[1],[2],[3] There were an estimated 2.2 million new cases of lung cancer and 1.8 million deaths in 2020. Accessibility Lydia Worms TORL Biotherapeutics / Translational Research in Oncology. patritumab deruxtecan (HER3-DXd), a potential first-in-class HER3 directed antibody drug conjugate (ADC). [12] Hardstock F, et al. owever, most patients eventually develop resistance to these therapies and. smcgovern@dsi.com AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019, and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. [2] ASCO. The sponsor was involved in study design, data collection and analysis, decision to publish, and preparation of the manuscript. In Boston, Massachusetts, one company is now making significant headway in the development of an innovative treatment for serious disorders of the liver. School of Pharmacy, Texas Tech University Health Science Center, Amarillo, TX and the Zhejiang University School of Medicine, Hangzhou, China. Cohort 3 includes patients with NSCLC with EGFR-activating mutations including any histology other than combined small cell and non-small cell lung cancer; patients in Cohort 3 are randomized 1:1 to receive the 5.6 mg/kg RDE regimen (Cohort 3a) or an escalating up-titration regimen of patritumab deruxtecan (Cohort 3b). HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.15 Approximately 25% to 30% of lung cancers have an EGFR-activating mutation, and it is estimated that about 83% of all NSCLC tumors express the HER3 protein, which can be associated with an increased incidence of metastases, reduced survival and resistance to standard of care treatment.16,17,18 Currently, no HER3 directed medicines are approved for the treatment of cancer. 6 Skoulidis F, et al. Daiichi Sankyo Europe GmbH A window-of-opportunity study of U3-1402, a HER3-targeting antibody-drug conjugate in operable breast cancer according to ERBB3 expression (TOT-HER3). 2019;19[9]:495-509. Vol. Global/US: Cohort 2 includes patients with squamous or non-squamous NSCLC without EGFR-activating mutations following platinum-based chemotherapy and following an anti-PD-1 or anti-PD-L1 antibody regimen. The ASCO Post, ASCO eLearning Abstract Discussant Vronique Diras, MD, of the Eugne Marquis Centre, in Rennes, France, concurred that patritumab deruxtecan showed promising activity across breast cancer subtypes in this heavily pretreated population with a poor prognosis. BMC Pharmacol Toxicol. GLOBOCAN 2020. [3] Cheema PK, et al. U3-1402, a Novel HER3-Targeting Antibody-Drug Conjugate, for the Treatment of Colorectal Cancer. ClinicalTrials.gov. Pembrolizumab for patients with metastatic, PD-L1 negative, triple negative breast cancer Patritumab deruxtecan (HER3-DXd), a HER3-targeted antibody drug conjugate, for patients with metastatic triple negative breast cancer Oral selective estrogen receptor down-modulators (SERDs) for patients with ER+ metastatic breast cancer Patritumab deruxtecan is currently being evaluated in a comprehensive development . Furthermore, the response was independent of baseline HER3 gene expression and HER3 protein levels, reported Aleix Prat, from the Hospital Clinic of Barcelona in . Oncol Rev. Authors doi: 10.1016/j.ceb.2008.12.010 By Novel anticancer targets: revisiting ERBB2 and discovering ERBB3. Investor Relations Contact: ASCO Career Center A Feature analyzing how - and why - immunology remains a steady area of investment for big pharma and private investors. The median progression-free survival (PFS) ranged from 5.5 months in TNBC to 7.4 months in HR-positive/HER2-negative disease and 11.0 months in HER2-positive disease; median overall survival (OS) was 14.6, 14.6, and 19.5 months, respectively. Published. +81 3 6225 1126 (office), Investor Relations Contact: 7,[14] Subsequent salvage therapies after EGFR TKI and platinum-based chemotherapy have PFS of 2.8 to 3.2 months.8 New treatment approaches are needed to overcome resistance and improve survival in this subtype of NSCLC. Curr Oncol. Targetome SA, a spin-off from the University of Lige (ULg), Belgium. This site needs JavaScript to work properly. Designed using Daiichi Sankyo's proprietary DXd ADC technology, patritumab deruxtecan is comprised of a human anti-HER3 antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker. Hansoh BioMedical R&D Company ( Shanghai Hansoh Biomedical Co., Ltd, Wilex/Heidelberg Pharma in collaboration with MabVax, Biogen Antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-low-expressing advanced breast cancer: results from a phase Ib study. Certain HER3 mutations have also been identified as oncogenic drivers, making them potential therapeutic targets. CA Cancer J Clin. GLOBOCAN 2020. Epub 2020 Jul 23. ClinicalTrials.gov. For patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and PFS compared to chemotherapy.13 However, most patients eventually develop resistance to these therapies and subsequent therapy after EGFR TKI with platinum-based chemotherapy have limited efficacy with