BIND-014: Phase II data

Bind said that based on a planned interim analysis it will advance the squamous histology NSCLC cohort but not the K-Ras ( KRAS)-mutation NSCLC cohort into the second stage of the open-label, international Phase II iNSITE 1 trial evaluating 60 mg/kg IV BIND-014 every 3 weeks in about 80 NSCLC patients. The company said the major criteria for advancing to the second stage included 6-week DCR, tolerability and OS data. In the squamous histology cohort, the 6-week DCR was 25% in the intent-to-treat (ITT) population (n=20) and 45.5% in the per protocol (PP) population (n=11). There were no tumor responses by RECIST criteria. The median OS in 9 patients was 11.1 months and the 1-year survival rate was 44%. In the KRAS-mutation cohort, the 6-week DCR was 17.4% in the ITT population (n=23) and 28.6% in the PP population (n=14), which Bind said did not meet the pre-specified criteria to advance into the second stage of the trial. ...