1210 - Long-term efficacy and safety of L-BLP25 vaccine in a multi-centre open-label study of patients with unresectable stage III NSCLC

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Non-Small-Cell Lung Cancer, Locally Advanced
Cancer Immunology and Immunotherapy
Presenter Charles Butts
Authors C.A. Butts1, R.N. Murray2, C.J. Smith3, P.M. Ellis4, K. Jasas5, A. Maksymiuk6, G. Goss7, M. Falk8, A.H. Loos9, D. Soulieres10
  • 1Department Of Oncology, Cross Cancer Institute, Edmonton/CA
  • 2Department Of Medical Oncology, Vancouver Cancer Centre, Vancouver/CA
  • 3Department Of Oncology, Tom Baker Cancer Centre, Calgary/CA
  • 4Department Of Oncology, Juravinski Cancer Centre, Hamilton/CA
  • 5Medical Oncology, Sir Charles Gairdner Hospital, Nedlands/AU
  • 6Department Of Oncology, CancerCare Manitoba, Winnipeg/CA
  • 7Medical Oncology, The Ottawa Hospital Cancer Centre, K1H 8L6 - Ottawa/CA
  • 8Global Clinical Development Unit, Merck KGaA, Darmstadt/DE
  • 9Global Biostatistics / Oncology, Merck KGaA, Darmstadt/DE
  • 10Departement Of Medicine, CHUM Hôpital Notre-Dame, Montreal/CA

Abstract

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/m2 (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 (

M. Falk: Martin Falk is a Merck Serono employee.

A.H. Loos: Dr Loos is a Merck employee.

All other authors have declared no conflicts of interest.