Mar 12 2010
Pfizer Inc. announced today the discontinuation of A4021018 (also known
as ADVIGO 1018), a Phase 3 trial examining the effects of
investigational compound figitumumab (CP-751,871) in combination with
erlotinib as a second/third-line treatment in patients with previously
treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).
An independent Data Safety Monitoring Committee (DSMC) recommended
A4021018 be stopped after concluding that the addition of figitumumab to
erlotinib is unlikely to demonstrate a statistically significant
improvement in the primary endpoint of overall survival compared to
erlotinib alone in the study population.
“As a pioneer in the IGF-1R field, we are
committed to a thorough evaluation of figitumumab. We will carefully
review our extensive clinical database and use this information to
refine the figitumumab clinical program with the goal of identifying the
right patient population in which to evaluate this compound.”
“This outcome is disappointing to us and to patients with NSCLC. Pfizer
is working to thoroughly analyze all available data from the figitumumab
program to better understand the compound and the IGF-1R (insulin growth
factor-1 receptor) pathway,” said Dr. Mace Rothenberg, senior vice
president of clinical development and medical affairs for Pfizer’s
Oncology Business Unit. “As a pioneer in the IGF-1R field, we are
committed to a thorough evaluation of figitumumab. We will carefully
review our extensive clinical database and use this information to
refine the figitumumab clinical program with the goal of identifying the
right patient population in which to evaluate this compound.”
The Company has notified A4021018 clinical investigators and has
initiated the notification procedure for all involved regulatory
agencies of the discontinuation of A4021018. Investigators have been
instructed to work with all of their patients in the A4021018 study on
an individual basis to determine an appropriate course of action.
In December 2009, Pfizer announced the stop of A4021016 (ADVIGO 1016), a
Phase 3 study examining the effects of figitumumab as first-line
treatment in patients with advanced non-adenocarcinoma NSCLC, after an
analysis by the DSMC showed that addition of figitumumab to carboplatin
plus paclitaxel would be unlikely to meet the primary endpoint of
improved overall survival compared to paclitaxel plus carboplatin alone.
Pfizer is continuing to study figitumumab in clinical trials for the
potential treatment of prostate, breast and lung cancers, and Ewing’s
sarcoma.
Source Pfizer Inc
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