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Pfizer to Present Data on Neratinib, Sutent at San Antonio Breast Cancer Symposium

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By Turna Ray

Pfizer is planning to present new findings on several targeted oncologics at a major breast cancer conference this week, offering a peek into the company's ongoing work in cancer personalization.

At the San Antonio Breast Cancer Symposium being held Dec. 9–13, Pfizer will present new clinical trial data on neratinib, an investigational pan-ErbB inhibitor in patients with HER2-positive breast cancer, as well as data on the marketed oncologic Sutent (sunitinib malate) in metastatic breast cancer.

Neratinib is an irreversible inhibitor of the ErbB-1 (EGFR), ErbB-2 (HER2) and ErbB-4 (HER4) kinases that came to Pfizer through its acquisition of Wyeth. Researchers at the meeting will present data on the safety and efficacy of neratinib in combination with paclitaxel in HER2 positive metastatic breast cancer. Separately, researchers will present data from a Phase II study on the cardiovascular and gastrointestinal safety profile of neratinib as monotherapy in advanced HER2-positive breast cancer.

Additional posters Pfizer is planning to present at the meeting on neratinib include a safety and efficacy assessment of the drug in combination with vinorelbine in ErbB2-positive metastatic breast cancer. Also, Pfizer will present data from a Phase I/II study on the safety of neratinib in combination with capecitabine in patients with solid tumors.

Pfizer is also slated to present at the conference this week final results from a Phase III study, the SUN 1107 trial, evaluating sunitinib versus capecitabine in patients with HER2 negative advanced breast cancer after they have failed on standard treatment. "Earlier this year, at the recommendation of an independent Data Monitoring Committee, 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," Pfizer said in a statement.

Sutent is currently indicated as a treatment for advanced kidney cancer, and for treating gastrointestinal stromal tumors when Gleevec cannot be taken or is not working. The vascular endothelial growth factor/angiogenesis inhibitor is in clinical trials for the treatment of gastric, liver, prostate, breast, lung, and colorectal cancer.

In partnership with Genomic Health, Pfizer intends to bring to market a companion diagnostic for Sutent in treating Stage I-III, localized, clear cell-type renal carcinoma [see PGx Reporter 01-09-2008].

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