Follow-Up Duration and Survival Trends in the HARMONi-6 Trial
Key Points
- The approximately 22-month follow-up and prespecified interim overall survival (OS) analysis from HARMONi-6 were appropriate and consistent with other landmark non-small cell lung cancer (NSCLC) studies, according to a lung cancer expert panel.
- Experts expressed cautious optimism that the OS benefit observed with ivonescimab will persist with longer follow-up, citing continued separation of the survival curves.
- The panel considered the enrolled population broadly representative of clinical practice and highlighted HARMONi-3 as an opportunity to evaluate outcomes in older patients.
Benjamin P. Levy, MD, of Johns Hopkins Sidney Kimmel Cancer Center, was joined by Jarushka Naidoo, MB, BCh, MHS, of Beaumont RCSI Cancer Centre, and Bo Wang, MD, of Willamette Valley Cancer Institute and Research Center, to examine several key questions surrounding the HARMONi-6 trial, including the maturity of the OS data and the applicability of the findings to older patients with advanced squamous NSCLC. The panel discussed whether the approximately 22 months of follow-up and interim OS analysis provided sufficient evidence to support the positive findings observed with ivonescimab plus chemotherapy.
Both Dr. Wang and Dr. Naidoo agreed that the timing of the analysis was appropriate, given that it was a prespecified interim analysis and consistent with the level of maturity seen in many landmark immunotherapy studies. While acknowledging concerns regarding censoring and the relatively early nature of the data, the experts emphasized that the OS benefit was both statistically significant and clinically meaningful.
Dr. Naidoo noted that the survival curves appeared to continue separating over time and suggested that the pattern resembled what has historically been observed with immunotherapy-based approaches, potentially supporting a biologic rationale for combining PD-1 and VEGF inhibition. Dr. Levy characterized the findings as a clear signal of activity and expressed cautious optimism that the survival advantage would persist with longer follow-up.