New Preliminary Data from Two Studies Show Clinical Activity of Neratinib
in Combination with Trastuzumab and in Combination with Paclitaxel in
Advanced HER-2 Positive Breast Cancer
COLLEGEVILLE, Pa., May 29 /PRNewswire-AsiaNet/ --
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today
announced preliminary data from two ongoing studies, one evaluating
neratinib (HKI-272) in combination with trastuzumab (Herceptin(R), Roche)
in HER-2 positive (ErbB-2 positive) breast cancer, and a separate study
investigating neratinib safety and efficacy when given with paclitaxel
(Taxol(R), Bristol-Myers Squibb) in patients with HER-2 dependent solid
tumors. The data gathered from both trials are scheduled to be presented
at the 45th Annual Meeting of the American Society of Clinical Oncology
Annual Meeting in Orlando, Florida, from May 29 to June 2, 2009.
Neratinib is an investigational orally administered irreversible
inhibitor of the HER-2 and EGFR kinases.
"The data gathered from these studies provide additional evidence
suggesting that neratinib, when combined with these therapies, is an
active agent in HER-2 positive breast cancer," says Ramona Swaby, M.D.,
Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia,
PA. "While improvements have been made in treating HER-2 positive breast
cancer, there remains an unmet medical need for more therapies for
patients with metastatic breast cancer. These data warrant ongoing and
future investigations to further understand and evaluate the utility of
neratinib against this aggressive disease."
Neratinib (HKI-272) in Combination with Trastuzumab for the Treatment
of Advanced Breast Cancer
This ongoing phase 1/2 study of neratinib in combination with
trastuzumab evaluated patients with advanced ErbB-2 positive breast
cancer that progressed following therapy with trastuzumab, the standard
of care in this disease setting. The primary endpoint of the two-part
study is 16-week progression-free survival (PFS). The first part of the
study includes patients being administered neratinib (160 mg or 240 mg)
daily plus weekly trastuzumab (4 mg/kg IV loading dose then 2 mg/kg). In
the second part of the study, patients receive a weekly dose of
trastuzumab with daily neratinib (240 mg).
To date, 45 patients have been enrolled and 28 patients were
evaluable for efficacy. The 16-week PFS rate (for part 2) was 45 percent
(95 percent CI, 26 percent to 62 percent); median PFS was 16 weeks (95
percent CI, 15 to 31 weeks). The complete response rate was 7 percent,
while 21 percent of evaluable patients showed partial response. The
objective response rate was 29 percent (95 percent CI, 13 percent to 49
percent).
In this study, adverse events of any grade were diarrhea, nausea,
anorexia, vomiting, asthenia, rash and fatigue. In the 45 patients
enrolled in this study, diarrhea was the most common adverse event,
observed in 91 percent of patients, and was the most significant grade 3
or 4 adverse event, occurring in 16 percent of patients. Two patients
receiving neratinib 240 mg reported adverse events leading to
discontinuation of therapy.
Safety and Efficacy of Neratinib (HKI-272) in Combination with
Paclitaxel in Patients with Solid Tumors
In a separate phase 1/2, open-label, 2-part study, ascending multiple
daily oral doses of neratinib (160 mg, 240 mg) were administered in
combination with IV paclitaxel 80 mg/m2, if tolerable, or 70 mg/m2 on
days 1, 8 and 15. Patients with solid tumors (endometrial, cervical,
colorectal and esophageal cancers) were entered in the phase 1 portion
(part 1), and only patients with metastatic ErbB-2 positive breast cancer
were enrolled in part 2. Safety and efficacy were investigated in
patients with ErbB-2 positive metastatic breast cancer.
A total of 102 patients were enrolled in part 2 of the study and 97
patients were evaluable for efficacy. The overall response rate at 16-
weeks (for part 2) was 63 percent (80 percent CI, 55.9 percent to 69.4).
