Major R&D Pipeline: 3ADCs slide image

Major R&D Pipeline: 3ADCs

ENHERTU®: NSCLC, CRC DESTINY-Lung01 study (HER2 mutated/overexpressing, 2L+, Ph2): TLR obtained in June Daiichi-Sankyo HER2 mutated: Granted breakthrough therapy designation in US, filing strategy to be discussed with health authorities HER2 overexpressing: Development strategy under discussion based on the data Presented DESTINY-CRC01 study (HER2 expressing, 3L+, Ph2) final results at ASCO 2021 40 DESTINY-CRC01 efficacy DESTINY-CRC01 safety Adverse Events in ≥20% of Patients HER2 IHC3+ or IHC2+/ISH+ Cohort A (n = 53) HER2 IHC2+/ISH- Cohort B (n=15) Any Grade HER2 IHC1+ Cohort C (n = 18) Best % Change From Baseline in the Sum of Diameters of Measurable Tumors -20 -40 -60 HER2 IHC3+ or IHC2+/ISH+ Cohort A (n = 49a) -80 A IHC3+ IHC2+/ISH+ Prior anti-HER2 treatment -100 Overall (N = 86) n (%) Any Grade Any Grade Patients with any TEAE 53 (100) 15 (100) 18 (100) Any Grade 86 (100) Grade ≥3 56 (65.1) Nausea 37 (69.8) 9 (60.0) 7 (38.9) 53 (61.6) 5 (5.8) Anemia 21 (39.6) 4 (26.7) 6 (33.3) 31 (36.0) 12 (14.0) Fatigue 21 (39.6) 7 (46.7) 3 (16.7) 31 (36.0) 1 (1.2) Decreased appetite 18 (34.0) 5 (33.3) 7 (38.9) 30 (34.9) 0 Platelet count decreased 17 (32.1) 4 (26.7) 7 (38.9) 28 (32.6) 8 (9.3) Vomiting 23 (43.4) 3 (20.0) 1 (5.6) 27 (31.4) 1 (1.2) Neutrophil count decreased Diarrhea 20 (37.7) 2 (13.3) 4 (22.2) 26 (30.2) 19 (22.1) 19 (35.8) 0 4 (22.2) 23 (26.7) 1 (1.2) Interstitial Lung Disease (ILD) * HER2 IHC2+/ISH+ with an NRAS mutation b A All Patients (N=86) Grade 1 n (%) 0 a4 patients from the full analysis set were excluded since 1 patient had no measurable target lesion and 3 patients had no postbaseline data. By local assessment. Grade 2 4 (4.7) Grade 3 1 (1.2) Grade 4 0 Grade 5 Any Grade/Total 3 (3.5)a 8 (9.3)b.c Promising efficacy profile, ORR 45.3%, mDOR 7 months, mPFS 6.9 months, mOS 15.5 months, were observed in HER2 positive cohort (Cohort A) Safety profile is consistent with the known safety profile Careful monitoring and prompt intervention for ILD are required AE, adverse events; ILD, interstitial lung disease a2 patients were from cohort A, 1 from cohort B. b4 patients were from cohort A, 3 from cohort B and 1 from cohort C. CILD grades are the highest/most severe grade recorded in a patient. CRC: colorectal cancer, DOR: duration of response, ORR: objective response rate, OS: overall survival, PFS: progression free survival, TLR: top line results 18
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