Real-world performance of blood-based proteomic profiling in first-line immunotherapy treatment in advanced stage non-small cell lung cancer

Autor: D. Oubre, R. Brian Mitchell, J. Orsini, Edgardo S. Santos, Patricia Rich, Scott Boniol, Warren Brenner, Jonathan Goldberg, Waseemullah Khan, Suman Sinha, Savita Bidyasar, Eric Scott Schaefer, Emily K. Pauli, Paul R. Walker, Kan Huang, Andrea Veatch, Linda Traylor, Maria Quejada, Wallace Akerley, Mitchell Haut, Mazen Khalil, Bassam Ghabach, Ray D. Page, Hafez Halawani, Jason Keith Boyd, J. Dubay
Rok vydání: 2021
Předmět:
Zdroj: Journal for ImmunoTherapy of Cancer, Vol 9, Iss 10 (2021)
Journal for Immunotherapy of Cancer
ISSN: 2051-1426
DOI: 10.1136/jitc-2021-002989
Popis: PurposeImmune checkpoint inhibition (ICI) therapy has improved patient outcomes in advanced non-small cell lung cancer (NSCLC), but better biomarkers are needed. A clinically validated, blood-based proteomic test, or host immune classifier (HIC), was assessed for its ability to predict ICI therapy outcomes in this real-world, prospectively designed, observational study.Materials and methodsThe prospectively designed, observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) includes 35 US sites having enrolled over 3570 NSCLC patients at any stage and line of therapy. After enrolment and prior to therapy initiation, all patients are tested and designated HIC-Hot (HIC-H) or HIC-Cold (HIC-C). A prespecified interim analysis was performed after 1-year follow-up with the first 2000 enrolled patients. We report the overall survival (OS) of patients with advanced stage (IIIB and IV) NSCLC treated in the first-line (ICI-containing therapies n=284; all first-line therapies n=877), by treatment type and in HIC-defined subgroups.ResultsOS for HIC-H patients was longer than OS for HIC-C patients across treatment regimens, including ICI. For patients treated with all ICI regimens, median OS was not reached (95% CI 15.4 to undefined months) for HIC-H (n=196) vs 5.0 months (95% CI 2.9 to 6.4) for HIC-C patients (n=88); HR=0.38 (95% CI 0.27 to 0.53), pConclusionBlood-based HIC proteomic testing provides clinically meaningful information for immunotherapy treatment decision in NSCLC independent of PD-L1. The data suggest that HIC-C patients should not be treated with ICI alone regardless of their PD-L1 expression.
Databáze: OpenAIRE