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TAK 資訊
TAK 事件
Takeda Reports Positive Phase 3 Results for Arcotatug Tavatecan
Takeda announced positive results from the Phase 3 G-HOPE-001 study of arcotatug tavatecan in patients with Claudin18.2-positive, previously treated, advanced gastric or gastroesophageal junction adenocarcinoma. Results from two prespecified interim analyses, which were shared in a late-breaking oral presentation at the 2026 European Society for Medical Oncology Congress, showed the study met its dual primary endpoints of overall survival and progression-free survival. The G-HOPE-001 study met both prespecified primary endpoints of OS and PFS, with arcotatug tavatecan demonstrating statistically significant improvements compared with treatment of physician's choice. Data from G-HOPE-001 will support a planned regulatory filing for this indication in Japan. In China, Innovent's New Drug Application for arcotatug tavatecan has been accepted with Priority Review by the National Medical Products Administration.
Takeda Launches ORZEYFUL for Narcolepsy in Japan and China
Takeda "announced that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1. NT1 is a chronic, rare neurological disease driven by orexin deficiency. People experience a range of symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, sleep paralysis, hallucinations and cognitive symptoms. Many patients experience challenges that may affect their quality of life and limit their independence. People with narcolepsy have approximately twice the rate of healthcare resource utilization compared with controls, including more frequent emergency department visits, hospitalizations, outpatient appointments and physician consultations... ORZEYFUL is the first therapy designed to restore orexin signaling and address the biological cause of NT1. This mechanism represents a potential paradigm shift from symptom management to a disease-targeted treatment. Landmark Phase 3 studies in people with NT1 demonstrated ORZEYFUL improved the full range of NT1 symptoms and quality of life compared with placebo9. Results showed consistent, clinically meaningful and statistically significant improvements with ORZEYFUL compared to placebo in wakefulness, sleepiness, cataplexy, disease severity and quality of life measures (p-values of less than0.001) across doses over 12 weeks."
Takeda Announces TAK-881 Clinical Trial Results
Takeda announced detailed results from the Phase 2/3 IgGNITE clinical trial, TAK-881-3001, evaluating investigational TAK-881, which, if approved, has the potential to become the first facilitated SCIG 20% therapy for patients with Primary Immunodeficiency Disease, PID, administered up to once-monthly. Data in participants aged 16 years and older are featured in two late-breaking posters at the 22nd Biennial Meeting of the European Society for Immunodeficiencies in Maastricht, the Netherlands. Key highlights: TAK-881 met its primary endpoint, demonstrating pharmacokinetic comparability to HYQVIA in patients 16 years and older; TAK-881 may shorten infusion times and offer the opportunity for fewer required infusion sites compared to HYQVIA with 50% less volume while maintaining up to once-monthly dosing; Adult infection outcomes and safety and tolerability profiles were comparable to HYQVIA based on descriptive analyses and consistent with established IG therapy standards
Takeda Announces Zasocitinib Psoriasis Study Data
Takeda announced new data from three Phase 3 LATITUDE psoriasis studies of zasocitinib, an investigational, next-generation, highly selective and potent oral tyrosine kinase 2, or TYK2, inhibitor, in adults with moderate-to-severe plaque psoriasis.1 Presented during late-breaking and oral sessions at the European Academy of Dermatology & Venereology, or EADV, Congress 2026, these results demonstrate zasocitinib's superior efficacy compared to deucravacitinib and reinforce the potential for zasocitinib to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill. In the Phase 3 LATITUDE Atlas head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib across the primary and all key secondary efficacy endpoints with higher rates of complete skin clearance observed as early as week 8 and more than 2.5 times as many patients achieving complete skin clearance at week 16. 36.5% of patients treated with zasocitinib achieved complete skin clearance; 62.5% of patients treated with zasocitinib achieved PASI 90 at week 16 versus 34.0% in the deucravacitinib group; 43.2% of patients treated with zasocitinib achieved clear skin at week 16 versus 18.5% in the deucravacitinib group; Zasocitinib was generally well-tolerated with no new safety signals identified. The safety and tolerability profile of zasocitinib remained consistent with prior Phase 3 psoriasis studies.2-5 The most common adverse events across Phase 3 LATITUDE psoriasis trials were upper respiratory tract infection, nasopharyngitis and acne. New long-term data from the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies demonstrated durable skin clearance with zasocitinib through week 52.3 Among patients who achieved a response at week 24, up to 93% maintained their skin clearance results through week 52 in LATITUDE PsO 3001 and week 40 in LATITUDE PsO 3002. Additional data from the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies demonstrated that zasocitinib-treated patients reported improvements in itch and quality of life as early as week 2 with continued improvements through week 24.
Takeda Announces New Data on Zasocitinib Psoriasis Studies
Takeda announced new data from three Phase 3 LATITUDE psoriasis studies of zasocitinib, an investigational, next-generation, highly selective and potent oral tyrosine kinase 2, or TYK2, inhibitor, in adults with moderate-to-severe plaque psoriasis.1 Presented during late-breaking and oral sessions at the European Academy of Dermatology & Venereology, or EADV, Congress 2026, these results demonstrate zasocitinib's superior efficacy compared to deucravacitinib and reinforce the potential for zasocitinib to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill. In the Phase 3 LATITUDE Atlas head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib across the primary and all key secondary efficacy endpoints with higher rates of complete skin clearance observed as early as week 8 and more than 2.5 times as many patients achieving complete skin clearance at week 16. 36.5% of patients treated with zasocitinib achieved complete skin clearance; 62.5% of patients treated with zasocitinib achieved PASI 90 at week 16 versus 34.0% in the deucravacitinib group; 43.2% of patients treated with zasocitinib achieved clear skin at week 16 versus 18.5% in the deucravacitinib group; Zasocitinib was generally well-tolerated with no new safety signals identified. The safety and tolerability profile of zasocitinib remained consistent with prior Phase 3 psoriasis studies.2-5 The most common adverse events across Phase 3 LATITUDE psoriasis trials were upper respiratory tract infection, nasopharyngitis and acne. New long-term data from the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies demonstrated durable skin clearance with zasocitinib through week 52.3 Among patients who achieved a response at week 24, up to 93% maintained their skin clearance results through week 52 in LATITUDE PsO 3001 and week 40 in LATITUDE PsO 3002. Additional data from the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies demonstrated that zasocitinib-treated patients reported improvements in itch and quality of life as early as week 2 with continued improvements through week 24.
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