Discovery and development of trastuzumab deruxtecan and safety management for patients with HER2-positive gastric cancer

A phase Ib/II, multicenter, open-label, dose-escalation, and dose-expansion study evaluating trastuzumab deruxtecan (T-DXd, DS-8201) monotherapy and combinations in patients with HER2-overexpressing gastric cancer (DESTINY-Gastric03).

(2021) Yelena Y. Janjigian et al.   JOURNAL OF CLINICAL ONCOLOGY

A phase II trial of [fam-] trastuzumab deruxtecan (T-DXd, DS-8201a) in subjects with HER2-positive, unresectable, or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

(2020) Charles S. Fuchs et al.   JOURNAL OF CLINICAL ONCOLOGY

Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low–Expressing Advanced Breast Cancer: Results From a Phase Ib Study

(2020) Shanu Modi et al.   JOURNAL OF CLINICAL ONCOLOGY

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-mutated metastatic non-small cell lung cancer (NSCLC): Interim results of DESTINY-Lung01.

(2020) Egbert F. Smit et al.   JOURNAL OF CLINICAL ONCOLOGY

A phase II, multicenter, open-label study of trastuzumab deruxtecan (T-DXd; DS-8201) in patients (pts) with HER2-expressing metastatic colorectal cancer (mCRC): DESTINY-CRC01.

(2020) Salvatore Siena et al.   JOURNAL OF CLINICAL ONCOLOGY

Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer

(2020) Kohei Shitara et al.   NEW ENGLAND JOURNAL OF MEDICINE

289P Risk factors for interstitial lung disease in patients treated with trastuzumab deruxtecan from two interventional studies

(2020) C.A. Powell et al.   ANNALS OF ONCOLOGY

Interstitial pneumonitis related to trastuzumab deruxtecan, a HER2‐targeting antibody drug conjugate, in monkeys

(2020) Kazuyoshi Kumagai et al.   CANCER SCIENCE

The Latest Research and Development into the Antibody–Drug Conjugate, [fam-] Trastuzumab Deruxtecan (DS-8201a), for HER2 Cancer Therapy

(2019) Takashi Nakada et al.   CHEMICAL & PHARMACEUTICAL BULLETIN

Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive gastric cancer: a dose-expansion, phase 1 study

(2019) Kohei Shitara et al.   LANCET ONCOLOGY

Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer

(2019) Shanu Modi et al.   NEW ENGLAND JOURNAL OF MEDICINE

Advances in HER2-Targeted Therapy: Novel Agents and Opportunities Beyond Breast and Gastric Cancer

(2018) Funda Meric-Bernstam et al.   CLINICAL CANCER RESEARCH

Re-evaluation of HER2 status in patients with HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab (KSCC1604)

(2018) Hiroshi Saeki et al.   EUROPEAN JOURNAL OF CANCER

Loss of HER2 positivity after anti-HER2 chemotherapy in HER2-positive gastric cancer patients: results of the GASTric cancer HER2 reassessment study 3 (GASTHER3)

(2018) Seyoung Seo et al.   Gastric Cancer

Comprehensive preclinical pharmacokinetic evaluations of trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody-drug conjugate, in cynomolgus monkeys

(2018) Yoko Nagai et al.   XENOBIOTICA

Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study

(2017) Peter C Thuss-Patience et al.   LANCET ONCOLOGY

Safety, pharmacokinetics, and antitumour activity of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody–drug conjugate, in patients with advanced breast and gastric or gastro-oesophageal tumours: a phase 1 dose-escalation study

(2017) Toshihiko Doi et al.   LANCET ONCOLOGY

Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity

(2016) Yusuke Ogitani et al.   CANCER SCIENCE

DS-8201a, A Novel HER2-Targeting ADC with a Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising Antitumor Efficacy with Differentiation from T-DM1

(2016) Y. Ogitani et al.   CLINICAL CANCER RESEARCH

Feasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast Cancer

(2015) Ian E. Krop et al.   JOURNAL OF CLINICAL ONCOLOGY

G-CSF and GM-CSF in Neutropenia

(2015) Hrishikesh M. Mehta et al.   JOURNAL OF IMMUNOLOGY

Comprehensive molecular characterization of gastric adenocarcinoma

(2014) Adam J. Bass et al.   NATURE

HER2 testing in gastric cancer: a practical approach

(2012) Josef Rüschoff et al.   MODERN PATHOLOGY

Pooled analysis of cardiac safety in patients with cancer treated with pertuzumab

(2011) D. Lenihan et al.   ANNALS OF ONCOLOGY

Longer-Term Assessment of Trastuzumab-Related Cardiac Adverse Events in the Herceptin Adjuvant (HERA) Trial

(2010) Marion Procter et al.   JOURNAL OF CLINICAL ONCOLOGY

Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial

(2010) Yung-Jue Bang et al.   LANCET

Assessment of a HER2 scoring system for gastric cancer: results from a validation study

(2008) M Hofmann et al.   HISTOPATHOLOGY