AstraZeneca week: Imfinzi label update, ASSURE CLL results posted, four trials registered
AstraZeneca's Imfinzi received a labeling supplement while results posted for a completed acalabrutinib trial, alongside four newly registered studies spanning breast, gastric, adrenal and sinus disease.
This week's roundup covers one label action, one completed trial with results posted, and four newly registered studies at various stages.
- IMFINZI (durvalumab) received a labeling supplement from the FDA. The submission is SUPPL 60 under BLA761069, for a 50 mg/mL injectable formulation, sponsored by AstraZeneca UK Ltd, with a submission status date of 2026-08-31.1
- Results were posted for the ASSURE trial of acalabrutinib in chronic lymphocytic leukemia, a completed Phase 3b study. The trial evaluated acalabrutinib 100 mg twice daily in approximately 540 participants with chronic lymphocytic leukemia to assess safety and efficacy.2 Actual enrollment reached 552 participants2, and primary completion occurred on 2025-11-042 (dates listed above).
- MONITOR (NCT07802626) is a Phase 3 trial, not yet recruiting, testing capivasertib added to standard endocrine therapy in HR-positive, HER2-negative metastatic breast cancer. Enrollment is estimated at 1084 participants.3 SWOG Cancer Research Network is the lead sponsor, with AstraZeneca and Guardant Health, Inc. among the collaborators.3
- EliXir (NCT07800858) is a single-arm, not-yet-recruiting study of baxdrostat in primary aldosteronism, sponsored by Queen Mary University of London with AstraZeneca as collaborator. Participants will receive baxdrostat 2 mg once daily for 24 weeks4, with an estimated enrollment of 30 participants4.
- GRACE (NCT07800754) is an AstraZeneca-sponsored observational study in Greece, not yet recruiting, describing epidemiological characteristics and management of patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice5, with an estimated enrollment of 300 participants.5
- POLARIS (NCT07795658) is an observational registry, not yet recruiting, of Chinese patients with severe chronic rhinosinusitis with nasal polyps, sponsored by Beijing Tongren Hospital with AstraZeneca as collaborator. The study plans to enroll approximately 1,000 adolescents and adults aged 12 years or older with bilateral CRSwNP at about 33 centers in China and follow them for 36 months.6
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.