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Iovance Biotherapeutics Reports Third Quarter and Year-to-Date 2020 Financial Results and Corporate Updates
Registration-Directed Study Initiated in Non-Small Cell Lung Cancer SAN CARLOS, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc.
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"Registration-Directed Study Initiated in Non-Small Cell Lung Cancer\nSAN CARLOS, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- 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 2020 financial results and provided a corporate update.\n “Subsequent to meeting with FDA, we have moved the BLA submission date for lifileucel to 2021 in order to reach agreement on the required potency assays to fully define TIL,” said Maria Fardis, PhD, President and CEO of Iovance. “In additional indications, we look forward to starting our registration-directed study in non-small cell lung cancer, and to presenting initial clinical data of TIL in combination with anti-PD-1 therapy in head and neck cancer. Our financial strength also allows us to advance our clinical programs and continue our operating plans. Overall, I believe that Iovance is well-positioned to be the leader in development, manufacturing and commercialization of TIL cell therapy for cancer.” Third Quarter 2020 and Recent Corporate Updates Clinical: TIL therapy, lifileucel, in melanoma: Iovance and the U.S. Food and Drug Administration (FDA) reached agreement on duration of follow up for pivotal data for the biologics license application (BLA) for lifileucel in metastatic melanoma. Additional work is underway on current and new potency assays in support of the BLA. Dialogue with FDA about the assays is expected to continue with BLA submission anticipated to occur in 2021.TIL therapy, lifileucel, in cervical cancer: the last patient was dosed in the pivotal Cohort 1 of the C-145-04 study of lifileucel, formerly LN-145, for metastatic cervical cancer.TIL therapy in non-small cell lung cancer (NSCLC): the protocol was finalized for the potential registration-directed study, IOV-LUN-202, to investigate LN-145 in patients with recurrent or metastatic NSCLC, without driver mutations, who previously received a single line of approved systemic therapy (combined checkpoint inhibitor (CPI) plus chemotherapy). Cohorts 1 and 3 have patients with TPS score of less than one percent, and Cohort 2 will enroll patients with TPS score of greater than or equal to one percent.TIL therapy, LN-145, in head and neck squamous c...