Iovance announced new LN-144 Phase 2 data in metastatic melanoma
Iovance Biotherapeutics yesterday morning announced early efficacy and safety data from Cohort 2 of the ongoing Phase 2 LN-144 metastatic melanoma trial. These data, being presented as a late-breaking poster on Friday at the Society for Immunotherapy of Cancer, show that administration of the company's Generation 2 manufacturing process in nine efficacy-evaluable metastatic melanoma patients resulted in a disease control rate of 78%, which includes three confirmed partial responders and a fourth PR awaiting confirmation, the company said.. These patients had four median prior therapies. The Gen 2 manufacturing process reduces the process time to 22 days and the cell product is cryopreserved for ease of administration and handling, it added. "The new study findings presented at SITC indicate encouraging preliminary efficacy from patients in Cohort 2 with advanced metastatic melanoma disease, who were treated with our cryopreserved TIL product LN-144," said Maria Fardis, Iovance CEO. "We are excited to be able to offer patients a TIL product manufactured with a significantly shorter process, minimizing the time a patient has to wait to receive their TIL. The cryopreservation of the product further offers the clinical sites flexibility of scheduling the patient dosing. The reduction in duration of manufacturing will reduce our manufacturing costs as well. We intend to make the decision regarding which manufacturing process to utilize for our ongoing and future clinical trials by year-end and in advance of initiation of our regulatory interactions."