{"id":51080,"date":"2022-11-21T15:02:15","date_gmt":"2022-11-21T14:02:15","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/data-across-daiichi-sankyo-dxd-adc-portfolio-at-2022-sabcs-demonstrates-bold-progress-in-advancing-treatment-for-patients-with-breast-cancer\/"},"modified":"2022-11-21T15:02:15","modified_gmt":"2022-11-21T14:02:15","slug":"data-across-daiichi-sankyo-dxd-adc-portfolio-at-2022-sabcs-demonstrates-bold-progress-in-advancing-treatment-for-patients-with-breast-cancer","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/data-across-daiichi-sankyo-dxd-adc-portfolio-at-2022-sabcs-demonstrates-bold-progress-in-advancing-treatment-for-patients-with-breast-cancer\/","title":{"rendered":"Data Across Daiichi Sankyo DXd ADC Portfolio at 2022 SABCS Demonstrates Bold Progress in Advancing Treatment for Patients with Breast Cancer"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nSurvival data from DESTINY-Breast03 and DESTINY-Breast02 phase 3 trials in patients with HER2 positive metastatic breast cancer further confirms efficacy of ENHERTU\n<\/li>\n<li>\nFirst presentation of datopotamab deruxtecan results in patients with HR positive, HER2 negative metastatic breast cancer shows promising clinical activity\n<\/li>\n<li>\nAnnual R&amp;D Day following SABCS to provide updates across Daiichi Sankyo R&amp;D portfolio\n<\/li>\n<\/ul>\n<p>BASKING RIDGE, N.J.&#8211;(BUSINESS WIRE)&#8211;Daiichi Sankyo (TSE: 4568) continues to boldly challenge the breast cancer treatment landscape with the presentation of 30 abstracts from its innovative DXd antibody drug conjugate (ADC) portfolio at the 2022 San Antonio Breast Cancer Symposium (#SABCS22) to be held December 6 to 10, 2022.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221118005606\/en\/794283\/5\/DS_logo_portrait_format_4color_rgb_120206.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221118005606\/en\/794283\/21\/DS_logo_portrait_format_4color_rgb_120206.jpg\"><\/a><\/p>\n<p>\nENHERTU<sup>\u00ae<\/sup> (trastuzumab deruxtecan) data from <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT03529110%3Fterm%3DDESTINY-Breast03%26draw%3D2%26rank%3D1&amp;esheet=52973030&amp;newsitemid=20221118005606&amp;lan=en-US&amp;anchor=DESTINY-Breast03&amp;index=1&amp;md5=8768ba6bd895708c0c064e9bb4703d32\" rel=\"nofollow noopener\" shape=\"rect\">DESTINY-Breast03<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT03523585%3Fterm%3DDESTINY-Breast02%26draw%3D2%26rank%3D1&amp;esheet=52973030&amp;newsitemid=20221118005606&amp;lan=en-US&amp;anchor=DESTINY-Breast02&amp;index=2&amp;md5=36a468985f36d57433f5b0d6c73f7fad\" rel=\"nofollow noopener\" shape=\"rect\">DESTINY-Breast02<\/a>, two head-to-head phase 3 trials in patients with previously treated HER2 positive metastatic breast cancer, will be highlighted in back-to-back oral presentations and included in the SABCS Press Program. A Spotlight Poster Discussion will feature the first reported results of datopotamab deruxtecan (Dato-DXd) in patients with HR positive, HER2 negative metastatic breast cancer from the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03401385%3Fterm%3DTROPION-PanTumor01%26draw%3D2%26rank%3D1&amp;esheet=52973030&amp;newsitemid=20221118005606&amp;lan=en-US&amp;anchor=TROPION-PanTumor01&amp;index=3&amp;md5=6c6c5a098200d852f947bba10f7f55be\" rel=\"nofollow noopener\" shape=\"rect\">TROPION-PanTumor01<\/a> phase 1 trial.\n<\/p>\n<p>\n\u201c<!-- no quote -->Three years after unveiling the impressive results of DESTINY-Breast01 at SABCS, we look forward to showcasing data from two additional head-to-head trials confirming the efficacy and safety profile of ENHERTU, including updated results from DESTINY-Breast03 and the first presentation of results from DESTINY-Breast02,\u201d said Ken Takeshita, MD, Global Head, R&amp;D, Daiichi Sankyo. \u201c<!-- no quote -->We will present for the first time preliminary data of datopotamab deruxtecan in patients with HR positive, HER2 negative metastatic breast cancer, as well as updated results in metastatic triple negative breast cancer. With these new data, Daiichi Sankyo continues reaching for our goal of changing the standard of care for patients across all breast cancer subtypes with our innovative DXd ADC portfolio.\u201d\n<\/p>\n<p>\nIn patients with metastatic triple negative breast cancer (TNBC), updated results from the TROPION-PanTumor01 phase 1 trial of datopotamab deruxtecan will be featured as a poster presentation and a Spotlight Poster Discussion will provide updated data from the datopotamab deruxtecan and durvalumab arm of the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03742102&amp;esheet=52973030&amp;newsitemid=20221118005606&amp;lan=en-US&amp;anchor=BEGONIA&amp;index=4&amp;md5=ef71893a51340d5b5fbaaa94169c5cce\" rel=\"nofollow noopener\" shape=\"rect\">BEGONIA<\/a> phase 1b\/2 trial.