The company enrolled 22 patients with advanced, previously treated solid tumors in the study before closing enrollment in July 2007. The results concern 19 patients evaluated for safety and also for efficacy prior to June 2007, including eight patients with non-small cell lung cancer (NSCLC).
Patients received three-week cycles of fixed-dose Gemzar (gemcitabine) and carboplatin with three escalating doses and three dosage schedules of Idera's investigational drug, IMO-2055. Interim data from the 19 patients suggest that it is feasible for the combination to be administered in patients with advanced solid tumors.
The only dose-limiting toxicities observed in these patients were neutropenia and thrombocytopenia, which are common side effects observed with gemcitabine and carboplatin. In these 19 patients, the response rate, progression-free survival (PFS) and overall survival are 5%, 4.1 months, and 12.9 months, respectively. In the subset of eight patients with NSCLC, the response rate, PFS and overall survival are 13%, 6.5 months and 12.9 months, respectively. The company expects to announce final data of this study by the end of 2007.
“Over the course of this trial, we have conducted additional preclinical studies of IMO-2055 in combination with targeted agents, including Tarceva, Avastin, and Erbitux, and have observed encouraging antitumor activity,” said Sudhir Agrawal, CEO and chief scientific officer.
“As previously announced, we are intending to initiate clinical studies of IMO-2055 in combination with Tarceva and Avastin in NSCLC and in combination with Erbitux in colorectal cancer by the end of the year.”