Innovent Biologics' IBI343 Shows Promise in Phase 1 Trial for Advanced Gastric Cancer

Innovent Biologics, Inc., a leading biopharmaceutical company based in Suzhou, China, has announced the publication of Phase 1 clinical trial results for its innovative anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, in the prestigious journal Nature Medicine. The trial focused on patients suffering from advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ), a significant health concern as gastric cancer continues to rank among the most prevalent malignancies globally.

The study, which enrolled 116 patients between October 2022 and June 2024, aimed to assess the safety and preliminary efficacy of IBI343. It is noteworthy that gastric cancer is responsible for approximately 970,000 new cases and 660,000 deaths annually, with China accounting for nearly 37% of the global burden (GLOBOCAN 2022). The urgency for effective treatments is underscored by the fact that the five-year survival rate for metastatic gastric cancer is less than 5%.

According to Professor Lin Shen, Corresponding Author and Principal Investigator at Beijing Cancer Hospital, "Following the eras of chemotherapy, targeted therapy, and immunotherapy, ADCs have opened a new frontier in the treatment of gastrointestinal tumors. IBI343 is a new generation of Fc-silent anti-CLDN18.2 ADC that has shown encouraging clinical benefits and low gastrointestinal toxicity in Phase 1 studies."

The trial's findings revealed promising results, especially in patients expressing high levels of CLDN18.2. At a dosage of 8 mg/kg, the confirmed overall response rate (ORR) was 47.1%, with a significant disease control rate of 88.2%. Notably, the median duration of response was 5.7 months, indicating a potential for meaningful clinical benefit.

Dr. Hui Zhou, Chief R&D Officer for the Oncology Pipeline at Innovent Biologics, emphasized, "There is a huge unmet clinical need for the treatment of advanced gastric cancer. The Phase 1 study results of IBI343 further verify the clinical value of this treatment in this population."

The trial also highlighted the safety profile of IBI343, with treatment-related adverse events primarily being manageable. Approximately 66.4% of patients experienced grade ≥3 treatment-emergent adverse events, with the most common being decreased neutrophil count and anemia. However, the incidence of severe gastrointestinal side effects was notably low, which could enhance patient adherence to treatment.

The encouraging results have paved the way for a multi-regional Phase 3 clinical trial, designated G-HOPE-001, which commenced in 2024. This study aims to further evaluate the efficacy and safety of IBI343 compared to standard treatments in a larger patient cohort.

The therapeutic potential of IBI343 is not limited to gastric cancer; it is also being explored in pancreatic cancer and other indications. As Dr. Zhou noted, Innovent is committed to collaborating with global researchers to advance this promising therapy.

In conclusion, the publication of these Phase 1 results in Nature Medicine marks a significant milestone in the quest for effective treatments for gastric cancer. If the upcoming Phase 3 trials confirm these findings, IBI343 could represent a transformative option for patients suffering from this challenging disease. The ongoing research underscores the importance of innovation in addressing the pressing medical needs of patients worldwide.