Iovance Biotherapeutics Announces Clinical Data for LN-145 in Non-Small Cell Lung Cancer at Society for Immunotherapy of Cancer Annual Meeting
November 12, 2021 at 07:01 am EST
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Iovance Biotherapeutics, Inc. announced additional clinical data for its tumor infiltrating lymphocyte (TIL) therapy LN-145 in patients with metastatic non-small cell lung cancer (mNSCLC) who enrolled in Cohort 3B of the ongoing basket study IOV-COM-202. The results are available in a poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 12-14, 2021, Washington, D.C. and virtual. The results demonstrate the feasibility of TIL cell therapy in heavily pre-treated patients with NSCLC, and warrant continued investigation of LN-145 as a single-agent and in combination in patients with mNSCLC in ongoing Iovance clinical studies IOV-LUN-202 and IOV-COM-202. Following one-time treatment with LN-145 monotherapy, the overall response rate (ORR) is 21.4% in the full analysis set (n=28) and 25% in the efficacy-evaluable set (n=24), including one complete response and five partial responses (August 24, 2021 data cutoff). Two responders, including the CR, had PD-L1 negative tumors and two responders had tumors with KRAS mutations. One complete response and one partial response are ongoing at 20.7 months and 3.0 months, respectively, at a median study follow up of 9.8 months. The treatment-emergent adverse event profile is consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2. The heavily pre-treated patients in Cohort 3B had received a median of 2 prior therapies. All patients had progressed on prior immune checkpoint inhibitor (ICI) therapy and all six responders received prior chemotherapy. TIL were most commonly grown and manufactured from tumor samples resected from the lung. Iovance is currently enrolling patients in the IOV-LUN-202 clinical study to investigate LN-145 in second-line mNSCLC where patients have progressed on prior ICI and chemotherapy. More than 20 clinical sites are currently active in the U.S. and Canada.
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.