PFS of approximately 4.4 to 6.4 months.7,14 Subsequent salvage therapies after EGFR TKI and platinum-based chemotherapy have PFS of 2.8 to 3.2 months.8 New treatment approaches are needed to overcome resistance and improve survival in this subtype of NSCLC. Webinar: TRPH-222 Interim Ph I Data: Leveraging SMARTag to Enhance Safety, Patritumab Deruxtecan | U3-1402 | HER3 ADC. Nat Rev Cancer. Oncogene. Krop noted that early attempts at targeting HER3 had limited success. Unable to load your collection due to an error, Unable to load your delegates due to an error, Cell-surface binding of HER3-DXd in MDA-MB-231 cells transduced with HER3, Trafficking (dots per cell) of pHrodo-labeled HER3-DXd in MDA-MB-231 cells transduced with HER3, Cell-growth inhibition activity of HER3-DXd, patritumab, and payload against MDA-MB-231 cells transduced with HER3. ASCO Daily News The primary objective of the dose expansion part of the study is to assess efficacy of patritumab deruxtecan as measured by confirmed objective response rate (ORR) assessed by blinded independent central review. Cohort 3 includes patients with NSCLC with EGFR-activating mutations including any histology other than combined small cell and non-small cell lung cancer; patients in Cohort 3 are randomized 1:1 to receive the 5.6 mg/kg RDE regimen (Cohort 3a) or an escalating up-titration regimen of patritumab deruxtecan (Cohort 3b). Scientific Reports. and transmitted securely. JCO Clinical Cancer Informatics January 2021. antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via a stable tetrapeptide-based cleavable linker. HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival. Cancer Res. GLOBOCAN 2020. Safety and efficacy have not been established. Thorax. HER3-DXd activity was observed in the presence and absence of HER2 overexpression. HER3-DXd bound to the surface of HER3WT and mutant cells in a similar, concentration-dependent manner but not to HER3EV. The safety profile of patritumab deruxtecan in patients treated with the 5.6 mg/kg dose (n=57) is consistent with that seen across all patients (n=81) in both the dose escalation and dose expansion cohort 1 of the study (doses range from 3.2 to 6.4 mg/kg). Patritumab deruxtecan is an investigational medicine that has not been approved for any indication in any country. Cancer.Net, ASCO.org Treatment-emergent adverse events led to treatment discontinuation in 9.9% of patients across all doses. These data suggest that HER3-DXd may have activity against tumors expressing wild type HER3 or clinically observed HER3 mutations, supporting further clinical evaluation. Sankyo. The development program includes, a pivotal phase 2 study in patients with locally advanced or metastatic EGFR-mutated. The study enrolled patients at multiple sites in Asia, Europe and North America. Receptor tyrosine-protein kinase ERBB3 (HER3) is expressed in most <i>EGFR</i>-mutated lung cancers but is not a known mechanism of resistance to EGFR inhibitors. [5] Schoenfield AJ, et al. Expert Opin Investig Drugs. 2020 Sep;29(9):901-910. doi: 10.1080/13543784.2020.1792443. About the Phase 1 Non-Small Cell Lung Cancer Study. Pfizer, Genentech / Roche, F. Hoffmann-La Roche (Roche), CytomX Therapeutics The Center for Vascular Biology Research and the Departments of 2018;6(8):138. Cohort 3 includes patients with NSCLC with EGFR-activating mutations including any histology other than combined small cell and non-small cell lung cancer; patients in Cohort 3 are randomized 1:1 to receive the 5.6 mg/kg RDE regimen (Cohort 3a) or an escalating up-titration regimen of patritumab deruxtecan (Cohort 3b). 2017;18(1):82. Nakada T, Sugihara K, Jikoh T, Abe Y, Agatsuma T. The latest research and development into the antibody-drug conjugate, [fam-] trastuzumab deruxtecan (DS-8201a), for HER2 cancer therapy. The Breakthrough Therapy Designation for patritumab deruxtecan acknowledges the need for new treatment approaches to overcome resistance and improve survival in patients with metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer, said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. Accessed September 2021. 9 World Health Organization. Patritumab deruxtecan (HER3-DXd) is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. Bookshelf Patritumab deruxtecan (U3-1402) is one of three lead DXd antibody drug conjugates (ADC) in the oncology pipeline of Daiichi Sankyo. [18] Scharpenseel, et al. Dr. Krop noted that in this heavily pretreated population, activity was observed across breast cancer subtypes and that responses were largely durable. 2018;11:2121-9. HER3 signaling and targeted therapy in cancer. eCollection 2022. Ann Transl Med. January 2021. Led by Daiichi Sankyo Company, Limited in Tokyo, Japan, the HER3-Lung study was a global study that evaluated the investigational HER3 inhibitor patritumab in combination with erlotinib for. 2021;71:7-33. trastuzumab deruxtecan is indicated for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) her2-positive breast cancer who have received two or more prior anti-her2-based regimens in the metastatic setting and for adults with locally advanced or PDF | Acral melanoma (AM) is a rare, life-threatening skin cancer. 