{"id":113305,"date":"2026-09-14T08:16:28","date_gmt":"2026-09-13T23:16:28","guid":{"rendered":"https:\/\/japanir.jp\/en\/ir\/4578-20260914-01_wp_financial_summary\/"},"modified":"2026-09-14T08:16:28","modified_gmt":"2026-09-13T23:16:28","slug":"4578-20260914-01_wp_financial_summary","status":"publish","type":"ir_release","link":"https:\/\/japanir.jp\/en\/company\/company-4578\/ir\/4578-20260914-01_wp_financial_summary\/","title":{"rendered":"Zepaleritinib combined with chemotherapy extends progression-free survival as first-line therapy for EGFR Exon 20 insertion-mutant non-small cell lung cancer in the REZILIENT3 Phase III trial, by a median of 6 months"},"content":{"rendered":"<p>Interim analysis of the REZILIENT3 trial shows that the combination of zepaleritinib and chemotherapy significantly improves progression-free survival (median PFS extended by 6.0 months) in first-line EGFR Ex21ins NSCLC (HR 0.50, P=0.00015). Overall survival interim analysis is immature; safety aligns with known profile. Presentation at WCLC 2026.<\/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":"2026-09-14","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/09\/4578-20260914-01.pdf","jir_short_summary":"Interim analysis of the REZILIENT3 trial shows that the combination of zepaleritinib and chemotherapy significantly improves progression-free survival (median PFS extended by 6.0 months) in first-line EGFR Ex21ins NSCLC (HR 0.50, P=0.00015). Overall survival interim analysis is immature; safety aligns with known profile. Presentation at WCLC 2026.","jir_summary":"### Section Heading\nThis trial enrolled 285 treatment-na\u00efve patients with locoregional advanced or metastatic NSCLC, comparing the combination of zepaleritinib and chemotherapy to chemotherapy alone. Interim analysis showed substantial PFS improvement and high ORR. Safety profile is consistent with known data. Further regulatory discussions will continue to enable rapid patient access.\n\n### Section 2 Heading\nPlanned presentation at WCLC 2026 Presidential Symposium 2. OS maturity is still low and follow-up continues. Acknowledgment of contributions from physicians, patients, and caregivers. Zepaleritinib is positioned as a key growth driver for the company, with exploration of its potential in other treatment lines.","jir_financial_highlights":"Median progression-free survival (PFS): 14.5 months (Combination group 14.5 vs chemotherapy alone 8.5 (hazard ratio 0.50, P=0.00015))\nObjective response rate (ORR): Combination 65.0%, vs 40.3% in control (P<0.0001)\nMedian duration of response: 14.2 months (Compared with control 9.9 months)\nOverall survival (OS) interim hazard ratio: 0.72 (95% confidence interval 0.42\u20131.23, maturity 30%)","jir_category":"","jir_hashtags":"#OtsukaHoldings, #cancertherapy, #InvestigationalDrugExon20insNSCLC, #REZILIENT3","jir_key_figures":"Median progression-free survival: 14.5 months (combination) vs 8.5 months (chemotherapy alone)\nPFS hazard ratio: 0.50 (95% CI 0.34\u20130.73)\nObjective response rate: combination 65.0% vs 40.3%\nMedian duration of response: 14.2 months (combination) vs 9.9 months\nOS hazard ratio: 0.72 (95% CI 0.42\u20131.23, maturity 30%)","jir_meta_title":"Otsuka Holdings: REZILIENT3 Interim Analysis \u2014 Zepaleritinib Plus Chemotherapy Significantly Extends PFS in EGFR Ex20ins NSCLC","jir_meta_description":"Interim analysis of REZILIENT3 centered on Otsuka Holdings\u2019 subsidiary indicates that zepaleritinib plus chemotherapy significantly prolongs PFS as first-line treatment for EGFR Ex20ins NSCLC. OS maturity is 30%, safety aligns with known profile; results to be presented at WCLC 2026.","jir_og_title":"REZILIENT3 Interim Analysis: Zepaleritinib Combination Significantly Extends NSCLC PFS","jir_og_description":"Interim analysis of REZILIENT3 shows that the combination of zepaleritinib and chemotherapy significantly improves PFS as first-line therapy for EGFR Ex20ins NSCLC. OS is under follow-up, safety as before. Presentation planned at WCLC 2026.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[{\"jir_chart_id\": \"revenue_trend\", \"jir_chart_type\": \"line\", \"jir_chart_title\": \"Median PFS Trend (Combination vs Monotherapy)\", \"jir_chart_json_data\": \"{\\\"type\\\":\\\"line\\\",\\\"data\\\":{\\\"labels\\\":[\\\"Pre Interim\\\",\\\"Post Interim\\\"],\\\"datasets\\\":[{\\\"label\\\":\\\"Combination PFS Median\\\",\\\"data\\\":[null,14.5]},{\\\"label\\\":\\\"Chemotherapy Alone PFS Median\\\",\\\"data\\\":[null,8.5]}]},\\\"options\\\":{}}\"}]","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-113305","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Zepaleritinib combined with chemotherapy extends progression-free survival as first-line therapy for EGFR Exon 20 insertion-mutant non-small cell lung cancer in the REZILIENT3 Phase III trial, by a median of 6 months - Japan IR<\/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:\/\/japanir.jp\/en\/company\/company-4578\/ir\/4578-20260914-01_wp_financial_summary\/\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-4578\/ir\/4578-20260914-01_wp_financial_summary\/\",\"url\":\"https:\/\/japanir.jp\/en\/company\/company-4578\/ir\/4578-20260914-01_wp_financial_summary\/\",\"name\":\"Zepaleritinib combined with chemotherapy extends progression-free survival as first-line therapy for EGFR Exon 20 insertion-mutant non-small cell lung cancer in the REZILIENT3 Phase III trial, by a median of 6 months - Japan IR\",\"isPartOf\":{\"@id\":\"https:\/\/japanir.jp\/en\/#website\"},\"datePublished\":\"2026-09-13T23:16:28+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-4578\/ir\/4578-20260914-01_wp_financial_summary\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/japanir.jp\/en\/company\/company-4578\/ir\/4578-20260914-01_wp_financial_summary\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-4578\/ir\/4578-20260914-01_wp_financial_summary\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/japanir.jp\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Zepaleritinib combined with chemotherapy extends progression-free survival as first-line therapy for EGFR Exon 20 insertion-mutant non-small cell lung cancer in the REZILIENT3 Phase III trial, by a median of 6 months\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/japanir.jp\/en\/#website\",\"url\":\"https:\/\/japanir.jp\/en\/\",\"name\":\"Japan IR\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/japanir.jp\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Zepaleritinib combined with chemotherapy extends progression-free survival as first-line therapy for EGFR Exon 20 insertion-mutant non-small cell lung cancer in the REZILIENT3 Phase III trial, by a median of 6 months - 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