Lion Biotech Funds Moffit Cancer Trial Expansion
Lion Biotech has signed into a clinical trial grant agreement with Moffitt Cancer Center to fund the expansion of an ongoing Phase I cancer study of Lion’s tumor infiltrating lymphocytes (TILs) in combination with Bristol-Myers Squibb’s ipilimumab in patients with metastatic melanoma.
The Moffit trial’s primary objective is to investigate the initial efficacy and safety of the TIL-Yervoy combination treatment as a first line therapy. The study’s secondary endpoints include tumor shrinkage as overall response rate and progression-free survival.
As part of the agreement, Lion will grant funding to Moffitt for the enrolment of an additional ten qualified participants resulting in 20 trial participants.
TIL therapy is an investigational melanoma treatment developed at the National Cancer Institute. TIL is a type of adoptive cell therapy that requires T-cell extraction from a patient’s tumors. These T-cells are then multiplied, creating thousands in the lab, and re-introduced into the patient to fortify their immune response. In the expanded study, the co-stimulatory antibody CD137 will be used to speed the growth of the T-cells.
Ipilimumab is an immune checkpoint inhibitor marketed by pharmaceutical firm Bristol-Myers Squibb under the brand name Yervoy. The immunotherapy drug has been shown to extend life of patients by up to 10 years. Indeed, last month, the National Institute for Health and Care Excellence (NICE) gave a final draft guidance recommending Yervoy as a first line treatment for patients with advanced and inoperable melanoma, based on new evidence supporting the drug’s efficacy.
Amod Sarnaik, expert in adoptive cell treatment and the trial's chief investigator, said, “Clinical evidence suggests that combining TILs with checkpoint inhibitors, such as ipilimumab, may provide greater benefit to a larger number of patients than either therapy alone. We look forward to further investigating the synergies of this promising treatment combination in the expanded trial, which we are actively enrolling.”