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EX - 99.1 2 tm2115478d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 IOVANCE BIOTHERAPEUTICS Iovance Biotherapeutics Reports First Quarter 2021 Financial Results and Corporate Updates Expanding First - in - Class TIL Cell Therapy Platform for Solid Tumors SAN CARLOS , Calif . , May 6 , 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 first quarter 2021 financial results and corporate updates . Maria Fardis , Ph.D. , President and Chief Executive Officer of Iovance , stated , “ During the first quarter of 2021 we continued to work on our potency assays in support of a BLA for lifileucel , which is our top priority at Iovance . We continued developing multiple assays in parallel and submitted additional potency assay data to the FDA . I am also very pleased to highlight the strength of clinical data for TIL being presented at the recent and upcoming medical meetings and journal publications , including the first clinical data for TIL in combination with pembrolizumab in melanoma at the upcoming ASCO Annual Meeting . We believe durable responses for Iovance TIL in relapsed or refractory metastatic melanoma , paired with data to be presented for TIL in combination with anti - PD1 therapy in earlier treatment settings , solidify the broader potential for Iovance TIL and further demonstrate our leadership in the development , manufacturing , and potential commercialization of TIL cell therapy . " First Quarter 2021 Highlights and Recent Corporate Updates Clinical : TIL therapy , lifileucel , in melanoma : Updated data from Cohort 2 in the C - 144-01 study of lifileucel in advanced melanoma were presented at the American Association for Cancer Research ( AACR ) 2021 Annual Meeting . As of the December 2020 data cutoff for the presentation , lifileucel showed a 36.4 % overall response rate ( 4.5 % complete responses and 31.8 % partial responses ) ; median duration of response ( DOR ) was not reached at 28.1 months of median study follow up as assessed by investigators ( n = 66 ) . Available care for Cohort 2 patients is chemotherapy , with an overall response rate of four to 10 percent and overall survival of only seven to eight months . Updated Cohort 2 data has been accepted for an oral presentation at the upcoming American Society of Clinical Oncology ( ASCO ) Annual Meeting . A manuscript of the Cohort 2 data has also been accepted for a forthcoming publication in a high impact oncology journal . TIL therapy , lifileucel , in cervical cancer : The C - 145-04 study of lifileucel , formerly LN - 145 , is intended to support a BLA submission for metastatic cervical cancer . Inclusion of both pivotal cohort 1 ( post - chemotherapy ) and cohort 2 ( post - anti - PD- 1 / PDL - 1 ) in the BLA may strengthen the potential label and reflect the expected upcoming treatment landscape in cervical cancer . Patient dosing is complete in both Cohorts 1 and 2 , and enrollment continues in Cohort 3 ( lifileucel in combination with pembrolizumab in cervical cancer patients who are naïve to anti - PD - 1 therapy ) .