Tokyo, Basking Ridge - The first patient has been dosed in the TROPIONLung17 phase 3 trial evaluating DATROWAY (datopotamab deruxtecan) compared to docetaxel in patients with TROP2 NMR positive locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations previously treated with immunotherapy and platinum-based chemotherapy.
DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).
The current standard first-line treatment for advanced NSCLC without actionable genomic alterations is immunotherapy with or without platinum-based chemotherapy. 1 However, most patients will eventually experience disease progression and traditional chemotherapy remains the current standard of care in the second-line and beyond settings. 2,3,4,5 While TROP2 is a protein broadly expressed on the surface and inside of NSCLC cells, there is no established predictive biomarker that can identify patients who may benefit from a TROP2 directed antibody drug conjugate. 6,7 TROPION-Lung17 is the first phase 3 clinical trial to prospectively enroll patients with tumors that test positively for TROP2 NMR, a biomarker measured using Quantitative Continuous Scoring (QCS), which is AstraZeneca's computational pathology platform.
'We initiated TROPION-Lung17 to further evaluate DATROWAY in this patient population, building on results from retrospective analyses of several clinical trials, including TROPION-Lung01, which showed a correlation between TROP2 NMR positivity and outcomes for patients with lung cancer,' said Abderrahmane Laadem, MD, Head, Late-Stage Oncology Clinical Development, Daiichi Sankyo.
'TROPION-Lung17 is the first phase 3 trial to prospectively enroll patients using a TROP2 biomarker to determine whether DATROWAY can improve survival compared to current standard of care chemotherapy.' 'TROPION-Lung17 aspires to bring a precision medicine approach to patients with advanced lung cancer in the second-line setting, where traditional chemotherapy remains the standard of care,' said Leora Horn, MD, MSC, FRCPC, Senior Vice President, Late Development Oncology, AstraZeneca. 'Research has shown DATROWAY has the potential to improve outcomes in this setting, and we are confident the TROP2 NMR biomarker and its investigational AI-powered companion diagnostic - previously granted a Breakthrough Device Designation in the U.S. can help us bring this medicine to the patients most likely to benefit.'
TROPION-Lung17 is the ninth phase 3 trial evaluating DATROWAY in NSCLC. Ongoing trials in advanced NSCLC include four phase 3 trials in the first-line metastatic setting evaluating DATROWAY in combination with immunotherapy in tumors without actionable genomic alterations (AVANZAR, TROPION-Lung07, TROPION-Lung08 and TROPION-Lung10) and one phase 3 trial of DATROWAY in combination with osimertinib, AstraZeneca's EGFR tyrosine kinase inhibitor (TKI), (TROPION-Lung14) in EGFR-mutated NSCLC. Additional later-line phase 3 trials include evaluating DATROWAY with or without osimertinib (TROPION-Lung15) and DATROWAY alone (TROPION-Lung17).
About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.
About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.
The DXd ADC Technology platform of Daiichi Sankyo consists of six ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 is being developed by Daiichi Sankyo.
Additional ADCs being developed by Daiichi Sankyo include DS-9606, which consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload and DS3610, which consists of an antibody attached to a novel immunomodulatory payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS-9606 and DS3610 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About Daiichi Sankyo
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need.
Contact:
Jennifer Brennan
Email: jennifer.brennan@daiichisankyo.com
Tel: +1 908 900 3183
