BAVITUXIMAB FOR NSCLC 

(Reuters) - Peregrine Pharmaceuticals Inc said revised data from its randomized, double-blind placebo-controlled phase II trial of bavituximab in patients with non-small cell lung cancer (NSCLC) showed that patients survived about 4.4 months longer on the drug than with chemotherapy alone.

The reworked analysis comes about five months after Peregrine said in September that the data it originally reported contained major discrepancies.

Data from the trial has been updated based on completion of an earlier review of discrepancies in the trial and the most current survival data from the trial, the company said Tuesday.

Updated results from the trial indicate a "meaningful improvement" in median overall survival of 11.7 months in the 3mg/kg bavituximab plus docetaxel arm compared to 7.3 months in the control arm (hazard ratio 0.73; p=0.217), the company said.

"Persistent separation in the survival curves was observed with response rates and progression free survival also favoring the 3mg/kg bavituximab plus docetaxel arm in this difficult to treat second-line NSCLC," the company noted.

Bavituximab was well-tolerated with no significant differences in adverse events between the trial arms. Peregrine said it plans to report additional data from the trial, including updated subgroup analysis and safety data, at an upcoming scientific meeting.

"These compelling results strongly support advancing the 3mg/kg bavituximab plus docetaxel combination into Phase III development in second-line NSCLC," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine.

"Data from this trial, along with results from seven other ongoing bavituximab trials across many different oncology indications, are helping guide our development efforts for this promising drug candidate. We look forward to reporting further data from these trials and to laying out our plans for advancing the program into late-stage development," he added.