Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer or HR Positive, HER2 Negative Breast Cancer
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Parallel applications based on TROPION-Lung01 and TROPION-Breast01 phase 3 trial results demonstrating
Daiichi Sankyo andAstraZeneca ’s datopotamab deruxtecan significantly improved progression-free survival versus chemotherapy in two types of cancer
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by
The validations confirm the completion of the applications and commence the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The applications are based on data from the pivotal TROPION-Lung01 and TROPION-Breast01 phase 3 trials presented during two Presidential Symposia at the
“The EMA validation is an important first step toward bringing this TROP2 directed antibody drug conjugate to eligible patients in
“Our ambition is for datopotamab deruxtecan to improve upon and replace conventional chemotherapy in the treatment of multiple cancer types,” said
Additional regulatory submissions for datopotamab deruxtecan in lung cancer and breast cancer are underway in the
About TROPION-Lung01
TROPION-Lung01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus docetaxel in patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment. Patients with actionable genomic alterations were previously treated with platinum-based chemotherapy and an approved targeted therapy. Patients without known actionable genomic alterations were previously treated, either in combination or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
The dual primary endpoints of TROPION-Lung01 are progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS). Key secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), time to response, disease control rate (DCR) as assessed by both BICR and investigator, and safety. TROPION-Lung01 enrolled approximately 600 patients in
About TROPION-Breast01
TROPION-Breast01
is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease.
The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, DCR, time to first subsequent therapy and safety. TROPION-Breast01 enrolled more than 700 patients in
About Advanced Non-Small Cell
Nearly 500,000 lung cancer cases were diagnosed in
About Hormone Receptor Positive, HER2 Negative Breast Cancer
More than 500,000 breast cancer cases were diagnosed in
About TROP2
TROP2 is a protein broadly expressed in several solid tumors, including the majority of NSCLC and HR positive, HER2 negative breast cancer cases.11,12 High TROP2 expression is associated with increased tumor progression and poor survival.12,13 There is currently no TROP2 directed ADC approved for the treatment of lung cancer.14,15
About 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 six DXd ADCs in the oncology pipeline of
A comprehensive development program called TROPION is underway globally with more than 14 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. Beyond the TROPION program, datopotamab deruxtecan also is being evaluated in novel combinations in several ongoing trials.
About the
About the DXd ADC Portfolio of
The DXd ADC portfolio of
Designed using Daiichi Sankyo’s proprietary DXd ADC Technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About
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References:
1Cancer.net.
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4 Majeed U, et al. J Hematol Oncol. 2021;14(1):108
5 Pircher A, et al.
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8 Iqbal N, et al. Mol Biol Int. 2014;852748.
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10 Lloyd M R, et al.
11 Goldenberg D, et al. Oncotarget. 2018;9(48): 28989-29006.
12 Mito R, et al. Pathol Int. 2020;70(5):287-294.
13 Vidula N, et al. Breast Cancer Res Treat. 2022 Aug;194(3):569-575.
14 Rodríguez-Abreau D et al.
15
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