Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses

Ann Oncol. 2015 Jun;26(6):1134-1142. doi: 10.1093/annonc/mdv104. Epub 2015 Feb 26.


Background: Tecemotide is a MUC1-antigen-specific cancer immunotherapy. The phase III START study did not meet its primary end point but reported notable survival benefit with tecemotide versus placebo in an exploratory analysis of the predefined patient subgroup treated with concurrent chemoradiotherapy. Here, we attempted to gain further insight into the effects of tecemotide in START.

Patients and methods: START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer. We present updated overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type.

Results: Updated OS data are consistent with the primary analysis: median 25.8 months (tecemotide) versus 22.4 months (placebo) (HR 0.89, 95% CI 0.77-1.03, P = 0.111), with ∼20 months additional median follow-up time compared with the primary analysis. Exploratory analysis of the predefined subgroup treated with concurrent chemoradiotherapy revealed clinically relevant prolonged OS with tecemotide versus placebo (29.4 versus 20.8 months; HR 0.81, 95% CI 0.68-0.98, P = 0.026). No improvement was seen with sequential chemoradiotherapy. High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers. Interactions between lymphocyte count, NLR, or prespecified HLA alleles and treatment effect were not observed.

Conclusion: Updated OS data support potential treatment benefit with tecemotide in patients treated with concurrent chemoradiotherapy. Exploratory biomarker analyses suggest that elevated sMUC1 or ANA levels correlate with tecemotide benefit.

Clinicaltrialsgov number: NCT00409188.

Keywords: ANA; MUC1; soluble MUC1; tecemotide.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Antinuclear / blood
  • Biomarkers, Tumor / blood*
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / blood
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / immunology
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Chemoradiotherapy, Adjuvant
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Lung Neoplasms / blood
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / immunology
  • Lung Neoplasms / mortality
  • Lung Neoplasms / pathology
  • Lymphocyte Count
  • Male
  • Membrane Glycoproteins / adverse effects
  • Membrane Glycoproteins / therapeutic use*
  • Middle Aged
  • Mucin-1 / blood*
  • Mucin-1 / immunology
  • Neutrophils
  • Predictive Value of Tests
  • Proportional Hazards Models
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Antibodies, Antinuclear
  • Biomarkers, Tumor
  • Cancer Vaccines
  • L-BLP25
  • MUC1 protein, human
  • Membrane Glycoproteins
  • Mucin-1

Associated data

  • ClinicalTrials.gov/NCT00409188