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, announced updated Phase 1 study results of IBI343, an innovative anti-CLDN18.2 ADC, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024. The results highlighted the excellent efficacy and favorable safety profile of IBI343 in an expanded cohort of CLDN18.2-positive patients with previously treated PDAC.
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 2024 ASCO and the updated results from the study's dose-expansion cohort were presented at the 2024 ESMO Asia Congress as follows:
As of September 6, 2024, a total of 43 patients with CLDN18.2-positive (≥60% tumor cells with membranous staining intensity ≥1+ by IHC) advanced PDAC received IBI343 6 mg/kg Q3W monotherapy. All participants had previously received at least 1 line of prior therapy, and 60.5% had received 2 or more lines of anticancer treatment.
43 patients were efficacy evaluable with overall objective response rate (ORR) of 32.6%, confirmed objective response rate (cORR) of 23.3%, and confirmed disease control rate (cDCR) of 81.4%.
As the data cutoff date, 4 out of 10 cORR patients had progressed, the median duration of response (mDoR) was 7.0 (4.0-NC) months, and the 6-month DoR rate was 63%. 26 patients occurred PFS events, with a median progression-free survival (mPFS) of 5.3 (4.1-7.4) months, and OS data is not yet mature.
The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals. 97.7% of the participants experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, decreased appetite, nausea, and white blood cell count decreased. 51.2% of the participants experienced ≥ grade 3 TEAEs, and no ≥ grade 3 nausea and vomiting occurred. No TEAE led to death.
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. After enrolling more advanced pancreatic cancer participants, the data update of IBI343 continued to show encouraging efficacy signals as well as manageable safety, and I hope its further development will eventually bring a breakthrough therapy in this difficult-to-treat cancer."
Dr. Hui Zhou, Senior Vice President of Innovent, said, "We are pleased to share the updated clinical data for IBI343. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate globally to demonstrate encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. IBI343 offers a new direction and renewed hope for pancreatic cancer treatment. It is worth mentioning that, the FDA has approved IBI343's IND application for this indication and granted Fast Track designa...
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