On December 1, 2023 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its oncology portfolio in multiple types of solid and blood cancers at the 2023 ESMO (Free ESMO Whitepaper) Asia Congress (#ESMOAsia23), San Antonio Breast Cancer Symposium (#SABCS23) and American Society of Hematology (ASH) (Free ASH Whitepaper) (#ASH23) Annual Meeting prior to its annual R&D Day (Press release, Daiichi Sankyo, DEC 1, 2023, https://www.businesswire.com/news/home/20231130031289/en/Daiichi-Sankyo-Demonstrates-Breadth-and-Depth-of-Oncology-Portfolio-Across-Multiple-Cancers-with-New-Data-at-ESMO-Asia-SABCS-and-ASH [SID1234638102]).
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Presentation highlights include the first presentation of results from three trials from Daiichi Sankyo’s DXd ADC and hematology portfolio, which include the DESTINY-Gastric06 phase 2 trial of ENHERTU (trastuzumab deruxtecan) in Chinese patients with previously treated HER2 positive locally advanced/metastatic gastric cancer or gastroesophageal junction adenocarcinoma at ESMO (Free ESMO Whitepaper) Asia, the DESTINY-Breast08 phase 1b trial of ENHERTU in combination with anastrozole or fulvestrant in patients with HER2 low metastatic breast cancer at SABCS and the VALENTINE-PTCL01 phase 2 trial of valemetostat in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) at ASH (Free ASH Whitepaper).
"Our goal is to push the boundaries of science to change the way cancer is treated," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These data reinforce the breadth and depth of our oncology pipeline and the important progress we are making in developing innovative medicines and exploring combination strategies for patients across a wide range of cancers, including breast, lung, gastric, acute myeloid leukemia and peripheral T-cell lymphoma."
Subgroup analyses of the TROPION-Lung05 phase 2 trial of datopotamab deruxtecan (Dato-DXd) in Asian patients with non-small cell lung cancer (NSCLC) with actionable genomic alterations and the DESTINY-Lung02 phase 2 trial of ENHERTU in Asian patients with HER2 mutant NSCLC will be presented at ESMO (Free ESMO Whitepaper) Asia. Additional subgroup analyses of the QuANTUM-First phase 3 trial in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), which formed the basis of recent approvals of VANFLYTA (quizartinib) in the EU, Japan and U.S. will be presented at ASH (Free ASH Whitepaper).
Daiichi Sankyo will hold its annual R&D Day for investors, analysts and media on Monday, December 11 at 5:30 – 7:00 pm EST/Tuesday, December 12 at 7:30 – 9:00 am JST. Company executives will provide highlights of Daiichi Sankyo’s research data presented at SABCS and ASH (Free ASH Whitepaper), as well as updates on the company’s R&D strategy.
ESMO Asia Data
Encore presentations of the TROPION-Lung01 phase 3 trial and TROPION-Lung05 phase 2 trial of datopotamab deruxtecan (Dato-DXd) as well as the DESTINY-PanTumor02 phase 2 trial of ENHERTU will be presented at ESMO (Free ESMO Whitepaper) Asia from December 1 – 3 in Singapore, along with other data, including:
Presentation Title
Presenter
Abstract
Presentation
ENHERTU (trastuzumab deruxtecan; T-DXd)
Lung
Trastuzumab deruxtecan (T-DXd) in Asian patients with human epidermal growth factor receptor 2 (HER2; ERBB2) mutant (HER2m) metastatic non–small cell lung cancer: subgroup analysis of DESTINY-Lung02
Y. Goto
510MO
Mini-Oral Session
December 2, 2023
9:00 – 10:30 am SGT
Pan
Tumor
Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: primary analysis from the DESTINY-PanTumor02 study
D. Oh
74MO
Mini-Oral Session
December 1, 2023
10:45 am – 12 :15 pm SGT
Gastric
Trastuzumab deruxtecan (T-DXd) in Chinese patients with previously treated HER2 positive locally advanced/ metastatic gastric cancer or gastroesophageal junction adenocarcinoma: primary efficacy and safety from the phase 2 single-arm DESTINY-Gastric06 trial
L. Shen
172P
Poster Presentation
December 2, 2023
Datopotamab deruxtecan (Dato-DXd)
Lung
Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic non-small cell lung cancer: results of the randomized phase 3 study TROPION-Lung01
M. Ahn
509MO
Mini-Oral Session
December 2, 2023
9:00 – 10:30 SGT
TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer with actionable genomic alterations
S. Kitazono
518MO
Mini-Oral Session
Sunday, December 3
9:00 – 10:30 am SGT
TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in Asian patients with previously treated non-small cell lung cancer with actionable genomic alterations
Y. Goto
552P
Poster Presentation
December 2, 2023
SABCS Data
