NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. today announced that the independent Data Monitoring
Committee for the Phase 3 ATLAS trial evaluating INLYTA® (axitinib) as
adjuvant therapy for patients at high risk of recurrent renal cell
carcinoma (RCC) after nephrectomy recommended stopping the trial at a
planned interim analysis due to futility. The recommendation was based
on the study failing to demonstrate a clear improvement in the primary
endpoint of extending disease-free survival (DFS) for patients treated
with INLYTA compared with patients treated with placebo. No new safety
signals were observed, and the safety profile was consistent with the
known profile of INLYTA in advanced RCC.
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“We are disappointed by the outcome of this study as we had hoped the
efficacy that INLYTA has demonstrated as a second-line treatment in
patients with advanced renal cell carcinoma would carry over to patients
with earlier stage disease, where it would delay or prevent disease
relapse. That goal was not achieved. We will conduct additional analyses
on the data that may provide insight into this result. Studies
evaluating INLYTA in combination with immune checkpoint inhibitors for
patients with a variety of advanced stage cancers, including RCC, will
continue,” said Mace Rothenberg, M.D., Chief Development Officer,
Oncology, Pfizer Global Product Development.
Detailed efficacy and safety data from ATLAS will be submitted for
presentation at a future medical meeting.
INLYTA has had a significant impact on the treatment of patients with
advanced RCC worldwide in its currently approved indications, supported
by an extensive body of evidence in scientific literature including more
than 50 publications. More than 66,000 patients have been treated with
INLYTA to date.1 For more information on INLYTA, please visit www.INLYTA.com.
About RCC
Each year, approximately 338,000 new cases of kidney cancer are
diagnosed worldwide, representing approximately 2-3 percent of all
cancers.2,3,4 Renal cell carcinoma (RCC) is the most common
type of kidney cancer, accounting for around 90 percent of cases.5
Approximately 75 percent of patients with clear cell RCC are
non-metastatic, and 70-80 percent will have a nephrectomy with curative
intent, or surgical removal of the tumor.6 However, a subset
will relapse after surgery and once their disease becomes metastatic,
their long-term prognosis is poor in advanced RCC with a 5-year survival
rate as low as 12%.7
About ATLAS
ATLAS (A Randomized Double-Blind Phase 3 Study of Adjuvant Axitinib
Versus Placebo in Subjects at High Risk of Recurrent RCC)(NCT01599754)
is a global, multicenter, randomized double-blind Phase 3 trial that
investigated the clinical efficacy and safety of adjuvant INLYTA (5 mg
twice daily) versus placebo in patients (n=724) at high risk of
recurrent RCC following nephrectomy. Patients were dosed up to 3 years
(for a minimum of 1 year) in the study and the primary endpoint was
disease-free survival (DFS). The study was conducted in collaboration
with SFJ Pharmaceuticals, who provided the funding and clinical
development supervision to generate the clinical data.
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.INLYTA.com.
About the SFJ Pharmaceuticals Group
SFJ is a global drug development company, which provides a unique and
highly customized co-development partnering model for the world's top
pharmaceutical and biotechnology companies. SFJ provides at-risk funding
and the global clinical development management and oversight, necessary
for regulatory submission for some of the most promising drug
development programs of Pharmaceutical and Biotechnology companies.
SFJ’s mission is to leverage its financial strength and global team of
pharmaceutical development experts to accelerate the development of
life-saving and life enhancing drugs for the benefit of physicians and
the patients they serve.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have
a meaningful impact on people living with cancer. Our growing pipeline
of biologics, small molecules, and immunotherapies is focused on
identifying and translating the best scientific breakthroughs into
clinical application for patients across a diverse array of solid tumors
and hematologic cancers. Today, we have 10 approved oncology medicines
and 17 assets currently in clinical development. By maximizing our
internal scientific resources and collaborating with other companies,
government and academic institutions, as well as non-profit and
professional organizations, we are bringing together the brightest and
most enterprising minds to take on the toughest cancers. Together we can
accelerate breakthrough treatments to patients around the world and work
to redefine life with cancer.
Working together for a healthier world®
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 health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care 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, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com
and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn,
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and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of
April 10, 2018. 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 its 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, uncertainties regarding the
commercial impact of the Phase 3 ATLAS trial results; the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical trial completion dates and regulatory submission
dates, as well as the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing clinical data; the risk that clinical trial data are subject to
differing interpretations; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when any drug applications may be filed for INLYTA in
combination with immune checkpoint inhibitors in any jurisdictions;
whether and when regulatory authorities may approve any such
applications, which will depend on the assessment by such regulatory
authority of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted and, if approved, whether
INLYTA will be commercially successful; decisions by regulatory
authorities regarding labeling and other matters that could affect the
availability or commercial potential of INLYTA; 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, 2017 and its subsequent reports of 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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1 Pfizer data on file.
2
Ferlay J, Shin HR, Bray F.GLOBOCAN 2008 v1.2, Cancer Incidence and
Mortality Worldwide: IARC CancerBase No. 10 Lyon, France: International
Agency for Research on Cancer; 2010. Available at: http://globocan.iarc.fr(link
is external). Accessed April 2018.
3 Ljungberg B,
Campbell S and Choi H. The Epidemiology of Renal Cell Carcinoma. Eur
Urol. 2011;60:615-621.
4 World Cancer Research Fund
International: Kidney Cancer statistics. Available from: http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/kidney-cancer-statistics.
Accessed April 2018.
5 What is Kidney Cancer. James
Whale Fund for Kidney Cancer. Available at: http://www.jameswhalefund.org/kidneycancer/what-is-kidney-cancer/(link
is external). Accessed April 2018.
6 Based on
comparison between 2015 Swedish population study (76%), Navigant
interviews (95%), and Quant Pulse (79%). 2018-2022.
7
The Surveillance, Epidemiology, and End Results (SEER) Program of the
National Cancer Institute (NCI). Cancer Stat Facts: Kidney and Renal
Pelvis Cancer. https://seer.cancer.gov/statfacts/html/kidrp.html.
Accessed April 2018.
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Source: Pfizer Inc.