In this trial, the combination of IMO-2055 with Tarceva and Avastin was well tolerated. Thirty-three patients were evaluable for efficacy, and showed a disease control rate of 79%, a median progression-free survival of 5.6 months and a median overall survival of 16 months.
"These results compare favorably with the recently published results of the BeTa trial of Avastin and Tarceva in second line treatment of patients with advanced NSCLC," commented David Smith, M.D., of US Oncology and a Principal Investigator on the Phase 1b trial. "We identified a recommended dose of IMO-2055 with standard doses of Tarceva and Avastin. Additional exploration of safety and efficacy from this trial suggests that IMO-2055 should be further investigated in NSCLC."
"We are very encouraged with the results of this clinical trial in heavily pre-treated patients with NSCLC, which is a difficult-to-treat disease with poor prognosis," said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer of Idera. "These data support the development of IMO-2055 as an immune modifier to potentiate the anticancer activity of biologically targeted agents. The results from the current NSCLC trial and the data anticipated from an ongoing Phase 2 trial of IMO-2055 in combination with Erbitux(R) in patients with head and neck cancer will inform our decisions on the next steps in development of IMO-2055."
The Phase 1b clinical trial in NSCLC evaluated four dose levels of IMO-2055 in combination with standard doses of Tarceva and Avastin. Patients received oral Tarceva at 150 mg once per day and Avastin at 15 mg/kg once every three weeks by intravenous infusion in addition to subcutaneous doses of IMO-2055 once per week until disease progression or other discontinuation criteria was met. The trial enrolled 36 patients who had failed at least one prior course of chemotherapy. The trial was conducted at 10 centers in the United States. Nineteen patients were recruited to the dose-escalation portion of the trial, in which 0.32 mg/kg was identified as the recommended Phase 2 dosage of IMO-2055. An additional 17 patients were recruited and treated at 0.32 mg/kg/week to further document safety and efficacy.
The study population was typical for a second- to fifth-line treatment population in a Phase 1 study. No new or unexpected toxicities were observed in the study, and rates of well-known side effects of the three agents were consistent with results from previously presented clinical trials of IMO-2055 and of the combination of Tarceva and Avastin. The most common adverse events were diarrhea, nausea, fatigue and rash.