#Innovent Biologics #pancreatic cancer #IBI343

Innovent Biologics Unveils Significant Phase 1 Study Results for IBI343 at ESMO Asia Congress 2024

On December 8, 2024, Innovent Biologics, Inc. presented substantial updates from its Phase 1 clinical trial for an innovative anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343. This groundbreaking therapy is designed for patients battling advanced pancreatic ductal adenocarcinoma (PDAC) and was showcased during an oral presentation at the ESMO Asia Congress 2024.

The study indicated promising results, particularly in patients classified with CLDN18.2-positive tumors, which are known to express a specific protein that IBI343 targets effectively. Pancreatic cancer poses an urgent clinical need, having one of the lowest survival rates among cancers; studies show that fewer than 10% of patients survive for five years post-diagnosis due to late-stage discovery and resistance to conventional treatments.

According to the GLOBOCAN 2022 statistics, the disease claims approximately 467,000 lives globally each year, with significant mortality rates in China alone, reporting over 110,000 deaths annually. This underscores the necessity for innovative treatment options like IBI343.

The Phase 1/1b study (NCT05458219) centered on expanding the cohort of CLDN18.2-positive patients, initially showing benefits during preliminary presentations at the 2024 ASCO. As of the latest data cutoff in September, 43 patients with advanced PDAC received a dosage of IBI343 at 6 mg/kg every three weeks. This group had already undergone at least one prior therapy, with over 60% having experienced two or more lines of treatment

The findings revealed an overall objective response rate (ORR) of 32.6%, with a confirmed ORR (cORR) of 23.3%, and a remarkable disease control rate (DCR) sitting at 81.4%. Further details indicated that among patients deemed as having responded, a median duration of response (mDoR) was reached at 7.0 months, adding a vital dimension of treatment longevity in such aggressive cancer types. The median progression-free survival (mPFS) was registered at 5.3 months, highlighting IBI343’s potential in improving patient outcomes compared to existing therapies.

Moreover, the safety results for IBI343 have been encouraging, showing a low incidence of gastrointestinal toxicity without any new safety concerns arising. Most treatment-emergent adverse events (TEAEs) were manageable, primarily consisting of anemia, decreased appetite, and nausea, without leading to severe complications such as grade 3 nausea or vomiting.

Professor Xianjun Yu from Fudan University Cancer Hospital commented, “Current treatment protocols for advanced pancreatic cancer are severely limited, often only yielding a chemotherapy response rate of 6-16%. The clinical data presented here indicates a breakthrough in IBI343, which could represent a significant advancement in managing this challenging disease.”

Dr. Hui Zhou, Senior Vice President of Innovent, expressed optimism over the findings.