Iovance is planning to submit a BLA for lifileucel in metastatic melanoma next year in the wake of positive Phase II data for the cell therapy in patients previously treated with an anti-PD-1 therapy
Shares of Iovance Biotherapeutics Inc. (NASDAQ:IOVA) rose $2.96 (14%) to $23.62 Friday after the company reported data from Cohort 2 of the Phase II C-144-01 study at the Society for Immunotherapy of Cancer (SITC) meeting in National Harbor, Md.
Lifileucel led to an independent review committee-assessed overall response rate (ORR) of 35% in 66 patients. BRAF V600-positive patients in the study were also previously treated with a BRAF inhibitor alone or in combination with a MEK inhibitor.
At 11.3 months, the median duration of response hadn't been reached.
Iovance produces lifileucel by expanding tumor-infiltrating lymphocytes isolated from tumor tissue, and the autologous cell therapy could treat patients that don't respond to or relapsed on PD-1 inhibitors, a standard of care.
By expanding the T cells ex vivo, the company believes it can bypass tumor microenvironment's immunosuppression mechanisms, which include tumor cell express of T cell checkpoint proteins and inhibition of T cell proliferation and activation.
The company is enrolling patients in the pivotal cohort of the Phase II study, which will serve as the basis for its BLA submission in late 2020. Lifileucel has Fast Track, Orphan Drug and regenerative medicine advanced therapy (RMAT) designations from FDA in the indication.