Innovent Announces Breakthrough Therapy Designation for IBI343 in Advanced Pancreatic Cancer
Innovent Biologics has announced that the Centre for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) for IBI343. This is a potentially best-in-class TOPO1i anti-CLDN18.2 antibody-drug conjugate (ADC) for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have already received at least one line of prior systemic therapy.
The BTD for IBI343 was awarded following positive data from an ongoing Phase 1 clinical trial across China, Australia, and the U.S. (NCT05458219).
The study showed favourable safety and tolerability, along with promising anti-tumour activity for IBI343 in advanced PDAC patients. The results from the trial's dose-expansion cohort were presented at the 2024 ESMO Asia Congress, revealing the following:
A total of 43 patients with CLDN18.2-positive advanced PDAC (with at least 60% tumour cells expressing membranous staining intensity ≥1+ by immunohistochemistry) received IBI343 at a dose of 6 mg/kg every 3 weeks.
All participants had previously undergone at least one line of therapy, and 60.5% had received two or more lines of treatment. The confirmed overall objective response rate (ORR) was 23.3%, with 26 patients experiencing progression-free survival (PFS). The median PFS was recorded at 5.3 months (range: 4.1–7.4).
In May 2024, IBI343 received its first BTD from the CDE for the treatment of CLDN18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who had progressed after at least two lines of prior treatments.
Additionally, in June 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to IBI343 for the treatment of advanced, unresectable, or metastatic PDAC that has relapsed and/or is refractory to one prior line of therapy. The first patient in the U.S. Phase 1 trial of IBI343 was successfully dosed in December 2024.
CLDN18.2 is a biomarker present in 50% to 70% of pancreatic cancer cases, making it a valuable target for therapeutic development. IBI343 is an antibody-drug conjugate composed of an anti-CLDN18.2 antibody linked to the cytotoxic drug exatecan.
Innovent plans to conduct pivotal studies to confirm the efficacy and safety of IBI343, both as a monotherapy and in combination therapies for pancreatic cancer and other solid tumours, including gastric cancer.
