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Annals of Oncology
1210 LONG-TERM EFFICACY AND SAFETY OF L-BLP25 VACCINE
IN A MULTI-CENTRE OPEN-LABEL STUDY OF PATIENTS
WITH UNRESECTABLE STAGE III NSCLC
C. Butts 1 , R.N. Murray 2 , C.J. Smith 3 , P.M. Ellis 4 , K. Jasas 5 , A. Maksymiuk 6 ,
G. Goss 7 , M. Falk 8 , A.H. Loos 9 , D. Soulières 10
1 Department of Oncology, Cross Cancer Institute, Edmonton, AB, CANADA,
2 Department of Medical Oncology, Vancouver Cancer Centre, Vancouver, BC,
CANADA, 3 Department of Oncology, Tom Baker Cancer Centre, Calgary,
CANADA, 4 Department of Oncology, Juravinski Cancer Centre, Hamilton, ON,
CANADA, 5 Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, WA,
AUSTRALIA, 6 Department of Oncology, CancerCare Manitoba, Winnipeg, MB,
CANADA, 7 Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON,
CANADA, 8 Global Clinical Development Unit, Merck KGaA, Darmstadt,
GERMANY, 9 Global Biostatistics / Oncology, Merck KGaA, Darmstadt,
GERMANY, 10 Departement of Medicine, CHUM Hôpital Notre-Dame, Montreal,
QC, CANADA
Introduction: L-BLP25 (Stimuvax®) is an antigen-specific cancer immunotherapeutic
agent targeting the mucin 1 tumour-associated antigen. Phase IIb data suggest
prolonged overall survival with L-BLP25 when administered after completion of
chemoradiotherapy for locally advanced non-small-cell lung cancer (NSCLC;
non-significant). This study was initiated in April 2005 to obtain safety data when
modifications of the adjuvant component of the immunotherapeutic were performed.
Here we report an updated analysis of long-term data based on the cut-off date 18
May 2011.
Methods: The primary objective of this open-label phase II study was to evaluate the
safety of the new formulation of L-BLP25 in patients with unresectable stage IIIA/B
NSCLC, with a secondary objective of assessment of survival time. Following
completion of initial chemoradiotherapy, patients with stage III NSCLC received
treatment with L-BLP25 starting with weekly injections over 8 weeks, followed by
injections given every 6 weeks from week 13 onwards until disease progression. A
single low dose of intravenous cyclophosphamide 300 mg/m 2 (maximum 600 mg)
was given 3 days before first vaccination.
Results: Twenty-two patients were enrolled. After a median follow-up of 70.3
months (median treatment duration 9.9 months [range, 1–73]), median survival time
was 51.9 months (95%CI, 17.5, not estimable [NE]) and median progression-free
survival was 31.4 months (95%CI, 5.7, NE). Five-year survival was 50% (95%CI, 29–
71%); previously reported 1- and 2-year survival rates, 82% (95%CI, 66–98%) and
64% (95%CI, 44–84%), respectively. Four patients survived more than 72 months.
Safety findings were consistent with previous reports; adverse events (AEs) consisted
mainly of fatigue (59%), injection-site reactions (55%) and mild-to-moderate
influenza-like illness. Two serious treatment-emergent AEs were assessed as being
treatment-related: cholecystitis and pneumonia.
Conclusions: Long-term follow-up of this small patient population provides
encouraging survival data for L-BLP25 maintenance therapy in stage III NSCLC.
Long-term safety data were consistent with previous reports and did not reveal any
new safety issues.
Disclosure: C. Butts: Charles Butts has provided consultancy and served on Speakers’
Bureaux for Merck Serono. A. Maksymiuk: Andrew Maksymiuk has some stock
shares in Merck Canada (