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Daiichi Sankyo Showcases Progress in Developing New Standards of Care for Patients with Industry-Leading DXd ADC Portfolio Across Multiple Cancers at ESMO

  • Three late-breaking abstracts, including two Presidential Symposia presentations, showcase datopotamab deruxtecan data from TROPION-Breast01 and TROPION-Lung01 phase 3 trials
  • New data featuring first progression-free and overall survival results from DESTINY-PanTumor02 phase 2 trial of ENHERTU® to be highlighted
  • Additional analysis from HERTHENA-Lung01 phase 2 trial of patritumab deruxtecan and updates from early phase trials of raludotatug deruxtecan in ovarian cancer and ifinatamab deruxtecan across several tumor types to be presented
  • Investor conference call to discuss ESMO presentations across five DXd ADCs in Daiichi Sankyo’s oncology portfolio

Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in multiple types of cancer at the 2023 European Society for Medical Oncology (#ESMO23) Congress to be held October 20 - 24, 2023. Three late-breaking abstracts, including two Presidential Symposia presentations, are among the more than 20 abstracts showcasing Daiichi Sankyo’s leadership and progress in developing new standards of care for patients with cancer.

Data at ESMO will highlight results from the TROPION-Breast01 and TROPION-Lung01 phase 3 trials (LBA11 and LBA12) evaluating datopotamab deruxtecan (Dato-DXd) versus chemotherapy in patients with HR positive, HER2 low or negative metastatic breast cancer and advanced non-small cell lung cancer (NSCLC) during back-to-back presentations at the Presidential Symposium 3. These data will be featured in an ESMO press briefing.

Other late-breaking data includes a mini-oral session featuring the first presentation of progression-free and overall survival results from the DESTINY-PanTumor02 phase 2 trial (#LBA34) evaluating ENHERTU® (trastuzumab deruxtecan) across multiple HER2 expressing solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other cancers.

Updates from other trials across Daiichi Sankyo’s DXd ADC portfolio include mini-oral sessions presenting an exploratory analysis of the intracranial efficacy of patritumab deruxtecan (HER3-DXd) in patients with EGFR-mutated metastatic NSCLC from the HERTHENA-Lung01 phase 2 trial, and updated data from an ongoing first-in-human phase 1 trial of raludotatug deruxtecan (R-DXd) in patients with previously treated ovarian cancer. A poster presentation also will feature updated clinical and biomarker results of ifinatamab deruxtecan (I-DXd) in patients with advanced solid tumors from an ongoing phase 1/2 trial.

“We continue to bring forward new research that demonstrates how our industry-leading DXd antibody drug conjugate portfolio has the potential to transform the current standards of care for patients across multiple tumor types and treatment settings. Data from TROPION-Breast01 and TROPION-Lung01, the first two pivotal trials from our datopotamab deruxtecan clinical development program, underscore the potential to change the way certain patients with HR positive, HER2 low or negative metastatic breast cancer as well as advanced non-small lung cancer are treated,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Additionally, data from our other ongoing trials of ENHERTU, patritumab deruxtecan, raludotatug deruxtecan and ifinatamab deruxtecan showcase our continued efforts to apply our DXd antibody drug conjugate technology to different targets and types of cancer with the goal of bringing new treatments to patients.”

Additional datopotamab deruxtecan data at ESMO includes the first presentation from the TROPION-Lung05 phase 2 trial in patients with previously treated NSCLC with actionable genomic alterations and updated data from the BEGONIA phase 1b/2 trial in patients with previously untreated advanced/metastatic triple negative breast cancer during two mini-oral sessions.

Other ENHERTU data to be highlighted in proffered paper or mini-oral sessions include the primary results from the DESTINY-PanTumor01 phase 2 trial in patients with solid tumors with HER2 activating mutations and a pooled analysis from the DESTINY-Lung01 and DESTINY-Lung02 phase 2 trials in patients with HER2 mutant metastatic NSCLC with and without brain metastases. A proffered paper session also will include updated survival results from the DESTINY-Breast04 phase 3 trial in patients with HER2 low metastatic breast cancer as well as pooled exploratory efficacy and safety analysis from the DESTINY-Breast01, DESTINY-Breast02 and DESTINY-Breast03 trials in patients with HER2 positive metastatic breast cancer with brain metastases.

Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, October 24, 2023 at 8:00-9:30 am ET / 9:00-10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the ESMO research data and address questions.

