Innovent's promising phase 1 results for gastric cancer treatment are now published in Nature Medicine.
In a significant development for the medical community, Innovent Biologics, a leading biotech company, has announced promising Phase 1 clinical trial results for its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343. This potential treatment is being explored for the management of advanced gastric and gastroesophageal junction adenocarcinoma, as well as pancreatic cancer.
Gastric cancer, one of the most common malignant tumors globally, accounts for an estimated 970,000 new cases and 660,000 deaths annually. In China alone, there are approximately 359,000 new cases and 260,000 deaths from gastric cancer each year, highlighting a significant unmet medical need.
IBI343 has demonstrated encouraging tumor response and survival benefit in patients with high expression of CLDN18.2, a tight junction protein expressed in differentiated epithelial cells on the gastric mucosa that is highly expressed in multiple types of cancer, including gastric cancer.
The published study is a global, multicenter Phase 1 clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of IBI343 in patients with advanced solid tumors. The trial results, published in Nature Medicine, showcased impressive results for IBI343 in the treatment of gastric and gastroesophageal junction adenocarcinoma.
At a dose of 6 mg/kg, the confirmed overall response rate (ORR) was 29.0%, with a disease control rate of 90.3%. The median progression-free survival (PFS) was 5.5 months. At a higher dose of 8 mg/kg, the confirmed ORR increased to 47.1%, with a median PFS of 6.8 months.
Notably, IBI343 demonstrated superior safety with few grade ≥3 gastrointestinal adverse events and no interstitial lung disease reported. These findings suggest that IBI343 could offer a promising treatment option with manageable side effects for patients with advanced gastric and gastroesophageal junction adenocarcinoma.
As of now, there are no published results from the ongoing Phase 3 clinical trial (G-HOPE-001, NCT06238843) for IBI343 in the treatment of advanced gastric/gastroesophageal junction adenocarcinoma. The trial, initiated in 2024 based on promising Phase 1 results, will provide further insights into the efficacy and safety of IBI343 in this patient population.
In addition to the gastric cancer trial, another Phase 3 trial, G-HOPE-002, is planned for advanced pancreatic cancer but has not yet reported results. The results from these trials will be crucial in determining the potential of IBI343 as a treatment option for these deadly cancers.
In conclusion, the Phase 1 results for IBI343 in gastric and gastroesophageal junction adenocarcinoma are promising, with a confirmed ORR of 29.0% at a dose of 6 mg/kg and a median PFS of 5.5 months. While the Phase 3 results for gastric cancer are not yet available, the promising Phase 1 results and the ongoing Phase 3 trial offer hope for patients with advanced gastric and gastroesophageal junction adenocarcinoma. Similarly, the planned Phase 3 trial for pancreatic cancer will provide further insights into the potential of IBI343 as a treatment option for this deadly disease.
The encouraging results from the Phase 1 clinical trial of IBI343, an anti-CLDN18.2 antibody-drug conjugate, mark a significant step forward in the field of science, particularly in health-and-wellness and medical-conditions like cancer. The study highlights the potential of IBI343 in the treatment of not only gastric cancer but also pancreatic cancer, offering hope for individuals suffering from these serious medical conditions.
