On August 17, 2017 Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, reported the publication of results in the Journal of Clinical Oncology from a National Cancer Institute (NCI) study evaluating the safety and efficacy of a MAGE A3 T cell receptor (TCR) engineered T-cell therapy (Press release, Kite Pharma, AUG 17, 2017, View Source [SID1234520274]). The cancer testis antigen MAGE A3 is frequently found in many cancers including bladder, esophageal, cervical, head and neck, lung, and ovarian cancers, among others. The research, led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at NCI’s Center for Cancer Research, was performed, in part, pursuant to a Cooperative Research and Development Agreement (CRADA) between NCI and Kite.
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In this dose-escalation study, 17 patients with a variety of metastatic solid tumors were treated with a single dose of a MHC class II (HLA-DPB*0401)-restricted MAGE A3 TCR engineered T-cell therapy after a chemotherapy conditioning regimen. Responses were observed in 4 patients, including a complete remission (CR) in a patient with metastatic cervical cancer that is ongoing at 29 months. Among the 9 patients treated at the target dose level, evidence of tumor regression was seen in 3 patients with esophageal cancer, urothelial cancer, and osteosarcoma. All three responders had significant levels of the TCR engineered T cells in blood, at 1 month post-treatment. The patient with urothelial cancer remains in partial remission at 19 months. No unexpected off-target toxicity was seen, and there were no treatment-related deaths.
“We are very excited by the results of this study conducted by our collaborators at the NCI, demonstrating the potential of TCR engineered T-cell therapy in common solid tumors,” said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. “The KITE-718 program is built upon this proof of concept study and incorporates Kite’s next generation T-cell manufacturing technology that is designed to enhance cell expansion and persistence. The findings from the NCI study will help inform us as we advance KITE-718 for the treatment of metastatic solid cancers, for which there is a great unmet medical need.”
KITE-718 is a single-arm, dose escalation study evaluating the safety and efficacy of T cells engineered with the same TCR used in the NCI study in patients with advanced cancers. KITE-718 is currently enrolling patients. For more information on KITE-718, please visit www.clinicaltrials.gov (NCT03139370).