Innovent Delivers Oral Presentations on Clinical Data of IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate) in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors at the 2024 ESMO Congress
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The data presented is from a Phase 1/2 study aimed at evaluating the safety, tolerability, and preliminary efficacy of IBI354 in participants with advanced solid tumors. A total of 368 participants with advanced solid tumors were enrolled and received different doses of IBI354 monotherapy, including 178 with breast cancer, 92 with ovarian cancer, 38 with colorectal cancer, and 60 with other tumors. Among them, 42.7% of the participants had previously undergone five or more systemic treatment regimens.
IBI354 monotherapy demonstrated excellent safety profile.
- The dosage was escalated to 18mg, with no DLT events observed.
- The most common treatment-related adverse events (TRAEs) were nausea, decreased white blood cell count and anemia. The incidence of interstitial lung disease (ILD) was only 1.6%, all of which were grade 1.
- Overall, 21.5% of patients experienced TRAEs ≥ grade 3, 2.4% experienced TRAEs leading to dose reduction and 1.6% experienced TRAEs leading to discontinuation, with no TRAEs leading to death.
IBI354 monotherapy showed promising efficacy signals in multiple tumor types.
- In platinum-resistant ovarian cancer cohort (n=87, treated at 6~12mg/kg IBI354), the overall objective response rate (ORR) was 40.2% and the disease control rate (DCR) was 81.6%. In the 12mg/kg subgroup (n=40), the ORR reached 52.5% and the DCR was 90.0%. In participants with HER2 1+ (n=27), the ORR reached 55.6% and the DCR was 88.9%. As of the data cutoff date, the median follow-up time was 6.5 months, and both progression-free survival (PFS) and duration of response (DoR) had not yet matured.
- In HER2-positive breast cancer cohort (n= 59, treated at 6~15mg/kg IBI354), the ORR and DCR were 67.8% and 88.1%, respectively.
- In HER2-low breast cancer cohort (n=67, treated at 6~15mg/kg IBI354), the ORR and DCR were 41.8% and 82.1%, respectively. In the 12mg/kg subgroup (n=26), the ORR and DCR were 61.5% and 88.5%, respectively.
- In HER2-positive gastrointestinal malignancies cohort (n=35, treated at 6~15mg/kg IBI354), the ORR and the DCR were 57.1% and 91.4%, respectively. 26 participants were diagnosed with colorectal cancer, of which 14 achieved an objective response (1 subject with HER2 IHC2+ FISH+ achieved a confirmed objective response), resulting in an ORR and DCR of 53.8% and 92.3%, respectively. As of press date, another participant with HER2 low expression (IHC2+ FISH-) colorectal cancer achieved a confirmed objective response.
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References [1] Armstrong DK, et al. J Natl Compr Canc Netw. 2019;17(8):896-909. [2] Gaillard S, et al. Gynecol Oncol. 2021 Nov;163(2):237-245. [3] Pujade-Lauraine E, et al. J Clin Oncol. 2014;32(13):1302-8. [4] Pujade-Lauraine E, et al. Lancet Oncol. 2021 Jul;22(7):1034-1046.
[5] [6] Naumann WR, et al. Drugs. 2011;71(11):1397-1412.
[7] Han B, et al. J Natl Cancer Cent. 2024 |
About IBI354 (Anti-HER2 Antibody-Camptothecin Derivative Conjugate)
IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent's proprietary novel topoisomerase inhibitor NT3 platform. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte,
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
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