AACR 2017: Interim Results of Phase Ib/II Trial of Neratinib in Combination With Ado-trastuzumab Emtansine in HER2-Positive Metastatic Breast Cancer
A poster presentation at the 2017 American Association for Cancer Research Annual Meeting in Washington, DC, detailed interim results of dual HER2 targeting for second-line treatment of metastatic breast cancer. Patients who had received first-line treatment with chemotherapy, trastuzumab, and pertuzumab were enrolled in a phase Ib/II FB-10 dose-escalation trial exploring standard-dose ado-trastuzumab emtansine plus oral neratinib at doses ranging from 120 mg/d to 240 mg/d.
In the 16 patients who were evaluable for efficacy, the objective response rate was 56%: 3 patients had a complete response lasting 17.1 months, 11.9 months, and 12+ months; 6 patients had a partial response; 3 patients had stable disease; and 4 patients had progressive disease. The most frequently observed grade 3 adverse events were diarrhea, nausea, thrombocytopenia, and hypertension.
Additional patients are being enrolled at the 160-mg/d neratinib dose, and phase II studies are planned.