Saridegib: Interim Phase Ib/II data

Infinity stopped an international Phase Ib/II trial after an interim analysis of the double-blind Phase II portion of the trial in 122 patients with previously untreated metastatic pancreatic cancer showed that once-daily oral saridegib plus gemcitabine would not meet the primary endpoint of median OS vs. placebo plus gemcitabine. The company said there was a higher rate of progressive disease in the saridegib plus gemcitabine arm. Specifically, the median OS for saridegib plus gemcitabine was less than the historical median OS of about 6 months for gemcitabine alone, while median OS for the placebo plus gemcitabine arm was greater than 6 months. No unexpected adverse events were reported. Final data are expected to be presented after additional analyses are completed.

Earlier this month, Infinity reported data from 16 evaluable patients in the open-label, dose-escalation Phase Ib portion of the trial showing that once-daily 110-160 mg oral saridegib plus gemcitabine led to median OS and PFS of 10.2 and 7.6 months, respectively. Additionally, 5 patients achieved a partial response. Data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco. Infinity previously reported data from the Phase Ib portion of the trial showing that saridegib was well tolerated with no serious adverse events reported (see BioCentury, May 30, 2011). ...