Pfizer Inc. announced today the discontinuation of A4021016 (also known
as ADVIGO 1016), a Phase 3 trial examining the effects of
investigational compound figitumumab (CP-751,871) as first-line
treatment in patients with advanced non-adenocarcinoma non-small cell
lung cancer (NSCLC) due to the study meeting predefined boundaries for
early termination.
“While these findings are disappointing, Pfizer is committed to using
information gained from this study to refine the design of future trials
of figitumumab in non-small cell lung cancer”
An analysis by an independent Data Safety Monitoring Committee (DSMC)
showed that the addition of figitumumab to paclitaxel plus carboplatin
would be unlikely to meet the primary endpoint of improving overall
survival compared to paclitaxel plus carboplatin alone. This
discontinuation follows a halt in new patient enrollment to A4021016 in
September 2009 when the DSMC observed an apparent imbalance of certain
serious adverse events between the treatment arms with more events,
including fatalities, occurring in patients who were randomized to
receive figitumumab.
"While these findings are disappointing, Pfizer is committed to using
information gained from this study to refine the design of future trials
of figitumumab in non-small cell lung cancer,” said Dr. Mace Rothenberg,
senior vice president of clinical development and medical affairs for
Pfizer’s Oncology Business Unit. "We are hopeful that we will be able to
identify a subset of patients who may have derived benefit from the
addition of figitumumab to chemotherapy. If this can be done, then
future trials will focus on this group of patients in our efforts to
deliver this drug to the right patient."
The Phase 3 study was initiated based on robust findings from a Phase 2
study that identified patients of squamous cell histology, the most
common form of non-adenocarcinoma and a disease with a high unmet
medical need, as those who could potentially benefit most from
figitumumab treatment.
The Company has notified A4021016 clinical investigators and has
initiated the notification procedure for all involved regulatory
agencies of the discontinuation of A4021016. Investigators have been
instructed to work with all of their patients in the A4021016 study on
an individual basis to determine an appropriate course of action.