Benzinga | Jun 29, 2021 06:32AM EDT

Iovance Biotherapeutics Announces Clinical Data For LN-145 ; Showed 21.4% Overall Response Rate In Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer Patients Following One Or More Prior Systemic Therapies Including Immunotherapy

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-na?ve 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."

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 today 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.

Dr. Graf Finckenstein also stated: "We are excited to share our initial results for LN-145 in non-small cell lung cancer, a new potential indication for Iovance TIL cell therapy, which show positive outcomes in patients with high unmet medical need. We see a substantial opportunity to advance LN-145 in the post-ICI setting for patients with lung cancer. These data also have the potential to drive momentum with enrollment in our registration supporting study, IOV-LUN-202, as well as in two additional non-small cell lung cancer cohorts in IOV-COM-202, and we move ahead with great enthusiasm."