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15 Dec 2020
Admin
News Article

Tropion-Lung01 Head-To-Head Phase 3 Trial Initiated To Evaluate Datopotamab Deruxtecan Versus Docetaxel In Previously Treated Patients With Advanced O

Tokyo &Amp; Munich &Amp; Basking Ridge, N.J.--(Business Wire)--Daiichi Sankyo Company, Ltd., (Hereafter, Daiichi Sankyo) And Astrazeneca Today Announced The Initiation Of Tropion-Lung01, A Global Pivotal Phase 3 Head-To-Head Study Of Datopotamab Deruxtecan (Dato-Dxd; Ds-1062), A Trop2 Directed Antibody Drug Conjugate (Adc), Versus Docetaxel In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer (Nsclc) Without Actionable Genomic Alterations Who Have Previously Received Platinum-Based Chemotherapy And Immunotherapy.Patients With Advanced Or Metastatic Nsclc Without Actionable Genomic Alterations (Such As Egfr, Alk, Ros1, Ntrk, Braf, Ret, Or Met Exon 14 Skipping) Have Demonstrated An Unmet Need After Currently Approved Front-Line And Second-Line Therapies Are Exhausted. Current Treatment Guidelines Recommend Varying Combinations Of Platinum-Based Chemotherapy And/Or Immune Checkpoint Inhibitors In The Front-Line And Second-Line Settings Based On Lung Cancer Subtype, Immune Biomarker Status And Other Factors.1 For Patients Whose Cancer Progresses After Initial Treatment Containing A Platinum-Based Chemotherapy And A Checkpoint Inhibitor, Therapeutic Options Are Limited.1Trop2 Expression Has Been Associated With Poor Overall And Disease-Free Survival In Several Types Of Solid Tumors. Trop2 Expression Has Been Observed In The Majority Of Adenocarcinoma And Squamous Cell Carcinoma Nsclc.2,3,4 There Are No Trop2 Directed Therapies Or Adcs Currently Approved For The Treatment Of Nsclc.&Ldquo;We Recognize The Need To Continue To Improve Treatment For Patients With Nsclc Who Are Not Eligible For Currently Approved Targeted Therapies, Particularly Those Who Progress Following Initial Treatment With An Immunotherapy And Platinum-Based Chemotherapy,&Rdquo; Said Antoine Yver, Md, Msc, Executive Vice President And Global Head, Oncology Research And Development, Daiichi Sankyo. &Ldquo;This Head-To-Head Trial Will Determine Whether Targeting Trop2 With Datopotamab Deruxtecan Will Improve Survival As Compared To The Standard Therapy Used In This Setting.&Rdquo;&Ldquo;Trop2 Is Highly Expressed In Nsclc And Other Cancers, Making It A Promising Target For Therapeutic Development,&Rdquo; Said JosÉ Baselga, Md, Phd, Executive Vice President, Oncology R&Amp;D, Astrazeneca. &Ldquo;This Trial Will Provide An Opportunity To Evaluate A Targeted Approach With Datopotamab Deruxtecan, A Potent Adc Specifically Designed To Enhance Selective Tumor Cell Death, While Reducing Systemic Exposure To Chemotherapy.&Rdquo;Tropion-Lung01 Was Initiated Following The Encouraging Clinical Activity Of Datopotamab Deruxtecan In Patients With Heavily Pre-Treated Advanced Nsclc Observed In The Ongoing Tropion-Pantumor01 Phase 1 Trial, Which Completed Enrollment Of Patients With Lung Cancer In October Of 2020. Preliminary Data From Tropion-Pantumor01 Was Recently Presented At The 2020 American Society Of Clinical Oncology (Asco) Virtual Scientific Program (#Asco20) And Updated Data Will Be Presented At An Upcoming Medical Meeting

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