Real-World Effectiveness of Racotumomab as Maintenance Therapy in Advanced Non-Small Cell Lung Cancer Patients.

BACKGROUND: Advanced non-small cell lung cancer (NSCLC) has limited curative options and poor survival. Racotumomab, an anti-idiotype monoclonal antibody vaccine targeting tumor gangliosides, has shown efficacy in clinical trials. This study evaluated its real-world effectiveness as maintenance therapy following first-line chemotherapy. MATERIALS AND METHODS: A multi-center observational study was conducted on 162 patients with advanced NSCLC who received racotumomab from 2012 to 2024. Effectiveness was evaluated in the intention-to-treat (ITT) cohort. Overall survival (OS) was estimated, with subgroup analyses conducted according to clinical and demographic factors. RESULTS: The median OS was 14.9 months (95% CI: 11.7-18.1), and the 5-year survival rate reached 20%. Patients diagnosed with stage III disease, those with better Eastern Cooperative Oncology Group (ECOG) performance status, and individuals younger than 65 years experienced significantly longer survival. Racotumomab demonstrated a favorable hazard ratio compared to historical controls (HR 0.44 vs. supportive care; HR 0.55 vs. docetaxel). CONCLUSIONS: In the era of immune checkpoint inhibitors, these real-world results indicate a promising role for racotumomab in the maintenance setting for advanced NSCLC. These findings provide a strong rationale for further investigation of racotumomab in the context of modern immunotherapy, particularly in combination trials with other immunomodulatory antibodies, along with the validation of clinical and biologic predictive biomarkers.