\n<\/p>\n<p>\nAdditionally, updates from other ongoing breast cancer trials from the DESTINY and TROPION clinical development programs of ENHERTU and datopotamab deruxtecan as well as collaborative trials across Daiichi Sankyo\u2019s DXd ADC portfolio including <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04420598&amp;esheet=52973030&amp;newsitemid=20221118005606&amp;lan=en-US&amp;anchor=DEBBRAH&amp;index=5&amp;md5=9d7290fc44480aa3eeab56ce9ad135fc\" rel=\"nofollow noopener\" shape=\"rect\">DEBBRAH<\/a>, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04553770&amp;esheet=52973030&amp;newsitemid=20221118005606&amp;lan=en-US&amp;anchor=TRIO-US+B-12+TALENT&amp;index=6&amp;md5=2b6c4697c6a9d3f9925fd365e4c1a0af\" rel=\"nofollow noopener\" shape=\"rect\">TRIO-US B-12 TALENT<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04610528&amp;esheet=52973030&amp;newsitemid=20221118005606&amp;lan=en-US&amp;anchor=SOLTI-TOT-HER3&amp;index=7&amp;md5=53b6b807a5b25df0529f0b9e68cd4285\" rel=\"nofollow noopener\" shape=\"rect\">SOLTI-TOT-HER3<\/a> will be presented.\n<\/p>\n<p>\nFollowing SABCS, Daiichi Sankyo will hold its annual R&amp;D Day for investors and analysts on Monday, December 12, 2022 at 5:30 pm ET. Company executives will provide an overview of Daiichi Sankyo\u2019s research data presented at SABCS, provide updates on the company\u2019s R&amp;D strategy, and address questions from investors and analysts.\n<\/p>\n<p>\nHighlights of the data from the DXd ADC portfolio of Daiichi Sankyo to be presented at SABCS 2022 include:\n<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor1 bwpadl1\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Presentation Title<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwrowaltcolor1 bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Author<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwrowaltcolor1 bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Abstract<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwrowaltcolor1 bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Presentation<\/b>\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl1\" colspan=\"5\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>ENHERTU (trastuzumab deruxtecan\/T-DXd; HER2 directed ADC)<\/b>\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl1 bwwidth10\" colspan=\"1\" rowspan=\"5\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>HER2 Positive<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTrastuzumab deruxtecan vs. treatment of physician\u2019s choice in patients with HER2 positive unresectable and\/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the phase 3 study DESTINY-Breast02\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nI. Krop\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nGS2-01\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nOral Presentation: General Session 2<br \/>\n<br \/>Wednesday, December 7, 2022<br \/>\n<br \/>9:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTrastuzumab deruxtecan vs. trastuzumab emtansine in patients with HER2 positive metastatic breast cancer: updated survival results of the randomized, phase 3 study DESTINY-Breast03\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nS. A. Hurvitz\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nGS2-02\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nOral Presentation General Session 2<br \/>\n<br \/>Wednesday, December 7, 2022<br \/>\n<br \/>9:15 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwpadl1 bwvertalignt bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTrastuzumab deruxtecan for the treatment of patients with HER2 positive breast cancer with brain and\/or leptomeningeal metastases: a multicenter retrospective study (ROSET-BM study)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nY. Takashi\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPD7-01\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSpotlight Poster Discussion 7<br \/>\n<br \/>Wednesday, December 7, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwpadl1 bwvertalignt bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDose-expansion study of trastuzumab deruxtecan as monotherapy or combined with pertuzumab in patients with metastatic human epidermal growth factor receptor 2-positive (HER2 positive) breast cancer in DESTINY-Breast07\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nE.P. Hamilton\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPD18-11\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSpotlight Poster Discussion 18<br \/>\n<br \/>Friday, December 9, 2022<br \/>\n<br \/>7:00 am CT<br \/>\n\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwpadl1 bwvertalignt bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nOpen-label, phase 3b\/4 study of trastuzumab deruxtecan in patients with or without baseline brain metastasis with advanced\/metastatic human epidermal growth factor receptor 2 positive (HER2 positive) breast cancer: DESTINY-Breast12\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nN. U. Lin\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nOT2-16-02\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Wednesday, December 7, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwrowaltcolor1 bwvertalignt\" colspan=\"5\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth10\" colspan=\"1\" rowspan=\"4\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>HER2 Low<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTRIO-US B-12 TALENT: neoadjuvant trastuzumab deruxtecan with or without anastrozole for HER2 low, HR positive early-stage breast cancer\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nS.A. Hurvitz\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nGS2-03\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nOral Presentation General Session 2<br \/>\n<br \/>Wednesday, December 7, 2022<br \/>\n<br \/>9:30 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignt bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTrastuzumab deruxtecan in patients with unstable central nervous system involvement from HER2 low advanced breast cancer: the DEBBRAH trial\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nJ.M. Perez-Garcia\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPD7-02\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSpotlight Poster Discussion 7<br \/>\n<br \/>Wednesday, December 7, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignt bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTrastuzumab deruxtecan + durvalumab as first-line treatment for unresectable locally advanced\/metastatic hormone receptor-negative (HR negative), HER2 low breast cancer: updated results from BEGONIA, a phase 1b\/2 study\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP. Schmid\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPD11-08\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSpotlight Poster Discussion 11<br \/>\n<br \/>Thursday, December 8, 2022<br \/>\n<br \/>7:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignt bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTrastuzumab deruxtecan vs. treatment of physician\u2019s choice in patients with HER2 low unresectable and\/or metastatic breast cancer: subgroup analyses from DESTINY-Breast04\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nN. Harbeck\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP1-11-01\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Tuesday, December 6, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwrowaltcolor1\" colspan=\"5\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth10\" colspan=\"1\" rowspan=\"7\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>HER2 Testing<\/b>\n<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nRetrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatment patterns, and outcomes of HER2 low breast cancer\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nG. Viale\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nHER2-15\n<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignm bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"3\">\n<p class=\"bwcellpmargin\">\nHER2 Low: A Separate Entity Special Session \u2013 Hall 3<br \/>\n<br \/>Wednesday, December 7, 2022<br \/>\n<br \/>9:45 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDetermination of HER2 low status in tumors of patients with unresectable and\/or metastatic breast cancer in DESTINY-Breast04\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA. Prat\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nHER2-18\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nProficiency assessment of HER2 low breast cancer scoring with the Ventana PATHWAY 4B5 and Dako HercepTest HER2 assays and the impact of pathologist training\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nJ. R\u00fcschoff\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nHER2-13\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignt bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA fully automatic artificial intelligence system for accurate and reproducible HER2 IHC scoring in breast cancer\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nY. Globerson\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP6-04-05\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Friday, December 