Bavituximab Oncology PDF Print E-mail

First-in-Class PS-Targeting Monoclonal Antibody

Currently in Phase II clinical development, bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that has demonstrated broad therapeutic potential across multiple oncology indications and represents a new approach to treating cancer. Bavituximab is currently being evaluated in three randomized Phase II clinical trials for non-small cell lung cancer (NSCLC) and pancreatic cancer.

Agreement with FDA on Phase III Bavituximab Clinical Trial Design

In May, 2013, we announced that we had reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase III registration trial design of our lead clinical immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer (NSCLC). The trial design was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel.

The Phase III clinical trial will be a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel alone enrolling approximately 600 patients at sites worldwide. The trial will enroll Stage IIIB/IV non-squamous, NSCLC patients who have progressed after standard front-line treatment. The primary endpoint of the trial will be overall survival (OS). We anticipate initiating the trial by year-end 2013.

  • Bavituximab Clinical Data

    • Second-line NSCLC: In February, 2013, we reported data from this randomized, double-blind placebo-controlled Phase II trial of bavituximab with docetaxel 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. Investors are reminded not to rely on clinical data that the company disclosed on or before September 7, 2012 regarding this trial.

    • Front-line NSCLC: This randomized, open-label Phase II trial is evaluating bavituximab with paclitaxel and carboplatin versus paclitaxel and carboplatin in 86 front-line NSCLC patients. Patient enrollment in this trial has been completed with top-line data reported in March, 2012. Overall survival data from the trial, which is an event driven endpoint, is expected in the first half of 2013.
    • Pancreatic Cancer: In February, 2013, we announced results from a 70 patient open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression. Results showed that the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). In the trial, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75). Further analysis of the data including subgroups show potentially promising trends and we look forward to presenting the full data set from this trial later this year at an upcoming scientific meeting.
    • Front-line NSCLC: In June 2011, we reported promising 12.4 month median overall survival (OS) from a trial evaluating bavituximab in combination with carboplatin and paclitaxel. This compares favorably to 10.3 month median OS from a separate historical control trial in a similar patient population using carboplatin and paclitaxel alone. Median OS is consistent with earlier encouraging data reported at ASCO 2010, including objective response rate (ORR) of 43% and median progression-free survival (PFS) of 6.1 months, versus historical control data of 15% ORR and 4.5 months median PFS using carboplatin and paclitaxel alone.
    • Front-line breast cancer: In November 2011, we reported promising 23.2 month median OS from a trial evaluating bavituximab in combination with carboplatin and paclitaxel. This compares favorably to 16 month median OS from a separate historical trial in a similar patient population using carboplatin and paclitaxel alone. Median OS was consistent with earlier encouraging data reported at ASCO 2010, including ORR of 74% and median PFS of 6.9 months, versus historical control data of 62% ORR and 4.8 month median PFS using carboplatin and paclitaxel alone.
    • Second-line breast cancer: In August 2011, we reported promising 20.3 month median OS from a trial evaluating bavituximab in combination with docetaxel. This compares favorably to 11.4 month median OS from a separate historical control trial in a similar patient population using docetaxel alone. Median OS is consistent with earlier encouraging data presented at ASCO 2010, including ORR of 61%, versus historical control data of 41% ORR using docetaxel alone.

    • Bavituximb Clinical Data

    Randomized Phase II Bavituximab Clinical Trials

    Phase II Single-Arm Bavituximab Clinical Trials

    Investigator-Sponsored Trials
 
Copyright © 2003-2013 Peregrine Pharmaceuticals Inc., All Rights Reserved