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ARTICLE | Clinical News

INCB7839: Additional Phase I/II data

July 5, 2010 7:00 AM UTC

Incyte reported additional data from the ongoing, open-label, dose-escalation Phase I/II INCB7839-202 trial in patients with metastatic breast cancer positive for epidermal growth factor (EGF) receptor 2 ( HER2, ErbB2, neu). In the intent-to-treat (ITT) population (n=46), twice-daily INCB7839 plus Herceptin trastuzumab produced an ORR of 24%, with 2 complete responses (CR) and 9 partial responses (PR). In patients with p95-positive and p95-negative HER2-positive disease, the ORR was 41% and 12%, respectively. Median progression-free survival (PFS) was 178 and 94 days for p95-positive and negative patients, respectively. In the per protocol (PP) population (n=37), which excluded patients with a lack of centrally confirmed HER2-positive status, twice-daily INCB7839 plus Herceptin produced an ORR of 30%.

In an expanded cohort of 20 patients receiving twice-daily INCB7839 plus Herceptin and Taxotere docetaxel, the ORR was 50% and 59% for the ITT and PP populations, respectively. Patients in the dose-escalation portion of the trial received 100, 200 or 300 mg twice-daily INCB7839 plus Herceptin, while patients in the expansion cohort received 300 mg twice-daily INCB7839 plus Herceptin and Taxotere. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...