Datopotamab Deruxtecan Showed Clinically Meaningful Overall Survival Improvement Versus Chemotherapy in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial
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In the overall trial population, survival results numerically favored
Daiichi Sankyo andAstraZeneca ’s datopotamab deruxtecan but did not reach statistical significance - TROPION-Lung01 previously met the dual primary endpoint of progression-free survival in the overall trial population
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Results support applications currently under review by regulatory authorities globally including the
U.S. and EU
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by
The final analysis of OS builds on the positive PFS results presented at the
The safety profile of datopotamab deruxtecan in TROPION-Lung01 was consistent with the previous analysis, including fewer dose reductions or discontinuations due to adverse events compared to docetaxel and with no new safety concerns identified. No new interstitial lung disease events of any grade were adjudicated as drug-related.
"The improvement in overall survival seen with datopotamab deruxtecan coupled with the previously reported clinically meaningful progression-free survival, more than doubling of overall response and prolonged duration of response compared to docetaxel suggest that this TROP2 directed antibody drug conjugate could potentially become an important new treatment for patients with nonsquamous non-small cell lung cancer in this advanced metastatic setting,” said
“Datopotamab deruxtecan is the only investigational therapy to show a clinically meaningful survival improvement in patients with previously treated nonsquamous non-small cell lung cancer versus docetaxel, which has long been unsurpassed in this post-targeted treatment and post-immunotherapy setting,” said
The data will be presented at an upcoming medical meeting and will support regulatory applications currently under review globally, including the
About TROPION-Lung01
TROPION-Lung01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (6.0mg/kg) versus docetaxel (75mg/m2) in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations
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, disease control rate as assessed by both BICR and investigator, and safety.
TROPION-Lung01 enrolled approximately 600 patients in
About Advanced Non-Small Cell
Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.3 NSCLC is the most common type of lung cancer, accounting for about 80% of cases.4 Approximately 75% and 25% of NSCLC tumors are of nonsquamous or squamous histology, respectively.1 While immunotherapy and targeted therapies have improved outcomes in the first-line setting, most patients eventually experience disease progression and receive chemotherapy.5,6,7 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC, despite limited effectiveness and known side effects.5,6,7
TROP2 is a protein broadly expressed in the majority of NSCLC tumors.8 There is currently no TROP2 directed ADC approved for the treatment of lung cancer.9,10
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 global clinical development program is underway with more than 20 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.
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:
1
2 Ahn M-J, et al. Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): results of the randomized phase 3 study TROPION-Lung01. Presented at:
3
4Cancer.net.
5 Chen R, et al. J Hematol Oncol. 2020:13(1):58.
6 Majeed U, et al. J Hematol Oncol. 2021;14(1):108.
7 Pircher A, et al.
8 Mito R, et al. Pathol Int. 2020;70(5):287-294.
9 Rodríguez-Abreau D, et al.
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