Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Wednesday that it has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for IBI343 as monotherapy for advanced pancreatic cancer.

A potentially best-in-class TOPO1i anti-CLDN18.2 ADC, IBI343 was granted BTD for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after at least one line of prior systematic treatment.

An ongoing Phase 1 study in China, Australia and the United States has demonstrated favourable safety and tolerability and promising antitumour activity of IBI343 monotherapy in advanced PDAC patients. Data from the study's dose-expansion cohort were presented at the 2024 ESMO Asia Congress.

The study enrolled a total of 43 patients with CLDN18.2-positive advanced PDAC. Participants received IBI343 6 mg/kg Q3W monotherapy. All had previously received at least one line of prior therapy, and 60.5% had received two or more lines of anticancer treatment. During the study, the confirmed overall objective response rate (ORR) was 23.3% and progression-free survival (PFS) events occurred in 26 patients, with a median progression-free survival (mPFS) of 5.3 months (4.1-7.4) as of the data cutoff date.