SAN FRANCISCO and SUZHOU, China, July 1, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced oral presentation of the latest Phase 1 clinical data of an innovative anti-CLDN18.2 ADC (IBI343) for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024 (NCT05458219). The data demonstrates promising efficacy and a favorable safety profile for IBI343 in patients with advanced gastric cancer whose tumors express CLDN18.2.
Gastric cancer is one of the most common malignant tumors in the world. According to the GLOBOCAN 2022 statistics[1], gastric cancer ranks as the 5th most common malignant tumor and the 5th leading cause of cancer death around the world. It accounts for an estimated 970,000 cases and 660,000 deaths worldwide. Each year, China reports 359,000 new cases and 260,000 deaths from gastric cancer, representing 37.0% and 39.4% of the global totals, respectively, highlighting a significant unmet medical need.
The data presented at this conference is from a Phase 1 study conducted in China and Australia with IBI343 and are as follows:
In participants with high expression of CLDN18.2 (≥75% tumor cells with membranous staining intensity ≥2+ by IHC) at the 6 mg/Kg dose (N=30), the ORR and DCR were 36.7% and 93.3%, respectively. At the 8 mg/kg dose (N=17), the ORR was 47.1% and the DCR was 88.2%.
With a median follow-up time of 7.2 months in the 6 mg/kg dose group, the median progression-free survival (mPFS) of participants with high CLDN18.2 expression was up to 6.8 months.
The majority of treatment emergent adverse events (TEAEs) were grade 1-2. In the 6 mg/kg dose group, 31.6% patients had ≥ Grade 3 treatment-related adverse events (TRAEs). ≥ Grade 3 gastrointestinal toxicities were extremely low (