Iovance Biotherapeutics Inc. said the U.S. Food and Drug Administration has granted regenerative medicine advanced therapy designation to its skin cancer drug lifileucel, which could accelerate the approval process.
The San Carlos, Calif.-based company is evaluating lifileucel in a phase 2 study, dubbed C-144-01. The trial showed that 37% of patients saw their tumors shrink for between 1.3 months and 14 months.
Regenerative medicine advanced therapy designations are for regenerative medicine drugs, defined by the FDA "as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products." The designation allows for increased access to the FDA during drug development and surrogate endpoints to be used for product approval, which could hasten the approval process.
But the FDA has cautioned Iovance that a phase 3 trial of lifileucel may not be feasible in its intended population of advanced melanoma patients who have previously been treated with at least one therapy, including a PD-1 blocking antibody, among others. And so, Iovance has added a new group of 80 to 100 patients to be enrolled in what it called the Cohort 4 study. The company expects to file a biologics license application with the FDA in the second half of 2020.
In a separate study called C-145-04, lifileucel is being evaluated to treat recurrent cervical cancer. The company said that according to preliminary data, 27% of the 15 patients experienced shrinking of their tumors.
Yet another study called C-145-03 will evaluate lifileucel's effectiveness with a recurring skin cancer of the head and neck that has spread to other parts of the body. Iovance said that according to initial data, 31% of 13 patients demonstrated tumor reduction. Duration of response ranged from 2.8 months to 7.6 months.