{"id":20563,"date":"2025-08-20T19:08:00","date_gmt":"2025-08-20T13:38:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=20563"},"modified":"2025-09-09T14:24:07","modified_gmt":"2025-09-09T08:54:07","slug":"enhertu-for-cancer-treatment-and-management","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/enhertu-for-cancer-treatment-and-management","title":{"rendered":"ENHERTU\u2019s Rapid Rise: How the HER2-Targeting ADC Is Redefining Cancer Treatment with Back-to-Back Label Expansions"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69fb65afdee54\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69fb65afdee54\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/enhertu-for-cancer-treatment-and-management\/#ENHERTUs_Journey_of_Growth_Broadening_the_Horizon\" >ENHERTU\u2019s Journey of Growth: Broadening the Horizon<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/enhertu-for-cancer-treatment-and-management\/#ENHERTU_Dosing_Variable_Cost_of_therapy_and_Sales_performance\" >ENHERTU Dosing, Variable Cost of therapy, and Sales performance<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/enhertu-for-cancer-treatment-and-management\/#Upcoming_Trials_and_Expectations_in_2025\" >Upcoming Trials and Expectations in 2025<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/enhertu-for-cancer-treatment-and-management\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>ENHERTU, a next-generation antibody-drug conjugate (ADC) jointly developed by <strong>Daiichi Sankyo\/ AstraZeneca<\/strong> since March 2019, except in Japan, where Daiichi Sankyo maintains exclusive rights. It is worth noting that recently, in November 2024, Daiichi Sankyo and AstraZeneca were awarded the Galien Foundation 2024 Prix Galien USA Award for Best Biotechnology Product for ENHERTU.<\/p>\n\n\n\n<p>Breast cancer remains a leading indication for <strong>ENHERTU<\/strong>. DelveInsight\u2019s estimates approximately <strong>300K <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/breast-cancer-market\" class=\"ek-link\">breast cancer incident cases<\/a> in the US in 2024, with around 15% classified as HER2+, which has remained a significant revenue driver for ENHERTU since its first launch in third-line <a href=\"https:\/\/www.delveinsight.com\/report-store\/her2-positive-breast-cancer-market\" class=\"ek-link\">HER2+ Breast Cancer<\/a>.&nbsp; Following the first launch, ENHERTU received approvals in <a href=\"https:\/\/www.delveinsight.com\/report-store\/her2-positive-gastric-cancer-market\" class=\"ek-link\">HER2+ Gastric cancer<\/a>, second-line HER2+ Breast Cancer, HER2-Low or ultra-low breast cancer, <a href=\"https:\/\/www.delveinsight.com\/report-store\/her2-mnsclc-market\" class=\"ek-link\">HER2+ NSCLC<\/a>, and a tumor-agnostic label in all solid tumors expressing HER2+.<\/p>\n\n\n\n<p>Post HER2+, Delveinsight expects ENHERTU to drive momentum with this new patient segment of HER2-low or ultra-low type, which represents roughly <strong>55-60% <\/strong>of all breast cancer cases. The high incidence of the new HER2-low subtype and the tumor-agnostic label highlight the strong market potential for ENHERTU, especially given its role as an innovative treatment option for patients with limited therapeutic options.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>Expectations in 2025: With HER2+ breast cancer being the leading revenue generator initially, expectations are high post HER2-low\/ultra-low Breast and Tumor Agnostic label<\/em>.<\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-enhertu-s-journey-of-growth-broadening-the-horizon\"><span class=\"ez-toc-section\" id=\"ENHERTUs_Journey_of_Growth_Broadening_the_Horizon\"><\/span>ENHERTU\u2019s Journey of Growth: Broadening the Horizon<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>ENHERTU received its first FDA approval in December 2019 for treating third-line and above <strong>HER2+ metastatic breast cancer patients<\/strong>. This was followed by approval in January 2021 for adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/gastroesophageal-junction-adenocarcinoma-market\">metastatic HER2+ gastric or gastroesophageal junction (GEJ) adenocarcinoma<\/a> who had received a trastuzumab-based treatment.<\/p>\n\n\n\n<p>Further, in August 2022, it received approval for <strong>HER2-low breast cancer<\/strong> in patients with advanced disease who had prior chemotherapy, as well as for <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-non-small-cell-lung-cancer-market\" class=\"ek-link\">unresectable or metastatic <strong>non-small cell lung cancer (NSCLC)<\/strong><\/a><strong> with HER2 mutations,<\/strong> after previous systemic therapy. Later in April 2024, the FDA approved it for HER2+ solid tumors in adults who had received prior systemic therapy and had no satisfactory alternative treatment options.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<div dir=\"ltr\" style=\"margin-left: 0pt;\" align=\"left\">\n<table style=\"border: none; border-collapse: collapse;\"><colgroup><col width=\"131\" \/><col width=\"163\" \/><col width=\"115\" \/><col width=\"115\" \/><col width=\"67\" \/><\/colgroup>\n<tbody>\n<tr style=\"height: 21.75pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #808080 1pt; border-bottom: solid #000000 1pt; border-top: solid #808080 1pt; vertical-align: top; background-color: #bee6ff; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\" colspan=\"5\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">List of approved indications and efficacy data<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #000000 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Indication<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT