New Preliminary Data From Two Studies Show Clinical

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30th May 2009, 12:34am - Views: 360





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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

Community Health Wyeth Pharmaceuticals 2 image

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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