9, 2022<br \/>\n<br \/>7:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignt bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nComputational pathology based HER2 expression quantification in HER2 low breast cancer\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA. Spitzm\u00fcller\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP6-04-03\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Friday, December 9, 2022<br \/>\n<br \/>7:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignt bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nART: Automated region segmentation of tumor on HER2-stained breast cancer tissue\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA. Kapil\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP6-04-16\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Friday, December 9, 2022<br \/>\n<br \/>7:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwvertalignt bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nHigh intra- and inter-block concordance of HER2 immunohistochemistry scores across breast cancer samples and impact of decalcification procedures\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA. Tsirka\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP6-04-17\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Friday, December 9, 2022<br \/>\n<br \/>7:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl1\" colspan=\"5\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Datopotamab Deruxtecan (Dato-DXd; TROP2 directed ADC)<\/b>\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth10\" colspan=\"1\" rowspan=\"2\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>HR Positive, HER2 Negative<\/b>\n<\/p>\n<p class=\"bwalignc bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPhase 1 TROPION-PanTumor01 study evaluating datopotamab deruxtecan in unresectable or metastatic hormone receptor positive (HR positive), HER2 negative breast cancer\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nF. Meric-Bernstam\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPD13-08\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSpotlight Poster Discussion 13<br \/>\n<br \/>Thursday, December 8, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDatopotamab deruxtecan, a TROP2 antibody-drug conjugate, vs. investigators\u2019 choice of chemotherapy in previously-treated, inoperable or metastatic HR positive, HER2 negative breast cancer: TROPION-Breast01\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA. Bardia\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwnowrap bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nOT1-03-04\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Tuesday, December 6, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwrowaltcolor1\" colspan=\"5\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth10\" colspan=\"1\" rowspan=\"3\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>TNBC<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDatopotamab deruxtecan + durvalumab as first-line treatment for unresectable locally advanced\/metastatic triple negative breast cancer: updated results from BEGONIA, a phase 1b\/2 study\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP. Schmid\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPD11-09\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSpotlight Poster Discussion 11<br \/>\n<br \/>Thursday, December 8, 2022<br \/>\n<br \/>7:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDatopotamab deruxtecan in advanced triple-negative breast cancer: updated results from the Phase 1 TROPION-PanTumor01 Study\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA. Bardia\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP6-10-03\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Friday, December 9, 2022<br \/>\n<br \/>7:00 am CT\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTROPION-Breast02: Phase 3, open-label, randomized study of first-line datopotamab deruxtecan versus chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer who are not candidates for anti-PD-(L)1 therapy\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nR. Dent\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nOT1-03-05\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Tuesday, December 6, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwrowaltcolor0 bwpadl1\" colspan=\"5\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Patritumab Deruxtecan (HER3-DXd; HER3 directed ADC)<\/b>\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth10\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>HR positive, HER2 negative<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth61\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nGenetic