A phase Ib study of TQB2450 plus anlotinib in patients with advanced triple-negative breast cancer

Jiayu Wang; Tao Sun; Quchang Ouyang; Yiqun Han; Binghe Xu

doi:10.1016/j.isci.2023.106876

A phase Ib study of TQB2450 plus anlotinib in patients with advanced triple-negative breast cancer

iScience. 2023 May 13;26(6):106876. doi: 10.1016/j.isci.2023.106876. eCollection 2023 Jun 16.

Authors

Jiayu Wang¹, Tao Sun², Quchang Ouyang³, Yiqun Han¹, Binghe Xu¹

Affiliations

¹ Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
² Liaoning Cancer Hospital & Institute, Shenyang, China.
³ Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha, China.

Abstract

This study explored the safety and preliminary efficacy of the anti-PD-L1 antibody TQB2450 combined with the multi-kinase inhibitor anlotinib in advanced triple-negative breast cancer (TNBC). Patients with advanced TNBC who received at least one line of systemic therapy with anthracyclines and/or taxanes were enrolled in the dose-escalation and dose-expansion cohorts. Between May 29, 2019 and September 28, 2020, 34 patients were enrolled (three in the dose-escalation cohort and 31 in the dose-expansion cohort). The ORR was 26.5% (95% CI, 12.9-44.4) and the DCR was 73.5% (95% CI, 55.6-87.1). The median PFS was 5.6 (95% CI, 2.9-7.5) months, and the median OS was not reached. Seventeen (50.0%) patients had grade ≥3 treatment-related adverse events, with the most common being QT interval prolongation (17.6%) and hypertension (14.7%). No treatment-related deaths occurred. TQB2450 combined with anlotinib as a chemotherapy-free treatment shows promising efficacy with a manageable safety profile for patients with previously treated advanced TNBC.

Keywords: Clinical medicine; Health sciences; Oncology.