Pfizer Inc. announced today that it has entered into an agreement with
GSK to explore the anti-cancer efficacy and the safety of GSK’s
trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991)
in a Phase I/II study (Study 200344) in patients with
advanced/metastatic melanoma.
Study 200344 is a dose-escalation, open-label study designed to
determine the recommended combination regimen (RCR) for trametinib plus
palbociclib in patients with melanoma. The study will also evaluate the
effect of the combination on tumor biomarkers, safety and anti-cancer
activity in patients with BRAFV600 wild type melanoma, including those
with NRAS mutations.
“Pfizer Oncology is committed to maximizing the value of our portfolio
for patients through the study of novel combinations. This includes
combining our own cancer medicines with each other, as well as with
those of other companies where there is strong scientific rationale,”
said Garry Nicholson, president and general manager, Pfizer Oncology
Business Unit. “Emerging data suggest the potential for trametinib and
palbociclib to work together to treat melanoma. We look forward to
collaborating with GSK to explore this potential and evaluate the
clinical activity of this combination in melanoma.”
The two companies will collaborate on the study, which GSK will conduct.
Financial terms of the agreement were not disclosed.
Trametinib, a reversible inhibitor of MEK1 and MEK2, is approved by the
U.S. Food and Drug Administration (FDA) under the name Mekinist® for the
treatment of adult patients with unresectable or metastatic melanoma
with BRAF V600E or V600K mutation as detected by an FDA-approved test.
Mekinist is not indicated for the treatment of patients who have
received a prior BRAF inhibitor therapy.
Palbociclib is an investigational oral and selective inhibitor of cyclin
dependent kinases (CDK) 4 and 6. In April 2013, palbociclib received
Breakthrough Therapy designation by the FDA for the potential treatment
of patients with breast cancer. Palbociclib is not approved for any
indication in any markets.
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 of biologics and small
molecules, 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. 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 each patient
at the right time. For more information, please visit www.Pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of
November 21, 2013. 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 an
investigational combination therapy of trametinib and palbociclib for
the potential treatment of melanoma, 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 including,
without limitation, the ability to meet anticipated clinical trial
commencement and completion dates, as well as the possibility of
unfavorable clinical trial results;
-
whether and when any applications may be filed with regulatory
authorities in various jurisdictions for the combination therapy for
the treatment of melanoma, and whether and when regulatory authorities
may approve any such applications, 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/A for the fiscal year ended December
31, 2012 and in its reports on Form 10-Q and Form 8-K.
Copyright Business Wire 2013