21.4% Overall Response Rate (ORR) in Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer (mNSCLC) Patients Following One or More Prior Systemic Therapies Including Immunotherapy
First Patient Dosed in Registration-Supporting IOV-LUN-202 Study in Second Line mNSCLC
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today 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 initial clinical results are available in a slide presentation on the Iovance website here.
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.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, “There remains a very significant unmet need to increase response rates and prolong survival in the second line non-small cell lung cancer treatment setting. The initial data for LN-145 in this difficult to treat patient population is very promising.”
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