EXTON, PA — Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) this week shared positive interim results from Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands, regarding its investigator-sponsored trial, INTRIM 1, involving tilsotolimod, Idera’s synthetic Toll-like receptor 9 agonist. Based on these results, the trial has been stopped early.
INTRIM 1 is a randomized, double-blind, placebo-controlled Phase 2 trial among patients with localized, excised melanoma (pathological tumor stage 3-4) with no regional metastases detected and no evidence of distant metastasis. The trial involved a single, intradermal injection of 8 mg tilsotolimod or saline placebo given at the primary tumor excision site, followed by re-excision and sentinel lymph node (SLN) biopsy 7-10 days later. Noting that there were more patients with ulcerated lesions in the placebo arm compared to the tilsotolimod arm, topline interim results of the respective SLN-positivity rates showed a 70% lower SLN+ rate among patients injected with tilsotolimod as compared to those injected with placebo; the placebo SLN+ rate was in the mid-40%s. Statistical significance exceeded the pre-specified p-value of 0.008. Adverse reactions included injection site reactions, malaise, fever and flu-like symptoms.
“This is an exciting result from tilsotolimod, and we are pleased for the patients and their families to whom it offers hope for the future,” said Vincent Milano, Idera’s Chief Executive Officer. “These results, together with data supporting tilsotolimod’s mechanism of action and encouraging safety profile from across the array of earlier pre-clinical and clinical work, reinforce the potential of tilsotolimod to offer benefit to patients with certain cancers. As a result, we plan to actively pursue a strategic partnership for tilsotolimod so that its full potential for patients may continue to be explored.”
This interim result validates previously reported results from INTRIM 1 that showed immune activation, including elevated frequencies of key dendritic cells, in early analysis by flow cytometry of the SLN biopsies. The trial will continue to relapse-free survival (RFS) and overall survival (OS) at 5 and 10 years after SLN biopsy.
“Currently, there are limited adjuvant treatments available to improve survival after surgical excision of a primary melanoma,” said Prof. Tanja de Gruijl of Amsterdam UMC. “We are delighted with the results we have seen in this study, which suggest that tilsotolimod administered at the excision site lowers the extent of tumor-positive lymph nodes and, if it improves overall survival, offers early melanoma patients a potential new treatment option.” Amsterdam UMC investigators plan to present the full data set at an upcoming medical meeting.
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