{"id":7959,"date":"2026-05-30T14:35:33","date_gmt":"2026-05-30T21:35:33","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&#038;p=7959"},"modified":"2026-05-30T14:37:29","modified_gmt":"2026-05-30T21:37:29","slug":"rakuten-medical-presents-new-data-on-asp-1929-photoimmunotherapy-as-monotherapy-for-recurrent-head-and-neck-cancer-at-asco-2026","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2026\/05\/30\/7959\/","title":{"rendered":"Rakuten Medical Presents New Data on ASP-1929 Photoimmunotherapy as Monotherapy for Recurrent Head and Neck Cancer at ASCO 2026"},"content":{"rendered":"<div id=\"pl-7959\"  class=\"panel-layout\" ><div id=\"pg-7959-0\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7959-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7959-0-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<ul>\n<li><b><i>ASP-1929-301, the first Phase 3 randomized controlled trial of ASP-1929, showed median OS of 15.7 months and ORR of 25.8%, with a tolerable safety profile in heavily pretreated recurrent HNSCC<\/i><\/b><\/li>\n<li><b><i>Real-world multicenter study data of ASP-1929 photoimmunotherapy in recurrent nasopharyngeal cancer showed 86.0% local response and 89.2% two-year survival<\/i><\/b><\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400\">Disclaimer: Rakuten Medical\u2019s Alluminox\u00ae platform-based photoimmunotherapy is investigational outside Japan.<\/span><\/i><\/p>\n<p><b>SAN DIEGO \u2014 May 30, 2026 \u2014 <\/b><span style=\"font-weight: 400\">Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox platform-based photoimmunotherapy, today announced new clinical and real-world data for ASP-1929 photoimmunotherapy (PIT) were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">The first poster presentation reported results from the global Phase 3 ASP-1929-301 study (<\/span><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03769506\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">NCT03769506<\/span><\/a><span style=\"font-weight: 400\">), a randomized, open-label, controlled trial evaluating ASP-1929 PIT as a monotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma (HNSCC) who had failed or progressed on or after at least two prior lines of therapy and were not eligible for surgery or radiation.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">A second poster presentation updated outcomes from an investigator-initiated nationwide, multicenter, real<\/span><span style=\"font-weight: 400\">\u2011<\/span><span style=\"font-weight: 400\">world study (<\/span><a href=\"https:\/\/center6.umin.ac.jp\/cgi-open-bin\/ctr\/ctr.cgi?function=brows&amp;action=brows&amp;recptno=R000068865&amp;type=summary&amp;language=J\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">UMIN000060367<\/span><\/a><span style=\"font-weight: 400\">) of ASP<\/span><span style=\"font-weight: 400\">\u2011<\/span><span style=\"font-weight: 400\">1929 PIT in recurrent nasopharyngeal cancer (NPC) in Japan.<\/span><\/p>\n<p><span style=\"font-weight: 400\">\u201cHead and neck cancer is the seventh most common cancer worldwide, with nearly one million new cases and about half a million deaths each year. Despite treatment, 20% to 30% of patients experience recurrence,\u201d said Anastasios Maniakas, M.D., Ph.D., assistant professor of Head and Neck Surgery at The University of Texas MD Anderson Cancer Center. \u201cIn our study, ASP-1929 photoimmunotherapy saw encouraging tumor response, durable local control, and a manageable safety profile. These findings support continued clinical evaluation.\u201d\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Rakuten Medical is currently conducting the global Phase 3 ASP-1929-381 study (<\/span><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06699212\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">NCT06699212<\/span><\/a><span style=\"font-weight: 400\">) evaluating ASP-1929 PIT in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC in the United States, Taiwan, Japan and Ukraine.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Details of the two poster presentations are as follows:<\/span><\/p>\n<p><span style=\"text-decoration: underline\"><b>Poster Presentation for Global Phase 3 ASP-1929-301 Study:<\/b><\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Title:<\/b> <a href=\"https:\/\/www.asco.org\/abstracts-presentations\/261461\" target=\"_blank\" rel=\"noopener\"><b>A phase 3, randomized, double-arm, open-label, controlled study of ASP-1929 photoimmunotherapy (PIT) versus physician\u2019s choice standard of care (SOC) for patients with locoregional, recurrent head and neck squamous cell carcinoma (HNSCC)<\/b><\/a><\/li>\n<li style=\"font-weight: 400\"><b>Poster:<\/b> <a href=\"https:\/\/rakuten-med.com\/us\/events\/asco26\/poster.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">View\/Download Poster [PDF]<\/span><\/a><\/li>\n<li style=\"font-weight: 400\"><b>Poster Presentation Recording:<\/b> <a href=\"https:\/\/youtu.be\/RC4M-6voGBE\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Watch the Video<\/span><\/a><span style=\"font-weight: 400\">\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Key Findings (Data cutoff: April 30, 2025):<\/b><span style=\"font-weight: 400\">\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">135 patients were randomized (ASP-1929 PIT: 89; SOC: 46), with approximately two-thirds having received <\/span><span style=\"font-weight: 400\">\u2265<\/span><span style=\"font-weight: 400\">3 prior lines of therapy<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Interpretation is limited by smaller sample size and higher dropout in the SOC arm (28.3% vs. 5.6% in the ASP-1929 PIT arm)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Efficacy (PIT vs. SOC):<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Progression-free survival (PFS), a primary endpoint, was similar between treatment arms (Median 3.2 vs. 3.1 months; Hazard Ratio (HR) 0.98)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Overall Survival (OS), another primary endpoint, showed a longer numerical trend with ASP-1929 PIT (Median 15.7 vs. 9.6 months; HR 0.83)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Objective Response Rate (ORR) and Disease Control Rate (DCR), key secondary endpoints, were numerically higher with ASP-1929 PIT (25.8% vs. 15.2% and 68.5% vs. 43.5%, respectively)<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Safety (PIT vs. SOC):<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Grade <\/span><span style=\"font-weight: 400\">\u2265<\/span><span