On October 16, 2023 Daiichi Sankyo (TSE: 4568) reported that it 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 (Press release, Daiichi Sankyo, OCT 16, 2023, https://www.businesswire.com/news/home/20231013885880/en/Daiichi-Sankyo-Showcases-Progress-in-Developing-New-Standards-of-Care-for-Patients-with-Industry-Leading-DXd-ADC-Portfolio-Across-Multiple-Cancers-at-ESMO [SID1234636041]). 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.

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Data at ESMO (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) research data and address questions.

Highlights of late-breaking data across Daiichi Sankyo’s DXd ADC portfolio at 2023 ESMO (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) 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