SAN FRANCISCO and SUZHOU, China, December 9, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune and ophthalmology. and other major diseases, announced updated results from the Phase 1 study of IBI343, an innovative anti-CLDN18.2 ADC, for the treatment of advanced diseases. pancreatic ductal adenocarcinoma (PDAC) in an oral presentation at ESMO Asia 2024. 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 at intermediate or late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than 10%.1. According to GLOBOCAN 2022 statistics2there are approximately 510,000 new cases and 467,000 deaths from pancreatic cancer each year worldwide, with China which represents 120,000 new cases and 110,000 deaths per year.
This Phase 1/1b The study is a multi-regional dose escalation and expansion clinical trial (NCT05458219). Preliminary data was presented at ASCO 2024 and updated results from the study dose expansion cohort were presented at ESMO Asia 2024 as follows:
- Of the September 6, 2024A total of 43 patients with CLDN18.2-positive advanced PDAC (≥60% tumor cells with ≥1+ membrane staining intensity by IHC) received IBI343 6 mg/kg every 3 weeks as monotherapy. All participants had received at least 1 line of prior treatment and 60.5% had received 2 or more lines of anticancer treatment.
- The effectiveness of 43 patients was evaluable with an 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%.
- At data cutoff, 4 of 10 cORR patients had progressed, median duration of response (mDoR) was 7.0 (4.0-NC) monthsand the 6-month DoR rate was 63%. 26 patients experienced PFS events, with median progression-free survival (mPFS) of 5.3 (4.1-7.4) monthsand the operating system data is not yet mature.
- The updated safety results demonstrated the favorable safety profile of IBI343 with a low rate of gastrointestinal toxicity and no new safety signals. 97.7% of participants experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, decreased neutrophil count, decreased appetite, nausea, and decreased neutrophil count. of white blood cells. 51.2% of participants presented TEAE of grade ≥ 3, and no nausea and vomiting ≥ grade 3 occurred. No TEAE resulted in death.
Teacher 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 at an advanced stage at the time of diagnosis, and the 5-year survival rate is only about 10%.1. Currently, chemotherapy remains the main first- and second-line treatment for advanced pancreatic cancer. Clinical options for second-line treatment are particularly limited, with a response rate to chemotherapy of only 6 to 16%, a median progression-free survival of 2 to 5 months, and a median survival of approximately 6 to 9 months.3representing an urgent clinical need. After recruiting more advanced participants with pancreatic cancer, IBI343’s updated data continued to show encouraging efficacy signals as well as manageable safety, and I hope its further development will bring possibly a breakthrough therapy in this difficult-to-treat cancer.
Dr. Hui ZhouSenior Vice President of Innovent, said: “We are pleased to share updated clinical data for IBI343. With its unique Fc-silenced antibody design, stable linker and potent TOPO1i payload, IBI343 is the world’s first ADC candidate to demonstrate encouraging efficacy and a favorable safety profile in the treatment. for advanced pancreatic cancer, IBI343 offers a new direction and renewed hope for the treatment of pancreatic cancer. It is worth mentioning that the FDA has approved the IND application of IBI343 for this purpose. indication and achieved Fast Track designation, and we will initiate patient recruitment for the Phase 1 trial of IBI343 in the United States. We will continue to advance IBI343’s clinical programs, hoping to bring breakthrough treatments to patients around the world. »
About IBI343（Anti-CLDN18.2 CAN）
IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to tumor cells expressing CLDN18.2, CLDN18.2-dependent ADC internalization will occur, and the drug will be released, leading to DNA damage and ultimately apoptosis of tumor cells. The released drug can also diffuse across the plasma membrane to reach and kill neighboring cells, resulting in a “bystander kill effect.”
As an innovative TOPO1i ADC, IBI343 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 .
In May 2024, the China National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) to IBI343 for use as monotherapy in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma ) CLDN18.2 positive who experienced disease progression after two history. systemic treatment lines. The phase 3 trial (NCT06238843) of IBI343 for this indication is ongoing.
In June 2024IBI343 Received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of unresectable or metastatic advanced pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one line of therapy anterior. The multi-regional Phase 1 trial (NCT05458219) of IBI343 for previously treated PDAC is ongoing.
About Innovent Biologics
Innovent is a leading biopharmaceutical company founded in 2011 with a mission to provide patients around the world with affordable, high-quality biopharmaceutical products. The company discovers, develops, manufactures and markets innovative medicines targeting some of the most incurable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and ocular diseases. Innovent has launched 11 products on the market. It has 5 new drug applications currently under regulatory review, 3 assets in phase III or pivotal clinical trials and 17 other molecules in early clinical phase. Innovent partners with more than 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto “Start with Integrity, Succeed with Action”, Innovent maintains the highest standards of industry practices and works collaboratively to advance the biopharmaceutical industry so that best-in-class pharmaceutical drugs can become widely available. accessible. For more information, visit www.innoventbio.comor follow Innovent on Facebook and LinkedIn.
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(1) Innovent does not recommend the use of unapproved medications/indications. |
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(2) Ramucirumab (Cyramza) and selpercatinib (Retsevmo) were developed by Eli Lilly and Company. |
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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 global incidence and mortality for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-June;74(3):229-263.
3 Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin, 2011, 61(2): 69-90.
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