New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination wit
May 29 2009 - 8:00AM
PR Newswire (US)
COLLEGEVILLE, Pa., May 29 /PRNewswire-FirstCall/ -- 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. DATASOURCE: Wyeth Pharmaceuticals CONTACT: Danielle
Halstrom, +1-215-280-3898 (on 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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