June 02, 2008 04:02 PM Eastern Daylight Time
New Pfizer Data Presented on CP-751,871 across
Non-Small Cell Lung
Cancer and Ewing’s Sarcoma
ADVIGO CP-751,871 Global Phase III Clinical Trial Program
Initiated (ADVancing IGF-1R in Oncology)
CHICAGO--Pfizer announced today results from several clinical trials further
describing the activity of its investigational compound CP-751,871 in
non-small cell lung cancer (NSCLC) and Ewing’s
Sarcoma, both diseases with high unmet medical need. The three oral
presentations and one poster discussion underscore that the insulin-like
growth factor receptor (IGF-1R) is increasingly recognized by the
medical community as a relevant target for investigation in cancer
research. The results were presented at the 44th
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, IL.
Updated Response Data from the 1002 NSCLC Trial
Updated study results from a Phase II, randomized, non-comparative study
showed 54 percent of patients with Stage III/IV treatment-naïve
NSCLC receiving the combination CP-751,871 plus carboplatin and
paclitaxel (n=97) experienced objective responses. The response rate
observed for patients treated with carboplatin and paclitaxel alone was
41 percent.
Of note, 78 percent of a subset of patients with squamous cell carcinoma
(n=23) and 57 percent of a subset of patients with adenocarcinoma (n=28)
receiving 20 mg/kg of CP-751,871 plus carboplatin and paclitaxel
experienced objective responses. Response rates were 46 percent and 25
percent, respectively, for squamous cell (n=13) and adenocarcinoma
patients (n=20) receiving carboplatin and paclitaxel alone. No response
advantage with CP-751,871 was seen in a subset of patients with
undifferentiated tumors (Not otherwise specified, NOS).
“Patients with advanced NSCLC typically face a
poor prognosis and we need to develop new strategies and new treatment
combinations to improve their survival,” said
lead investigator Daniel Karp, M.D., director of the M.D. Anderson
Cancer Center Clinical and Translational Research Center (CTRC). “The
updated study results add to our growing understanding of the potential
safety and efficacy of CP-751,871. In this trial, increasing the dose to
20 mg/kg in Stage 2 of the trial resulted in an increased overall
response rate in all differentiated histologies, including
adenocarcinoma, non-adenocarcinoma, and particularly in squamous
histologies, which we consider to be of interest for future study.”
Dr. Karp also presented progression-free survival (PFS) results from the
study. At the dose level of 20 mg/kg, the observed progression-free
survival was 5 months in the CP-751,871 plus carboplatin/paclitaxel arm
and 4 months in the carboplatin/paclitaxel only arm. The highest
observed PFS was in the group of patients with squamous histologies (5.6
months in the CP-751,871 plus carboplatin/paclitaxel arm and 4.3 months
in the carboplatin/paclitaxel only arm) corresponding to the patients
that demonstrated the highest response rates. PFS was defined as either
the length of time before the cancer progressed or death.
In this study, CP-751,871 was generally well tolerated. The most common
Grade 3 or 4 side effects reported were hyperglycemia (increased blood
sugar) (20 percent) and neutropenia (30 percent).
Correlative Science Study Results Support Karp Data
This abstract summarized ancillary studies conducted to investigate the
molecular make up of lung tumors and its relevance to anti-IGF-IR
therapy. Members of the IGF-IR pathway appear to be expressed
differentially across lung tumor histologies which may help to explain
the differential activity of CP-751,871 across these histologies. Tumor
differentiation also appears to play a role. Data were also presented
demonstrating that EGFR inhibition sensitizes tumors to CP-751,871
treatment.
“These results help us to understand better
how CP-751,871 works, provide support for our phase III trial strategy
and underscore Pfizer’s commitment to bring
science and innovation to the forefront of drug development,”
said Antonio Gualberto, M.D., Ph.D., Global Clinical Lead for the
CP-751,871 program, Pfizer Global Research and Development.
ADVIGO Phase III Registration
Program (ADVancing IGF-IR in Oncology)
Based on these data, Pfizer has initiated a large global Phase III
clinical trial program for CP-751,871 in NSCLC, including some studies
with patients with non-adenocarcinoma (ADVIGO 1016, ADVIGO 1018). The
program includes trials for patients who are newly diagnosed and for
those who have already been treated with other therapies.
Pfizer has made a major commitment to CP-751,871 and has invested
significant resources in the Phase III program, which will include more
than 2,000 patients around the world.
For more information on the ADVIGO registration program please visit, http://PfizerCancerTrials.com.
Preliminary Data Presented on CP-751,871 in Sarcoma
Phase I data presented at ASCO showed single agent CP-751,871 was
generally well-tolerated in patients with relapsed or refractory sarcoma
(n=22), including Ewing’s sarcoma (n=9). A
response of stable disease or better was seen in 12 out of 20 evaluable
patients, including one confirmed partial response in a 12-year-old
patient with Ewing’s sarcoma, the second most
common malignant bone tumor in young patients and the most deadly bone
tumor.
CP-751,871 was generally well tolerated in patients with relapsed or
refractory sarcoma. Grade 3 or 4 treatment-related side effects reported
included Grade 4 uric acid increase (n=1) and Grade 3 bilateral
deep-vein thrombosis (n=1).
About CP-751,871
CP-751,871, a fully human IgG2 monoclonal antibody, is a highly specific
inhibitor of the IGF-1R pathway. It is believed that through this
inhibition, CP-751,871 blocks one of the key signaling pathways in
cancer cells that lead to uncontrolled growth and survival of tumor
cells.
Pfizer recently initiated a global Phase III clinical trial registration
program for CP-751,871 in non-adenocarcinoma NSCLC. In addition, Pfizer
is studying CP-751,871 in clinical trials for the treatment of many
other cancers, including prostate, breast and colon cancers and Ewing’s
sarcoma. To date, more than 500 patients have participated in CP-751,871
clinical trials in multiple tumor types.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of treatments and currently has 22 innovative compounds in
clinical development across four platforms. By leveraging the strength
of our resources and scientific talent, Pfizer Oncology strives to
discover and develop novel treatment options to improve the outlook for
oncology patients. Pfizer currently devotes more than 22 percent of its
total R&D budget to the field of oncology, investing annually in
worldwide research initiatives. We also partner with healthcare
providers, governments and local communities around the world to provide
better quality healthcare and health system support.
For more information on the above information, please visit http://www.Pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of
June 2, 2008. Pfizer assumes no obligation to update any 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 a product
candidate, CP-751,871, including its 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 such product
candidate as well as their decisions regarding labeling and other
matters that could affect its availability or commercial potential; 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, 2007 and in its reports on Form 10-Q and
Form 8-K.
