A Multicenter Open-Label Study to Assess the Safety of a New Formulation of BLP25 Liposome Vaccine in Patients With Unresectable Stage III Non–Small-Cell Lung Cancer

Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial

“…[6][7][8][9][10][11] Tecemotide (L-BLP25) is a MUC1 antigenspecifi c immunotherapy capable of inducing a T-cell response to MUC1 in both a preclinical MUC1-transgenic lung cancer mouse model 12 and in patients. [13][14][15] A National Cancer Institute (NCI) project to prioritise cancer antigens ranked MUC1 very highly on the basis of predefi ned criteria. 16 In a randomised phase 2 trial of tecemotide as maintenance therapy versus best supportive care in responding and stable patients with stage IIIB or IV non-small-cell lung cancer, a potential survival benefi t with tecemotide in stage IIIB patients was reported.…”

“…13,14 A single-arm phase 2 trial of tecemotide after chemoradiotherapy for unresectable stage III nonsmall-cell lung cancer showed similar survival results. 15 On the basis of these promising fi ndings, we initiated the START (Stimulating Targeted Antigenic Response To non-small-cell lung cancer) study to assess the effi cacy of tecemotide when compared with placebo as a maintenance therapy in patients with stage III non-smallcell lung cancer who have received chemoradiotherapy.…”

Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial

“…Maintenance vaccinations were administered at 6-week intervals starting at week 13, at the investigators' discretion. The nominal dose of L-BLP25 is different to that previously stated Butts et al 2010). In clinical studies prior to 2008, the density determination of L-BLP25 prior to freeze-drying of the final powdered product led to the content of L-BLP25 being declared as 1,000 lg.…”

Vaccines for the treatment of non-small cell lung cancer: Investigational approaches and clinical experience

“…This analysis indicated that the vaccine was not associated with any identifiable safety issues or autoimmune reactions [84]. Also, the safety of a new formulation of L-BLP25 with subtle changes to the monophosphoryl lipid A component of the vaccine, was the primary endpoint of a phase II study in patients with unresectable stage III NSCLC with stable disease or a clinical response to upfront chemoradiotherapy [85]. Twenty-two patients received L-BLP25 1000 g every week for eight weeks plus BSC, plus maintenance, until disease progression.…”