New Drug on the Fast Track for Melanoma Treatment

A new drug may be on the way to treat patients with advanced melanoma, as the FDA granted LN-144, which is produced by Iovance Biotherapeutics, a fast track designation. The drug uses tumor-infiltrating lymphocyte (TIL) technology to bolster the body’s immune system to attack cancer cells.
BY JASON HARRIS
PUBLISHED: SEPTEMBER 05, 2017
Maria Fardis, PhD
Maria Fardis, Ph.D.
A new drug may be on the way to treat patients with advanced melanoma, as the FDA granted LN-144, which is produced by Iovance Biotherapeutics, a fast track designation. The drug uses tumor-infiltrating lymphocyte (TIL) technology to bolster the body’s immune system to attack cancer cells.

The designation is based on data Iovance submitted from C-144-01, a phase 2 multicenter study. Efficacy data for 14 of the 16 patients who were treated showed that LN-144 induced an overall response rate (ORR) of 29 percent (four patients). Researchers observed tumor reduction in 77 percent of patients.

The purpose of the FDA’s fast track designation is to accelerate the development and regulatory review of drugs intended to treat serious conditions and fill an unmet medical need. The designation allows for a rolling review of a company’s biologic license application.

Adoptive cell therapy with TIL involves collection of autologous lymphocytes from the tumor via surgical resection, ex vivo (out of body) expansion of TIL followed by lymphodepletion using fludarabine and cyclophosphamide, then infusion of TIL. Researchers administer up to six doses of IL-2 (600,000 IU/kg) to support multiplication of TIL and engraftment.

C-144-01 is still recruiting, with the goal of enrolling 60 patients into two cohorts. In the first cohort, patients will receive noncryopreserved TIL product to be administered to patients, while patients in cohort 2 will receive a cryopreserved product. Eventually, researchers plan to add a third cohort retreating patients from the first two study arms.

Results from the study were first presented in a poster at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. The disease control rate was 64 percent (9/14) in these initial findings. At a median follow-up of 4.7 months, one patient had a complete response that last more than 15 months, three had a partial response and five had stable disease. Four patients progressed while on treatment. Median time to first response was 1.6 months.

The median age of all 16 treated patients was 54.5 years (range, 41-72). Patients also displayed a high tumor burden at baseline. The median sum of diameter for target lesions was 10.2 cm, and 81 percent of patients had stage 4 disease. Nine patients (56.3 percent) had BRAF mutations. Researchers said that BRAF status did not appear to play a role in efficacy.



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