Pfizer Shuts Down Phase III NSCLC Trial

Pfizer has shut down the Phase III trial of figitumumab (CP-751,871)
as first-line treatment in patients with advanced non-adenocarcinoma
non-small cell lung cancer (NSCLC). The trial’s independent Data
Safety Monitoring Committee (DSMC) concluded that adding figitumumab
to paclitaxel plus carboplatin would be unlikely to meet the primary
endpoint of improving overall survival compared to paclitaxel plus
carboplatin alone.

In September 2009, Pfizer stopped enrolling new patients in the trial
whenthe DSMC “observed an apparent imbalance of certain serious
adverse events between the treatment arms with more events, including
fatalities,” in patients who received figitumumab, according to a
Pfizer statement.

“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 NSCLC,” 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 trial was initiated based on robust findings from a Phase II 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 drug is still being tested in another NSCLC trial with erlotinib
and a trial with another chemotherapy regimen is in the planning
stages. Pfizer is also studying figitumumab for the potential
treatment of other cancers, including prostate and breast cancers, and
Ewing’s sarcoma.