Abstract CT170: A phase II, multicenter study to evaluate the efficacy and safety 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
Authors: Leidner Rom , Sukari Ammar , Chung Christine , Ohr James , Haigentz Missak , Cohen Ezra , Brown Robert , Suzuki Sam , Gorbatchevsky Igor , Fardis Maria , Ferris Robert L. 
Published: August 2018

Abstract
Adoptive cell therapy (ACT) may be effective in treating immunogenic tumors with high mutational load, such as melanoma and virally-associated tumors, like cervical cancer, with several patients in studies performed at various institutions achieving durable, complete responses for years. Despite the heterogeneity of squamous cell carcinomas of the head and neck (HNSCC), most tumors are either virally-associated (e.g., HPV in oropharyngeal) or carry high mutational load (e.g., tobacco-related) providing an increased diversity of potential targets ideal for the polyclonal nature of ACT. Furthermore, outcomes for patients with recurrent and/or metastatic HNSCC remain poor. Therefore, a clear rationale exists for the potential application of ACT in patients with HNSCC. Clinical trial C-145-03 (NCT03083873) is a prospective phase II multicenter, open-label study evaluating the efficacy of a single autologous tumor infiltrating lymphocyte infusion (LN-145) followed by IL-2 after a non-myeloablative lymphodepletion (NMA-LD) regimen in patients with recurrent and/or metastatic HNSCC. Study-related therapy begins with resection of a tumor lesion that is then shipped to a central GMP manufacturing facility where TIL are extracted, expanded, packaged, and shipped for administration (LN-145). One week prior to LN-145 infusion, patients undergo NMA-LD consisting of cyclophosphamide (60 mg/kg) daily x 2 days followed by fludarabine (25 mg/m2) daily x 5 days. LN-145 is infused 24 hours after the last dose of fludarabine followed by up to 6 doses of IL-2 (600,000 IU/kg) every 8-12 hours. The primary efficacy endpoints are the objective response rate per RECIST v1.1 and the safety summarization of treatment-emergent adverse events (AEs) including serious AEs, AEs leading to discontinuation, and clinical laboratory tests. Secondary efficacy endpoints include CR, DOR, PFS, and OS. Patients must have been treated with at least one systemic chemotherapy or immunotherapy treatment for recurrent and/or metastatic HNSCC and, in addition to the tumor targeted for excision and TIL manufacture, must have an additional measurable lesion for assessment of response. Additional eligibility criteria include amongst others: adequate bone marrow, liver, pulmonary, cardiac, and renal function; ECOG performance status of 0 or 1. Systemic steroids greater than 10 mg/day prednisone equivalents are prohibited as are a history of serious immunotherapy-related adverse events.
Citation Format: Rom Leidner, Ammar Sukari, Christine Chung, James Ohr, Missak Haigentz, Ezra Cohen, Robert Brown, Sam Suzuki, Igor Gorbatchevsky, Maria Fardis, Robert L. Ferris. A phase II, multicenter study to evaluate the efficacy and safety 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 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr CT170.