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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

6150 - Efficacy of racotumomab or nimotuzumab vs docetaxel as second-line therapy for advanced non-small cell lung cancer patients

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Maurenis Hernandez

Citation

Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288

Authors

M. Hernandez1, E. Neninger2, E. Santiesteban3, K. Camacho3, N. Hernandez4, R. Amador5, S. Acosta6, Y. Gonzalez7, Y. Jimenez8, M. Corella9, R.A. Ortiz10, L. Bello11, A. Calana12, G. Pichs13, M. Cala14, Y. Flores15, C. Viada16, M. Robaina17, T. Crombet Ramos18

Author affiliations

  • 1 Clinical research, Center of Molecular Immunology, 0000 - Havana/CU
  • 2 Clinical Oncology, Hospital Clinico Quirurgico Hermanos Ameijeiras, 10300 - Havana/CU
  • 3 Clinical Oncology, Jose R. Lopez Tabranes Hospital, 0000 - Matanzas/CU
  • 4 Clinical Oncology, Miguel Enriquez Hospital, 000 - La Habana/CU
  • 5 Clinical Oncology, III Congreso Hospital, Pinar del Rio/CU
  • 6 Clinical Oncology, Saturnino Lora Hospital, Santiago de Cuba/CU
  • 7 Clinical Oncology, Comandante Pinares Hospital, Artemisa/CU
  • 8 Clinical Oncology, Camilo Cienfuegos Hospital, Sancti Spiritus/CU
  • 9 Clinical Oncology, Vladimir I. Lenin Hospital, Holguin/CU
  • 10 Clinical Oncology, “Celestino Hernández” Hospital, Villa Clara/CU
  • 11 Clinical Oncology, Antonio Luaces Iraola Hospital, Ciego de Avila/CU
  • 12 Clinical Oncology, Gustavo Aldereguia Lima Hospital, Cienfuegos/CU
  • 13 Clinical Oncology, Celia Sanchez Manduley Hospital, Granma/CU
  • 14 Clinical Oncology, Juan Bruno Zayas Hospital, Santiago de Cuba/CU
  • 15 Clinical Oncology, National Institute of oncology and Radiobiology, La Habana/CU
  • 16 Clinical research, Center of Molecular Immunology, La Habana/CU
  • 17 Clinical research, National Coordinating center for Clinical Trials, La Habana/CU
  • 18 Clinical research, Center of Molecular Immunology, 11600 - Havana/CU
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Resources

Abstract 6150

Background

Racotumomab-alum is an anti-idiotypic vaccine that induces immunological response against N-glycolilated gangliosides in NSCLC patients. Nimotuzumab is a humanized anti-EGFR monoclonal antibody that has shown activity in NSCLC patients. The aim of this study is to evaluate safety and efficacy of racotumomab-alum or nimotuzumab versus docetaxel as second line or switch maintenance therapy for advanced NSCLC.

Methods

This phase III, multicenter, open label, randomized trial is designed to enroll 743 stage IIIB-IV NSCLC patients, after first line therapy, with PS 0-2, with written informed consent. The primary endpoint is Overall Survival (OS). Patients are been randomized (2:2:1) to 3 arms: racotumomab-alum, nimotuzumab or docetaxel, and stratified according to response to first line (progressor or non-progressor patients). Racotumomab-alum treatment consists in 5 bi-weekly intradermal doses and re-immunizations every 4 weeks. Nimotuzumab arm receives 6 weekly infusions followed by bi-weekly doses. Docetaxel is used at 75 mg/m2 for 6 cycles, if there is no evidence of progressive disease after 3 cycles. As second-line therapy, both experimental drugs will be classified as non-inferior (NI) to docetaxel, if 1- year OS rate is 23.1 % and HR C/T=0.76, [d0 (0,28), d0= - ln HR(C/T)] using a 10% NI margin. Here we report the interim analysis in 255 progressor patients.

Results

106 patients in racotumomab, 97 in nimotuzumab and 54 in docetaxel arm with at least 1 year follow up were analyzed (ITT). The median OS and 1-year survival rate were 4.67 months (CI: 4.0-5.3) and 14.5 % with nimotuzumab, 4.83 months (CI: 3.7-5.9) and 23.5 % with racotumomab-alum and 5.85 months (CI: 3.9-7.7) and 20.2 % with docetaxel, respectively. Most frequent treatment-related adverse events were induration (10.7%), local erythema in injection site (8.8%) and arthralgia (8.2%) with racotumomab-alum; myalgia (12.1%), fever (7.9%) and nausea (7.0%) with nimotuzumab, and nausea (16.5%), asthenia (13.2%) and vomiting (12.1%) after docetaxel.

Conclusions

These data do not confirm the non-inferiority of racotumomab-alum or nimotuzumab versus docetaxel as second-line therapy. Both experimental treatments were safely administered at primary level of health assistance.

Clinical trial identification

RPCEC0000017.

Legal entity responsible for the study

Center of Molecular Immunology.

Funding

Center for Molecular Immunology.

Editorial Acknowledgement

Disclosure

M. Hernandez, C. Viada, T. Crombet: Employed: Center of Molecular Immunology. All other authors have declared no conflicts of interest.

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