September 20, 2016
1 min read

FDA grants fast track designation to galinpepimut-S for malignant plural mesothelioma

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The FDA granted fast track designation to galinpepimut-S for the treatment of malignant pleural mesothelioma, according to the drug’s manufacturer.

“This fast track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma ... [We] expect the fast track designation to expedite the time to market, thereby enhancing the value proposition of galinpepimut-S in this indication,” Angelos M. Stergiou, MD, vice chairman and CEO of SELLAS Life Sciences Group, said in a press release.

Galinpepimut-S (WT1 cancer vaccine, SELLAS Life Sciences Group) — a late clinical-stage immunotherapy — was evaluated in a randomized, double blind, placebo-controlled phase 2 study that included 40 patients with malignant pleural mesothelioma treated at Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center.

Results — presented this year at the ASCO Annual Meeting and the International Mesothelioma Interest Group— showed median OS was 24.8 months among patients treated with galinpepimut-S compared with 16.6 months in the control arm. The survival benefit was even greater among patients with a complete tumor resection who were subsequently treated with galinpepimut-S.

The cancer vaccine also induced CD8–positive and CD4–positive T-cell activation, and demonstrated a favorable safety and tolerability profile.

A pivotal phase 3 trial in patients with malignant pleural mesothelioma is scheduled to begin in the second half of 2017.

The vaccine also is being developed to target hematologic cancers and solid tumors, including acute myeloid leukemia, multiple myeloma, ovarian cancer and other cancers. Clinical studies are underway to evaluate galinpepimut-S in patients with multiple myeloma, as well as in combination with nivolumab (Opdivo, Bristol-Myers Squibb) to treat ovarian cancer.

“SELLAS has made rapid progress against its strategic goals in the past 6 months, and this milestone follows the FDA's fast track designation for AML, and recent orphan drug designations in the U.S. and Europe for galinpepimut-S in both AML and malignant pleural mesothelioma,” Stergiou said.