A randomized, multicenter, pacebo-controlled clinical trial of Racotumomab-alum vaccine as switch maintenance therapy in advanced non-small cell lung cancer patients
Clin Cancer Res 2014; 20(14):1-12
Pivotal, multicenter, placebo-controlled clinical trial show the efficacy and safety of Racotumomab as switch maintenance therapy in patients with advanced NSCLC. 176 patients with stage IIIb/IV NSCLC who have at least stable disease after 1st line therapy, were randomized to receive Racotumomab (87) or placebo (89).The intent to treat median overall survival was 8.23 months for the Racotumomab group versus 6.80 months for the control group (HR 0.63, p = 0.004). Median intent- to-treat progression free survival was 5.33 vs 3.90 months, (HR 0.73, p: 0.039). The product was well tolerated. The most common adverse events were burning and pain at the site of administration, bone pain and asthenia.
A high antibody response against NeuGcGM3 gangliosides was obtained. Patients who devoloped a high level of cytotoxicity had longer survival.