Calliditas reports positive Phase 2 head and neck cancer trial results for setanaxib
Calliditas Therapeutics AB has announced encouraging results from a Phase 2 trial examining setanaxib, its leading NOX enzyme inhibitor, in conjunction with pembrolizumab, for treating patients with squamous cell carcinoma of the head and neck (SCCHN). This randomized, placebo-controlled, double-blind study evaluated the efficacy of setanaxib 800mg taken twice daily, combined with pembrolizumab 200mg administered intravenously every three weeks, a standard regimen for SCCHN.
The trial included 55 patients with recurrent or metastatic SCCHN and moderate or high Cancer Associated Fibroblasts (CAF) density tumors. Tumor biopsies were conducted before randomization and after a minimum of nine weeks of treatment. The analysis revealed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) among those treated with setanaxib and pembrolizumab compared to the placebo group. Specifically, the median PFS was five months for the setanaxib group versus 2.9 months for the placebo group, with a hazard ratio of 0.58. OS rates at six months were 92% for the setanaxib group versus 68% for the placebo group, and at nine months, OS rates were 88% versus 58%, respectively, with a hazard ratio of 0.45.
Additionally, the disease-control rate improved in the setanaxib group, with 70% of patients showing at least stable disease compared to 52% in the placebo group. Although no significant differences were found in the primary endpoint of the best percentage change from baseline in tumor size, transcriptomic analysis showed a significant increase in CD8+ T-cells in tumors treated with setanaxib, suggesting enhanced tumor immunological activity.
The combination of setanaxib and pembrolizumab was generally well-tolerated, with no new safety issues identified. Kevin Harrington, a Professor in Biological Cancer Therapies at The Institute of Cancer Research in London and a Consultant Clinical Oncologist at The Royal Marsden NHS Foundation, as well as an investigator on the trial, expressed optimism about the results, noting their importance in advancing setanaxib for this difficult-to-treat patient population.
CEO Renée Aguiar-Lucander also highlighted the significance of these findings, underscoring the potential of setanaxib's anti-fibrotic effects and the positive clinical evidence supporting their NOX platform. CMO Richard Philipson expressed gratitude to the investigators, clinical trial site staff, and patients who contributed to this important study.
Calliditas is conducting further clinical trials with setanaxib, including a Phase 2 trial in primary biliary cholangitis (PBC) expected to yield results in Q3 2024, and an investigator-led Phase 2 trial in idiopathic pulmonary fibrosis (IPF) with top-line data anticipated in Q4 2024. Additionally, a Phase 2 proof of concept trial in Alport syndrome is projected to deliver results in the first half of 2025.
Calliditas plans to hold a Research and Development (R&D) day in Stockholm later in the month to provide more details about the Phase 2 trial and other data supporting setanaxib's mechanism of action.
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