Infinity Pharmaceuticals expands Phase II lung cancer trial

The study is designed to evaluate IPI-504 as a monotherapy in patients with stage IIIb/IV non-small cell lung cancer (NSCLC) whose tumors have relapsed or become refractory to prior treatment with a tyrosine kinase inhibitor. Initially, the study enrolled a total of 20 patients in two equal groups – one group with known epidermal growth factor receptor (EGFR) mutations and one group with wild-type EGFR.

At least one patient in each arm met the criteria to trigger the expansion Phase of the study by achieving extended stable disease during treatment with IPI-504. The study will now enroll an additional 19 patients in each arm for a total of 58 patients.

This Phase II study is currently enrolling patients at eight sites, with additional sites expected to open shortly. Furthermore, Infinity has recently announced the initiation of a Phase I clinical study of IPI-493, its oral Hsp90 inhibitor, in patients with advanced solid tumors.

IPI-504 is also being evaluated in the Ring trial, an international Phase III registration study of IPI-504 in patients with refractory gastrointestinal stromal tumors, and in a Phase Ib trial in combination with docetaxel in patients with solid tumors. Additional clinical studies of IPI-504 are anticipated to begin by early 2009.

Lecia Sequist, lead investigator of the study, said: “Entering the expansion Phase of this trial is an important step forward for IPI-504. The expansion of both arms of the trial could help us determine better treatment options for patients with multiple underlying genetic mutations.”