Innovent Biologics, Inc. (1801.HK), a biopharmaceutical company, announced that its Arcotatug tavatecan, or IBI343, met its primary endpoint after the interim analysis of the Phase 3 study of Arcotatug Tavatecan in the treatment of previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who have received at least two prior systemic therapies.
Gastric/gastroesophageal junction adenocarcinoma
Gastric cancer is the most common malignant tumor, and the 5-year survival rate of patients with metastatic gastric cancer is less than 5%. The company noted China and Japan as the areas with high gastric cancer incidence.
Currently, the standard treatments for patients with advanced metastatic gastric cancer are chemotherapy and immune checkpoint inhibitor therapy combined with fluoropyrimidine and platinum.
Arcotatug tavatecan or IBI343
Arcotatug tavatecan is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate, or ADC, and is currently under NMPA's review.Arcotatug tavatecan is also being evaluated as a potential first-line treatment for gastric and pancreatic cancers.
G-HOPE-001 Trial Details
G-HOPE-001 is a multicenter, randomized, open-label phase 3 trial conducted in both China and Japan, which evaluates the efficacy and safety of Arcotatug tavatecan monotherapy against an investigator-selected therapy in patients with previously treated, Claudin 18.2-positive, locally advanced unresectable or metastatic G/GEJA who have received at least two prior systemic therapies. The primary endpoints were progression-free survival (PFS) and overall survival (OS).
Key Highlights
The company said that, in Phase 3 G-HOPE-001, Arcotatug tavatecan met its primary endpoint in the first interim analysis. Detailed efficacy data, including PFS and OS results, are expected to be presented at a future scientific meeting.
In addition, Arcotatug tavatecan demonstrated excellent efficacy and a tolerable safety profile in the treatment of advanced gastric cancer, said the company.
Based on the positive interim analysis, Innovent's NDA for Arcotatug Tavatecan has been accepted by the NMPA under priority review for patients with metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who have received at least two prior systemic therapies.
Innovent noted that Arcotatug tavatecan is further studied with patients with CLDN18.2-positive advanced pancreatic cancer in a phase 3 clinical study and is being explored as the first-line treatment for patients with gastric and pancreatic cancers.
Innovent shares closed trading at HK$76.4, down 0.59% on the Hong Kong Stock Exchange.
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