78985-78993. ICH GCP; Registro de ensayos clnicos de EE. Clipboard, Search History, and several other advanced features are temporarily unavailable. The dose escalation part of the study evaluated patients with EGFR-mutated disease either with progression on osimertinib or T790M-negative after progression on erlotinib, gefitinib or afatinib. Designed using Daiichi Sankyos proprietary DXd ADC technology, patritumab deruxtecan is comprised of a fully human anti-HER3. 2020;20(1):260. HER3 is expressed in 83% of NSCLC tumours [1]. ERBB3 mutations in cancer: biological aspects, prevalence and therapeutics. Disclaimer, National Library of Medicine Shanghai Fosun Pharmaceutical Development Co, Ltd. GT Biopharma. +49 (89) 7808751 (mobile), Japan: Thorax. Before An official website of the United States government. he U.S. FDAs BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. smcgovern@dsi.com Certain HER3 mutations have also been identified as oncogenic drivers, making them potential therapeutic targets. in december 2021, the fda granted a breakthrough therapy designation to patritumab deruxtecan for the treatment of patients with metastatic or locally advanced egfr -mutated non-small cell lung cancer (nsclc) with disease progression on or after treatment with a third-generation tki and platinum-based therapies. following platinum-based chemotherapy and following an anti-PD-1 or anti-PD-L1 antibody regimen. [17] Muller-Tidow C, et al. 2020 Edition, ADC Review | The Bookstore Antibody-Drug Conjugates: The 21st Century Magic Bullets for Cancer, ADC Review | The Bookstore Cytotoxic Payloads for AntibodyDrug Conjugates, https://clinicaltrials.gov/ct2/show/NCT02980341, https://clinicaltrials.gov/ct2/show/NCT03260491, Project Optimus: How to Prepare for Success, Axplora: the News name of Farmabios, Novasep and PharmaZell. The Breakthrough Therapy Designation for, acknowledges the need for new treatment approaches to overcome resistance and improve survival in patients, with metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer, said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. JCO Oncology Practice HER3 is expressed in approximately 30% to 50% of breast cancers across subtypes, is associated with poor prognosis, and is not targeted by any current therapies.1Dr. 4 Engelman JA, et al. 78985-78993. Sarah McGovern The authors are employees of Daiichi Sankyo Co., Ltd. Compassion for Patients. The population was heavily pretreated, with a median number of 2 prior regimens for advanced disease (range, 1 to 13) for patients with TNBC, 6 prior regimens (range, 2 to 13) for patients with HR-positive/HER2-negative disease, and 5.5 prior regimens (range, 2 to 11) for patients with HER2-positive disease. 2019;9:7406. the dose escalation portion and two expansion cohorts. Secondary study endpoints include investigator-assessed ORR, safety and pharmacokinetics. For patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and PFS compared to chemotherapy. Please enable it to take advantage of the complete set of features! is evaluating patritumab deruxtecan at the RDE (5.6 mg/kg every three weeks) in three cohorts. Bayer HealthCare Pharmaceuticals in association with 5 Schoenfield AJ, et al. Accessed September 2021. Passion for innovation. Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide, with 80% to 85% classified as NSCLC. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon, our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025. -, Baselga J, Swain SM. The study enrolled patients at multiple sites in Asia, Europe and North America. It is currently being investigated across multiple cancers as both a monotherapy and in combination with other anticancer treatments. HER3-DXd is a human anti-HER3 IgG1 monoclonal antibody that is in clinical evaluation for NSCLC, metastatic breast cancer, and colorectal cancer. in december 2021, the fda granted a breakthrough therapy designation to patritumab deruxtecan for the treatment of patients with metastatic or locally advanced egfr -mutated non-small cell lung cancer (nsclc) with disease progression on or after treatment with a third-generation tki and platinum-based therapies. While the efficacy of targeted therapy with EGFR TKIs is well-established in the treatment of advanced EGFR-mutated NSCLC, which comprises approximately 30% of patients, the development of a broad range of resistance mechanisms commonly leads to disease progression. 2013-2020 Sunvalley Communication, LLC. PATRITUMAB DERUXTECAN [WHO-DD] U3 1402; U3-1402; U3-1402A; Resources. 18 Scharpenseel, et al. Harvard Medical School, Boston, Massachusetts. The drug was originally developed by Catalent Biologics subsidiary Redwood Bioscience. 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