By Fineline Cube 
China-based Innovent Biologics, Inc. (HKG: 1801) announced the oral presentation of results from two clinical studies for its IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Phase I/II Study in Advanced Malignant Melanoma
One study focused on Phase I/II evaluation of IBI363 in advanced malignant melanoma subtypes (acral and mucosal) previously treated with immunotherapy. The results demonstrated that IBI363 alone exhibited good efficacy and safety in these “cold tumors,” with a confirmed objective response rate (cORR) of 23.3% and a disease control rate (DCR) of 76.7%. The median progression-free survival (PFS) for patients treated with 1mg/kg Q2W was 5.7 months, the median overall survival (OS) was 14.8 months, and the 12-month overall OS rate was 61.5%.
Phase I Study in Advanced Colorectal Cancer
The other study was a Phase I evaluation of IBI363 as monotherapy or in combination with bevacizumab in advanced colorectal cancer (CRC). The results indicated that IBI363 alone showed breakthrough anti-tumor therapeutic potential, with a median OS of 16.1 months. Subgroup analysis revealed OS benefits regardless of liver metastasis. The IBI363/bevacizumab combination achieved a 15.1% cORR and 61.6% DCR, with PFS reaching 4.7 months and OS remaining immature. The combination was overall well-tolerated.-Fineline Info & Tech