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Lepu Biopharma, AstraZeneca Cancer Drug Meets Phase 3 Survival Goal

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Lepu Biopharma (HKG:2157) said antibody-drug conjugate CMG901 (AZD0901) met the primary overall survival endpoint in a global Phase 3 trial in patients with Claudin 18.2-positive advanced gastric and related cancers.

The drug, which is being developed and commercialized globally by AstraZeneca under a 2023 licensing agreement, also met a key secondary endpoint of overall survival in the broader second-line and later treatment population, according to a Tuesday Hong Kong bourse filing.

The progression-free survival endpoint showed improvement but did not reach statistical significance. The company said the drug's safety profile was consistent with previous studies, with no new safety signals identified.

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