Biotech

Pfizer today announced data from an ongoing, investigational Phase 1b study of INLYTA® combined with the checkpoint inhibitor pembrolizumab, a PD-1 inhibitor known as KEYTRUDA®, in treatment-naïve patients with advanced renal cell carcinoma.

Pfizer Inc. (NYSE:PFE) today announced data from an ongoing, investigational Phase 1b study of INLYTA® (axitinib) combined with the checkpoint inhibitor pembrolizumab (A4061079, NCT02133742), a PD-1 inhibitor known as KEYTRUDA® and marketed by Merck, known as MSD outside the United States and Canada, in treatment-naïve patients with advanced renal cell carcinoma (RCC). The study was designed to establish dosing and evaluate the safety and anti-tumor activity of INLYTA when combined with pembrolizumab in first-line treatment of advanced RCC.
Preliminary results from a similar, separate study combining INLYTA with
avelumab (JAVELIN Renal 100, NCT02493751), an investigational, fully
human anti-PD-L1 IgG1 monoclonal antibody that is being co-developed by
Merck KGaA, Darmstadt, Germany, and Pfizer were also presented. The data
suggest evidence of anti-tumor activity for INLYTA in combination with
avelumab and were presented during a poster discussion session at the
ESMO 2016 Congress, the annual meeting of the European Society for
Medical Oncology being held in Copenhagen, Denmark.
Based on these Phase 1 results, two independent global Phase 3 trials
evaluating these combinations – INLYTA plus pembrolizumab and INLYTA
plus avelumab – each compared with SUTENT® (sunitinib) in
first-line advanced RCC are now enrolling patients.
“Combining immunotherapy agents with currently approved therapies such
as INLYTA may provide a meaningful improvement in outcome for patients
with renal cancer,” said Chris Boshoff, M.D., Ph.D., head of
immuno-oncology, early development and translational oncology, Pfizer
Global Product Development. “The results presented today indicate that
there is a potential additive or synergistic effect between INLYTA and a
checkpoint inhibitor in RCC.”
Early indicators from the A4061079 study point to strong response rates
with the INLYTA/pembrolizumab combination, with 37 patients (71.2%,
confidence internal 56.9, 82.9) achieving objective responses (three
complete responses and 34 partial responses); 10 patients had stable
disease and 5 patients had disease progression.
Separately, in the JAVELIN Renal 100 study of INLYTA in combination with
avelumab, five out of six patients treated so far had confirmed partial
responses (objective response rate 83.3%, 95% confidence interval: 35.9,
99.6) and one patient with tumor shrinkage not meeting partial response
criteria had stable disease.
INLYTA is an oral vascular endothelial growth factor (VEGF) receptor
inhibitor for the treatment of patients with advanced RCC after failure
of one prior systemic therapy approved in 63 countries. It was the first
treatment to demonstrate superior progression-free survival benefit in a
Phase 3 study versus sorafenib, a tyrosine kinase inhibitor, in
second-line treatment of advanced RCC.
About Avelumab
Avelumab (also known as MSB0010718C) is an investigational fully human
anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions,
avelumab is thought to enable the activation of T-cells and the adaptive
immune system. By retaining a native Fc-region, avelumab is thought to
potentially engage the innate immune system and induce
antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014,
Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic
alliance to co-develop and co-commercialize avelumab.
About INLYTA® (axitinib)
INLYTA is an oral therapy that is designed to inhibit tyrosine kinases,
including vascular endothelial growth factor (VEGF) receptors 1, 2 and
3; these receptors can influence tumor growth, vascular angiogenesis and
progression of cancer (the spread of tumors). In the U.S., INLYTA is
approved for the treatment of advanced renal cell carcinoma (RCC) after
failure of one prior systemic therapy. INLYTA is also approved by the
European Medicines Agency (EMA) for use in the EU in adult patients with
advanced RCC after failure of prior treatment with sunitinib or a
cytokine.
INLYTA Important Safety Information
Hypertension including hypertensive crisis has been observed. Blood
pressure should be well controlled prior to initiating INLYTA. Monitor
for hypertension and treat as needed. For persistent hypertension,
despite use of antihypertensive medications, reduce the dose.
Discontinue INLYTA if hypertension is severe and persistent despite use
of antihypertensive therapy and dose reduction of INLYTA, and
discontinuation should be considered if there is evidence of
hypertensive crisis.
Arterial and venous thrombotic events have been observed and can be
fatal. Use with caution in patients who are at increased risk or who
have a history of these events.
Hemorrhagic events, including fatal events, have been reported. INLYTA
has not been studied in patients with evidence of untreated brain
metastasis or recent active gastrointestinal bleeding and should not be
used in those patients. If any bleeding requires medical intervention,
temporarily interrupt the INLYTA dose.
Cardiac failure has been observed and can be fatal. Monitor for signs or
symptoms of cardiac failure throughout treatment with INLYTA. Management
of cardiac failure may require permanent discontinuation of INLYTA.
Gastrointestinal perforation and fistula, including death, have
occurred. Use with caution in patients at risk for gastrointestinal