determinants of response to patritumab deruxtecan in hormone receptor positive (HR positive), HER2 negative breast cancer: a correlative analysis from SOLTI-TOT-HER3 trial\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth7\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nF. Bras\u00f3-Maristany\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth6\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP5-02-31\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl1 bwwidth16\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nPoster Presentation<br \/>\n<br \/>Thursday, December 8, 2022<br \/>\n<br \/>5:00 pm CT\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n<b>About the DXd ADC Portfolio of Daiichi Sankyo<\/b>\n<\/p>\n<p>\nThe DXd ADC portfolio of Daiichi Sankyo currently consists of five ADCs in clinical development across multiple types of cancer. The company\u2019s three lead ADCs include ENHERTU, a HER2 directed ADC and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca; and patritumab deruxtecan (HER3-DXd), a HER3 directed ADC. Two additional ADCs including ifinatamab deruxtecan (I-DXd; DS-7300), a B7-H3 directed ADC, and DS-6000, a CDH6 directed ADC, are being developed through a strategic early-stage research collaboration with Sarah Cannon Research Institute.\n<\/p>\n<p>\nEach ADC is designed using Daiichi Sankyo\u2019s 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.\n<\/p>\n<p>\nDatopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan and DS-6000 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.\n<\/p>\n<p>\n<b>ENHERTU U.S. Important Safety Information<\/b>\n<\/p>\n<p>\n<b>Indications<\/b>\n<\/p>\n<p>\nENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nUnresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:<br \/>\n<br \/>\u2013 In the metastatic setting, or<br \/>\n<br \/>\u2013 In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nUnresectable or metastatic HER2-low (IHC 1+ or IHC 2+\/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy<br \/>\n\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nUnresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy<\/p>\n<p>This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nLocally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen\n<\/li>\n<\/ul>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwleftsingle bwrightsingle bwtopsingle bwpadl2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY <\/b>\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwleftsingle bwrightsingle\" colspan=\"1\" rowspan=\"1\">\n<ul class=\"bwlistdisc\">\n<li>\n<b>Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD\/pneumonitis. Advise patients of the risk and to immediately report symptoms. <\/b>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwleftsingle bwrightsingle bwsinglebottom\" colspan=\"1\" rowspan=\"1\">\n<ul class=\"bwlistdisc\">\n<li>\n<b>Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.<\/b>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n<b>Contraindications<\/b>\n<\/p>\n<p>\nNone.\n<\/p>\n<p>\n<b>Warnings and Precautions<\/b>\n<\/p>\n<p>\n<b>Interstitial Lung Disease \/ Pneumonitis<\/b>\n<\/p>\n<p>\nSevere, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD\/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and\/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD\/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in \u226428 days from date of onset, maintain dose. If resolved in &gt;28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD\/pneumonitis is suspected (e.g., \u22650.5 mg\/kg\/day prednisolone or equivalent). For symptomatic ILD\/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD\/pneumonitis is suspected (e.g., \u22651 mg\/kg\/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.\n<\/p>\n<p>\n<span class=\"bwuline\">Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg\/kg)<\/span>\n<\/p>\n<p>\nIn patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg\/kg, ILD occurred in 12% of patients. Fatal outcomes due to ILD and\/or pneumonitis occurred in 1.0% of patients treated with ENHERTU. Median time to first onset was 5 months (range: 0.9 to 23).\n<\/p>\n<p>\n<span class=\"bwuline\">Locally Advanced or Metastatic Gastric Cancer (6.4 mg\/kg)<\/span>\n<\/p>\n<p>\nIn patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg\/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21).\n<\/p>\n<p>\n<b>Neutropenia<\/b>\n<\/p>\n<p>\nSevere neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] &lt;1.0 to 0.5 x 10<sup>9<\/sup>\/L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC &lt;0.5 x 10<sup>9<\/sup>\/L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by one level. For febrile neutropenia (ANC &lt;1.0 x 10<sup>9<\/sup>\/L and temperature &gt;38.3\u00ba C or a sustained temperature of \u226538\u00ba C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by one level.