Peregrine Pharmaceuticals Inc. (PPHM) reported data from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in patients with second-line non-small cell lung cancer or NSCLC. The company said that updated results from this Phase II trial indicated a meaningful improvement in median overall survival of 11.7 months in the 3mg/kg bavituximab + docetaxel arm compared to 7.3 months in the control arm (HR=0.73; p value=0.217).
Persistent separation in the survival curves was observed with response rates and progression free survival also favoring the 3mg/kg bavituximab + docetaxel arm in this difficult to treat second-line NSCLC.
The company said the results also demonstrated that bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.
The company noted that it plans to report additional data from the trial, including updated subgroup analysis and safety data, at an upcoming scientific meeting.
Peregrine's randomized, double-blind, placebo-controlled Phase II trial was designed to evaluate docetaxel with bavituximab or placebo and enrolled 121 patients with previously treated locally advanced or metastatic NSCLC. Patients enrolled in the trial were not selected based on genetic or other biomarkers. All patients had confirmed Stage IIIb or IV non-squamous NSCLC and had progressed following one prior chemotherapy regimen. The trial was designed to evaluate overall response rate (ORR) measured in accordance with RECIST criteria, progression-free survival (PFS), duration of response, overall survival (OS), and safety.
"With these data in hand, we are now preparing for additional discussions with regulatory bodies including an end-of-Phase II meeting with the FDA by mid-year with an overall goal of being in a position to initiate a pivotal trial near year-end," said Robert Garnick, head of regulatory affairs at Peregrine.
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