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EX - 99.1 2 tm2124236d1_ex99-1.htm EXHIBIT 99.1 IOVANCE BIOTHERAPEUTICS Exhibit 99.1 Iovance Biotherapeutics Reports Second Quarter and First Half 2021 Financial Results and Corporate Updates Expanding Leadership for TIL Cell Therapy in Solid Tumors SAN CARLOS , Calif . , August 5 , 2021 -- Iovance Biotherapeutics , Inc. ( NASDAQ : IOVA ) , a late - stage biotechnology company developing novel T cell - based cancer immunotherapies ( tumor - infiltrating lymphocyte , TIL , and peripheral - blood lymphocyte , PBL ) , today reported second quarter 2021 financial results and corporate updates . Frederick Vogt , Ph.D. , J.D. , Interim President and Chief Executive Officer of Iovance , stated , “ During the first half of 2021 we advanced our TIL pipeline and presented clinical data across multiple solid tumor indications and treatment settings , including single - agent TIL in metastatic non - small cell lung cancer and melanoma , as well as initial clinical data for TIL in combination with pembrolizumab in early line melanoma . Our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lifileucel to support our planned BLA submission . We are increasingly confident in the broad potential for TIL as the next class of paradigm - shifting therapy for cancer patients with significant unmet need . " Second Quarter 2021 Highlights and Recent Corporate Updates Regulatory Clinical Potency assays for lifileucel : Following FDA feedback regarding the potency assays for lifileucel , Iovance will continue ongoing work developing and validating its potency assays and plans to submit additional assay data and anticipates meeting with the FDA before the end of 2021. The company's biologics license application ( BLA ) submission for lifileucel is now expected to occur during the first half of 2022. Resolution of the potency assay for lifileucel in melanoma is also a key step towards our regulatory plans in other indications . TIL therapy in melanoma : 0 0 Metastatic melanoma : follow up data from Cohort 2 in the C - 144-01 study of lifileucel in advanced melanoma were presented at the American Society for Clinical Oncology ( ASCO ) 2021 Annual Meeting . As of the April 2021 data cutoff for the presentation , the overall response rate ( ORR ) was 36.4 % ( 4.5 % complete response rate and 31.8 % partial response rate ) and median duration of response ( DOR ) was not reached at 33.1 months of median study follow up as assessed by investigators ( n = 66 ) . Detailed Cohort 2 data were also published in a manuscript in the Journal of Clinical Oncology , an ASCO journal . Anti - PD - 1 naïve melanoma : initial clinical data for lifileucel in combination with pembrolizumab were presented in a poster at ASCO 2021. The ORR was 86 % and the complete response rate was 43 % at a median follow up of 8.2 months in anti - PD - 1 naïve melanoma patients in Cohort 1A in the IOV - COM - 202 basket study . ( n = 7 ) .