AstraZeneca posts Phase 3 LOGOS, KALOS asthma results; updates Soliris label
New Phase 3 results for PT010 in asthma and a Soliris label update headline a week that also includes a new CAR-T myeloma trial and a prostate cancer registry study.
AstraZeneca's week centered on two Phase 3 asthma readouts and an FDA label action for Soliris, alongside a newly recruiting CAR-T trial and a not-yet-recruiting prostate cancer registry study.
- The FDA approved a labeling supplement for Soliris (eculizumab), with the submission status dated 2026-06-30 and the approval covering a new label and medication guide.1
- The Phase 3 "LOGOS" trial (NCT04609904) of budesonide, glycopyrronium, and formoterol fumarate (BGF, PT010) in adults and adolescents with inadequately controlled asthma is now completed, with results first posted on 2026-07-02. The study enrolled 2187 participants2 and measured change from baseline in FEV1 AUC0-3 at Week 24 as the primary outcome.2
- The companion Phase 3 "KALOS" trial (NCT04609878), testing the same PT010 combination against PT009 and Symbicort, also completed, with results first posted on 2026-06-30. The study enrolled 2274 participants3 and, like LOGOS, assessed a pooled rate of severe asthma exacerbations across the two replicate studies.3
- A new Phase 1/2 study of AZD4045, an allogeneic Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA),4 is now recruiting patients with relapsed or refractory multiple myeloma (NCT07681596). The purpose is to assess safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of AZD4045 as a monotherapy and in association with daratumumab and aldesleukin.4 Enrollment is estimated at 101 participants,4 with primary completion expected 2031-03-06.
- The observational "PROLONG" study of olaparib plus abiraterone in NHA pre-exposed metastatic castration-resistant prostate cancer patients in the GCC region (NCT07674121) is not yet recruiting. The primary outcome evaluates time to treatment discontinuation or death at 6 and 12 months in first-line NHA pre-exposed mCRPC patients treated with olaparib plus abiraterone.5 Estimated enrollment is 75 participants.5
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