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

**Authors:** Sailyn Alfonso Alemán, Haslen Cáceres Lavernia, Kirenia Camacho Sosa, Soraida C. Acosta Brooks, Orestes Santos Morales, Carmen E. Viada González, Meylán Cepeda Portales, Mayelín Troche Concepción, Loipa Medel Pérez, Leticia Cabrera Benítez, Milagros C. Domecq Salmón, Daymys Estévez Iglesias, Mayra Ramos Suzarte, Tania Crombet Ramos

PMC · DOI: 10.3390/vaccines13101035 · Vaccines · 2025-10-07

## TL;DR

This study shows that the cancer vaccine racotumomab improves survival in advanced lung cancer patients when used after initial chemotherapy.

## Contribution

The study provides real-world evidence of racotumomab's effectiveness as maintenance therapy for advanced NSCLC.

## Key findings

- Median overall survival was 14.9 months with a 20% 5-year survival rate.
- Patients with stage III disease, better ECOG status, and under 65 years had longer survival.
- Racotumomab had a better hazard ratio compared to historical controls like supportive care and docetaxel.

## Abstract

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.

## Linked entities

- **Chemicals:** docetaxel (PubChem CID 148124)
- **Diseases:** non-small cell lung cancer (MONDO:0005233), NSCLC (MONDO:0005233)

## Full-text entities

- **Diseases:** NSCLC (MESH:D002289), tumor (MESH:D009369), stage III disease (MESH:D007676)
- **Chemicals:** docetaxel (MESH:D000077143), gangliosides (MESH:D005732), Racotumomab (MESH:C000590234)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

4 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12568215/full.md

## References

47 references — full list in the complete paper: https://tomesphere.com/paper/PMC12568215/full.md

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Source: https://tomesphere.com/paper/PMC12568215