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FDA grants fast track designation to LN-144 for advanced melanoma
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The FDA granted fast track designation to LN-144 for the treatment of advanced melanoma, according to the drug’s manufacturer.
LN-144 (Iovance Biotherapeutics) is an adoptive cell therapy designed to use tumor-infiltrating lymphocyte technology.
The phase 2 C-144-01 trial — expected to enroll up to 60 patients in two cohorts — is designed to evaluate LN-144 in patients with metastatic melanoma. In the first cohort, a noncryopreserved tumor-infiltrating lymphocyte product can be administered to patients. In the second cohort, a cryopreserved product is administered.
All patients in the study received prior anti-PD-1 therapy and underwent a median three previous therapies.
An analysis of 16 patients enrolled in the first cohort revealed a 29% objective response rate. One patient achieved complete response that continued more than 15 months after administration of a single tumor-infiltrating lymphocyte treatment. Most (77%) patients achieved reduction in target tumor size.
“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,” Maria Fardis, PhD, MBA, CEO of Iovance Biotherapeutics, said in a company-issued press release. “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.”