ID\/Acronym<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Results<\/span><\/p>\n<\/td>\n<td style=\"border-left: solid #000000 1pt; border-right: solid #808080 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Dosage<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 42pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #000000 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HER2+ locally advanced or metastatic gastric or GEJ adenocarcinoma<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT03329690\/DESTINY-Gastric01<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">OS: 12.5 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">PFS: 5.6 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 40.5 %<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 11.3 months<\/span><\/p>\n<\/td>\n<td style=\"border-left: solid #000000 1pt; border-right: solid #808080 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">6.4 mg\/kg<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #000000 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\" rowspan=\"3\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HER2+ metastatic breast cancer<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT03248492\/DESTINY-Breast01<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 60.3%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 14.8 months<\/span><\/p>\n<\/td>\n<td style=\"border-left: solid #000000 1pt; border-right: solid #808080 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\" rowspan=\"10\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">5.4 mg\/kg<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 42pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT03523585\/DESTINY-Breast02<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">PFS: 17.8 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">OS: 39.2 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 69.7%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 19.6 months<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT03529110\/DESTINY-Breast03<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 82.7%<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 72.75pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #000000 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\" rowspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HER2+, HER2-low, and HER2-ultralow metastatic breast cancer<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT03734029\/DESTINY-Breast04<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HR+ Cohort<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">OS: 23.9 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">PFS: 10.1 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 52.9%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 10.7 months<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HR+ and HR\u02d7 Cohort<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">OS: 23.4 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">PFS: 9.9 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 52.3%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 10.7 months<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 63pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT04494425\/DESTINY-Breast06<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HER2-low<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">PFS: 13.2 months<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 62%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 14.1 months<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HER2-low and HER2-ultralow<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">PFS: 13.2<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 62.6%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 14.3 months<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #000000 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HER2-mutant NSCLC<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT03505710\/DESTINY-Lung01<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 52.9%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 6.9 months<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #000000 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">&nbsp;<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT04644237\/ DESTINY-Lung02 trial<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">PFS-9.9 months<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"border-left: solid #808080 1pt; border-right: solid #000000 1pt; border-bottom: solid #000000 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\" rowspan=\"3\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">HER2+ (IHC 3+) unresectable or metastatic solid tumors<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT04482309\/DESTINY-PanTumor02<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 51.4%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 19.4 months<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT03505710\/DESTINY-Lung01<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 52.9%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 6.9 months<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 21.75pt;\">\n<td style=\"border-left: solid #000000 1pt; border-right: solid #000000 1pt; border-bottom: solid #808080 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NCT04744831\/DESTINY-CRC02<\/span><\/p>\n<\/td>\n<td style=\"border-left: solid #000000 1pt; border-right: solid #000000 1pt; border-bottom: solid #808080 1pt; border-top: solid #000000 1pt; vertical-align: top; background-color: #f5f5f5; padding: 0pt 5pt 0pt 5pt; overflow: hidden; overflow-wrap: break-word;\" colspan=\"2\">\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Confirmed