TROPION-Lung01 Study Design and Baseline demographics slide image

TROPION-Lung01 Study Design and Baseline demographics

Best change from baseline in target lesion size (%) BEGONIA Arm 7: Dato-DXd + Durvalumab Antitumour Responses in 1L a/mTNBC 100 Confirmed ORR was 79% (49/62; 95% CI, 66.8ā€“88.3) with 6 CR and 43 PR ā—† Antitumour responses were observed regardless of PD-L1 expression level as assessed by 2 separate PD-L1 assays and scoring methods 50- 0 -50- H High # PD-L1 expression L Low -100 U Unknown/Missing SP263 PD-L1 TAP 10% cutoff LLLHLLLLHLLHH 22C3 PD-L1 CPS 10 cutoff LL LLHLLLLHLLHHLLLLLU Progressive disease Stable disease LLL HLLLLLLL HLHLLLLL Not evaluable Partial response .L LHLLL LLLHLHLL Complete response Dotted lines indicate thresholds for partial response (-30%) and progressive disease (20%). PD-L1 expression was assessed by 1) immunohistochemistry using the VENTANA PD-L1 (SP263) Assay with expression defined as the percentage of the tumour area populated by tumour or immune cells with membranous staining (TAP), or 2) immunohistochemistry using the 2203 antibody with expression defined as the number of PD-L1-staining tumour cells, lymphocytes, and macrophages, divided by the total number of viable tumour cells, multiplied by 100 (CPS). *Ifthe best percentage change from baseline of target lesions cannot be calculated due to progression, withdrawal, or death, the value is imputed at +20%.***Patients with PD as best overall response. *Unconfirmed response. 1L, first line; a/m TNBC, advanced/metastatic triple-negative breast cancer; CI, confidence interval; CPS, combined positive score; CR, complete response; Dato-DXd, datopotamab deruxtecan; ORR, objective response rate; PD-L1, programmed cell death ligand-1; PR, parial response; TAP, tumour area positivity. Data cutoff. 02 Feb 2023 Daiichi-Sankyo 39
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