Rates of any adverse event leading to death were similar at 4.5% of L-BLP25-treated patients and 7.3% of placebo-treated patients, Dr. Butts said. Grade 3 or 4 potentially immune-related adverse events were low, at just two patients in both groups (0.2% vs. 0.4%).
"There really were no safety concerns seen in the trial," he said.
L-BLP25 is currently being investigated in the similarly designed phase III INSPIRE (L-BLP25 Liposome Vaccine Trial in Asian NSCLC Patients: Stimulating Immune Response) trial in 420 unresectable, locally advanced stage III NSCLC patients in Hong Kong, China, Korea, Singapore, and Taiwan.
START was supported by Merck KGaA. Dr. Butts reported a consultant/advisory role and honoraria from Merck KGaA and Merck Serono. Dr. Vansteenkiste reported a consultant/advisory role with Merck Serono and GlaxoSmithKline, and research support from Eli Lilly and AstraZeneca.