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AstraZeneca and Amgen TEZSPIRE Phase III Trial Results Positive
Positive high-level results from the Phase III CROSSING trial in patients with eosinophilic esophagitis showed that AstraZeneca (AZN) and Amgen's (AMGN) TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia compared to placebo. The safety profile of TEZSPIRE in the trial was generally consistent with its approved indications.
Amgen and AstraZeneca Announce Phase 3 CROSSING Trial Results for Tezspire
Amgen (AMGN) and AstraZeneca (AZN) announced top-line results from the Phase 3 CROSSING trial of Tezspire in patients living with eosinophilic esophagitis. Tezspire demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia. The safety profile of Tezspire was generally consistent with its approved indications. CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of Tezspire at one of two doses administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy. In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue. The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire and measured as a mean change from baseline in DSQ score. Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. Hypersensitivity reactions were observed in the clinical trials following the administration of Tezspire. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset. In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with Tezspire. The most common adverse reactions are asthma: pharyngitis, arthralgia, and back pain. Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia.
First Patient Dosed in TROPION-Urothelial04 Trial Evaluating Datroway
The first patient has been dosed in the TROPION-Urothelial04 phase 3 trial evaluating Datroway plus rilvegostomig or Datroway monotherapy versus current standard of care as an adjuvant treatment in patients with muscle invasive urothelial cancer at high risk of recurrence following radical surgical resection with or without prior neoadjuvant therapy. Daiichi Sankyo and AstraZeneca also are evaluating Datroway plus platinum-based chemotherapy compared to gemcitabine and platinum-based chemotherapy in patients with metastatic urothelial carcinoma following progression during or after treatment with enfortumab vedotin in combination with pembrolizumab in the TROPION-Urothelial03 phase 2/3 trial.
本页仅供研究参考，不构成投资建议。模型可能出错。过往表现不代表未来结果。