In this preliminary analysis, the adverse event profile of the
combination of neratinib (240 mg) plus paclitaxel (80 mg/m2) was similar
to that reported with both agents as monotherapy. Adverse events of any
grade were diarrhea, alopecia, infection, peripheral neuropathy,
leucopenia, anemia, nausea, rash, fatigue and vomiting. The most common
adverse event was diarrhea, observed in 89 percent of the 102 patients
enrolled in part 2 and was the most significant grade 3 or 4 adverse
event, occurring in 25 percent of patients. Fourteen patients had dose
reductions and one patient withdrew from the study due to an adverse
event.
"Emerging clinical data continue to suggest that neratinib, in
combination with these therapies is tolerable and active in treating HER-
2
positive disease, even in those women who have progressed while on
other targeted therapies," says Gary L. Stiles, M.D., Chief Medical
Officer, Wyeth Pharmaceuticals. "These additional data build upon results
presented at the 2008 San Antonio Breast Cancer Symposium, and Wyeth is
committed to evaluating further the potential of this investigational
therapy."
In 2008, the American Cancer Society estimated that more than 182,000
women in the United States would be diagnosed with breast cancer, and
more than 40,000 would die from the disease. The HER-2 receptor is over-
expressed in 25 percent to 30 percent of patients with breast cancer.
About Wyeth
Wyeth is one of the world's largest research-driven pharmaceutical
and health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceuticals, vaccines,
biotechnology products, nutritionals and non-prescription medicines that
improve the quality of life for people worldwide. The Company's major
divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and
Fort Dodge Animal Health.
The statements in this press release that are not historical facts
are forward-looking statements that are subject to risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied by such statements. In particular, clinical
trial data are subject to differing interpretations, and the views of
regulatory agencies, medical and scientific experts and others may differ
from ours. There can be no assurance that neratinib will ever receive
regulatory approval or be successfully developed and commercialized.
Other risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by forward-looking statements
include, among others, risks related to our proposed merger with Pfizer,
including satisfaction of the conditions of the proposed merger on the
proposed timeframe or at all, contractual restrictions on the conduct of
our business included in the merger agreement, and the potential for loss
of key personnel, disruption in key business activities or any impact on
our relationships with third parties as a result of the announcement of
the proposed merger; the inherent uncertainty of the timing and success
of, and expense associated with, research, development, regulatory
approval and commercialization of our products and pipeline products;
government cost-containment initiatives; restrictions on third-party
payments for our products; substantial competition in our industry,
including from branded and generic products; emerging data on our
products and pipeline products; the importance of strong performance from
our principal products and our anticipated new product introductions; the
highly regulated nature of our business; product liability, intellectual
property and other litigation risks and environmental liabilities; the
outcome of government investigations; uncertainty regarding our
intellectual property rights and those of others; difficulties associated
with, and regulatory compliance with respect to, manufacturing of our
products; risks associated with our strategic relationships; global
economic conditions; interest and currency exchange rate fluctuations and
volatility in the credit and financial markets; changes in generally
accepted accounting principles; trade buying patterns; the impact of
legislation and regulatory compliance; risks and uncertainties associated
with global operations and sales; and other risks and uncertainties,
including those detailed from time to time in our periodic reports filed
with the Securities and Exchange Commission, including our current
reports on Form 8-K, quarterly reports on Form 10-Q and annual
report on Form 10-K, particularly the discussion under the caption "Item
1A, Risk Factors" in our Annual Report on Form 10-K for the year ended
December 31, 2008, which was filed with the Securities and Exchange
Commission on February 27, 2009. The forward-looking statements in this
press release are qualified by these risk factors. We assume no
obligation to publicly update any forward-looking statements, whether as
a result of new information, future developments or otherwise.
SOURCE: Wyeth Pharmaceuticals
CONTACT: Danielle Halstrom
+1-215-280-3898 (one site)
of Wyeth Pharmaceuticals, or
Douglas Petkus
+1-973-660-5218; or
Investors:
Justin Victoria
+1-973-660-5340
both of Wyeth
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