TerSera recalls Zoladex lot over cold-chain lapse; AstraZeneca's EMERALD-2 HCC trial completes

This week's AstraZeneca-linked updates include a new drug recall notice, a completed Phase III liver cancer trial, and a newly posted observational gastric cancer study, while four previously noted COPD and AZD7760 records hold steady.

• TerSera Therapeutics initiated a Class II recall of Zoladex (goserelin) 3.6 mg implant, manufactured by AstraZeneca UK Limited, after a product sat in a non-temperature-controlled FedEx trailer at outdoor ambient conditions for 25.5 hours.¹ The recall covers 296 cartons distributed nationwide in the USA, from lot YN0099 with an expiration date of 01/31/2028.¹
• EMERALD-2 (NCT03847428), a Phase III trial of durvalumab (Imfinzi) alone or combined with bevacizumab (Avastin) as adjuvant therapy in hepatocellular carcinoma patients at high risk of recurrence after curative resection or ablation, is now listed as completed. The primary endpoint compared recurrence-free survival for durvalumab plus bevacizumab versus placebo, defined as time from randomization to first radiologic recurrence or death, assessed by blinded independent central review per RECIST 1.1 criteria.² The trial enrolled 908 participants across 217 sites in 24 countries.²
• GRACE (NCT07800754), titled "Epidemiological Characteristics And Management Strategies Of Gastric/Gastrophaegal Junction Cancer Patients In Routine Clinical Practice: A Greek Multicenter Observational Study," is recruiting patients with stage II-IVB gastric or gastroesophageal junction adenocarcinoma. The retrospective-prospective, multicenter, single-country study aims to describe epidemiological characteristics and management strategies in routine clinical practice in Greece.³ It plans to enroll 300 participants from 10-15 oncology clinics, including patients diagnosed between June 1, 2025 and the end of the recruitment period in Q3 2027.³
• BRIDGE-COPD (NCT06646419), a cluster randomized study testing a post-exacerbation transition bundle across hospitals in China, remains listed as completed. The study randomized 36 county level hospitals to intervention or control at a 2:1 ratio, enrolling 1368 subjects at 38 per hospital.⁴
• PRIORITY-COPD (NCT07221981), an observational study of COPD patients with frequent exacerbations in Russia, remains completed. The study design pairs a 52-week retrospective look-back with a 24-week forward-looking phase, covering 2000 patients at roughly 35 sites.⁵
• AZD7760, a monoclonal antibody combination of suvratoxumab (MEDI4893) and AZD7745, remains active not recruiting in a Phase I study in healthy Japanese adults (NCT07612813). The randomized, double-blind, placebo-controlled dose escalation study is evaluating safety and pharmacokinetics, testing two dosages each given as a single IV dose.⁶
• PEAK (NCT06749457), a related Phase I/IIa study of AZD7760, remains active not recruiting. It is evaluating safety and pharmacokinetics in healthy participants in Phase I and in participants with end-stage kidney disease receiving hemodialysis through a central venous catheter in Phase IIa,⁷ with enrollment of 244 participants.⁷