A phase III study of belagenpumatucel-L, an allogeneic tumour cell vaccine, as maintenance therapy for non-small cell lung cancer. Issue 16 (November 2015)

• Record Type: Journal Article
• Authors: Giaccone, G.; Bazhenova, L.A.; Nemunaitis, J.; Tan, M.; Juhász, E.; Ramlau, R.; van den Heuvel, M.M.; Lal, R.; Kloecker, G.H; Eaton, K.D.; Chu, Q.; Dunlop, D.J.; Jain, M.; Garon, E.B.; Davis, C.S.; Carrier, E.; Moses, S.C.; Shawler, D.L.; Fakhrai, H.
• Is Part Of: European journal of cancer. Volume 51:Issue 16(2015:Nov.)
• Page Start: 2321
• Page End: 2329
• Publication Date: 2015-11
• Subjects: Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2015.07.035
• Languages: English
• ISSNs: 0959-8049

Abstract

<abstract xml:lang="en" abstract-type="author" id="ab005"> <title id="st080">Abstract</title> <sec> <title id="st085">Background</title> <p id="sp0005">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.</p> </sec> <sec> <title id="st090">Methods</title> <p id="sp0010">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.</p> </sec> <sec> <title id="st095">Results</title> <p id="sp0015">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 17.8 months with belagenpumatucel-L versus placebo, respectively; hazard ratio (HR) 0.94, <italic>p</italic> = 0.594). There were also no differences in progression-free survival (4.3 months versus 4.0 for belagenpumatucel-L vs placebo, respectively; HR 0.99, <italic>p</italic> = 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 (<italic>p</italic> = 0.002) and that prior radiation was a positive prognostic factor (median survival 28.4 months with belagenpumatucel-L versus 16.0 months with placebo; HR 0.61, <italic>p</italic> = 0.032).</p> </sec> <sec> <title id="st100">Conclusions</title> <p id="sp0020">Although the overall trial did not meet its survival endpoint, improved survival for belagenpumatucel-L is suggested in patients who were randomised within 12 weeks of completion of chemotherapy and in those who had received prior radiation. Further studies of belagenpumatucel-L in NSCLC are warranted.</p> </sec> </abstract>