START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer.

• DOI: 10.1200/jco.2013.31.15_suppl.7500
• Publication Date: 2020-03-11T15:43:13Z
• Authors: Charles Andrew Butts; Mark A. Socinski; Paul Mitchell; Nick Thatcher; Libor Havel; Maciej Jerzy Krza...; Sergiusz Nawrocki; Tudor-Eliade Ciul...; Lionel Bosquée; Jose Manuel Trigo...; Alexander I. Spira; Lise Tremblay; Jan Nyman; Rodryg Ramlau; Christoph Helwig; Martin H. Falk; Frances A. Shepherd
• Keywords: Clinical endpoint

7500 Background: L-BLP25 is a MUC1 antigen specific cancer immunotherapy. We report results from the phase III START study of in patients (pts) not progressing after primary chemoradiotherapy (CRT) for stage NSCLC. Methods: From Jan 2007 to Nov 2011, 1513 pts with unresectable NSCLC that did progress CRT (platinum based chemo and ≥50 Gy) were randomized (2:1; double-blind) (806 µg lipopeptide) or placebo (PBO) SC weekly x 8 then Q6 weeks until disease progression withdrawal. Cyclophosphamide 300 mg/m 2 1 saline was given 3 days prior first L-BLP25/PBO dose. Primary endpoint overall survival (OS). Results: The analysis population (n=1239) defined prospectively try account clinical hold by excluding 6 months (m) before hold. Arms balanced baseline characteristics. Median age 61 y; 38.2% had IIIA 61.3% IIIB; 65% concurrent 35% sequential CRT. OS 25.6 m vs. 22.3 PBO (adjusted HR 0.88, 95% CI 0.75-1.03, p=0.123). Secondary endpoints time-to-progression time-to-symptom-progression support consistency results: 0.87 (95% 0.75-1.00, p=0.053) 0.85 0.73-0.98, p=0.023). In predefined subgroup analyses, (n=806) median 30.8 (L-BLP25) 20.6 (PBO; 0.78, 0.64-0.95, p=0.016), while 19.4 24.6 1.12, 0.87-1.44, p=0.38; interaction p=0.032, Cox PH model). Sensitivity analyses revealed there no benefit (HR 1.09, 0.75-1.56, p=0.663). LEBLP25 well tolerated safety concerns identified emergent evidence immune related adverse events. Conclusions: maintenance therapy tolerated, but significantly prolong OS. showed smaller treatment effect due hold, suggesting longer uninterrupted required. Clinically meaningful prolongation observed Clinical trial information: NCT00409188.