PFS benefit consistent across metastatic
BRCA-positive patients, including those with hormone
receptor-positive and triple negative disease
Pfizer Inc. (NYSE:PFE) today announced that the Phase 3 EMBRACA
trial in patients with germline (inherited) BRCA1/2-positive
(gBRCA+) locally advanced and/or metastatic breast cancer (MBC)
demonstrated superior progression-free survival (PFS) in patients
treated with talazoparib, compared to patients who received
physician’s choice standard of care chemotherapy. Median PFS was
8.6 months (95% CI: 7.2, 9.3) for patients treated with talazoparib
and 5.6 months (95% CI: 4.2, 6.7) for those treated with
chemotherapy [HR: 0.54 (95% CI: 0.41, 0.71), p<0.0001]. This
represents a 46% reduction in the risk of disease progression. In
addition, the proportion of patients achieving a complete or
partial response (objective response rate) in the talazoparib group
was more than twice that of the control arm (62.6% for talazoparib
vs. 27.2% for chemotherapy [OR: 4.99 (95% CI: 2.9-8.8),
p<0.0001]). Talazoparib is an investigational, oral,
dual-mechanism poly ADP ribose polymerase (PARP) inhibitor that is
taken once daily. The data will be presented today as an oral
presentation at the 2017 San Antonio Breast Cancer Symposium.
“Patients with germline BRCA-positive breast cancer are
typically diagnosed at a younger age than those with nonhereditary
breast cancer, and there are no therapies specifically approved for
them outside of current standard of care therapies,” said Jennifer
Litton, MD, lead investigator and associate professor in the breast
medical oncology department of The University of Texas MD Anderson
Cancer Center. “EMBRACA supports the potential of talazoparib to
give these patients additional time without disease progression,
compared to chemotherapy.”
Pfizer will be discussing these data from EMBRACA, the largest
Phase 3 trial performed to date of a PARP inhibitor in patients
with gBRCA+ MBC, with worldwide health authorities. There are
currently limited treatment options for patients with this
molecular subtype.
“Results from the EMBRACA study are very encouraging and a great
example of precision drug development. By enrolling only patients
with germline BRCA-positive metastatic breast cancer, treatment
with talazoparib reduced the risk of disease worsening by nearly
half, compared with current standard of care chemotherapy. This
includes heavily pretreated patients, those with hormone
receptor-positive disease and those who had a history of brain
metastases,” said Mace Rothenberg, MD, chief development officer,
Oncology, Pfizer Global Product Development.
The results of the EMBRACA trial also showed that the PFS
benefit with talazoparib was consistent across prespecified
subgroups, including hormone receptor (HR) status (triple negative
[TNBC] or hormone receptor-positive [HR+]), BRCA mutation (1 or 2),
prior chemotherapy (whether patients had none or up to three
chemotherapies before talazoparib), and history of central nervous
system (CNS) metastases. There also was a statistically significant
delay in the time to clinically meaningful deterioration in global
health status/quality of life with talazoparib versus chemotherapy
(HR 0.38 [95% CI 0.26-0.55], p<0.0001), as measured by the EORTC
QLQ-C30, a cancer-specific, patient-reported quality of life
questionnaire.
Adverse events (AEs) observed with talazoparib were consistent
with findings from previous trials. The most common AEs observed
with talazoparib (any grade in at least 15% of patients) were
anemia (52.8%), fatigue (50.3%), nausea (48.6%), neutropenia
(34.6%), headache (32.5%), thrombocytopenia (26.9%), alopecia
(25.2%), vomiting (24.8%), diarrhea (22%), constipation (22%),
decreased appetite (21.3%), back pain (21%) and dyspnea (17.5%).
The incidence of serious AEs was 31.8% in the talazoparib arm and
29.4% in the chemotherapy arm. Discontinuations due to AEs occurred
in 7.7% of patients in the talazoparib arm and 9.5% of patients in
the chemotherapy arm.
