Celgene's Abraxane exceeds primary endpoint target in pancreatic cancer trial
Celgene announced primary endpoint findings and updated results of secondary endpoints from the phase II international LAPACT trial of Abraxane plus gemcitabine in patients with locally advanced pancreatic cancer. An analysis of patients with newly diagnosed, locally advanced pancreatic cancer treated with up to 6 cycles of Abraxane plus gemcitabine as an investigational induction therapy found that patients had a median time to treatment failure of 8.8 months, which exceeded the protocol-specified target of 6.6 months. Secondary endpoints included evaluation of the disease control rate, overall response rate, progression free survival and overall survival in patients treated with an Abraxane plus gemcitabine induction therapy. One or more treatment emergent adverse event occurred in 99% of patients during induction. The most common adverse events were neutropenia, anemia and fatigue. In this prospective, phase II trial conducted in the US, Canada and Europe, patients with protocol-defined locally advanced, unresectable pancreatic cancer received an induction regimen of up to 6 cycles of Abraxane plus gemcitabine, followed by the investigator's choice of either continuation of the Abraxane plus gemcitabine regimen, treatment with chemoradiation, or surgery. More than half of patients completed the induction phase with Abraxane plus gemcitabine treatment. Forty two percent of patients did not complete induction treatment and the reasons for treatment discontinuation during induction included adverse events, progressive disease, protocol non-compliance, physician decision, death and other reasons.