\n<\/p>\n<p>\n<span class=\"bwuline\">Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg\/kg)<\/span>\n<\/p>\n<p>\nIn patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg\/kg, a decrease in neutrophil count was reported in 65% of patients. Sixteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 664). Febrile neutropenia was reported in 1.1% of patients.\n<\/p>\n<p>\n<span class=\"bwuline\">Locally Advanced or Metastatic Gastric Cancer (6.4 mg\/kg)<\/span>\n<\/p>\n<p>\nIn patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg\/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.\n<\/p>\n<p>\n<b>Left Ventricular Dysfunction<\/b>\n<\/p>\n<p>\nPatients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is &gt;45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is &lt;10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is &lt;40% or absolute decrease from baseline is &gt;20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of &lt;40% or absolute decrease from baseline of &gt;20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF &lt;50% prior to initiation of treatment.\n<\/p>\n<p>\n<span class=\"bwuline\">Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg\/kg)<\/span>\n<\/p>\n<p>\nIn patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg\/kg, LVEF decrease was reported in 3.6% of patients, of which 0.4% were Grade 3.\n<\/p>\n<p>\n<span class=\"bwuline\">Locally Advanced or Metastatic Gastric Cancer<\/span><span class=\"bwuline\"> (6.4 mg\/kg)<\/span>\n<\/p>\n<p>\nIn patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg\/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF.\n<\/p>\n<p>\n<b>Embryo-Fetal Toxicity<\/b>\n<\/p>\n<p>\nENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose of ENHERTU.\n<\/p>\n<p>\n<b>Additional Dose Modifications<\/b>\n<\/p>\n<p>\n<b>Thrombocytopenia<\/b>\n<\/p>\n<p>\nFor Grade 3 thrombocytopenia (platelets &lt;50 to 25 x 10<sup>9<\/sup>\/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets &lt;25 x 10<sup>9<\/sup>\/L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by one level.\n<\/p>\n<p>\n<b>Adverse Reactions<\/b>\n<\/p>\n<p>\n<span class=\"bwuline\">Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg\/kg)<\/span>\n<\/p>\n<p>\nThe pooled safety population reflects exposure to ENHERTU 5.4 mg\/kg intravenously every 3 weeks in 984 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, and DESTINY-Lung02. Among these patients 65% were exposed for &gt;6 months and 39% were exposed for &gt;1 year. In this pooled safety population, the most common (\u226520%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (71%), decreased hemoglobin (66%), decreased neutrophil count (65%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (47%), increased aspartate aminotransferase (48%), vomiting (44%), increased alanine aminotransferase (42%), alopecia (39%), increased blood alkaline phosphatase (39%), constipation (34%), musculoskeletal pain (32%), decreased appetite (32%), hypokalemia (28%), diarrhea (28%), and respiratory infection (24%).\n<\/p>\n<p>\n<span class=\"bwuline\">HER2-Positive Metastatic Breast Cancer<\/span>\n<\/p>\n<p>\n<i>DESTINY-Breast03<\/i>\n<\/p>\n<p>\nThe safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg\/kg intravenously every three weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30).\n<\/p>\n<p>\nSerious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in &gt;1% of patients who received ENHERTU were vomiting, interstitial lung disease, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (one patient each).\n<\/p>\n<p>\nENHERTU was permanently discontinued in 14% of patients, of which ILD\/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD\/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose reduction were nausea, neutropenia, and fatigue.\n<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), hypokalemia (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), respiratory infection (22%), headache (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%).\n<\/p>\n<p>\n<span class=\"bwuline\">HER2-Low Metastatic Breast Cancer<\/span>\n<\/p>\n<p>\n<i>DESTINY-Breast04<\/i>\n<\/p>\n<p>\nThe safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+\/ISH-) breast cancer who received ENHERTU 5.4 mg\/kg intravenously every 3 weeks in DESTINY-Breast04. The median duration of treatment was 8 months (range: 0.2 to 33) for patients who received ENHERTU.