Antengene Introduces Breakthrough ATG-022 for the treatment of Gastric Cancer
Antengene has introduced ATG-022, a first-in-class CLDN18.2-targeting antibody-drug conjugate (ADC), as an investigational therapy to receive Breakthrough Therapy designation from China’s National Medical Products Administration (NMPA) for the treatment of CLDN18.2-positive, HER2-negative unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma.
ATG-022 is a CLDN18.2-targeting antibody-drug conjugate (ADC) designed to deliver potent antitumour activity across a broad spectrum of gastric and gastroesophageal junction cancers. It aims to provide clinical benefit in patients with CLDN18.2-positive, HER2-negative, unresectable or metastatic disease who have progressed after multiple lines of therapy.
Among patients with moderate-to-high CLDN18.2 expression (IHC 2+ ≥20%), the therapy achieved an objective response rate (ORR) of ~42.9% and a disease control rate (DCR) of ~95.2%. For patients with low expression (IHC 2+ <20%), ORR was ~30.0% and DCR ~50.0%. Complete responses (CRs) have been recorded, including in an elderly patient with extensive metastases after multiple lines of therapy. Notably, no cases of interstitial lung disease, ophthalmologic, or neurologic toxicities have been observed to date.
Gastric and gastroesophageal junction (GEJ) adenocarcinoma are aggressive cancers that arise from the glandular cells lining the stomach and the area where the stomach connects to the oesophagus. They are among the leading causes of cancer-related death worldwide, often diagnosed at advanced stages due to late onset of symptoms.
ATG-022 is the 'first-and-only' investigational CLDN18.2-targeting ADC to receive Breakthrough Therapy designation from China’s NMPA for the treatment of gastric and gastroesophageal junction adenocarcinoma.
