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 Immunotherapy
Non-Small Cell Lung Cancer
Therapy
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.