Submission Based on Data from Randomized Phase 2 Trial, Which Showed
Glasdegib in Combination with Chemotherapy Nearly Doubled Overall
Survival Compared to Chemotherapy Alone
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug
Administration (FDA) accepted the company’s New Drug Application and
granted Priority Review designation for glasdegib, an investigational
oral smoothened (SMO) inhibitor, being evaluated for the treatment of
adult patients with previously untreated acute myeloid leukemia (AML) in
combination with low-dose cytarabine (LDAC), a type of chemotherapy.
“Patients with acute myeloid leukemia who are ineligible for intensive
chemotherapy are in critical need of new treatment options to improve
their overall survival,” said Mace Rothenberg, M.D., chief development
officer, Oncology, Pfizer Global Product Development. “In an
investigational Phase 2 study, glasdegib in combination with low-dose
cytarabine showed a significant improvement in overall survival compared
to patients who received low-dose cytarabine alone. Glasdegib is the
first smoothened inhibitor to potentially offer such a benefit to
patients with acute myeloid leukemia, and we are proud that our
application was accepted by the FDA for Priority Review.”
The FDA grants Priority Review designation to medicines that may offer
significant advances in treatment or may provide a treatment where no
adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal
date for a decision by the FDA is in December 2018.
The submission is based on results from the Phase 2 BRIGHT 1003 study, a
randomized, open-label, multicenter trial investigating glasdegib
combined with LDAC (n=88) versus LDAC alone (n=44) in 132 patients with
previously untreated AML or high-risk myelodysplastic syndrome (MDS) who
were not eligible for intensive chemotherapy. Results demonstrated a
significant improvement in the primary endpoint of overall survival
(OS). Median OS was 8.8 months for patients treated with glasdegib plus
LDAC compared with 4.9 months for patients treated with LDAC only. This
difference represented a 49.9 percent reduction in the risk of death for
patients treated with glasdegib plus LDAC (HR: 0.501, 95% CI: 0.334,
0.752, one-sided p-value 0.0003). The BRIGHT 1003 results were presented
in 2016 at the 58th American Society of Hematology Annual Meeting.
The most frequently (≥30% of patients) reported adverse events (AEs) in
patients treated with glasdegib plus LDAC compared to LDAC alone were
anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs
12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%) and
thrombocytopenia (30% vs 27%). The most frequently (≥15% of patients)
reported serious AEs for patients treated with glasdegib plus LDAC
compared to LDAC alone were febrile neutropenia (29% vs 20%) and
pneumonia (21% vs 17%).
About Glasdegib
Glasdegib is an investigational, oral, once-daily therapy that is
thought to inhibit the SMO receptor, thereby disrupting the Hedgehog
pathway. Abnormal Hedgehog pathway activation is thought to play a role
in the development of multiple types of cancers, including solid tumors
and hematologic malignancies. It has not received regulatory approval in
any country.
The Phase 3 BRIGHT AML 1019 trial (NCT03416179), which is evaluating the
addition of glasdegib to intensive or non-intensive chemotherapy in
patients with newly diagnosed AML, began enrolling earlier this year.
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is the most common type of acute leukemia
in adults and accounts for approximately 80 percent of all cases of
acute leukemia.1 An estimated 19,520 people are expected to
be diagnosed with AML in the U.S. in 2018.1 Despite recent
advancements, only approximately one in four patients with AML survive
longer than five years, and additional treatment options are needed to
reduce incidence of disease progression and relapse.2,3 This
is especially true for patients who are unable to receive intensive
chemotherapy and are triaged to other treatments associated with poorer
outcomes.
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 14 assets currently in clinical development. By maximizing our
internal scientific resources and collaborating with other companies,
government and academic institutions, as well as patients and 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.
Pfizer Inc.: 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,
YouTube,
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of
June 27, 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 a product
candidate, glasdegib, and Pfizer Oncology, 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 trial commencement
and 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,
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 regulatory authorities will be satisfied with the
design of and results from our clinical studies; whether and when new
drug applications may be filed in any other jurisdictions for glasdegib
or for any other oncology products; whether and when the new drug
application for glasdegib pending with the FDA or any such other
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 the efficacy and safety
information submitted, and, if approved, whether glasdegib or any such
other oncology products will be commercially successful; decisions by
regulatory authorities regarding labeling and other matters that could
affect the availability or commercial potential of glasdegib or any
other oncology products; 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 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
.
__________________________
1 American Cancer Society. Key statistics for acute myeloid
leukemia. Available at https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html.
Accessed January 23, 2018.
2 SEER Cancer Stat Facts: Acute Myeloid Leukemia. National
Cancer Institute. Bethesda, MD, April 2017. Available at: http://seer.cancer.gov/statfacts/html/amyl.html.
Accessed January 23, 2018.
3 Dombret H, Seymour JF, Butrym A, et al. International phase
3 study of azacitidine vs conventional care regimens in older patients
with newly diagnosed AML with >30% blasts. Blood 2015; 126(3): 291-9.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180627005392/en/
Pfizer Media:
Jessica Smith, (212) 733-6213
Jessica.M.Smith@pfizer.com
or
Pfizer
Investor:
Ryan Crowe, (212) 733-8160
Ryan.Crowe@pfizer.com
Source: Pfizer Inc.