IMO-2055: Phase II data
Top-line data from an open-label, international Phase II trial in 106 patients with recurrent or metastatic SCCHN who were naïve to Erbitux cetuximab showed that once-weekly subcutaneous 0.32 mg/kg IMO-2055 plus Erbitux missed the primary endpoint of median PFS vs. Erbitux alone. Specifically, median PFS as determined by the investigator's assessment was 2.9 months in both arms, while median PFS as determined by an independent radiology review was 1.5 months for IMO-2055 plus Erbitux vs. 1.9 months for Erbitux alone. Last year, Idera regained rights to IMO-2055 following the termination of a 2007 deal with Merck KGaA (Xetra:MRK, Darmstadt, Germany). Merck decided it would not conduct further development of the product after an increased incidence of neutropenia and electrolyte imbalances were reported in a Phase Ib trial to treat SCCHN. Merck did agree to complete the Phase II trial for SCCHN (see BioCentury, July 11, 2011 & Dec. 5, 2011).
In January, Idera reported additional data from a Phase Ib trial of IMO-2055 to treat non-small cell lung cancer (NSCLC) showing that the compound plus Tarceva erlotinib and Avastin bevacizumab led to a DCR of 79% (see BioCentury, Jan. 30). Data from a Phase Ib trial of IMO-2055 to treat colorectal cancer are expected this quarter. Idera said it plans to make a decision regarding next steps for the IMO-2055 program after it evaluates data from the Phase II SCCHN trial and the Phase Ib NSCLC and colorectal cancer trials. ...