Lion To Advance TIL to Phase III

Lion Biotechnologies’ has posted long-term follow-up data for its Phase II trial for metastatic melanoma, conducted by the National Cancer Institute (NCI) and utilizing the tumor-infiltrating lymphocyte (TIL) technology currently licensed by the company and being developed under a Cooperative Research and Development Agreement (CRADA) with the NCI. The single-site trial included 93 patients in three cohorts.

The follow-up data reported by the NCI show an Objective Response (OR) rate of 49% for patients treated with TILs alone. Objective Response is Partial Response (PR) plus Complete Response (CR), with Partial Response defined as a reduction in tumor volume of greater than 50%. Of the 43 patients in this cohort, 12% showed Complete Response, and these patients continue to live more than seven years following treatment, with no measurable disease.

Two additional cohorts of 25 patients each were treated with a combination of TILs and Total Body Irradiation (TBI). The cohort receiving TILs and 200 Gy TBI showed a 52% OR and 20% CR; the patients in the latter group continue to live more than seven years following treatment, with no measurable disease. A cohort receiving TILs therapy and 1200 Gy TBI showed 72% OR and 40% CR. Nine of the 10 patients in this cohort showing Complete Response continue to live more than six years following treatment, with no measurable disease.

Overall, patients in the three cohorts showed 22% CR, and 95% of those patients continue to live with no measurable disease for six to nine years following treatment. Based on the data, the company plans to advance to Phase III.