Datopotamab Deruxtecan Met Dual Primary Endpoint of Progression-Free Survival in Patients With Advanced Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial - Seite 2

TROPION-Lung01 enrolled patients with and without actionable genomic alterations, such as EGFR and ALK. Patients with actionable genomic alterations were previously treated with platinum-based chemotherapy and an approved targeted therapy. Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

The data will be presented at a forthcoming medical meeting and shared with health authorities.

Notes

Non-small cell lung cancer
More than one million people worldwide are diagnosed with advanced NSCLC each year.^1,2 While immunotherapy and targeted therapies have improved outcomes in the 1st-line metastatic setting, most patients eventually experience disease progression and receive chemotherapy.^3-5 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC in the absence of other treatment options and despite limited effectiveness and known side effects.^3-5

TROP2 is a protein highly expressed in a large majority of lung cancers.⁶ There are currently no TROP2-directed ADCs approved for the treatment of patients with lung cancer.^7,8

TROPION-Lung01
TROPION-Lung01 is a global, randomized, multicenter, open-label Phase III trial evaluating the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) versus docetaxel (75 mg/m²) in patients with locally advanced or metastatic NSCLC, with or without actionable genomic alterations, treated with at least one prior therapy. Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a prior PD-1 or PD-L1 inhibitor. Patients with actionable genomic alterations were previously treated with platinum-based chemotherapy and targeted therapy as approved for their detected genomic alteration.

The dual primary endpoints of TROPION-Lung01 are PFS as assessed by blinded independent central review (BICR) and OS. Key secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, time to response and disease control rate as assessed by both BICR and investigator, and safety.

TROPION-Lung01 enrolled approximately 600 patients at sites in Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

Datopotamab deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of five lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.