CRLX 101 (Cerulean Pharma) fails in Phase II trial for NSCLC

A randomized Phase IIb study of CRLX 101, from Cerulean Pharma, in patients with advanced Non-Small Cell Lung Cancer (NSCLC) did not meet its primary efficacy endpoint, overall survival benefit. Patients in the trial had measureable disease, previously progressed through one or two different regimens of chemotherapy, and had evidence of disease progression prior to enrollment.

The study enrolled 157 patients in Russia and Ukraine who were randomized in a two-to-one ratio to two treatment arms, CRLX 101 plus Best Supportive Care (BSC) compared to BSC alone. Consistent with earlier clinical trials, CRLX 101 showed signals of activity, including tumor reductions that meet RECIST criteria, and a favorable safety profile. CRLX 101 is being studied in four other ongoing clinical trials.