Iovance Biotherapeutics Announces Clinical Data for LN-145 in Non-Small Cell Lung Cancer
June 29, 2021 at 06:30 am EDT
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Iovance Biotherapeutics, Inc. announced 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. Cohort 3B enrolled patients that had progressed on prior immune checkpoint inhibitor (ICI) therapy, including patients with oncogene-driven tumors who received prior tyrosine kinase inhibitor therapy. The overall response rate (ORR) by investigator per RECIST 1.1 was 21.4% (n=28, one complete response and five partial responses) and the disease control rate (DCR) was 64.3% following one-time treatment with LN-145 monotherapy, including two responders with PD-L1 negative tumors. Median duration of response was not reached at a median study follow up of 8.2 months. The treatment-emergent adverse event profile was consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2. All patients treated in Cohort 3B received prior anti-PD-1/L1 therapy and all six responding patients also received prior chemotherapy. Historically, ORRs of approximately 20% were reported with ICIs as second-line therapy in ICI-naïve patients who progressed on front-line chemotherapy. Iovance anticipates presenting additional Cohort 3B data at a medical meeting in the second half of 2021. The Cohort 3B data using Iovance’s TIL cell therapy are the first reported clinical data on TIL administered as a one-time monotherapy in mNSCLC from a prospective, multi-center study, and add significantly to the existing scientific data previously reported by Iovance’s collaborator H. Lee Moffitt Cancer Center. Iovance also announced that it dosed the first patient in IOV-LUN-202. Iovance previously opened the IOV-LUN-202 trial to investigate LN-145 in second-line mNSCLC where patients have progressed on one prior ICI and chemotherapy. This trial is designed to be supportive of registration.
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.