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    4568   JP3475350009

DAIICHI SANKYO COMPANY, LIMITED

(4568)
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Daiichi Sankyo Company, Limited and AstraZeneca announce ENHERTU® Demonstrated Clinically Meaningful and Durable Response in Patients with HER2 Positive Advanced Gastric Cancer in DESTINY-Gastric02 Phase 2 Trial

09/18/2021 | 03:03am EST

Detailed results from the positive DESTINY-Gastric02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan), the Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca HER2 directed antibody drug conjugate (ADC), provided a clinically meaningful and durable tumor response in patients with HER2 positive metastatic and/or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with a trastuzumab-containing regimen. Results were presented during a late-breaking Mini Oral presentation at the European Society for Medical Oncology (#ESMO21) 2021 Virtual Congress (#LBA55). In the primary analysis of DESTINY-Gastric02, the first trial of ENHERTU specifically in Western patients with HER2 positive metastatic gastric cancer or GEJ adenocarcinoma, ENHERTU (6.4 mg/kg) demonstrated a confirmed overall response rate (ORR) of 38.0% (n=30; CI: 27.3-49.6) as assessed by independent central review (ICR). Out of a total of 79 patients treated with ENHERTU, three (3.8%) complete responses (CR) and 27 (34.2%) partial responses (PR) were observed. These results were consistent with those from the pivotal DESTINY-Gastric01 phase 2 trial, previously published in The New England Journal of Medicine, which evaluated ENHERTU in patients from Japan and South Korea with HER2 positive advanced gastric or GEJ adenocarcinoma who had progressed on two or more prior treatment regimens, including trastuzumab, a fluoropyrimidine and platinum-containing chemotherapy. After a median follow-up of 5.7 months, the median duration of response (DoR) of ENHERTU was 8.1 months (95% CI: 4.1-NE). The median progression-free survival (PFS) was 5.5 months (95% CI: 4.2-7.3). An exploratory endpoint of confirmed disease control rate (DCR) of 81% (95% CI: 70.6-89.0) was seen. The overall safety profile of ENHERTU in DESTINY-Gastric02 was consistent with that seen in DESTINY- Gastric01. The most common grade 3 or higher drug-related treatment-emergent adverse events seen in DESTINY-Gastric02 were anemia (7.6%), neutropenia (7.6%), nausea (3.8%), fatigue (3.8%), vomiting (1.3%), diarrhea (1.3%), decreased appetite (1.3%) and decreased platelet count (1.3%). Seven patients (8.9%) discontinued treatment due to drug-related treatment-emergent adverse events. There were six cases (7.6%) of treatment-related interstitial lung disease (ILD) or pneumonitis reported, as determined by an independent adjudication committee. The majority (83%) were low grade (grade 1 or grade 2), with one grade 5 (ILD or pneumonitis-related death).


© S&P Capital IQ 2021
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Financials
Sales 2022 1 021 B 8 979 M 8 979 M
Net income 2022 64 911 M 571 M 571 M
Net cash 2022 625 B 5 495 M 5 495 M
P/E ratio 2022 79,4x
Yield 2022 1,00%
Capitalization 5 120 B 45 122 M 45 022 M
EV / Sales 2022 4,40x
EV / Sales 2023 4,14x
Nbr of Employees 16 033
Free-Float 97,6%
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Number of Analysts 14
Last Close Price 2 671,00 JPY
Average target price 3 789,29 JPY
Spread / Average Target 41,9%
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Sunao Manabe President, CEO & Representative Director
Hiroyuki Okuzawa CFO, Director, Executive Officer & Head-Management
Ken Takeshita Global Director-Research & Development
Noritaka Uji Independent Outside Director
Tsuguya Fukui Independent Outside Director
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