, which provides an excellent basis for advancing setanaxib in this difficult-to-treat population,” added Kevin Harrington, investigator on the trial and professor of biological cancer. therapies at the Institute of Cancer Research (ICR), London.

Moving forward, the company is conducting additional clinical trials with setanaxib and will start its Phase 2 trial in PBC (primary biliary cholangitis) in Q3 2024.

“I am pleased that we have seen statistical significance and clinically meaningful improvements in long-term PFS and OS outcomes in this indication. I would like to express my thanks to the investigators, clinical trial site staff and, most importantly, the patients, who all contributed to this important study,” commented Richard Philipson, Chief Medical Officer of Calliditas.

The company also plans to hold a research and development (R&D) day in Stockholm later this month to provide additional details regarding the phase 2 trial and other data supporting setanaxib’s mechanism of action.