\n<\/p>\n<p>\nSerious adverse reactions occurred in 28% of patients receiving ENHERTU. Serious adverse reactions in &gt;1% of patients who received ENHERTU were ILD\/pneumonitis, pneumonia, dyspnea, musculoskeletal pain, sepsis, anemia, febrile neutropenia, hypercalcemia, nausea, pyrexia, and vomiting. Fatalities due to adverse reactions occurred in 4% of patients including ILD\/pneumonitis (3 patients); sepsis (2 patients); and ischemic colitis, disseminated intravascular coagulation, dyspnea, febrile neutropenia, general physical health deterioration, pleural effusion, and respiratory failure (1 patient each).\n<\/p>\n<p>\nENHERTU was permanently discontinued in 16% of patients, of which ILD\/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 39% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose interruption were neutropenia, fatigue, anemia, leukopenia, COVID-19, ILD\/pneumonitis, increased transaminases, and hyperbilirubinemia. Dose reductions occurred in 23% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose reduction were fatigue, nausea, thrombocytopenia, and neutropenia.\n<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (70%), decreased hemoglobin (64%), decreased neutrophil count (64%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (44%), alopecia (40%), vomiting (40%), increased aspartate aminotransferase (38%), increased alanine aminotransferase (36%), constipation (34%), increased blood alkaline phosphatase (34%), decreased appetite (32%), musculoskeletal pain (32%), diarrhea (27%), and hypokalemia (25%).<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Contacts:<\/b><br \/><b>Global\/US:<\/b><br \/>Jennifer Brennan<br \/>\n<br \/>Daiichi Sankyo, Inc.<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;&#111;&#x3a;&#106;&#x62;&#114;e&#x6e;n&#x61;&#110;&#x32;&#64;&#x64;&#115;&#x69;&#46;c&#x6f;m\" rel=\"nofollow noopener\" shape=\"rect\">&#x6a;&#x62;&#x72;&#x65;&#x6e;&#x6e;&#x61;&#x6e;&#x32;&#x40;&#x64;&#x73;&#x69;&#x2e;&#x63;&#x6f;&#x6d;<\/a><br \/>+ 1 908 992 6631 (office)<br \/>\n<br \/>+1 908 900 3183 (mobile)<\/p>\n<p><b>Investor Relations Contact<\/b>:<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#x44;&#x61;&#x69;&#x69;&#x63;&#x68;&#x69;&#x53;&#x61;&#x6e;&#x6b;&#x79;&#x6f;&#x49;&#x52;&#x40;&#x64;&#x61;&#x69;&#x69;&#x63;&#x68;&#x69;&#x73;&#x61;&#x6e;&#x6b;&#x79;&#x6f;&#x2e;&#x63;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">D&#97;&#x69;&#x69;c&#104;&#x69;&#x53;a&#110;&#x6b;&#x79;o&#73;&#x52;&#x40;d&#97;&#x69;&#x69;c&#104;&#105;&#x73;&#x61;n&#107;&#x79;&#x6f;&#46;&#99;&#x6f;&#x6d;<\/a>\n<\/p>\n<p> <a href=\"http:\/\/www.businesswire.com\/news\/home\/20221118005606\/en\/Data-Across-Daiichi-Sankyo-DXd-ADC-Portfolio-at-2022-SABCS-Demonstrates-Bold-Progress-in-Advancing-Treatment-for-Patients-with-Breast-Cancer\/?feedref=Zd8jjkgYuzBwDixoAdXmJgT1albrG1Eq4mAeVP392103_ypKzv-7ah0oHKWbnuHnevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxZM7XiMhduiSeKMTNDLRqI_doMC3CVAuyHo5cJ7XfDuvA==\"> Read full story here <\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Survival data from DESTINY-Breast03 and DESTINY-Breast02 phase 3 trials in patients with HER2 positive metastatic breast cancer further confirms efficacy of ENHERTU First presentation of datopotamab deruxtecan results in patients with HR positive, HER2 negative metastatic breast cancer shows promising clinical activity Annual R&amp;D Day following SABCS to provide updates across Daiichi Sankyo R&amp;D portfolio &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/data-across-daiichi-sankyo-dxd-adc-portfolio-at-2022-sabcs-demonstrates-bold-progress-in-advancing-treatment-for-patients-with-breast-cancer\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-51080","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Data Across Daiichi Sankyo DXd ADC Portfolio at 2022 SABCS Demonstrates Bold Progress in Advancing Treatment for Patients with Breast Cancer - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/data-across-daiichi-sankyo-dxd-adc-portfolio-at-2022-sabcs-demonstrates-bold-progress-in-advancing-treatment-for-patients-with-breast-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Data Across Daiichi Sankyo DXd ADC Portfolio at 2022 SABCS Demonstrates Bold Progress in Advancing Treatment for Patients with Breast Cancer - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Survival data from DESTINY-Breast03 and DESTINY-Breast02 phase 3 trials in patients with HER2 positive metastatic breast cancer further confirms efficacy of ENHERTU First presentation of datopotamab deruxtecan results in patients with HR positive, HER2 negative metastatic breast cancer shows promising clinical activity Annual R&amp;D Day following SABCS to provide updates across Daiichi Sankyo R&amp;D portfolio ... 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