AstraZeneca reported mixed Phase 3 resultsfor two drug candidates, saying Ultomiris did not meet its primary endpoint in adults and adolescents with thrombotic microangiopathy after hematopoietic stem cell transplant, while sonesitatug vedotin, or Sone-Ve, showed a statistically significant overall survival benefit in advanced gastric and gastroesophageal junction cancers.
In the ALXN1210-TMA-313 trial, Ultomiris failed to achieve statistical significance for event-free survival through 26 weeks versus placebo in patients ages 12 and older with HSCT-TMA. The company said the study showed a trend toward benefit, and discussions with health authorities are continuing, including in the context of real-world evidence. AstraZeneca said the safety profile remained consistent with the known profile of Ultomiris and with that seen in patients undergoing HSCT.
By contrast, the CLARITY-Gastric01 Phase 3 trial of Sone-Ve met its dual primary endpoint of overall survival in third- and later-line treatment and its key secondary overall survival endpoint in the second- and later-line setting. The study showed a statistically significant and highly clinically meaningful improvement in overall survival versus investigator’s choice of therapy in CLDN18.2-positive advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma. The progression-free survival endpoint showed a trend favoring Sone-Ve but did not reach statistical significance.
AstraZeneca said the result may support expanding CLDN18.2 positivity to at least 25% expression, a threshold that could encompass about 60% of patients in this setting. The company described Sone-Ve as the first Phase 3 trial to show an overall survival benefit with an anti-CLDN18.2 antibody-drug conjugate in this disease.
The company said data from both programs will be presented at a future medical meeting and shared with regulators.
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