Tous Actualités
Suivre
Abonner Wyeth Pharmaceuticals

Wyeth Pharmaceuticals

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, Pennsylvania (ots/PRNewswire)

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.

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

Plus de actualités: Wyeth Pharmaceuticals
Plus de actualités: Wyeth Pharmaceuticals