This Week’s Biopharma News: Big Moves in Bispecifics

Akeso’s PD-1/VEGF bispecific beats PD-1 plus chemo in lung cancer, Amgen wins EC approval for its DLL3-targeted T-cell engager, and Aragen scales Renaissance’s Fast Track anti-GD2 antibody

June 9, 2026
5 min

The Medicine Maker

Overview

Ivonescimab, a PD-1/VEGF bispecific antibody, demonstrated improved overall survival compared to tislelizumab plus chemotherapy in advanced squamous non-small cell lung cancer (NSCLC). In the phase 3 HARMONi-6 trial, patients receiving ivonescimab had a median overall survival of 27.9 months versus 23.7 months in the control group (tislelizumab plus chemotherapy).

Background

The treatment landscape for advanced squamous NSCLC is evolving, with immunotherapy and chemotherapy combinations being the current standard of care. The introduction of bispecific antibodies like ivonescimab may offer new therapeutic options, particularly for patients who have limited responses to existing treatments. Understanding the efficacy and safety of these novel agents is crucial for optimizing patient outcomes.

Data Highlights

Parameter	Ivonescimab + Chemo	Control (Tislelizumab + Chemo)
Median Overall Survival	27.9 months	23.7 months
24-Month Survival Rate	64.7%	48.6%
Median Progression-Free Survival	11.1 months	6.9 months
Grade 3 or Higher Adverse Events	69.2%	58.9%

Key Findings

Ivonescimab reduced the risk of death by 34% compared to tislelizumab plus chemotherapy.
Median overall survival was significantly longer in the ivonescimab group (27.9 months) than in the control group (23.7 months).
Progression-free survival was improved with ivonescimab, showing a median of 11.1 months versus 6.9 months in the control.
69.2% of patients on ivonescimab experienced grade 3 or higher treatment-related adverse events, indicating a need for careful monitoring.
The trial results were presented at an ASCO plenary session, highlighting the significance of the findings.

Clinical Implications

The findings from the HARMONi-6 trial suggest that ivonescimab may be a valuable addition to the treatment options for patients with advanced squamous NSCLC. However, the higher incidence of severe adverse events necessitates careful patient selection and monitoring during treatment. Further studies are needed to evaluate the long-term safety of ivonescimab.

Conclusion

Ivonescimab represents a promising advancement in the management of advanced squamous NSCLC, with improved survival outcomes compared to current standard therapies. Further studies are needed to confirm these findings and assess long-term safety and efficacy.