HARMONi Clinical Trial

• Expected survival ≥3 months
• Locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC that has progressed on 3rd generation EGFR-TKI (e.g., osimertinib)
• At least 1 measurable noncerebral per RECIST v1.1 lesion
• Adequate organ and hematologic function
• Prior treatment with one non-EGFR therapy is allowed (i.e amivantamab, REQORSA, etc,).
• Prior treatment with immune checkpoint inhibitors, anti-angiogenic therapy and chemotherapy (including ADCs) remain exclusionary
• Tumor does not surround important blood vessels, have obvious necrosis and/or cavitation or invade the surrounding vital organs and blood vessels
• No symptomatic metastases of the central nervous system
• No history of esophageal gastric varices, severe ulcers or wounds that do not heal
• No history of severe bleeding tendencies or coagulopathy, or hemoptysis within last 4 weeks

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).

Abbreviations: ALK=anaplastic lymphoma kinase; CNS=central nervous system; DCR=disease control rate; DOR=duration of response; ECOG=eastern cooperative oncology group; EGFR=epidermal growth factor receptor; IRRC=independent radiologic review committee; NSCLC=non-small cell lung cancer; ORR=overall response rate; OS=overall survival; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; PFS=progression-free survival; PK=pharmacokinetics; TKI=tyrosine kinase inhibitor; Q3W=every 3 weeks; VEGF=vascular endothelial growth factor.