Tag: Datopotamab deruxtecan

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...

During the annual ESMO 2023 Congress, organized by the European Society for Medical Oncology, held October 20 - 24, 2023 in Madrid, Spain, antibody-drug conjugates or ADCs took center stage, with presentations demonstrating the potential these ADCs show in the rapidly changing treatment landscape for various cancers.

Updated results from the BEGONIA phase 1b/2 trial for the cohort of patients treated with datopotamab deruxtecan + durvalumab (Imfinzi®; AstraZeneca;  Arm 7) showed that the treatment combination demonstrated durable tumor responses without  new safety signals in patients with previously untreated advanced or metastatic triple negative breast cancer (mTNBC) with six months additional follow-up from the previous data cut-off.