Switch maintenance therapy with racotumomab or nimotuzumab vs docetaxel for NSCLC patients

Date

09 Oct 2016

Session

Poster display

Presenters

Maurenis Hernandez

Citation

Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378

Authors

M. Hernandez1, E. Neninger2, R.A. Ortiz3, K. Camacho4, R.M. Amador5, L. Bello6, Y. Flores7, S. Acosta8, G. Pichs9, M. Cala10, M. Corella11, Y. Jimenez12, Y. Diaz13, C.E. Viada14, M. Robina15, A. Valdes14, I.C. Mendoza15, P.P. Guerra15, A. Macias14, T. Crombet14

Author affiliations

  • 1 Clinical Research, Center of Molecular Immunology, 11600 - Havana/CU
  • 2 Clinical Oncology, Hermanos Ameijeiras Hospital, Havana/CU
  • 3 Clinical Oncology, Celestino Hernandez Hospital, Santa Clara/CU
  • 4 Clinical Oncology, Jose R Lopez Tabranes Hospital, Matanzas/CU
  • 5 Clinical Oncology, III Congreso Hospital, Pinar del Rio/CU
  • 6 Clinical Oncology, Antonio Luaces Hospital, Ciego de Avila/CU
  • 7 Clinical Oncology, National Institute of Oncology, Havana/CU
  • 8 Clinical Oncology, Saturnino Lora Hospital, Santiago de Cuba/CU
  • 9 Clinical Oncology, Celia Sanchez Hospital, Manzanillo/CU
  • 10 Clinical Oncology, Juan Bruno Zayas Hospital, Santiago de Cuba/CU
  • 11 Clinical Oncology, Vladimir Ilich Lenin Hospital, Holguin/CU
  • 12 Clinical Oncology, Camilo Cienfuegos Hospital, Sancti Spiritus/CU
  • 13 Clinical Oncology, Comandante Pinares Hospital, Artemisa/CU
  • 14 Clinical Research, Center of Molecular Immunology, Havana/CU
  • 15 Clinical Research, National coordinating Center for Clinical Trials, Havana/CU
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Background

Maintenance therapy is a common strategy in NSCLC treatment that improves PFS and OS. 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 OS. Patients are been randomized (2:2:1) to 3 arms: racotumomab-alum, nimotuzumab or docetaxel, and stratified according to response to first line. 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 are no evidences of progressive disease after 3 cycles. As switch maintenance therapy, both experimental drugs will be classified as non-inferior (NI) to docetaxel, if 1- year OS rate is 36% (HRC/T = 0.66) [ d0 (0,41), d0= - ln HR(C/T)] using a 15% NI margin. Here we report the final analysis in non-progressor patients (n = 237).

Results

93 patients in each experimental arm and 51 in docetaxel arm with at least 1 year follow up were analyzed (ITT). The median OS and 1-year survival rate were 11.4 months (CI: 7.07-12.46) and 48.3 % with nimotuzumab, 9.67 months (CI: 6.52-12.82) and 45.5 % with racotumomab-alum and 9.76 months (CI: 7.07-12.46) and 33.5 % with docetaxel, respectively. Most frequent treatment-related adverse events were induration, local erythema and pain in injection site with racotumomab-alum; myalgia, nausea and fever with Nimotuzumab, and anemia, nausea and malaise after docetaxel.

Conclusions

Racotumomab-alum [CI 90% NI (-∞;0.14)] and Nimotuzumab [CI 90% NI (- ∞; -0.002) are non-inferior to docetaxel as switch maintenance therapy. Both experimental treatments were safely administered at primary level of health assistance.

Clinical trial identification

RPCEC00000179

Legal entity responsible for the study

Cuban Ministry of Health Center of Molecular Immunology

Funding

Cuban Ministry of Health Center of Molecular Immunology

Disclosure

All authors have declared no conflicts of interest.

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