Highlights of late-breaking data across Daiichi Sankyo’s DXd ADC portfolio at 2023 ESMO include:

Presentation Title

Lead Author

Abstract

Presentation

Datopotamab deruxtecan (Dato-DXd)

Breast

Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2 negative breast cancer: primary results from the randomized phase 3 TROPION-Breast01 trial

A. Bardia

LBA11

Presidential 3

Monday, October 23

4:30 – 4:42 pm CEST

Lung

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic non-small cell lung cancer (NSCLC): results of the randomized phase 3 study TROPION-Lung01

M. Ahn

(presented by A. Lisberg)

LBA12

Presidential 3

Monday, October 23

4:42 – 4:54 pm CEST

ENHERTU (trastuzumab deruxtecan; T-DXd)

Pan-Tumor

Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: primary efficacy analysis from the DESTINY-PanTumor02 study

 

F. Meric-

Bernstam

LBA34

 

Mini-Oral Session

Monday, October 23

4:40 – 4:45 pm CEST

Additional highlights of data to be presented at 2023 ESMO include:

Presentation Title

Lead

Author

Abstract

Presentation

Datopotamab deruxtecan (Dato-DXd)

Breast

Datopotamab deruxtecan (Dato-DXd) + durvalumab as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer: updated results from BEGONIA, a phase 1b/2 study

P. Schmid

379MO

Mini-Oral Session

Sunday, October 22

8:30 – 8:35 pm CEST

Lung

TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer with actionable genomic alterations

L. Paz-Ares

1314MO

Mini-Oral Session

Saturday, October 21

9:30 – 9:35 am CEST

TROPION-Lung07: a phase 3 trial of datopotamab deruxtecan (Dato-DXd) plus pembrolizumab with or without platinum chemotherapy as first-line therapy in advanced/metastatic non-small cell lung cancer with PD-L1 expression

I. Okamoto

1505TiP

 

Poster Presentation

Monday, October 23

ENHERTU (trastuzumab deruxtecan; T-DXd)

Breast

Trastuzumab deruxtecan vs treatment of physician’s choice in patients with HER2 low unresectable and/or metastatic breast cancer: updated survival results of the randomized, phase 3 DESTINY-Breast04 study

S. Modi

376O

Proferred Paper Session

Saturday, October 21

10:25 – 10:35 pm CEST

A pooled analysis of trastuzumab deruxtecan in patients with HER2 positive metastatic breast cancer with brain metastases from DESTINY-Breast-01, -02, -03

S. Hurvitz

377O

Proferred Paper Session

Saturday, October 21

10:55 – 11:05 pm CEST

Lung

Trastuzumab deruxtecan in patients with HER2 (ERBB2)-mutant metastatic non-small cell lung cancer with and without brain metastases: pooled analyses from DESTINY-Lung01 and DESTINY-Lung02

D. Planchard

1321MO

Mini-Oral Presentation

Sunday, October 22

9:05 – 9:10 am CEST 

Phase 1b multicenter study of trastuzumab deruxtecan and immunotherapy with or without chemotherapy in first-line treatment of patients with advanced or metastatic non squamous non-small cell lung cancer and HER2 overexpression: DESTINY-Lung03

D. Planchard

1507TiP

 

Poster Presentation

Monday, October 23

Pan-Tumor

DESTINY-PanTumor02 study of trastuzumab deruxtecan in patients with HER2 expressing solid tumors: exploratory biomarker analyses of HER2 expression and gene amplification in tissue and plasma

V. Makker

148P

Poster Presentation

Saturday, October 21

Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with solid tumors harboring specific HER2 activating mutations: primary results from the international phase 2 DESTINY-PanTumor01 study

B. Li

654O

Proffered Paper Session

Sunday, October 22

9:20 – 9:30 am CEST

Patritumab Deruxtecan (HER3-DXd)

Lung

Intracranial efficacy of HER3-DXd in patients with previously treated advanced EGFR-mutated NSCLC: results from HERTHENA-Lung01

M. Johnson

1319MO

Mini-Oral Session

Sunday, October 22

9:00 – 9:05 am CEST

Raludotatug Deruxtecan (R-DXd)

Ovarian

Raludotatug deruxtecan (R-DXd; DS-6000) monotherapy in patients with previously treated ovarian cancer: subgroup analysis of a first-in-human phase 1 study

K. Moore

745MO

 

Mini-Oral Session

Sunday, October 22

11:35 – 11:40 am CEST

Ifinatamab Deruxtecan (I-DXd)

Pan-Tumor

Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: updated clinical and biomarker results from a phase 1/2 study

M. Patel

690P

Poster Presentation

Monday, October 23

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. Four additional Daiichi Sankyo DXd ADCs include patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, and DS-3939, a TA-MUC1 directed ADC.

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.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

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