Picoplatin: Final Phase III data

Final data from the open-label, international Phase III SPEAR trial in 401 patients showed that IV picoplatin once every 3 weeks plus best supportive care (BSC) had a median OS of 20.6 weeks vs. 19.7 weeks for BSC alone (p=0.0895). Picoplatin plus BSC significantly increased PFS (9 vs. 6.6 weeks, p=0.0281) and median time to progression vs. BSC alone (11.3 vs. 6.7 weeks, p=0.0002). In 273 patients who did not receive post-study chemotherapy, picoplatin plus BSC significantly improved median OS vs. BSC alone (18.3 vs. 14.4 weeks, p=0.0345). In 294 patients who were refractory or relapsed within 45 days of first-line platinum-based therapy, picoplatin plus BSC also significantly improved median OS vs. BSC alone (21.3 vs. 18.4 weeks, p=0.0173). Data were presented at the American Society of Clinical Oncology meeting in Chicago.

Poniard previously reported that picoplatin plus BSC missed the primary endpoint of significantly improving OS vs. BSC alone based on an analysis of 320 patient deaths. The company said that a significant factor contributing to the outcome of the trial could be that a greater number of patients in the BSC arm received chemotherapy following progression compared with the picoplatin arm (see BioCentury, Nov. 23, 2009). ...