Phase II trial of WT1 cancer vaccine doubles progression-free survival in malignant pleural mesothelioma- SELLAS Life Sciences

SELLAS Life Sciences Group announced that results from a Phase II trial of the Company's WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM) were presented at the plenary session of the iMig 2016 Conference. Treatment with galinpepimut-S in a randomized, double-blind, placebo-controlled Phase II trial conducted at Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center resulted in improved overall survival in patients with MPM and doubling of progression-free survival. The trial showed a median overall survival of 21.4 months for WT1 vaccine-treated patients versus a median 16.6 months overall survival for patients in the placebo control arm.

The WT1 cancer vaccine also resulted in a median progression-free survival of 11.4 months, double that of the control arm, 5.7 months, in patients with MPM. The WT1 vaccine demonstrated a favorable safety and tolerability profile in MPM patients. Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit. Patients who mounted an immune-response with galinpepimut-S had a significant survival benefit. Finally, galinpepimut-S was very well tolerated by patients in this trial. Based on these results, SELLAS is preparing to initiate a pivotal Phase IIb/III trial of its WT1 vaccine in patients with MPM by the third quarter of 2016.

Comment: In April 2016 the European Medicines Agency announced Orphan Drug Designation for the Company's WT1 cancer vaccine for the treatment of patients with acute myeloid leukemia and patients with malignant pleural mesothelioma.