Interim analysis of REZILIENT3 shows a progression-free survival (PFS) extension for the Zepzelcab and chemotherapy combination. Current outlook remains unchanged for the consolidated results for the fiscal year ending December 2026, with ongoing assessments and discussions toward FDA authorization.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4578","jir_company_name":"Otsuka Holdings Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-08-13","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/08\/4578-20260813-01.pdf","jir_short_summary":"Interim analysis of REZILIENT3 shows a progression-free survival (PFS) extension for the Zepzelcab and chemotherapy combination. Current outlook remains unchanged for the consolidated results for the fiscal year ending December 2026, with ongoing assessments and discussions toward FDA authorization.","jir_summary":"### Section Heading\nThis release reports interim results from global Phase III REZILIENT3 trial conducted by our 100% subsidiary Taisho Pharmaceutical Co., Ltd., Taisho Oncology, and partner Cullinan Therapeutics. The study targets adult patients with untreated locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations. The primary endpoint, progression-free survival (PFS), showed statistical and clinical significance in the combination arm, with manageable safety. IMS has recommended breaking the blind, and we will continue discussions toward FDA approval. There is no change to the consolidated earnings forecast for the fiscal year ending December 2026.\n\n### Section 2 Heading\nZepzelcab is a low-molecular EGFR inhibitor targeting ex20ins mutations, with potential to expand its use as a first-line therapy. From an IR perspective, this represents a key milestone for mid- to long-term value creation, and we are awaiting discussions with the FDA to pursue approval. The company plans to utilize the REZILIENT3 results for future conference presentations and regulatory submissions.","jir_financial_highlights":"Consolidated earnings forecast: Unknown (Unknown)","jir_category":"","jir_hashtags":"#Otsuka Holdings, #Zepzelcab, #EGFRex20insnotimmunotherapy, #ClinicalTrialREZILIENT3","jir_key_figures":"REZILIENT3 trial participants: 285 cases (untreated locally advanced or metastatic NSCLC, EGFR ex20ins mutation)\nSignificant improvement in PFS: achieved in interim analysis\nApproval expected: waiting on discussions with the FDA (no change to forecast at present)","jir_meta_title":"Otsuka Holdings: Zepzelcab REZILIENT3 Interim Analysis Released; Full-Year Outlook Unchanged for December 2026","jir_meta_description":"Taisho Pharmaceuticals and Taisho Oncology, along with Cullinan Therapeutics, report interim analysis of the REZILIENT3 Phase III trial in EGFR ex20ins NSCLC showing PFS extension; discussions with the FDA continue. No change to the full-year 2026 forecast.","jir_og_title":"PFS Improvement in REZILIENT3 Interim Analysis; Advancing Toward FDA Approval | Otsuka Holdings","jir_og_description":"Combination of Zepzelcab and chemotherapy improves NSCLC PFS. Discussions with the FDA continue toward approval. Full-year 2026 earnings forecast unchanged.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6875,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"financial_summary","footnotes":""},"sector":[],"importance":[],"class_list":["post-103008","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n