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Peregrine Pharmaceuticals,
Inc.
, today reported data from its randomized,
double-blind placebo-controlled Phase II trial of bavituximab in
patients with second-line non-small cell lung cancer (NSCLC). 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. Updated results from this Phase II trial
indicate 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
results also demonstrated that bavituximab was well-tolerated with no
significant differences in adverse events between the trial arms.
Peregrine 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.
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