Iovance Biotherapeutics Announces Preliminary Phase 2 Data for TIL Treatment in Head and Neck and Cervical Cancers
January 24, 2018 at 09:01 pm
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Iovance Biotherapeutics, Inc. reported preliminary clinical results from two ongoing open-label Phase 2 studies in head and neck and cervical cancers. The company reported preliminary data from C-145-03, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Three of the eight patients treated with LN-145 had a reduction in tumor size of at least 30% and qualified as a Partial Response (PR) as per RECIST 1.1 criteria. The Objective Response Rate (ORR) in the study is 38% to date. These patients had a median of 4 prior treatments for their cancer and had all received prior anti-PD-1 therapy. Two of eight had also received prior anti-CTLA-4. The most common side effects were pyrexia, chills, and hypotension. Iovance will continue to enroll patients in this study to the full sample size of 47 per protocol. The company also reported preliminary data from C-145-04, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. Two patients are currently evaluable. One treated with LN-145 had a confirmed PR and one patient had stable disease.
Iovance Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company develops and delivers tumor infiltrating lymphocyte (TIL), therapies for patients with solid tumor cancers. Its lead product candidate, Amtagvi (lifileucel), is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The Company also marketing Proleukin (aldesleukin), aninterleukin-2, or IL-2, product used in the Amtagvi treatment regimen. Its development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings for solid tumor cancers. Amtagvi and Proleukin are part of a treatment regimen that also includes lymphodepletion. The Company is also developing next generation therapies using TIL, such as genetically modified TIL cell therapy.