Innovent Biologics Secures Breakthrough Therapy Designation for IBI343

Innovent Biologics, Inc. (Innovent), a premier biopharmaceutical firm that develops, produces, and markets high-quality medications for treating oncology, cardiovascular and metabolic disorders, autoimmune diseases, ophthalmology, and other significant conditions, announced that the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) for IBI343, a potentially leading TOPO1i anti-CLDN18.2 ADC, as a standalone treatment for patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are CLDN18.2-positive and have experienced progression after receiving at least one prior systemic therapy.

The BTD for IBI343 was awarded based on findings from an ongoing phase 1 clinical trial taking place in China, Australia, and the US (NCT05458219), which showed positive safety and tolerability, along with encouraging antitumor effects of IBI343 monotherapy in patients with advanced PDAC. Information from the study’s dose-expansion group was shared verbally at the 2024 ESMO Asia Congress:

A group of 43 patients with advanced PDAC that is CLDN18.2-positive (=60% tumor cells showing membranous staining intensity =1+ via IHC) were treated with IBI343 6 mg/kg as a monotherapy every three weeks. Every participant had received at least one previous treatment line, and 5% had undergone two or more lines of cancer therapy.

The established total objective response rate (ORR) was 23.3%, and progression-free survival (PFS) events were noted in 26 patients, with a median progression-free survival (mPFS) of 5.3 months (4.1-7.4) at the data cutoff date.