NEW YORK--(BUSINESS WIRE)--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.
“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.
About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide. NSCLC accounts for
about 85 percent of lung cancer cases and 25 to 30 percent are of
squamous histology. Nearly 60 percent of NSCLC patients are diagnosed
late with Stage IIIB/IV advanced disease. Despite recent advances, NSCLC
remains difficult to treat, particularly in the metastatic setting.
About Figitumumab (CP-751,871)
Figitumumab, an investigational fully human monoclonal antibody, is a
highly specific inhibitor of the insulin growth factor-1 receptor
(IGF-1R) pathway. The IGF-1R pathway is thought to be one of the
fundamental signaling pathways that leads to uncontrolled growth and
survival of tumor cells, and may represent a resistance mechanism
against EGFR inhibitors and other anti-cancer therapies.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options to improve the outlook for
cancer patients worldwide. Our strong pipeline, one of the most robust
in the industry, is studied with precise focus on identifying and
translating the best scientific breakthroughs into clinical application
for patients across a wide range of cancers, including breast, lung,
prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer
Oncology has biologics and small molecules in clinical development and
more than 200 clinical trials underway.
By working collaboratively with academic institutions, individual
researchers, cooperative research groups, governments, and licensing
partners, Pfizer Oncology strives to cure or control cancer with
breakthrough medicines, to deliver the right drug for the right patient
at the right time.
For more information please visit www.Pfizer.com.
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health
and well-being at every stage of life. We strive to set the standard for
quality, safety and value in the discovery, development and
manufacturing of medicines for people and animals. Our diversified
global health care portfolio includes human and animal biologic and
small molecule medicines and vaccines, as well as nutritional products
and many of the world’s best-known consumer products. Every day, Pfizer
colleagues work across developed and emerging markets to advance
wellness, prevention, treatments and cures that challenge the most
feared diseases of our time. Consistent with our responsibility as the
world’s leading biopharmaceutical company, we also collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for all
who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of
March 11, 2010. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about potential
indications for figitumumab, including their potential benefits, that
involves substantial risks and uncertainties. Such risks and
uncertainties include, among other things, the uncertainties inherent in
research and development; decisions by regulatory authorities regarding
whether and when to approve any drug applications that may be filed for
any such indications as well as their decisions regarding labeling and
other matters that could affect the availability or commercial potential
of such indications; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2009 and in its reports on Form 10-Q and Form 8-K.
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