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Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial

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Abstract

Purpose

To present an updated survival analysis of an open-label, parallel-group, phase IIB trial of BLP25 liposome vaccine (L-BLP25) in patients with stage IIIB or IV non-small-cell lung cancer (NSCLC).

Methods

Patients were randomized to either L-BLP25 plus best supportive care (BSC) or BSC alone. Patients in the L-BLP25 arm received subcutaneous vaccinations of L-BLP25 930 μg weekly for 8 weeks, followed by maintenance vaccinations at 6-week intervals.

Results

Median survival time was 4.2 months longer in patients receiving L-BLP25 plus BSC (n = 88) than in those receiving BSC alone (n = 83; 17.2 months vs. 13.0 months, respectively; hazard ratio [HR] 0.745, 95% confidence interval [CI] 0.533–1.042). The 3-year survival rate was 31% in patients receiving L-BLP25 plus BSC and 17% in those receiving BSC (P = 0.035). In the stratified subset of patients with stage IIIB loco-regional (LR) disease, median survival time was 17.3 months longer in patients receiving L-BLP25 plus BSC (n = 35) than in those receiving BSC (n = 30; 30.6 months vs. 13.3 months, respectively; HR 0.548, 95% CI 0.301–0.999). In this subgroup, 3-year survival was 49% in patients receiving L-BLP25 plus BSC and 27% in those receiving BSC (P = 0.070).

Conclusions

Confirming the initial results, further follow-up continues to show that survival time for patients with stage IIIB/IV NSCLC was longer with L-BLP25 plus BSC compared with BSC alone, with the greatest difference seen in patients with stage IIIB LR disease.

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Acknowledgments

This trial was supported by Biomira Inc., Edmonton, Canada, in collaboration with Merck KGaA, Darmstadt, Germany. The authors take full responsibility for the content of this publication. Editorial assistance, including drafting and revision of the manuscript as directed by the authors, was provided by Ian Faulkner, International Medical Press, funded by Merck KGaA, Darmstadt, Germany.

Conflict of interest

Frank Beier is employed as a Senior Biostatistician at Merck KGaA in Darmstadt. Martin Falk is an employee of Merck KGaA. Charles Butts has provided consultancy and served on Speakers' Bureaux for Merck Serono.

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Authors and Affiliations

  1. Cross Cancer Institute, 11560 University Avenue, Edmonton, AB, T6G 1Z2, Canada

    Charles Butts

  2. CancerCare Manitoba, Winnipeg, MB, Canada

    Andrew Maksymiuk

  3. The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada

    Glenwood Goss

  4. Centre Hospitalier de l’Université de Montreal, Montreal, QC, Canada

    Denis Soulières

  5. Clatterbridge Centre for Oncology, Bebington, UK

    Ernie Marshall

  6. Universite Laval, Sainte-Foy, QC, Canada

    Yvon Cormier

  7. Juravinski Cancer Centre, Hamilton, ON, Canada

    Peter M. Ellis

  8. Western General Hospital, Edinburgh, UK

    Allan Price

  9. Fraser Valley Cancer Centre, Surrey, BC, Canada

    Ravinder Sawhney

  10. Merck KGaA, Darmstadt, Germany

    Frank Beier & Martin Falk

  11. Vancouver Cancer Centre, Vancouver, BC, Canada

    Nevin Murray

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  1. Charles Butts
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  2. Andrew Maksymiuk
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  3. Glenwood Goss
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  4. Denis Soulières
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  7. Peter M. Ellis
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  8. Allan Price
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  9. Ravinder Sawhney
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  10. Frank Beier
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Correspondence to Charles Butts.

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Butts, C., Maksymiuk, A., Goss, G. et al. Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial. J Cancer Res Clin Oncol 137, 1337–1342 (2011). https://doi.org/10.1007/s00432-011-1003-3

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  • DOI: https://doi.org/10.1007/s00432-011-1003-3

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