#China #Suzhou #Innovent Biologics #IBI343 #ASCO 2025

Innovent Biologics Presents IBI343 Data at ASCO 2025

On June 2, 2025, Innovent Biologics, Inc. revealed updated results from their Phase 1 clinical trial of IBI343 at the American Society of Clinical Oncology (ASCO) Annual Meeting. IBI343 is a novel anti-CLDN18.2 antibody-drug conjugate, designed to combat advanced pancreatic cancer, one of the most aggressive forms of malignancy globally.

The study primarily focused on patients with CLDN18.2-positive advanced pancreatic cancer, a significant challenge in oncology due to the disease's late-stage diagnosis and high resistance to standard therapies. Current statistics indicate an alarming 5-year survival rate of less than 10% for pancreatic cancer patients, underlining the necessity for innovative treatment options.

Promising Data from the Phase 1 Study

With extended follow-up, the data showed favorable outcomes for patients receiving the 6mg/kg dose of IBI343. A total of 83 patients participated, demonstrating an overall response rate of 22.7% and a disease control rate of 81.8%. The median progression-free survival (mPFS) reached 5.4 months, whereas median overall survival (mOS) was recorded at 9.1 months. These findings indicate that IBI343 holds significant promise for a patient demographic that has exhausted existing treatment options.

Notably, the trial also reported a robust safety profile, with treatment-emergent adverse events being primarily mild and manageable. Common side effects included anemia and a reduction in white blood cells, but there were no reports of severe nausea or vomiting, which is a common concern with cancer therapies.

The Urgent Need for New Treatments

Professor Xianjun Yu from Fudan University Cancer Hospital emphasized the critical need for alternative therapies, stating that most patients have limited options after initial treatments. Current second-line chemotherapy treatments yield low response rates and limited survival benefits, further highlighting the importance of new and effective therapies like IBI343.

Dr. Hui Zhou, Senior Vice President of Innovent, shared their commitment to further developing IBI343, while stressing its unique design, which encompasses an Fc-silent antibody and a stable linker that enhances therapeutic efficacy. Innovent hopes to leverage their strengths in research and development to advance clinical trials and improve patient outcomes.

Future Prospects

Currently, IBI343 is being scrutinized in Phase 3 trials for advanced gastric cancer and is actively enrolling participants in a multi-regional study for pancreatic ductal adenocarcinoma. Both indications have gained significant traction, with the drug receiving Fast Track Designation from the FDA and Breakthrough Therapy Designation from China’s National Medical Products Administration.

As Innovent continues to navigate the complex landscape of oncology treatment, the results from the Phase 1 trial at ASCO 2025 add a promising chapter in the fight against pancreatic cancer. The biopharmaceutical company's dedication to creating accessible and effective therapies may pave the way for significant advancements in this challenging field.

For more information about Innovent Biologics and IBI343, visit Innovent's official website.