Innovent Presents IBI363 Data with Bevacizumab for Advanced Colorectal Cancer at 2024 ESMO Congress

Innovent Biologics, Inc. has recently announced promising clinical data for its innovative treatment IBI363 combined with bevacizumab for advanced colorectal cancer. The data was presented at the 2024 ESMO Congress. Innovent, a leading biopharmaceutical company, is currently conducting Phase 1/2 clinical trials in China, the United States, and Australia to evaluate the safety and efficacy of IBI363 in subjects with advanced solid tumors.

The Phase 1 study aimed to assess the safety, tolerability, and preliminary efficacy of IBI363 in combination with bevacizumab. A total of 35 subjects with advanced colorectal cancer participated in the study, receiving different dose levels of the combination treatment. The results demonstrated promising anti-tumor efficacy with a positive safety profile.

As of the data cutoff date, August 30, 2024, 35 subjects received the combination treatment. Among these, 91.4% had microsatellite stable (MSS) or proficient mismatch repair (pMMR) colorectal cancer, and 51.4% had liver metastases. Most subjects had already undergone two or more lines of systemic anti-tumor treatments, and 25.7% had prior immunotherapy. The study reported that the most common treatment-related adverse events (TRAEs) were arthralgia, thyroid disorders, and rash, with a 22.9% incidence of TRAEs at grade 3 or higher. Immune-related adverse events (irAEs) of grade 3 or higher occurred in 5.7% of the subjects, and no new safety signals were identified.

Regarding efficacy, 32 subjects underwent at least one post-baseline tumor assessment. The overall response rate (ORR) was 21.9%, with a confirmed ORR of 15.6%, and a disease control rate (DCR) of 65.6%. The median duration of response (DoR) was 8.1 months, and the median progression-free survival (PFS) was 4.1 months. The median overall survival (OS) was not reached during the follow-up period.

The study also highlighted the promising efficacy of the combination treatment in various subgroups of patients. For those with liver metastases, the ORR was 11.8%, and the DCR was 58.8%. In patients without liver metastases, the ORR was 33.3%, and the DCR was 73.3%. Furthermore, the combination treatment showed efficacy in both immunotherapy-treated and immunotherapy-naïve patients, as well as in patients with and without KRAS/NRAS exon 2/3/4 mutations.

Additionally, data from a Phase 1 study of IBI363 monotherapy presented at ASCO 2024 indicated good tolerability and promising efficacy. Ongoing studies are exploring IBI363 in other malignancies, including non-small cell lung cancer (NSCLC), melanoma, and other solid tumors. Updates on these studies will be shared at future academic conferences and in journals.

Professor Tao Zhang of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, emphasized that colorectal cancer remains a significant global health challenge. While immunotherapy has been a breakthrough for MSI-H/dMMR tumors, its efficacy in non-MSI-H/dMMR advanced colorectal cancer is limited. The combination of PD-1 and IL-2 may overcome immune resistance and activate tumor-specific CD8+ T cells. The IBI363 and bevacizumab combination has shown promising clinical benefits, including objective response rates and disease control rates, with manageable safety.

Dr. Hui Zhou, Senior Vice President of Innovent, highlighted that the combination of IBI363 with bevacizumab demonstrated strong anti-tumor effects in non-MSI-H/dMMR advanced colorectal cancer. These results suggest significant potential for IBI363 in this disease area. Innovent is confident in the broad development prospects of IBI363 and anticipates more mature data from higher doses and extended follow-up to advance clinical development.

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein developed by Innovent Biologics. It functions by blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, targeting and activating tumor-specific T cells. Innovent continues to conduct clinical studies to further explore the efficacy and safety of IBI363 in advanced tumors.