ORR: 46.9%<\/span><\/p>\n<p dir=\"ltr\" style=\"line-height: 1.3800000000000001; margin-top: 0pt; margin-bottom: 0pt;\"><span style=\"font-size: 9pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">DoR: 5.5 months<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><span id=\"docs-internal-guid-70311f09-7fff-26c1-6f6d-bc927b029a42\">&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"ENHERTU_Dosing_Variable_Cost_of_therapy_and_Sales_performance\"><\/span>ENHERTU Dosing, Variable Cost of therapy, and Sales performance<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>ENHERTU is administered as an intravenous infusion once every 3 weeks. Due to its variation in dose, its lower per-dose strength may seem cost-effective initially, but often requires more vials per patient, increasing overall drug use and treatment costs. This impacts healthcare budgeting, reimbursement, and inventory planning.<\/p>\n\n\n\n<p>The <strong>Average Cost of Therapy for ENHERTU varies significantly<\/strong> across indications, based on median progression-free survival (PFS). Within the United States, in HER2-mutant second-line NSCLC, treatment costs is approximately 165,000 based on a median PFS of 9.9 months, whereas for HER2-low breast cancer, an annual cost of therapy has been assumed considering a median PFS of 10.1 and 13.2 months based on data from DESTINY&nbsp; BREAST-04 and DESTINY BREAST-06 respectively. Contrary to dosing in other indications, for <strong>HER2+ gastric cancer<\/strong>, slightly higher dosing of 6.4mg\/kg has been recommended based on the FDA label.&nbsp;<\/p>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img decoding=\"async\" width=\"1024\" height=\"317\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/01\/09190300\/global-sales-of-enhertu-based-on-indication-in-2024-1024x317.png\" alt=\"global-sales-of-enhertu-based-on-indication-in-2024\" class=\"wp-image-32024\" style=\"width:840px;height:auto\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/01\/09190300\/global-sales-of-enhertu-based-on-indication-in-2024-1024x317.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/01\/09190300\/global-sales-of-enhertu-based-on-indication-in-2024-300x93.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/01\/09190300\/global-sales-of-enhertu-based-on-indication-in-2024-150x46.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/01\/09190300\/global-sales-of-enhertu-based-on-indication-in-2024-768x238.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/01\/09190300\/global-sales-of-enhertu-based-on-indication-in-2024-1536x476.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2023\/01\/09190300\/global-sales-of-enhertu-based-on-indication-in-2024-2048x634.png 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>As per Daiichi, breast cancer contributes to about 85% of ENHERTU\u2019s total net revenue, but its use in other types of cancer is steadily growing, creating new opportunities for both treatment and sales.<\/p>\n\n\n\n<p>Notably, <strong>ENHERTU\u2019s combined sales surpassed <\/strong>the <strong>USD 1 billion <\/strong>mark <strong>in 2022,<\/strong> reaching approximately USD 1.2 billion. This momentum continued, with sales more than doubling to<strong> USD 2.5 billion in 2023.<\/strong> In FY 2024, combined revenues reported by Daiichi Sankyo and AstraZeneca exceeded <strong>USD 3.5 billion, <\/strong>marking an impressive year-over-year growth of around 40% compared to FY 2023. Furthermore, the market for ENHERTU is expected to grow exponentially in the coming years.<\/p>\n\n\n\n<p>Breast cancer continues to be the primary source of revenue for ENHERTU, largely due to the high prevalence of the disease and its expanded approval based on HER2 expression in multiple subtypes. The combination of broad clinical utility, growing physician familiarity, and established reimbursement frameworks in major markets such as the US, Europe, and Japan has made breast cancer the largest contributor to ENHERTU\u2019s commercial success.<\/p>\n\n\n\n<p>It is worth highlighting that ENHERTU\u2019s patent is set to expire in the US in 2033 and between 2033 and 2035 in Europe, which could lead to increased competition from generic versions and potentially reduced market exclusivity and revenue for the developers.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Upcoming_Trials_and_Expectations_in_2025\"><\/span>Upcoming Trials and Expectations in 2025<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Although<strong> ENHERTU<\/strong> is approved for<strong> HER2-mutant NSCLC,<\/strong> researchers are now testing it as a first-line treatment in this group through a Phase III trial (DESTINY-Lung04), with results expected in the second half of 2025, and another Phase Ib trial (DESTINY-Lung03) for first-line treatment of patients with advanced or metastatic non-squamous NSCLC and HER2 overexpression, with results expected in 2026. At this point, no other company is developing an ADC for late-stage HER2-mutated NSCLC. With fewer competitors, ENHERTU will have an edge in the coming years, as other companies focus on developing tyrosine kinase inhibitors.<\/p>\n\n\n\n<p>Furthermore, ENHERTU is being evaluated as monotherapy or in combination with anti-cancer agents in a Phase II study (DESTINY-PanTumor03), with results expected in 2H 2025 for HER2-expressing tumors, excluding breast and gastric cancers.<\/p>\n\n\n\n<p>It\u2019s worth noting that <strong>ENHERTU\u2019s Phase II trial (DESTINY-PanTumor02) <\/strong>has received multiple regulatory designations, including Accelerated Approval, Breakthrough Therapy, PRIME, Sakigake, and Priority Review, for a range of HER2-expressing tumors such as bladder, biliary tract, cervical, endometrial, ovarian, pancreatic cancers, rare tumors, and others, excluding breast, gastric, and colorectal cancers. The study is expected to be completed by July 2027.