Iovance Biotherapeutics, Inc., a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that the U.S. Food and Drug Administration(FDA) has granted Fast Track designation for LN-144, the Company’s adoptive cell therapy using its TIL technology, for the treatment of advanced melanoma.
“We are pleased that the FDA has granted Fast Track designation to LN-144 for the treatment of advanced melanoma. The Fast Track designation underscores that advanced melanoma remains a serious condition and that LN-144 may have the potential to address this unmet medical need,” said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Iovance Biotherapeutics. “We look forward to a closer interaction with the FDA as we advance the clinical development of LN-144 for the treatment of advanced melanoma.”
C-144-01 is a Phase 2 study evaluating LN-144, Iovance’s lead product, for treatment of patients with metastatic melanoma. The study is currently enrolling and is expected to enroll up to 60 patients in two cohorts: Cohort 1 allows for non-cryopreserved TIL product to be administered to patients, while Cohort 2 involves administration of a cryopreserved product. In June 2017, the Company presented a poster at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting with data from 16 patients enrolled in the first cohort of this study. The data reported showed clinically-meaningful outcomes in the evaluable patients, with a 29% Objective Response Rate (per RECIST v1.1) including one complete response continuing beyond 15 months post-administration of a single TIL treatment, and 77% of patients had reduction in target tumor size. The Phase 2 study was conducted in a heavily pre-treated patient group, all of which had received prior anti-PD-1 therapy and 88% with prior anti-CTLA-4 checkpoint inhibitors, with a median of three prior therapies.
Filed Under: Drug Discovery