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The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to Innovent Biologics' IBI343as a monotherapy treatment for CLDN18.2-positive pancreatic ductal adenocarcinoma (PDAC).
The designation includes subjects who have experienced progression after a minimum of one previous systemic treatment.
It is supported by the data from an ongoing Phase I trial carried out across the US, Australia and China. The therapy was shown to be safe and tolerable as a single agent, with significant antitumour activity in advanced PDAC subjects.
43 subjects with this condition were treated with the therapy. The treatment resulted in a confirmed overall objective response rate (ORR) of 23.3%. Median progression-free survival was recorded at 5.3 months.
Innovent Biologics senior vice-president Dr Hui Zhou stated: “As the world's first CLDN18.2 ADC to receive BTD in this difficult-to-treat cancer, IBI343 monotherapy has shown encouraging efficacy and tolerable safety in late-line treatment of patients with advanced pancreatic cancer.
“Subject to PoC data readout, we plan to initiate pivotal MRCT studies to further confirm its efficacy and safety in this indication. Additionally, we will also explore the potential of IBI343 in combination therapy for pancreatic cancer and other solid tumours, including gastric cancer.”
Pancreatic cancer, known for its low five-year survival rate of around 10%, is a particularly aggressive form of the disease.
In May 2024, the therapy was granted its first BTD by CDE for treating individuals with CLDN18.2-positive advanced junction gastric/gastro-oesophageal adenocarcinoma (GC).
In June, the US Food and Drug Administration granted the therapy fast track status for advanced PDAC treatment.
"CDE grants BTD to Innovent’s IBI343 for pancreatic cancer" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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