Incyte presents additional results from INCB7839 Phase I/II trial for HER2-positive metastatic breast cancer

Incyte Corporation (Nasdaq:INCY) announced today additional positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 66 patients with HER2-positive metastatic breast cancer during a poster session at the American Society of Clinical Oncology (ASCO) meeting in Chicago, IL, June 4 to June 8, 2010.

INCB7839 has been shown to markedly reduce the cleavage of the EGFR family member HER2 thereby inhibiting the release of the HER2 extracellular domain (ECD) and the generation of a constitutively active kinase in the remaining truncated HER2 protein (p95HER2). Data previously published by other groups have shown that these breast cancer patients, characterized as p95HER2-positive, tend to be resistant to chemotherapy and trastuzumab-based therapies and have poor clinical outcomes as compared to patients with full-length HER2, characterized as p95HER2-negative patients (Scaltriti et al 2007).

In contrast to outcomes reported for p95HER-positive patients in the published literature, results from this study suggest that, when treated with a combination of INCB7839 and trastuzumab, the subset of patients with p95HER2-positive metastatic cancer showed clinical benefit in terms of overall response rate (ORR) and progression-free survival (PFS) when compared to the p95HER2-negative patients.

"Biomarker and clinical results from this ongoing trial support our hypothesis that treatment with INCB7839 has the potential to inhibit HER2 cleavage and prevent the formation of the truncated, constitutively active kinase p95HER2. This activity, which is expected to restore and improve treatment with trastuzumab, may lead to improved therapeutic outcomes in p95HER2-positive breast cancer patients," stated Victor Sandor, Vice President, Global Oncology Drug Development at Incyte.


Incyte Corporation


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