style=\"font-weight: 400\">3 treatment-emergent adverse events (TEAEs) were more frequent with ASP-1929 PIT (58.3% vs. 36.4%); however, fewer TEAEs led to dose modification, delay, interruption (15.5% vs. 30.3%) or discontinuation (4.8% vs. 9.1%)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Adverse events in the ASP-1929 PIT arm were primarily driven by localized and inflammatory reactions, most of which were low grade and clinically manageable<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Quality of Life (QoL):<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">No overall negative impact on QoL was observed in the ASP-1929 PIT arm compared with SOC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">ECOG performance status improved in 19.1% of patients in the ASP-1929 PIT arm vs. 0% in the SOC arm<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline\"><b>Poster Presentation for Real\u2011World Japanese Multicenter Data for Recurrent NPC:<\/b><\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Title:<\/b> <a href=\"https:\/\/www.asco.org\/abstracts-presentations\/263351\" target=\"_blank\" rel=\"noopener\"><b>Real-world efficacy and safety of photoimmunotherapy for recurrent nasopharyngeal carcinoma: A nationwide multicenter study in Japan<\/b><\/a><\/li>\n<li style=\"font-weight: 400\"><b>Poster: <\/b><a href=\"https:\/\/rakuten-med.com\/us\/wp-content\/uploads\/sites\/6\/2026\/05\/Tanaka-et-al_ASCO-2026-poster_NPC.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">View\/Download Poster [PDF]<\/span><\/a><\/li>\n<li style=\"font-weight: 400\"><b>Key Findings:<\/b><span style=\"font-weight: 400\">\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Efficacy:<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Among 43 evaluable patients, 31 (72.1%) achieved a local CR lasting <\/span><span style=\"font-weight: 400\">\u2265<\/span><span style=\"font-weight: 400\">2 months<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Including 6 (14.0%) PR, the overall local response rate was 86.0% (37\/43)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">More than half of the patients (22\/43, 51.2%) remained alive with no evidence of disease at the time of last follow-up<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The 2-year OS was 89.2%<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Safety:<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Grade <\/span><span style=\"font-weight: 400\">\u2265<\/span><span style=\"font-weight: 400\">3 TEAEs were observed in 10 patients (23%), while Grade <\/span><span style=\"font-weight: 400\">\u2265<\/span><span style=\"font-weight: 400\">3 treatment-related adverse events (TRAEs) were observed in 7 patients (16%)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Osteomyelitis and mucositis were the most common Grade <\/span><span style=\"font-weight: 400\">\u2265<\/span><span style=\"font-weight: 400\">3 adverse events, highlighting the importance of careful local infection control<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Two fatal carotid hemorrhages occurred, possibly in association with underlying osteomyelitis<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7959-1\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7959-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7959-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"1\" ><div class=\"panel-widget-style panel-widget-style-for-7959-1-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><b>About Alluminox\u00ae platform<br \/>\n<\/b><span style=\"font-weight: 400\">The Alluminox platform is Rakuten Medical\u2019s investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye\u00ae 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical\u2019s pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and\/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical\u2019s Alluminox platform-based photoimmunotherapy is investigational.<\/span><\/p>\n<p><b>About ASP-1929<br \/>\n<\/b><span style=\"font-weight: 400\">Rakuten Medical\u2019s first pipeline drug developed on its Alluminox\u00ae platform is ASP-1929, an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR) antibody cetuximab and IRDye\u00ae 700DX, a light activatable dye. ASP-1929 binds to EGFR, a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority.<\/span><\/p>\n<p><b>About Rakuten Medical, Inc.<br \/>\n<\/b><span style=\"font-weight: 400\">Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox\u00ae platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical\u2019s photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries\/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit <\/span><a href=\"http:\/\/www.rakuten-med.com\"><span style=\"font-weight: 400\">www.rakuten-med.com<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/p>\n<p><b>Media &amp; Investor Contact:<br \/>\n<\/b><span style=\"font-weight: 400\">Ai Yoshikawa<br \/>\n<\/span><span style=\"font-weight: 400\">Associate Director, Global Corporate Communications &amp; Investor Relations<br \/>\n<\/span><span style=\"font-weight: 400\">Tel: +81-(0)70-4196-0845<br \/>\n<\/span><span style=\"font-weight: 400\">Email: <\/span><a href=\"mailto:ai.yoshikawa@rakuten-med.com\"><span style=\"font-weight: 400\">ai.yoshikawa@rakuten-med.com<\/span><\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div id=\"pg-7959-2\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-7959-2-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7959-2-0-0\" class=\"so-panel widget widget_sow-button panel-first-child panel-last-child\" data-index=\"2\" ><div style=\"padding: 30px 0px 0px 0px;\" class=\"panel-widget-style panel-widget-style-for-7959-2-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-button so-widget-sow-button-flat-6fd36f18507f-7959\"\n\t\t\t\n\t\t><div class=\"ow-button-base ow-button-align-center\"\n>\n\t\t\t<a\n\t\t\t\t\thref=\"https:\/\/rakuten-med.com\/us\/contact\/\"\n\t\t\t\t\tclass=\"rakuten-btn sowb-button ow-icon-placement-left ow-button-hover\" \t>\n\t\t<span>\n\t\t\t\n\t\t\tContact Us\t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>ASP-1929-301, the first Phase 3 randomized controlled trial of ASP-1929, showed median OS of 15.7 months and ORR of 25.8%, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_acf_changed":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":""},"class_list":{"0":"post-7959","1":"press_releases","2":"type-press_releases","3":"status-publish","5":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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