China-based biopharmaceutical company Innovent Biologics, Inc. (HKG: 1801) presented updated data from the Phase I study of its IBI343, an innovative anti-CLDN18.2 antibody drug conjugate (ADC), for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024.
Updated Data Highlights Efficacy and Safety
As of September 6, 2024, a total of 43 patients with CLDN18.2-positive advanced PDAC received IBI343 6 mg/kg Q3W monotherapy. All patients were efficacy evaluable, with an overall objective response rate (ORR) of 32.6%, a confirmed objective response rate (cORR) of 23.3%, and a confirmed disease control rate (cDCR) of 81.4%. These results indicate the potential efficacy of IBI343 in treating patients with CLDN18.2-positive advanced PDAC.
IBI343’s Mechanism of Action and Regulatory Designations
IBI343 is a recombinant human anti-CLDN18.2 monoclonal ADC that binds to CLDN18.2-expressing tumor cells, leading to ADC internalization and drug release, which results in DNA damage and eventually apoptosis of the tumor cells. This year, the drug received a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for use as a monotherapy in patients with CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have experienced disease progression following two prior lines of systemic treatment. Subsequently, IBI343 earned Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic PDAC that has relapsed and/or is refractory to one prior line of therapy.-Fineline Info & Tech
