Innovent Reveals Phase 1 Trial Results for Anti-CLDN18.2 ADC in Pancreatic Cancer at ESMO Asia 2024

Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical firm that specializes in the development, manufacturing, and marketing of high-quality therapeutic agents targeting oncology, cardiovascular and metabolic diseases, autoimmune disorders, ophthalmology, and other significant health conditions, has presented updated findings from a Phase 1 clinical trial of IBI343, a novel anti-CLDN18.2 antibody-drug conjugate, for advanced pancreatic ductal adenocarcinoma (PDAC) at the ESMO Asia Congress 2024. The data underscored the remarkable efficacy and favorable safety profile of IBI343 in a larger group of CLDN18.2-positive patients who had received prior treatment for PDAC.

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Pancreatic cancer ranks among the most aggressive cancers globally. Most individuals receive their diagnosis at advanced stages, often developing resistance to conventional chemotherapy, which contributes to a 5-year survival rate below 10%. GLOBOCAN 2022 reports around 510,000 new pancreatic cancer cases annually, resulting in approximately 467,000 deaths worldwide, with China reporting 120,000 new cases and 110,000 deaths each year. 

This Phase 1/1b trial (NCT05458219) is a multi-regional, dose-escalation and expansion clinical study. Initial findings were shared at the 2024 ASCO meeting, while the updated outcomes from the dose-expansion cohort were unveiled during the 2024 ESMO Asia Congress. 

As of September 6, 2024, 43 patients with CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC), defined as having at least 60% of tumor cells showing membranous staining of intensity ≥1+ by immunohistochemistry (IHC), were treated with IBI343 at a dose of 6 mg/kg every three weeks as a monotherapy. All participants had undergone at least one line of prior therapy, with 60.5% having received two or more lines of treatment for cancer. 

Out of these, 43 patients were included in the efficacy evaluation, yielding an overall objective response rate (ORR) of 32.6%, a confirmed objective response rate (cORR) of 23.3%, and a confirmed disease control rate (cDCR) of 81.4%. 

At the data cutoff, among the 10 patients who achieved cORR, 4 had experienced disease progression. The median duration of response (mDoR) was recorded at 7.0 months (range 4.0 - not calculated), with a 6-month duration of response rate of 63%. Progression-free survival (PFS) events occurred in 26 patients, leading to a median progression-free survival (mPFS) of 5.3 months (range 4.1-7.4), while overall survival (OS) data remain immature. 

The updated safety results indicated that IBI343 demonstrates a favorable safety profile, with consistently low gastrointestinal toxicity and no new safety concerns emerging. Treatment-emergent adverse events (TEAEs) were reported by 97.7% of participants, with the most frequently observed TEAEs being anemia, reduced neutrophil count, decreased appetite, nausea, and reduced white blood cell count. A total of 51.2% of participants experienced TEAEs rated ≥ grade 3, with no instances of ≥ grade 3 nausea or vomiting reported. Additionally, none of the TEAEs resulted in fatalities.

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According to the data provided by the Synapse Chemical, As of December 11, 2024, there are 5 investigational drugs for the CLDN18.2 x TOP1 target, including 20 indications, 10 R&D institutions involved, with related clinical trials reaching 16, and as many as 12 patents.

The drug IBI-343 is an antibody drug conjugate (ADC) that targets CLDN18.2 and TOP1. It is intended for use in the treatment of neoplasms, digestive system disorders, and endocrinology and metabolic diseases.