AstraZeneca is readying its own cancer-targeting drug for regulatory approval after trial win

AstraZeneca $AZN reported Phase III results on Sunday showing that its cancer drug sonesitatug vedotin cut the likelihood of death by 42% among previously treated patients with advanced gastric cancer. The company is preparing to file the drug for regulatory approval, according to The Wall Street Journal.

The drug, known as Sone-Ve, is an antibody-drug conjugate. In the CLARITY-Gastric01 trial, it was compared with investigator's choice of therapy in patients whose tumors expressed the Claudin 18.2 protein on at least 25% of cells. Median overall survival was 10.6 months with Sone-Ve and 6.4 months with the comparator. The data were unveiled during the European Society for Medical Oncology Congress in Madrid.

In patients treated in the third-line or later setting, where overall survival was a primary endpoint, Sone-Ve reduced the risk of death by 53%. Median overall survival in that group was 10.0 months versus 5.0 months.

The trial did not meet its other primary endpoint. Progression-free survival in the overall trial population, as assessed by blinded independent central review, showed a trend toward improvement but did not reach statistical significance. Median progression-free survival was 4.2 months with Sone-Ve and 3.8 months with the comparator.

Fewer patients on Sone-Ve had Grade 3 or higher treatment-related adverse events, at 36.4% versus 44.8% for the comparator. The company said no new safety signals were identified.

"Sone-Ve could replace traditional chemotherapy-based regimens as a new standard of care in this setting," Susan Galbraith, executive vice president of oncology haematology R&D at AstraZeneca, said in a statement.

Galbraith told journalists at the congress that the data are strong enough to take to regulators, according to The Wall Street Journal. The Journal said Sone-Ve is the first in a planned portfolio of wholly owned antibody-drug conjugates from AstraZeneca.

Sone-Ve is also being tested in the CLARITY-Gastric02 Phase III trial as a first-line treatment for advanced or metastatic gastric cancer, in combination with capecitabine, with or without rilvegostomig, the company said. AstraZeneca licensed the drug from China's KYM Biosciences in March 2023.

AstraZeneca has estimated peak annual revenue of $3 billion to $5 billion for Sone-Ve, the company said. Takeda Pharmaceutical presented data on a rival antibody-drug conjugate, arcotatug tavatecan, according to The Wall Street Journal.