Highlights of Daiichi Sankyo data across several subtypes of breast cancer to be presented at SABCS from December 5 – 9 in San Antonio, Texas, include:
Presentation Title
Author
Abstract
Presentation
ENHERTU (trastuzumab deruxtecan; T-DXd)
HER2 Low
Breast
Trastuzumab deruxtecan (T-DXd) in combination with anastrozole or fulvestrant in patients with HER2 low HR+ advanced/metastatic breast cancer: a phase 1b, open-label, multicenter, dose-expansion study (DESTINY-Breast08)
K. Jhaveri
RF02-03
Rapid-Fire Mini-Oral
December 7, 2023
12:00 – 12:45 pm CST
An open-label, interventional multicenter study of trastuzumab deruxtecan monotherapy in patients with unresectable and/or metastatic HER2 low or HER2 immunohistochemistry 0 breast cancer: DESTINY-Breast15
S. Modi
PO2-19-06
Poster Presentation
December 6, 2023
5:00 – 7:00 pm CST
HER2 Positive
Breast
European real-world experience of patients with HER2+ advanced/metastatic breast cancer accessing trastuzumab deruxtecan through a named patient program: first interim analysis of EUROPA T-DXd
M. De Laurentiis
PO3-16-12
Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST
Real-world experience with trastuzumab deruxtecan in patients with breast cancer: 6 month interim analysis of an all patient post marketing surveillance in Japan
J. Tsurutani
PO3-17-07
Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST
Population pharmacokinetics of trastuzumab deruxtecan (T-DXd) in HER2 positive breast cancer subjects: analyses across 12 Phase 1-3 studies
C. Li
PO3-04-01
Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST
Exposure-efficacy and exposure-safety analysis of trastuzumab deruxtecan in patients with advanced metastatic HER2+ breast cancer: analyses from phase 3 studies DESTINY-Breast02 and DESTINY-Breast03
C. Li
PO3-04-02
Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST
Datopotamab deruxtecan (Dato-DXd)
HR Positive
Breast
Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously treated inoperable or metastatic hormone receptor positive, HER2 negative breast cancer: results from TROPION-Breast01
A. Bardia
GS02-01
Oral Presentation
December 7, 2023
8:15 – 8:30 am CST
TNBC
Durvalumab + datopotamab deruxtecan in patients with PD-L1 positive advanced/metastatic triple negative breast cancer: arm 8 of the phase 1b/2, open label, platform BEGONIA study
P. Schmid
PO1-19-10
Poster Presentation
December 6, 2023
12:00 – 2:00 pm CST
ASH Data
Highlights of Daiichi Sankyo data from its hematology portfolio to be presented at ASH (Free ASH Whitepaper) from December 9 – 12 in San Diego, California, include:
Presentation Title
Presenter
Abstract
Presentation
Valemetostat (EZHARMIA in Japan only)
T-cell
Lymphoma
Efficacy and safety of valemetostat monotherapy in patients with relapsed or refractory peripheral T-cell lymphomas: primary results of the phase 2 VALENTINE-PTCL01 study
S. Horwitz
302
Oral Presentation
December 9, 2023
4:15 pm PST
Valemetostat for relapsed or refractory peripheral T- cell lymphomas: primary results from a phase 1 trial
E. Jacobsen
303
Oral Presentation
December 9, 2023
4:30 pm PST
B-cell
Lymphoma
Valemetostat for relapsed or refractory B-cell lymphomas: primary results from a phase 1 trial
K. Izutsu
1731
Poster Presentation
December 9, 2023
5:30 – 7:30 pm PST
VANFLYTA (quizartinib)
FLT3-ITD
AML
QuANTUM-First: FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD)-specific measurable residual disease (MRD) clearance assessed through induction and consolidation is associated with improved overall survival in newly diagnosed FLT3-ITD+ AML patients
A. Perl
832
Oral Presentation
December 11, 2023
3:30 pm PST
QuANTUM-First: safety by treatment phase and by age in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) positive acute myeloid leukemia (AML)
H. Erba
972
Oral Presentation
December 11, 2023
5:45 pm PST
Patient-reported outcomes in acute myeloid leukemia patients with FLT3-ITD mutation receiving quizartinib vs. standard chemotherapy: results from the QuANTUM-First trial
E. Oliva
918
Oral Presentation
December 11, 2023
4:00 pm PST
QuANTUM-First: clinical bridging study for FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) companion diagnostic development
J. Rohrbach
4260
Poster Presentation
December 11, 2023
6:00 – 8:00 pm PST
Kinetics of complete remission (CR) and CR duration and its impact on overall survival (OS) and event-free survival (EFS) in QuANTUM-First
P. Montesinos
4254
Poster Presentation
December 11, 2023
6:00 – 8:00 pm PST
About the DXd ADC Portfolio of Daiichi Sankyo
The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, NJ. U.S.A. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.
Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.