Summit Therapeutics and Akeso announced positive results from the Phase III HARMONi-2 trial, evaluating ivonescimab, an investigational bispecific antibody, as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with PD-L1 positive expression.
Ivonescimab demonstrated a statistically significant improvement in progression-free survival (PFS) compared to pembrolizumab, a current standard of care. Patients receiving ivonescimab experienced a median PFS of 11.14 months versus 5.82 months for those receiving pembrolizumab (49%).
The PFS benefit was observed across various subgroups, including those with low and high PD-L1 expression, squamous and non-squamous histologies, and other high-risk patients. Additionally, ivonescimab showed higher overall response rates and disease control rates than pembrolizumab.
Safety profiles were comparable between ivonescimab and pembrolizumab, with similar rates of serious treatment-related adverse events and treatment discontinuations due to such events.
The HARMONi-2 trial results support the potential of ivonescimab as a promising new treatment option for first-line advanced NSCLC patients with PD-L1 positive tumors. The company plans to initiate the Phase III HARMONi-7 trial in early 2025 to evaluate ivonescimab in this setting further.
Encouraging data from a Phase II perioperative NSCLC study and three additional Phase II studies evaluating ivonescimab in solid tumors beyond NSCLC were also presented at scientific conferences.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
