Innovent Updates Phase 1 Data on Anti-CLDN18.2 ADC for Pancreatic Cancer at ESMO Asia 2024

SAN FRANCISCO and SUZHOU, China, Dec. 8, 2024 -- Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company, has shared updated results from their Phase 1 study of IBI343, an anti-CLDN18.2 ADC, for advanced pancreatic ductal adenocarcinoma (PDAC). The new data, presented at the ESMO Asia Congress 2024, showcased the drug's remarkable effectiveness and safe usage in patients with CLDN18.2-positive PDAC who had previously undergone treatment.

Pancreatic cancer is one of the deadliest cancers globally, often only detected in later stages and showing resistance to conventional treatments. With a five-year survival rate of less than 10%, it represents a major health challenge. The GLOBOCAN 2022 report indicated approximately 510,000 new cases and 467,000 deaths annually, with China alone accounting for 120,000 new cases and 110,000 deaths each year.

The Phase 1/1b study, a multi-regional clinical trial, focuses on dose escalation and expansion (NCT05458219). Initial findings were shared at the 2024 ASCO, with the latest outcomes from the expanded cohort presented at ESMO Asia 2024.

As of September 6, 2024, 43 patients with CLDN18.2-positive advanced PDAC, all of whom had received at least one prior therapy, were treated with IBI343 at a dosage of 6 mg/kg every three weeks. Of these, 60.5% had undergone two or more previous treatments. Key efficacy results include an overall objective response rate (ORR) of 32.6%, a confirmed ORR (cORR) of 23.3%, and a confirmed disease control rate (cDCR) of 81.4%. The median duration of response (mDoR) was 7 months, and the 6-month duration of response rate was 63%. The median progression-free survival (mPFS) reached 5.3 months.

Safety data indicated that IBI343 was well tolerated, with a low incidence of gastrointestinal side effects and no new safety concerns. Nearly all participants (97.7%) experienced treatment-emergent adverse events (TEAEs), commonly anemia, decreased neutrophil count, reduced appetite, nausea, and decreased white blood cell count. About 51.2% reported Grade 3 or higher TEAEs, but no Grade 3 or higher nausea or vomiting occurred, and no treatment-related deaths were observed.

Professor Xianjun Yu from Fudan University Cancer Hospital emphasized the dire need for effective treatments for advanced pancreatic cancer, given its aggressive nature and limited therapeutic options after initial treatments fail. The updated data for IBI343 show promising efficacy and manageable toxicity, offering hope for developing new therapies for this challenging cancer.

Dr. Hui Zhou, Senior Vice President of Innovent, expressed satisfaction with the clinical data for IBI343, noting its unique design and potent payload. The drug is the first ADC to show promising results in advanced pancreatic cancer, offering a new therapeutic direction. The US FDA has approved IBI343's IND application and granted it Fast Track designation, paving the way for further trials in the US.

IBI343 is an innovative anti-CLDN18.2 ADC that targets CLDN18.2-expressing tumor cells, leading to their destruction through DNA damage and apoptosis. The drug also exerts a "bystander killing effect" by affecting neighboring cells. The therapeutic potential of IBI343 is also being explored in gastric cancer.

In China, IBI343 has received breakthrough therapy designation for treating CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma, with a Phase 3 trial ongoing. In the US, the FDA has granted Fast Track Designation to IBI343 for treating advanced PDAC that has relapsed or is resistant to prior therapy, with a multi-regional Phase 1 trial underway.

Innovent Biologics, founded in 2011, aims to provide high-quality biopharmaceuticals globally. The company focuses on developing treatments for cancer, cardiovascular, metabolic, autoimmune, and eye diseases, with several innovative therapies already on the market and more in various stages of clinical development.