<\/p>\n\n\n\n<p>Despite side effects such as <a href=\"https:\/\/www.delveinsight.com\/report-store\/interstitial-lung-disease-market\" class=\"ek-link\">interstitial lung disease (ILD)<\/a>, ENHERTU remains at the forefront of the HER2-targeted therapy landscape, benefiting from strong clinical efficacy, multiple regulatory approvals, and an expanding range of indications. Within the emerging HER2-low segment, multiple therapies such as <strong>Duality Biologics\/BioNTech\u2019s DB-1303\/BNT323, Immutep\u2019s Eftilagimod alpha, Daiichi Sankyo\/Merck\u2019s Ifinatamab deruxtecan, Bliss Biopharmaceutical\u2019s BB-1701, Zymeworks\/Jazz Pharmaceuticals\u2019 Zanidatamab, Dragonfly Therapeutics\u2019 DF1001, and RemeGen\/Pfizer (Seagen)<\/strong> are being evaluated in late and mid-stage trials in various indications (breast cancer, gastric cancer, urothelial cancer, NSCLC, and others) expressing HER2-low.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Looking ahead, ENHERTU is poised to significantly broaden its clinical impact as it continues to demonstrate efficacy across a range of HER2-expressing cancers. With multiple early-, mid-, and late-stage trials underway in lung, colorectal, biliary, and other solid tumors, the drug\u2019s role is expanding well beyond its current indications. ENHERTU\u2019s first-mover advantage, expanding tumor-agnostic applications, and robust clinical pipeline position it strongly against future entrants. <\/p>\n\n\n\n<p>As precision oncology continues to evolve, ENHERTU is well-placed to retain a leadership role in redefining treatment standards for HER2-expressing cancers. Looking forward, in the next three years, ENHERTU is positioned to become one of the most successful breast cancer drugs ever.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-her2-positive-breast-cancer-market\"><img decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/05\/12133001\/Metastatic-HER2-positive-Breast-Cancer-Market-Outlook--1024x194.png\" alt=\"Metastatic HER2 positive Breast Cancer Market Outlook\" class=\"wp-image-32046\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/05\/12133001\/Metastatic-HER2-positive-Breast-Cancer-Market-Outlook--1024x194.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/05\/12133001\/Metastatic-HER2-positive-Breast-Cancer-Market-Outlook--300x57.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/05\/12133001\/Metastatic-HER2-positive-Breast-Cancer-Market-Outlook--150x28.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/05\/12133001\/Metastatic-HER2-positive-Breast-Cancer-Market-Outlook--768x145.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/05\/12133001\/Metastatic-HER2-positive-Breast-Cancer-Market-Outlook--1536x291.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/05\/12133001\/Metastatic-HER2-positive-Breast-Cancer-Market-Outlook-.png 1584w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>ENHERTU, a next-generation antibody-drug conjugate (ADC) jointly developed by Daiichi Sankyo\/ AstraZeneca since March 2019, except in Japan, where Daiichi Sankyo maintains exclusive rights. It is worth noting that recently, in November 2024, Daiichi Sankyo and AstraZeneca were awarded the Galien Foundation 2024 Prix Galien USA Award for Best Biotechnology Product for ENHERTU. Breast cancer [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":20567,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":6,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[127,19910,927,174,16851,16958,17768,17769,2400,19025,1111],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-20563","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-breast-cancer","tag-cancer-management","tag-cancer-treatment","tag-colorectal-cancer","tag-enhertu","tag-gastric-cancer","tag-her2-breast-cancer","tag-her2-breast-cancer-market","tag-her2-therapy","tag-her2-gastric-cancer","tag-nsclc","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- 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href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Enhertu<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Gastric cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">HER2 Breast Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">HER2 Breast Cancer Market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">HER2 therapy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">HER2+ Gastric Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">NSCLC<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Breast Cancer<\/span>","<span class=\"advgb-post-tax-term\">Cancer Management<\/span>","<span class=\"advgb-post-tax-term\">Cancer Treatment<\/span>","<span class=\"advgb-post-tax-term\">Colorectal Cancer<\/span>","<span class=\"advgb-post-tax-term\">Enhertu<\/span>","<span class=\"advgb-post-tax-term\">Gastric cancer<\/span>","<span class=\"advgb-post-tax-term\">HER2 Breast Cancer<\/span>","<span class=\"advgb-post-tax-term\">HER2 Breast Cancer Market<\/span>","<span class=\"advgb-post-tax-term\">HER2 therapy<\/span>","<span class=\"advgb-post-tax-term\">HER2+ Gastric Cancer<\/span>","<span class=\"advgb-post-tax-term\">NSCLC<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 months ago","modified":"Updated 8 months ago"},"absolute_dates":{"created":"Posted on Aug 20, 2025","modified":"Updated on Sep 9, 2025"},"absolute_dates_time":{"created":"Posted on Aug 20, 2025 7:08 pm","modified":"Updated on Sep 9, 2025 2:24 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