Abstract P070: The safety and efficacy of Durvalumab and Paclitaxel combination in metastatic triple-negative breast cancer: An open-label phase I/II trial with 2-years follow-up

Abstract

Abstract Weekly paclitaxel is an excellent therapeutic choice for metastatic triple-negative breast cancer, a type of cancer that typically has short survival. There is evidence that TNBC is relatively more immunogenic; THEREFORE, we tested the safety and efficacy of weekly paclitaxel at 80 mg/m2/IV given in combination with Durvalumab, (an anti-PD-L1). During a period of 24 MONTHS, 14 patients received the combination OF six cycles of concurrent weekly paclitaxel given on days 1, 8, and 15/IV and Durvalumab given on days 1 and 15/IV of every 28 days' cycle. Upon completion of this combination, Durvalumab was given every 2 weeks until disease progression or unacceptable toxicity. The combination therapy had an excellent safety profile with no dose reduction, dose-limiting toxicity, OR death related to combination therapy. Adverse events (AEs) reported in 10 (71%) of patients, regardless of grade, while grade 3 or 4 AEs happening in 3 (21%) patients only. The most common AEs, were peripheral neuropathy and headache, which happened in 4 patients (29%) followed by fatigue and skin rash occurred in 3 patients (21%). Other less common AEs included: Anemia, leukopenia and/or neutropenia, diarrhea, alopecia, palpitation, and weight gain. The overall response rate for the combination was 36% (confirmed), with a median duration OF RESPONSE of 10 months. The median progression-free survival (PFS) and overall survival (OS) was 5.0 AND 20.7 months, respectively. In conclusion, WE ARE REPORTING an excellent safety profile for the weekly paclitaxel and Durvalumab combination. The data should be looked at with caution due to the small number of patients. Due to excellent safety profile, further trials involving additional, possibly synergistic, agents to the paclitaxel/Durvalumab combination are encouraged. Citation Format: Hazem Ghebeh, Adher Al-Sayed, Kauser Suleman, Riham Eiada Eiada, Asma Tulbah, Taher Al-Tweigeri. The safety and efficacy of Durvalumab and Paclitaxel combination in metastatic triple-negative breast cancer: An open-label phase I/II trial with 2-years follow-up [abstract]. In: Abstracts: AACR Virtual Special Conference: Tumor Immunology and Immunotherapy; 2021 Oct 5-6. Philadelphia (PA): AACR; Cancer Immunol Res 2022;10(1 Suppl):Abstract nr P070.