Yidafan (ivonescimab)

Since the first BsAb approval in 2014, the field has rapidly expanded, with solid tumor oncology advancing dynamically. The major focus has been on combining BsAbs with immunotherapy strategies, followed by targeting known oncogenic pathways. The shift toward biotechnology-led innovation underscores the growing therapeutic and financial interest in this field. Optimizing the efficacy and safety of these molecules is key to paving the way for the next era of immune and precision oncology.

Despite initial responses to first-line firmonertinib-based combination therapy, progression-free survival (PFS) 13 months, the patient developed sequential resistance to subsequent regimens, including liver/brain metastases and treatment-related toxicities. After fourth-line therapy failure and severe intolerance to albumin-bound paclitaxel and bevacizumab, two cycles of ivonescimab-a first-in-class programmed cell death protein receptor-1 (PD-1)/vascular endothelial growth factor-A (VEGF-A) bispecific antibody-induced significant regression of pulmonary target lesions (PR), sustained over six cycles with minimal toxicity...While the rapid PR and favorable safety profile are promising, longer follow-up is required to assess durability and survival benefits. These findings underscore the need for further investigation of bispecific antibodies in precision oncology paradigms for multi-refractory EGFR-driven NSCLC.

P3, N=780, Not yet recruiting, Groupe Oncologie Radiotherapie Tete et Cou

PD-1(L1)/VEGF BsAbs like ivonescimab represent a novel therapeutic strategy with potential for improved efficacy and mitigated toxicity compared to combination therapies. Ongoing trials will define broader applications.

P2, N=88, Recruiting, UNICANCER | Not yet recruiting --> Recruiting

P3, N=1600, Recruiting, Summit Therapeutics | N=1080 --> 1600 | Trial completion date: Dec 2028 --> Dec 2029 | Trial primary completion date: Dec 2027 --> Dec 2028

P2, N=28, Recruiting, University of Michigan Rogel Cancer Center | Not yet recruiting --> Recruiting

P2, N=180, Recruiting, Akeso

P2, N=49, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University

P2, N=42, Not yet recruiting, Women's Hospital School Of Medicine Zhejiang University

P2, N=66, Not yet recruiting, Peking University Cancer Hospital & Institute

P2, N=158, Not yet recruiting, European Organisation for Research and Treatment of Cancer - EORTC