On January 15, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company has completed dosing the last patient in the registration-enabling Cohort 4 of the C-144-01 study of lifileucel in the treatment of patients with advanced melanoma (Press release, Iovance Biotherapeutics, JAN 15, 2020, View Source [SID1234553233]). Cohort 4 has the primary endpoint of objective response rate (ORR) to be read out by an Independent Review Committee.

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"We are quite pleased to complete patient dosing of this pivotal cohort in our study of lifileucel ahead of schedule due to increased demand, bringing this potential therapy one step closer to patients," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "We remain on track to submit a Biologics License Application (BLA) subsequent to discussions with FDA, for regulatory approval of lifileucel in late 2020. Lifileucel could be the first approved cell therapy product for solid tumors."

Iovance Tumor Infiltrating Lymphocytes (TIL) for melanoma, lifileucel, is an investigational, patient-derived cell therapy that involves a 22-day manufacturing process at a centralized facility. Cohort 4 in the C-144-01 study includes post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. Lifileucel has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track and Orphan Drug designations in advanced melanoma.