Antitumor efficacy endpoints and assessments
tumor, tumors, TNBC tumors
DISEASE PROGRESSION, TUMOR, MAY, SECONDARY, TUMORS
Efficacy and survival outcomes were analyzed as prespecified secondary endpoints and included objective response rate (confirmed complete or partial response) assessed in response-evaluable patients, and progression-free survival and OS, assessed in the intention-to-treat population. Objective response rate and progression-free survival were investigator assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, based on the May 15, 2020, data cut-off. For tumor assessment, computed tomography or magnetic resonance imaging was performed at screening and at protocol-specified intervals (every 9 weeks for the first 6 months, then every 12 weeks thereafter) until disease progression, withdrawal of consent, or receipt of subsequent anticancer therapy. OS was analyzed following the final database lock on July 17, 2020. Genetic and/or expression markers in blood and tumors and immunologic markers, including PD-L1 expression, were analyzed as post hoc exploratory objectives. Baseline PD-L1 status was measured using the Ventana SP142 PD-L1 assay; tumors were scored as PD-L1 positive if the proportion of PD-L1-expressing tumor-infiltrating immune cells was ≥ 1% and PD-L1 negative if < 1%, per the assay interpretation guide for TNBC tumors [