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• W3207894443 abstract "The presence of tumor-infiltrating lymphocytes (TIL) in the tumor microenvironment is associated with survival outcomes in many solid tumors, including melanoma (Mel), head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC). Lifileucel (LN-144), has shown efficacy with durable responses in advanced Mel (Sarnaik et al., ASCO 2020) and metastatic cervical cancer (Jazaeri et al., ASCO 2019). Activity of LN-145 in combination with pembrolizumab in HNSCC has also been demonstrated (Jimeno et al., SITC 2020). TIL therapy has shown evidence of efficacy in metastatic NSCLC in a Phase 1 study (Creelan et al., ASCO 2020). Combination of TIL and immune checkpoint inhibitors (ICIs) in ICI-naïve patients have not been previously investigated. This combination offers an alternative treatment to traditional chemotherapy in multiple indications with a one-time treatment of TIL therapy. IOV-COM-202 (NCT03645928) is an actively enrolling, Phase 2 global, open-label multi-cohort, non-randomized study designed to evaluate the safety and efficacy of TIL therapy as a single agent or in combination with immune checkpoint inhibitors. All patients receive either, lifileucel, LN-144 Gen 3, LN-145 or LN-145-S1 (PD-1 select TIL), which is manufactured at centralized GMP facilities generating a cryopreserved infusion product which is shipped to the treatment centers. Cohorts 1, 2 and 3 enroll Mel, HNSCC and NSCLC patients, respectively (Table 1). Patients undergo a nonmyeloablative lymphodepletion (NMA-LD) regimen prior to TIL infusion, followed by up to 6 doses of intravenous IL-2. Patients in Cohorts 1A, 2A, and 3A start pembrolizumab following tumor harvest for TIL generation, but prior to NMA-LD. Pembrolizumab is dosed per label. Patients in Cohorts 1B, 1C and 3B receive LN-145-S1, lifileucel, and LN-145, respectively. Cohort 3C patients receive a dose of ipilimumab and nivolumab prior to tumor harvest, with nivolumab continuing Q4W for up to 2 years, or until progression or unacceptable toxicity. Key eligibility includes: ≥ 18 years of age; RECIST measurable disease; ≥ 1 lesion(s) available for TIL generation; ECOG PS 0-1. Primary endpoint: ORR per RECIST v1.1. Secondary endpoints: safety, CR rate, DOR, DCR, PFS, and OS.Table 1IOV-COM-202 Study DesignCOHORTPATIENT POPULATIONSAMPLE SIZETREATMENT REGIMEN1AMelanoma: PD-1/PD-L1 naiveN = 12Lifileucel + pembrolizumab1BMelanoma: ≥ 1 prior systemic therapy(ies)N = up to 27LN-145-S1 as single agent1CMelanoma: ≥ 1 prior systemic therapy(ies)N = up to 27LN-144 Gen 3 as single agent2AHNSCC: PD-1/PD-L1 naiveN = 19LN-145 + pembrolizumab3ANSCLC: PD-1/PD-L1 naiveN = 12LN-145 + pembrolizumab3BNSCLC: ≥ 1 prior systemic therapy(ies)N = 12LN-145 as single agent3CNSCLC: 1 prior systemic therapyN = up to 26LN-145 + ipilimumab + nivolumab Open table in a new tab ▪▪▪ ▪▪▪" @default.
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• W3207894443 date "2021-10-01" @default.
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• W3207894443 title "P14.05 Phase 2, Study of Iovance Autologous Tumor Infiltrating Lymphocytes (Lifileucel, LN-144, LN-145, LN-145-S1) In Patients With Solid Tumors" @default.
• W3207894443 doi "https://doi.org/10.1016/j.jtho.2021.08.335" @default.
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