TH-302: Phase III ongoing

Threshold said it now expects to report data in 2H15 from an open-label, international Phase III trial comparing 300 mg/m 2 TH-302 on days 1 and 8 of a 21-day cycle plus doxorubicin vs. doxorubicin alone. The company said it expected top-line efficacy data in 1H15. Threshold said the delay is due to revised guidance on timing for the number of events required for the primary efficacy analysis -- 434 patient deaths. The guidance is based on the results of a planned interim analysis conducted by an IDMC, which recommended that the trial continue as planned. The trial completed enrollment last year of 620 patients with unresectable STS who have not previously received chemotherapy outside the adjuvant or neoadjuvant setting. Threshold has an SPA from FDA for the trial. In July 2013, FDA approved 2 amendments to the trial to increase enrollment to 620 patients from 450 and remove an interim futility analysis of the PFS secondary endpoint (see BioCentury, July 15, 2013). ...