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The FDA has granted Fast Track Designation for galinpepimut-S for the treatment of malignant pleural mesothelioma (MPM) patients.

FDA; Galinpepimut-S.... - Click to enlarge in new windowFDA; Galinpepimut-S. FDA; Galinpepimut-S

Galinpepimut-S, a WT1 cancer vaccine, is a late clinical-stage immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, acute myeloid leukemia, multiple myeloma, ovarian, and other cancers. A pivotal phase III trial in patients with MPM is planned in the second half of 2017.


According to phase II MPM study data of galinpepimut-S presented at the 2016 International Mesothelioma Interest Group and the ASCO 2016 Annual Meeting:


* As of May 2016, median overall survival of 24.8 months was recorded for galinpepimut-S-treated MPM patients, compared to a median 16.6 month overall survival for patients in the control arm;


* Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit;


* Galinpepimut-S induced CD8+ and CD4+ T cell activation; and


* Galinpepimut-S demonstrated a favorable safety and tolerability profile in MPM patients and was well-tolerated by patients in the trial.