Core Insights - Innovent Biologics presented clinical data for IBI363, a first-in-class PD1/IL-2α-bias bispecific antibody fusion protein, combined with bevacizumab for advanced colorectal cancer at the 2024 ESMO Congress [1][6] - The combination therapy demonstrated promising anti-tumor efficacy and a manageable safety profile in patients with advanced colorectal cancer [2][3] Group 1: Clinical Study Results - A total of 35 subjects were treated with IBI363 and bevacizumab, showing a 21.9% overall response rate (ORR) and a 65.6% disease control rate (DCR) [2][3] - The median duration of response (DoR) was 8.1 months, with a median progression-free survival (PFS) of 4.1 months [3] - Among subjects with liver metastases, the ORR was 11.8%, while those without had an ORR of 33.3% [3] Group 2: Efficacy in Different Patient Populations - In patients who had received prior immunotherapy, the ORR was 25.0%, compared to 20.8% in immunotherapy-naïve patients [4] - For patients with KRAS/NRAS exon 2/3/4 mutations, the ORR was 21.4%, while those without such mutations had an ORR of 30.0% [4] Group 3: Safety Profile - The most common treatment-related adverse events included arthralgia, thyroid disorders, and rash, with a total incidence of grade 3 or higher adverse events at 22.9% [2] - Immune-related adverse events of grade 3 or higher occurred in 5.7% of subjects, indicating a safety profile similar to IBI363 monotherapy [2][6] Group 4: Future Development and Potential - Ongoing studies are exploring IBI363 in other malignancies and combination regimens for advanced colorectal cancer, with updates expected at future academic conferences [5] - The combination of IBI363 and bevacizumab is seen as having significant potential for treating non-MSI-H/dMMR advanced colorectal cancer, a population with limited response to current immunotherapies [6][7]
Innovent Announces Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Combined with Bevacizumab in Advanced Colorectal Cancer at the 2024 ESMO Congress