In addition to EMBRACA, talazoparib demonstrated promising
activity in patients with gBRCA+ MBC in the Phase 2 ABRAZO trial.
Patients in ABRAZO had either been previously treated with
platinum-based chemotherapy or were heavily pretreated with at
least three prior lines of non-platinum-based chemotherapy.1
About EMBRACA
EMBRACA is a global Phase 3, open-label, randomized, parallel,
2-arm trial of talazoparib versus protocol-specific physician’s
choice of standard single-agent chemotherapy (PCT [capecitabine,
eribulin, gemcitabine or vinorelbine]) in gBRCA+ patients who may
have received up to three prior cytotoxic chemotherapy regimens for
locally advanced and/or metastatic breast cancer. Patients enrolled
had a diagnosis of TNBC or HR+/HER2-negative breast cancer. The
trial randomized (2:1) 431 patients to receive talazoparib (1.0 mg)
once daily or PCT.
About Germline BRCA1/2-Positive Breast Cancer
BRCA1 and BRCA2 are human genes that produce proteins involved
in DNA repair. When either of these genes is altered or mutated,
DNA repair may not progress correctly. This can lead to the
development of certain types of cancer such as breast cancer.2,3,4
BRCA mutations can be hereditary (germline) or occur spontaneously
(sporadic).2 Together, BRCA1 and BRCA2 mutations account for about
20 to 25 percent of hereditary breast cancers and about 5 to 10
percent of all breast cancers.5,6 Up to 65 percent of women who
inherit a BRCA mutation will develop breast cancer by age 70.2
Epidemiologic studies indicate that individuals with gBRCA+ status
are diagnosed with breast cancer at a median age of 40-45, which is
approximately 20 years younger than the overall breast cancer
population.7
About Talazoparib
Talazoparib is an investigational anti-cancer compound called a
PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies
suggest that talazoparib is highly potent and has a dual mechanism
of action, with the potential to induce tumor cell death by
blocking PARP enzyme activity and trapping PARP on the sites of DNA
damage. Talazoparib is currently being evaluated in advanced gBRCA+
breast cancer as well as other cancer types with deficiencies in
DNA damage repair (DDR). It is also being studied in DDR-deficient
prostate cancer and in combination with immunotherapy in various
tumor types. Talazoparib has not been approved by any regulatory
authorities for the treatment of any disease.
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
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addition, to learn more, please visit us on www.pfizer.com and
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DISCLOSURE NOTICE: The information contained in this
release is as of December 8, 2017. 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, talazoparib, and Pfizer’s oncology portfolio,
including their potential benefits and regulatory submission plans,
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, without limitation, 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
jurisdictions for talazoparib or any other oncology products;
whether and when 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, and, if approved,
whether talazoparib 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 talazoparib or 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, 2016 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 Turner et al. Final results of a phase 2 study of talazoparib
(TALA) following platinum or multiple cytotoxic regimens in
advanced breast cancer patients (pts) with germline BRCA1/2
mutations (ABRAZO). ASCO 2017.
http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.1007.2
National Cancer Institute. BRCA1 and BRCA2: Cancer risk and genetic
testing.
https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet.
Accessed November 28, 2017.3 Evers et al. A high throughput
pharmaceutical screen identifies compounds with specific toxicity
against BRCA2-deficient tumors. Clin Cancer Res. 2010 Jan 1; 16(1):
99–108.4 Livraghi L, Garber J. PARP inhibitors in the management of
breast cancer: Current data and future prospects. BMC Medicine.
2015;13:188.5 Easton DF. How many more breast cancer predisposition
genes are there? Breast Cancer Research. 1999; 1(1):14–17.6 Campeau
PM, Foulkes WD, Tischkowitz MD. Hereditary breast cancer: New
genetic developments, new therapeutic avenues. Human Genetics.
2008; 124(1):31–42.7 Kim et al. Incidence of Germline BRCA1- and
BRCA2-Mutated Breast Cancer in the United States. San Antonio
Breast Cancer Symposium. 2016.
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