ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI343 (Novel Anti-CLDN18.2 ADC) From the Phase 1 Clinical Study in Patients with Advanced Pancreatic Cancer

Rhea-AI Summary

Innovent Biologics presented updated Phase 1 clinical trial results for IBI343, a novel anti-CLDN18.2 ADC, for advanced pancreatic cancer treatment at ASCO 2025. The study showed promising results with a confirmed overall response rate of 22.7% and disease control rate of 81.8% in CLDN18.2-positive patients at 6mg/kg dose (N=44). Median progression-free survival was 5.4 months, with overall survival of 9.1 months. Notably, patients with one prior treatment line achieved 12.1 months median overall survival. IBI343 demonstrated a favorable safety profile with manageable side effects. The drug has received Breakthrough Therapy Designation from China's NMPA and Fast Track Designation from the US FDA. This development is significant given pancreatic cancer's poor prognosis, with global annual cases reaching 510,000 and a 5-year survival rate below 10%.

Positive

• Promising efficacy with 22.7% confirmed overall response rate and 81.8% disease control rate
• Favorable safety profile with no grade 3 or higher nausea and vomiting reported
• Received Breakthrough Therapy Designation in China and Fast Track Designation in US
• Improved survival metrics compared to standard chemotherapy (12.1 months mOS for first-line treatment)

Negative

• 98.8% of patients experienced treatment-emergent adverse events
• Common side effects include anemia and decreased neutrophil and white blood cell counts

SAN FRANCISCO and SUZHOU, China, June 2, 2025 /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, updated the Phase 1 study results of IBI343, a novel anti-CLDN18.2 ADC, for the treatment of advanced pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

With extended follow-up and more mature data on progression-free survival (PFS) and overall survival (OS), IBI343 has demonstrated promising therapeutic efficacy in patients with CLDN18.2-positive advanced pancreatic cancer. These encouraging results suggest the potential of IBI343 in this challenging-to-treat malignancy. Supported by these robust clinical findings, IBI343 has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA). Concurrently, the Phase 1 clinical trial of IBI343 is also being conducted in the United States, where the drug candidate has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA).

Pancreatic cancer is one of the most aggressive malignancies worldwide. Most patients are diagnosed in the middle and late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than 10%¹. According to the GLOBOCAN 2022 statistics2, there are approximately 510,000 new cases and 467,000 deaths globally from pancreatic cancer each year, with China accounting for 120,000 new cases and 110,000 deaths annually.

This Phase 1/1b study is a multi-regional, dose escalation and expansion clinical trial (NCT05458219). Preliminary data were presented at ASCO 2025 and ESMO Asia 2024 and the updated results from the study's dose-expansion cohort were presented at the 2025 ASCO as follows:

• As of March 14, 2025, a total of 83 patients with pancreatic cancer had received at least one dose of IBI343 with a median follow-up time of 11.1 months.
• As the data cutoff date, in patients with CLDN18.2 1+2+3+≥60% expression treated at the 6mg/kg dose (N=44), the confirmed overall objective response rate (cORR) was 22.7% and the disease control rate (DCR) was 81.8%. The median progression-free survival (mPFS) was 5.4 months, and the median overall survival (mOS) was 9.1 months. Among them, 17 patients had received only one line of prior treatment, achieving a mPFS of 5.4 months and a mOS of 12.1 months; and 18 patients had received two lines of prior treatment, the mPFS was 5.3 months and the mOS was 9.1 months.
• The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals. 98.8% of the patients experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, and white blood cell count decreased. Notably, no ≥ grade 3 nausea and vomiting occurred.

Professor Xianjun Yu from Fudan University Cancer Hospital, said, "Pancreatic cancer is one of the most malignant tumors of the digestive tract. Most patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only about 10%¹. Currently, chemotherapy is still the main first- and second-line treatment for advanced pancreatic cancer. The clinical options for second-line treatment are particularly limited, with a chemotherapy response rate of only 6-16%, median progression free survival of 2 to 5 months, and a median survival of approximately 6 to 9 months³, representing an urgent clinical need. With longer follow-up, the mature PFS and OS data from the latest IBI343 update demonstrate promising therapeutic potential, suggesting a breakthrough in this difficult-to-treat malignancy."

Dr. Hui Zhou, Senior Vice President of Innovent, said, "We are pleased to present an oral update on IBI343's clinical data at this year's ASCO conference. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate to show encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. We hope to continue advancing the clinical trials of IBI343 for pancreatic cancer patients. Innovent will leverage its unique strengths in R&D innovation and clinical translation to develop a new generation of globally competitive oncology - focused innovative pipeline to benefit patients worldwide.."

About IBI343（Anti-CLDN18.2 ADC）

IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect".

As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancer.

The Phase 3 trial of IBI343 for advanced gastric / gastroesophageal junction adenocarcinoma is now recruiting patients. The relevant indication has been included in China's NMPA breakthrough therapy list.

IBI343's Phase 1 trial for advanced pancreatic ductal adenocarcinoma is enrolling patients in an multi-regional study. This indication has received Fast Track designation from the FDA and been included in the NMPA's BTD list.

About Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement:

1. Innovent Biologics does not recommend the use of unapproved drugs/indications.

2. Ramucirumab injection (Ciranza®), selpercatinib capsules (Ritu®) and pirtobrutinib tablets (Capra®) were developed by Eli Lilly and Company

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

References

1 Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33. doi: 10.3322/caac.21708.

2 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.

3 Jemal A, Bray F, Center MM, et al. Global cancer stastics. CA Cancer J Clin, 2011, 61(2): 69-90.

 

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SOURCE Innovent Biologics

FAQ

What are the key efficacy results of IBI343 in IVBIY's Phase 1 trial for pancreatic cancer?

IBI343 showed a 22.7% confirmed overall response rate and 81.8% disease control rate in CLDN18.2-positive patients, with median progression-free survival of 5.4 months and overall survival of 9.1 months.

What regulatory designations has IVBIY's IBI343 received?

IBI343 has received Breakthrough Therapy Designation from China's NMPA and Fast Track Designation from the US FDA.

What are the main side effects of IVBIY's IBI343 in pancreatic cancer treatment?

The most common side effects include anemia, decreased neutrophil count, and decreased white blood cell count, with 98.8% of patients experiencing treatment-emergent adverse events.

How does IBI343's survival data compare in different treatment lines for pancreatic cancer?

Patients with one prior treatment line achieved 12.1 months median overall survival, while those with two prior treatment lines showed 9.1 months median overall survival.

What is the current market need for pancreatic cancer treatments that IBI343 addresses?

Pancreatic cancer has a low 5-year survival rate below 10%, with current second-line chemotherapy showing only 6-16% response rates and 6-9 months median survival.