Safety and Efficacy of Racotumomab-Alum Vaccine as Second-Line Therapy for Advanced Non-Small Cell Lung Cancer

Abstract

Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The aim of this study was to evaluate safety and efficacy of racotumomab-alum in advanced NSCLC patients with progressive disease. This expanded access program included 86 histologically confirmed NSCLC patients, 18 years or older age, with advanced disease and without therapeutic option, with ECOG performance status ≤3, adequate organ functions and signed informed consent. The primary endpoint was overall survival and toxicity was measure assessed treatment-related toxicity according CTCAEv3. The study was approved by ethical review boards of participant institutions. Racotumomab-alum treatment consisted in 5 biweekly intradermal doses (1 mg/mL) during the induction phase of treatment (2 months). The maintenance phase consisted in monthly re-immunizations until unacceptable toxicity or PS worsening. The median overall survival time of all patients treated with racotumomab-alum was 8.96 months. The survival rates at 12 and 24 months were 42.8% and 28.0%, respectively. Patients that completed the induction phase of treatment (five doses or more) reached a median OS of 12.1 months. The most common adverse events were injection site reaction, bone pain, cough and asthenia. Racotumomabalum cancer vaccine could be considered an effective and safe treatment option as second-line * First share authorship. # Corresponding author. E. Santiesteban et al. 845 therapy for advanced NSCLC. Further clinical studies should be conducted to confirm this result.

Racotumomab in Non-Small Cell Lung Cancer as Maintenanceand Second-Line Treatment

“…[47] A multicenter study evaluating survival in patients with non-small cell carcinoma treated with racotumomab as second-line therapy reported an overall survival of 8.9 months. [48] In the present study, overall survival from the start of immunization in 35 patients treated with racotumomab as second-line was 6.8 months, slightly lower than that reported by Rittmeyer and by Santiesteban, [47,48] who also did not perform molecular studies to stratify patient treatment according to mutations or immunohistochemistry. Our patients who received treatment in…”

“…stage IV attained 10.2 months of survival, exceeding that reported by Rittmeyer [47] and Santiesteban, [48] and also superior to our results for stage IIIB, although the latter sample included only 4 patients.…”

Cellular and molecular immunology of lung cancer: therapeutic implications

“…Vaccines that target epidermal growth factor (EGF) or its cell membrane receptor (EGFR), often overexpressed in epithelial tumors including lung cancer, have been evaluated in early clinical trials [15]. Racotumomab (formerly IE10), which incorporates a Neu-glycosylated sialic acid-containing ganglioside (NeuGc-GM3) expressed on tumor cell surfaces, was evaluated in a phase II/III trial [147,148], with promising extension of both overall and progression-free survival and well tolerated effects. Use of racotumomab as switch maintenance therapy followed by second line therapy is currently being investigated in a phase III trial (NCT01460472).…”