Major R&D Pipeline: 3ADCs

Dato-DXd: Breast cancer, NSCLC Presented interim results of TROPION-PanTumor01 study TNBC cohort at ESMO BC 2021 Presented interim results of TROPION-PanTumor01 study NSCLC cohort at ASCO 2021 TNBC cohort interim results Patients, n (%) a NSCLC cohort interim results Best change in SoD, % Best Overall Response (BICR) N=21 Objective response rate 9 (43) Dato-DXd Dose 80 CR/PR (confirmed) 5 (24) 4 mg/kg 6 mg/kg 60 60 CR/PR (pending confirmation) 4 (19) Patientsa (n=50) (n=50) 8 mg/kg (n=80) 40 40 Disease control rateb 20 (95) ORR, n (%) 12 (24) 13 (26) 19 (24) Progressive disease 1 (5) 20 20 0 CR/PR 10 (20) 11 (22) 19 (24) CR/PR (too early to be confirmed) 2 (4) 2 (4) 0 DCR, n (%) 38 (76) 35 (70) 64 (80) -20 PD, n (%) 7 (14) 10 (20) 7 (9) NE 10.5 9.0 -40 DOR, median (95% CI), mo (2.8-NE) (4.1-NE) (5.8-NE) -60 6 mg/kg PFS, median (95% CI), mob 4.3 (3.5-8.4) 6.9 5.2 (2.7-8.8) -80 -100 8 mg/kg CR, complete response; PR, partial response; SoD, sum of diameters, a Includes response evaluable patients who had ≥1 postbaseline tumor assessment or discontinued treatment. Postbaseline tumor assessments were not yet available for 3 patients at the data cutoff. One patient was not confirmed to have a target lesion per BICR and therefore had a best overall response of non-CR/non-PD; b Includes patients with a best overall response of CR, PR, stable disease, or non-CR/non-PD. Demonstrated promising efficacy and manageable safety profile in heavily treated patients with metastatic TNBC (4.1-7.1) BICR, blinded independent central review; CR, complete response; DCR, disease control rate; DOR, duration of response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response. a Includes response evaluable patients who had ≥1 postbaseline tumor assessment or discontinued treatment. b Median PFS was limited by immature duration of follow-up in the 4- and 6-mg/kg dosing cohorts. Demonstrated promising efficacy and manageable safety profile in patients with advanced or metastatic NSCLC The study data and analysis support 6mg/kg as the dose for the pivotal trial NSCLC: non small cell lung cancer, TNBC: triple negative breast cancer 19 Daiichi-Sankyo

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