AstraZeneca is building out a portfolio of targeted cancer drugs, and the first pivotal readout from its wholly owned antibody-drug conjugates is a win: sonesitatug vedotin (Sone-Ve) reduced the risk of death by 42% in previously treated advanced gastric cancer in a phase 3 trial.
The drug is one part of a broader AstraZeneca push in gastrointestinal cancers. Sone-Ve, licensed from KYM Biosciences in 2023, is also in a phase 3 trial as a first-line gastric cancer treatment and in phase 2 trials in Claudin 18.2-positive pancreatic and biliary tract cancers, and the company recently announced a clinical collaboration with Summit Therapeutics to test it with ivonescimab, according to an Oct. 25 news release. AstraZeneca is also developing a Claudin 18.2 T-cell engager licensed from Harbour Biomed, a pan-KRAS inhibitor program licensed from Jacobio and an armored CAR T for liver cancer, and Enhertu, which it develops with Daiichi Sankyo, is already approved for HER2-positive advanced gastric cancer.
In the CLARITY-Gastric01 trial, median overall survival was 10.6 months with Sone-Ve compared with 6.4 months with investigator’s choice of therapy (hazard ratio 0.58). In the third-line and later setting, where overall survival was a primary endpoint, the risk of death fell 53%, with median survival of 10.0 months compared with 5.0 months. At 12 months, 42.6% of patients on Sone-Ve were alive, compared with 27.8% on the comparator.
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