Innovent Biologics, Inc. presented Phase 1 clinical data of IBI343 (TOPOi anti-CLDN18.2 ADC) for the treatment of advanced pancreatic ductal adenocarcinoma or biliary tract cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (NCT05458219). In addition, clinical data of the treatment for advanced gastric or gastroesophageal tumors from this Phase 1 trial will be published in oral presentation at the ESMO Gastrointestinal Cancers Congress 2024 this month. Safety and efficacy of IBI343 (anti-CLDN18.2 ADC) in patients with advanced pancreatic ductal adenocarcinoma or biliary tract cancer: preliminary results from a Phase I study: Abstract#:3037: This Phase I study is conducted in China and Australia, aiming to evaluate the safety, tolerability and preliminary efficacy of IBI343 in subjects with advanced solid tumors.

Data on patients with advanced pancreatic ductal adenocarcinoma or biliary tract cancer were presented at this congress. As of December 19, 2023, a total of 35 patients with advanced pancreatic ductal adenocarcinoma (PDAC) or biliary tract cancer (BTC) were enrolled, and all subjects had received at least one prior systemic treatment, with a median of 2 lines of treatment. The results showed that: As of January 15, 2024, 25 subjects had performed at least one post-baseline tumor evaluation.

7 subjects achieved partial response (PR), 5 of which were PDAC patients, 2 were BTC patients. The objective response rate (ORR) was 28.0% (95% CI: 12.1-49.4), and the disease control rate (DCR) was 80.0% (95% CI: 59.3-93.2). In the 6 mg/kg dose group, 13 subjects with CLDN18.2 1/2/3+=60% had at least one post-baseline tumor assessment, of which 5 achieved PR with an ORR of 38.5% (95%CI: 13.9-68.4) and a DCR of 84.6% (95% CI:54.6-98.1).

Among the 10 subjects with advanced PDAC in this subgroup, the ORR was 40% (95% CI: 12.2-73.8). DoR and PFS data are not mature yet. In terms of safety, 80.0% of subjects experienced treatment-related adverse events (TRAEs).

Common TRAEs were anemia (42.9%), neutrophil count decreased (28.6%), nausea (25.7%), vomiting (25.7%) and white blood cell count decreased (22.9%). 25.7% of participants developed = grade 3 TRAEs. No TRAE led to death.