A phase III study of belagenpumatucel-L, an allogeneic tumour cell vaccine, as maintenance therapy for non-small cell lung cancer.

Abstract

BACKGROUND:

Treatment options after first-line chemotherapy are limited in non-small cell lung cancer (NSCLC). Belagenpumatucel-L is a therapeutic vaccine comprised of 4 transforming growth factor (TGF)-β2-antisense gene-modified, irradiated, allogeneic NSCLC cell lines that may be useful for maintenance after initial treatment.

METHODS:

Stage III/IV NSCLC patients who did not progress after platinum-based chemotherapy were randomised 1:1 to receive maintenance belagenpumatucel-L or placebo. Patients were eligible for randomisation between one and four months from the end of induction chemotherapy. The primary endpoint was overall survival.

RESULTS:

This phase III trial enrolled 270 patients in the belagenpumatucel-L arm and 262 in the control arm. Belagenpumatucel-L was well tolerated with no serious safety concerns. There was no difference in survival between the arms (median survival 20.3 versus 17.8months with belagenpumatucel-L versus placebo, respectively; hazard ratio (HR) 0.94, p=0.594). There were also no differences in progression-free survival (4.3months versus 4.0 for belagenpumatucel-L vs placebo, respectively; HR 0.99, p=0.947). A prespecified Cox regression analysis demonstrated that the time elapsed between randomisation and the end of induction chemotherapy had a significant impact on survival (p=0.002) and that prior radiation was a positive prognostic factor (median survival 28.4months with belagenpumatucel-L versus 16.0months with placebo; HR 0.61, p=0.032).

CONCLUSIONS:

Although the overall trial did not meet its survival endpoint, improved survival for belagenpumatucel-L is suggested in patients who were randomised within 12weeks of completion of chemotherapy and in those who had received prior radiation. Further studies of belagenpumatucel-L in NSCLC are warranted.

• Authors: G Giaccone, L A Bazhenova, J Nemunaitis, M Tan, E Juhász, R Ramlau, M M van den Heuvel, R Lal, G H Kloecker, K D Eaton, Q Chu, D J Dunlop, M Jain, E B Garon, C S Davis, E Carrier, S C Moses, D L Shawler, H Fakhrai
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 51 Issue 16 Pg. 2321-9 (Nov 2015) ISSN: 1879-0852 [Electronic] England
• PMID: 26283035 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015. Published by Elsevier Ltd.

Chemical References

• Cancer Vaccines
• belagenpumatucel L

Topics

• Adult
• Aged
• Cancer Vaccines (adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, immunology, mortality, pathology)
• Disease Progression
• Disease-Free Survival
• Double-Blind Method
• Female
• Humans
• Intention to Treat Analysis
• Kaplan-Meier Estimate
• Lung Neoplasms (drug therapy, immunology, mortality, pathology)
• Maintenance Chemotherapy (methods)
• Male
• Middle Aged
• Proportional Hazards Models
• Time Factors
• Treatment Outcome