perforation or fistula. Monitor for symptoms of gastrointestinal
perforation or fistula periodically throughout treatment.
Hypothyroidism requiring thyroid hormone replacement has been reported.
Monitor thyroid function before initiation of, and periodically
throughout, treatment.
No formal studies of the effect of INLYTA on wound healing have been
conducted. Stop INLYTA at least 24 hours prior to scheduled surgery.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been
observed. If signs or symptoms occur, permanently discontinue treatment.
Monitor for proteinuria before initiation of, and periodically
throughout, treatment. For moderate to severe proteinuria, reduce the
dose or temporarily interrupt treatment.
Liver enzyme elevation has been observed during treatment with INLYTA.
Monitor ALT, AST, and bilirubin before initiation of, and periodically
throughout, treatment.
For patients with moderate hepatic impairment, the starting dose should
be decreased. INLYTA has not been studied in patients with severe
hepatic impairment.
Women of childbearing potential should be advised of potential hazard to
the fetus and to avoid becoming pregnant while receiving INLYTA.
Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose.
Grapefruit or grapefruit juice may also increase INLYTA plasma
concentrations and should be avoided.
Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5
inducers.
The most common (≥20%) adverse events (AEs) occurring in patients
receiving INLYTA (all grades, vs sorafenib) were diarrhea (55% vs 53%),
hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite (34%
vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), hand-foot syndrome
(27% vs 51%), weight decreased (25% vs 21%), vomiting (24% vs 17%),
asthenia (21% vs 14%), and constipation (20% vs 20%).
The most common (≥10%) grade 3/4 AEs occurring in patients receiving
INLYTA (vs sorafenib) were hypertension (16% vs 11%), diarrhea (11% vs
7%), and fatigue (11% vs 5%).
The most common (≥20%) lab abnormalities occurring in patients receiving
INLYTA (all grades, vs sorafenib) included increased creatinine (55% vs
41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%),
decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33%
vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%),
increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased
ALT (22% vs 22%), and increased AST (20% vs 25%).
For more information and full Prescribing Information, visit www.pfizer.com.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have
a meaningful impact on those living with cancer. As a leader in oncology
speeding cures and accessible breakthrough medicines to patients, Pfizer
Oncology is helping to redefine life with cancer. Our strong pipeline of
biologics, small molecules and immunotherapies, 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 its breakthrough medicines. Pfizer Oncology
knows that success in oncology is not measured solely by the medicines
you manufacture, but rather by the meaningful partnerships you make to
have a more positive impact on people’s lives. Learn more about how
Pfizer Oncology is applying innovative approaches to improve the outlook
for people living with cancer at http://www.pfizer.com/research/therapeutic_areas/oncology.
Pfizer Inc.: Working together for a healthier worldTM
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of healthcare products. Our global portfolio
includes medicines and vaccines as well as many of the world’s
best-known consumer healthcare 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 one of the world’s
premier innovative biopharmaceutical companies, we 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. For more information, please visit us at www.pfizer.com.
In addition, to learn more, follow us on Twitter at @Pfizer
and @Pfizer_News,
LinkedIn,
YouTube,
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of
October 9, 2016. 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 INLYTA
(axitinib), including a potential indication for INLYTA in combination
with pembrolizumab (A4061079, NCT02133742) for the treatment of advanced
renal cell carcinoma (RCC) and a potential indication for INLYTA in
combination with avelumab (MSB0010718C) for the treatment of advanced
RCC, including their potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties inherent in
research and development, including the ability to meet anticipated
clinical study commencement and completion dates as well as the
possibility of unfavorable study results, including unfavorable new
clinical data and additional analyses of existing clinical data; risks
associated with preliminary data; the risk that clinical trial data are
subject to differing interpretations, and, even when we view data as
sufficient to support the safety and/or effectiveness of a product
candidate, regulatory authorities may not share our views and may
require additional data or may deny approval altogether; whether and
when drug applications may be filed in any jurisdictions for any
potential indications for the combination therapies; whether and when
any such applications may be approved by regulatory authorities, which
will depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the availability
or commercial potential of the combination therapies; 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, 2015, and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results,” as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at 
www.sec.gov and www.pfizer.com.

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