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EX - 99.1 2 tm2131899d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 IOVANCE BIOTHERAPEUTICS Iovance Biotherapeutics Reports Third Quarter and Year - to - Date 2021 Financial Results and Corporate Updates Advancing TIL Platform in Multiple Solid Tumors and Treatment Settings -- SAN CARLOS , Calif . , November 4 , 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 third quarter and year - to - date 2021 financial results and corporate updates . Frederick Vogt , Ph.D. , J.D. , Interim President and Chief Executive Officer of Iovance , stated , “ During 2021 , we have continued to report long - term clinical data demonstrating the durability of one - time treatment with lifileucel in metastatic melanoma while broadening the potential for TIL cell therapy to address more patients in additional indications and treatment settings . We look forward to highlighting our TIL cell therapy platform at the upcoming Society for Immunotherapy of Cancer annual meeting . Our top priority remains our ongoing work to address feedback from the U.S. Food and Drug Administration ( FDA ) regarding the potency assays for lifileucel to support our planned biologics license application ( BLA ) submission . We remain increasingly confident in the broad potential for TIL as the next class of paradigm - shifting therapy for cancer patients with significant unmet need . " Third Quarter 2021 Highlights and Recent Corporate Updates Regulatory Clinical Potency assays for lifileucel : Following FDA feedback regarding the potency assays for lifileucel , Iovance has continued ongoing work developing and validating its potency assays and has engaged in discussions with the FDA during the second half of 2021. The anticipated BLA submission for lifileucel continues to be planned for 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 . U.S. FDA Fast Track designation for lifileucel in combination with pembrolizumab in metastatic melanoma : The FDA granted Fast Track designation for lifileucel in combination with pembrolizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care . Fast Track designation allows for potential Accelerated Approval and Priority Review as well as more frequent interactions with the FDA . TIL therapy in combination with pembrolizumab in advanced solid tumor cancers : Iovance is investigating TIL in combination with pembrolizumab in earlier treatment settings in metastatic melanoma , cervical cancer , non - small cell lung cancer ( NSCLC ) , and head and neck squamous cell carcinoma ( HNSCC ) patients who are naïve to therapy with immune checkpoint inhibitors ( ICI ) . Data for certain indications for TIL in combination with pembrolizumab will be highlighted in an oral presentation at the upcoming SITC annual meeting . Early clinical data previously presented in metastatic melanoma ( ASCO 2021 ) and HNSCC ( SITC 2020 ) suggest that the response rate for TIL in combination with pembrolizumab may be increased in patients who are ICI - naïve .