Tag: Datopotamab deruxtecan

Antibody–drug conjugates (ADCs) deliver potent anticancer drugs to tumor cells while limiting exposure to healthy tissues. In clinical practice, however, this selectivity is not absolute. ADCs can still damage healthy cells, causing adverse effects that may limit the dose patients can tolerate, interrupt treatment, or affect quality of life. A recommended dose therefore does not guarantee safety; it reflects a balance among antitumor activity, toxicity, and the ability to sustain treatment. To address this challenge, researchers are refining ADC design at multiple levels, including dual-targeting antibodies, conditional activation, Fc engineering, site-specific conjugation, and linker chemistry. These approaches aim to improve tumor selectivity and treatment tolerability, but clinical evidence must establish each construct's benefits and limitations. Data presented at World ADC San Diego, held October 12–15, 2026, at the Town & Country, with more than 1,300 attendees from over 400 companies across seven scientific tracks, provided a timely view of how these strategies are being evaluated. This article examines how ADC design has evolved, how individual engineering choices may influence clinical performance, and what these developments mean for drug developers, clinicians, and patients.

Antibody-drug conjugates (ADCs) have transformed cancer treatment, with 22 approved agents and more than 400 in clinical development, yet only about 11% of ADCs entering phase 1 ultimately reach approval. Poor penetration into solid tumors, heterogeneous target expression, payload resistance, and narrow therapeutic windows continue to limit their success. This article examines why ADCs fail in the clinic and how next-generation approaches, including bispecific ADCs, dual-payload designs and checkpoint inhibitor combinations, aim to close that gap.

Datopotamab deruxtecan: First TROP2-Directed ADC Approved for First-Line Treatment of mTNBC in Patients Ineligible for Immunotherapy

TROP-2 and the Promise and Peril of High-Affinity in ADCs -- Over the last decades, Antibody–drug conjugates (ADCs) have emerged as a transformative class of cancer therapeutics, offering the promise of targeted cytotoxicity with the precision of monoclonal antibodies.* To fulfill this promise, the ideal ADC includes an antibody that is specific for binding to the target antigen, has high binding affinity for that target, and, at the same time, has low immunogenicity.  In addition, the antibody should have a long plasma half-life and rapid internalization.

Datopotamab deruxtecan (datopotamab deruxtecan-dlnk in the U.S. only; Datroway®; Daiichi Sankyo and AstraZeneca; see ADC Drug Map) has been approved by the U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

A first patient has been dosed in the TROPION-Lung12 phase 3 trial (NCT06564844), a global, multicenter, three-arm, open-label phase 3 trial designed to evaluate the efficacy and safety of adjuvant datopotamab deruxtecan (6 mg/kg; Datroway®; Daiichi Sankyo and AstraZeneca; see: ADC Drug Map) in combination with the PD-1/TIGIT bi-specific antibody rilvegostomig* (750 mg) or rilvegostomig monotherapy (750 mg) monotherapy versus observation or standard of care adjuvant chemotherapy regimens.

Datopotamab deruxtecan (Datroway®; Daiichi Sankyo, previously known as DS-1062 and TROP2 ADC, see ADC Drug Map) an antibody-drug conjugate or ADC, being jointly developed and commercialized globally by Daiichi Sankyo and AstraZeneca, has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy.

AstraZeneca and Daiichi Sankyo Submit New BLA for Accelerated Approval of Datopotamab Deruxtecan in advanced EGFR-mutated NSCLC

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992 (also known as BSI-992), to conduct a...