Pfizer to present study findings from its expanded breast cancer portfolio

Dec 4 2009

Pfizer Oncology announced today that it will be presenting study findings evaluating several compounds including those from its newly expanded breast cancer portfolio following the recent acquisition of Wyeth, focusing on the needs of multiple breast cancer patient populations at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) being held December 9 – 13. Presentations will highlight results from long-term follow-up of Aromasin^® (exemestane tablets) in an adjuvant switch study of postmenopausal women with early breast cancer; data on neratinib, an investigational, orally administered, pan-ErbB inhibitor in patients with HER2 (also known as ErbB2) positive breast cancer; as well as findings on Sutent^® (sunitinib malate) in metastatic breast cancer.

“As the needs of the breast cancer community continue to evolve, we are working diligently to develop novel treatment options to help a variety of patient populations,” said Maria Koehler MD, PhD, Vice President, Women’s Cancers Strategy for Pfizer Oncology. “At this important meeting, we are pleased to share research from our expanded pipeline, including neratinib and sunitinib, which builds upon our strong heritage in breast cancer research with Aromasin.”

Pfizer will present an exploratory analysis from the updated 91-month median follow-up data of the Intergroup Exemestane Study (IES) study (Oral #12; December 10). IES, a landmark trial with the longest follow-up of endocrine treatment in the adjuvant switch setting, is a randomized, double-blind, multinational trial of postmenopausal women with early breast cancer. IES evaluates the clinical benefits of switching 2,352 patients to Aromasin after two to three years of tamoxifen versus continuing 2,372 patients on tamoxifen for a full five years of therapy.

Pfizer will also present data relating to the efficacy and safety of neratinib, an orally administered, irreversible inhibitor of the ErbB-1 (EGFR), ErbB-2 (HER2) and ErbB-4 (HER4) kinases. Data presentations at the meeting include the evaluation of the safety and efficacy of neratinib in combination with paclitaxel in HER2 positive metastatic breast cancer (Poster #5081; December 12), as well as data on gastrointestinal and cardiovascular safety profiles based on a Phase 2 study of neratinib monotherapy in patients with advanced HER2 positive breast cancer (Poster #5096; December 12).

Final results will be presented from the Phase 3 SUN 1107 trial evaluating single-agent sunitinib versus single-agent capecitabine in patients with HER2 negative advanced breast cancer after failure of standard treatment. Earlier this year, at the recommendation of an independent Data Monitoring Committee (DMC), the trial was stopped after the DMC determined that sunitinib would be unable to reach the primary endpoint of improved progression-free survival compared to capecitabine, in the study population.

“We are working to improve our understanding of the mechanisms and biology of breast cancer to facilitate better matching of patients to treatments, with the goal of increased benefits from selected therapies,” added Dr. Koehler. “Whether it is through studying the addition of new compounds into existing regimens, or pursuing novel treatment strategies, we strive to improve outcomes for breast cancer patients worldwide.”

In ongoing support of the breast cancer community, new data from the BRIDGE (Bridging Gaps, Expanding Outreach – Metastatic Breast Cancer Patient) survey, a wide-reaching assessment of the needs, experiences and attitudes of women living with metastatic breast cancer (Poster #3085; December 12) will be presented. The survey was expanded to include 392 additional participants from four additional countries - Brazil, Venezuela, Canada and Australia. The survey now spans 13 countries across five continents, with a total of 1,342 respondents.

Additional Pfizer Data Presentations

• New analyses from the TEAM (Tamoxifen, Exemestane, Adjuvant, Multicenter) trial will also be presented at SABCS, comparing five years of exemestane as initial therapy to tamoxifen followed by exemestane for five years: The TEAM trial, a prospective, randomized, Phase 3 trial in postmenopausal women with hormone-sensitive early breast cancer (Oral #11; December 10).
• Safety and efficacy of neratinib in combination with vinorelbine in ErbB2+ metastatic breast cancer (Poster #5095; December 12)
• Safety of neratinib in combination with capecitabine in patients with solid tumors: a phase 1/2 study (Poster #5108; December 12)