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EX - 99.1 2 tm2120950d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 IOVANCE BIOTHERAPEUTICS Iovance Biotherapeutics Announces Clinical Data for LN - 145 in Non - Small Cell Lung Cancer 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 SAN CARLOS , Calif . , June 29 , 2021 -- 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 . " 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 . "