Abstract PD1-01: Durvalumab (MEDI4736) concurrent with nab-paclitaxel and dose dense doxorubicin cyclophosphamide (ddAC) as neoadjuvant therapy for triple negative breast cancer (TNBC)

Background: The goal of this Phase I/II trial (NCT02489448) was to assess the safety and efficacy of concurrent durvalumab with weekly nab-paclitaxel (100 mg/m2) x 12 followed by ddAC x 4 as neoadjuvant therapy for stage I-III TNBC and to identify biomarkers of response. The primary efficacy endpoint was pathologic complete response (pCR: ypT0,is/N0). Methods: The Phase I portion of the trial assessed two dose levels of durvalumab 3 and 10 mg/kg q 2 weeks. The trial followed Simon’s two step design, with early stopping for futility if 1 % on immune and tumor cells was considered positive. Tumor infiltrating lymphocyte (TIL) count was assessed on HE 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD1-01.