Idera (IDRA) Reports IMO-2055 Missed Top-Line Endpoint in Phase 2
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Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced top-line results of a randomized, controlled Phase 2 clinical trial of IMO-2055, the Company’s investigational oncology product candidate targeting Toll-like Receptor 9 in combination with Erbitux (cetuximab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in patients who previously progressed on chemotherapy. The study did not meet its primary endpoint of improved progression-free survival following treatment with IMO-2055 in combination with cetuximab compared to treatment with cetuximab alone. The median progression-free survival based on investigator assessments was 2.9 months in both arms; based on independent radiology review, it was 1.9 months in the cetuximab arm and 1.5 months in the combination arm.
The Phase 2 trial was designed and conducted by Merck KGaA of Darmstadt, Germany, under Idera’s oncology collaboration with Merck KGaA that was terminated in November 2011. As part of the termination, Idera regained from Merck KGaA all rights for developing TLR9 agonists for the treatment of cancer, including all rights to IMO-2055, and Merck KGaA agreed to conduct the Phase 2 trial through completion.
This Phase 2 clinical trial was a randomized, controlled trial of IMO-2055 in combination with cetuximab in second-line cetuximab-naïve patients with recurrent or metastatic SCCHN who have previously progressed on chemotherapy. In this study, 106 patients with SCCHN were randomized into two arms of 53 patients each. In one arm, patients were treated with IMO-2055 at a dose of 0.32 mg/kg given subcutaneously once weekly in combination with weekly cetuximab. In the other arm of the study, patients were treated with cetuximab alone. Crossover of the patients who progressed on cetuximab alone was permitted to the combination arm of IMO-2055 and cetuximab. The trial was conducted at multiple centers in Europe and the United States.
The primary endpoint of the study was progression-free survival. Secondary outcome measures included overall response rate (by RECIST), disease control rate, overall survival, and safety and tolerability in subjects treated with IMO-2055 plus cetuximab compared to cetuximab alone. In the study, the combination of IMO-2055 and cetuximab did not meet the primary endpoint. The median progression-free survival based on investigator assessments was 2.9 months in both arms; based on independent radiology review, it was 1.9 months in the cetuximab arm and 1.5 months in the combination arm. The hazard ratio in both evaluations was 1.1 with no statistical difference between the treatment arms. The relative dose intensity was 96% for IMO-2055 and 99% for cetuximab in the combination arm and was 96% for cetuximab in the cetuximab-alone arm. The detailed data from this trial are expected to be presented at a scientific conference.
The Phase 2 trial was designed and conducted by Merck KGaA of Darmstadt, Germany, under Idera’s oncology collaboration with Merck KGaA that was terminated in November 2011. As part of the termination, Idera regained from Merck KGaA all rights for developing TLR9 agonists for the treatment of cancer, including all rights to IMO-2055, and Merck KGaA agreed to conduct the Phase 2 trial through completion.
This Phase 2 clinical trial was a randomized, controlled trial of IMO-2055 in combination with cetuximab in second-line cetuximab-naïve patients with recurrent or metastatic SCCHN who have previously progressed on chemotherapy. In this study, 106 patients with SCCHN were randomized into two arms of 53 patients each. In one arm, patients were treated with IMO-2055 at a dose of 0.32 mg/kg given subcutaneously once weekly in combination with weekly cetuximab. In the other arm of the study, patients were treated with cetuximab alone. Crossover of the patients who progressed on cetuximab alone was permitted to the combination arm of IMO-2055 and cetuximab. The trial was conducted at multiple centers in Europe and the United States.
The primary endpoint of the study was progression-free survival. Secondary outcome measures included overall response rate (by RECIST), disease control rate, overall survival, and safety and tolerability in subjects treated with IMO-2055 plus cetuximab compared to cetuximab alone. In the study, the combination of IMO-2055 and cetuximab did not meet the primary endpoint. The median progression-free survival based on investigator assessments was 2.9 months in both arms; based on independent radiology review, it was 1.9 months in the cetuximab arm and 1.5 months in the combination arm. The hazard ratio in both evaluations was 1.1 with no statistical difference between the treatment arms. The relative dose intensity was 96% for IMO-2055 and 99% for cetuximab in the combination arm and was 96% for cetuximab in the cetuximab-alone arm. The detailed data from this trial are expected to be presented at a scientific conference.
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