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LEGEND В І ОТЕСН Legend Biotech Reports Third Quarter 2021 Financial Results and Recent Highlights November 16 , 2021 • Enrollment of the Phase 3 CARTITUDE - 4 study evaluating ciltacabtagene autoleucel ( cilta - cel ) for multiple myeloma patients with 1-3 prior lines of therapy was completed by Janssen Biotech , Inc. • U.S. Food and Drug Administration ( FDA ) has extended the Prescription Drug User Fee Act ( PDUFA ) target date for cilta - cel by three months to February 28 , 2022 • Legend Biotech initiated the Phase 1 clinical trial in the US for LB1901 , an investigational autologous CD4 - targeted chimeric antigen receptor T - cell ( CAR - T ) therapy for relapsed or refractory peripheral T - cell lymphoma ( PTCL ) or cutaneous T - cell lymphoma ( CTCL ) • New and updated data will be presented at the upcoming 63rd American Society of Hematology ( ASH ) Annual Meeting and Exposition SOMERSET , N.J .-- ( BUSINESS WIRE ) -- Nov . 16 , 2021-- Legend Biotech Corporation ( NASDAQ : LEGN ) ( Legend Biotech ) , a global , clinical - stage biotechnology company developing and manufacturing novel therapies , today reported its 2021 third quarter unaudited financial results . " It continues to be a banner year for us , as we launch our clinical trial in the US for the T cell lymphoma program and see promising developments in our pipeline , " said Ying Huang , PhD , CEO and CFO of Legend Biotech . " We intend to close the year on a strong note by presenting new and updated results from our CARTITUDE Clinical Development Program at the 63rd American Society of Hematology Annual Meeting next month and work to bring cilta - cel to more patients . " Recent Highlights • In October 2021 , Legend Biotech and its collaboration partner Janssen Biotech , Inc. ( Janssen ) completed the enrollment of the Phase 3 CARTITUDE - 4 study , evaluating cilta - cel in patients with multiple myeloma who have received 1-3 prior lines of therapy including a proteasome inhibitor and immunomodulatory agent and are refractory to lenalidomide . The purpose of this study is to compare the efficacy of cilta - cel with standard therapy - either pomalidomide , bortezomib and dexamethasone ( PVD ) or daratumumab , pomalidomide and dexamethasone ( DPd ) . • The U.S. FDA has extended the PDUFA target date for cilta - cel by three months to February 28 , 2022. The extension allows the FDA sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request . • On October 18 , 2021 , Legend Biotech hosted its first Research & Development ( R & D ) Day in New York , sharing updates on Legend Biotech's pipeline advancements , including expanded capabilities in cell therapy , and milestones in the cilta - cel clinical development program . The Legend Biotech pipeline has been updated to reflect the disclosures made at this event , including the targets for two of the company's investigational autologous CAR - T therapies , LB2101 and LB2102 . Additionally , the investigator - initiated clinical trial in China evaluating an investigational autologous CAR - T targeting CD33 and CLL - 1 for the treatment of acute myeloid leukemia has been removed . The Phase I dose escalation study showed a lack of CAR - T expansion and efficacy . • In September 2021 , the Phase 1 , open - label , multicenter clinical trial began in the United States for LB1901 , an investigational autologous CD4 - targeted CAR - T therapy for the treatment of adults with relapsed or refractory peripheral T - cell lymphoma ( PTCL ) or cutaneous T - cell lymphoma ( CTCL ) . The primary objectives of the trial are to characterize the safety and tolerability of LB1901 and determine the optimal dose . Key Upcoming Milestones • New and updated data from the CARTITUDE Clinical Development Program will be presented at the 63rd ASH Annual Meeting and Exposition taking place from December 11-14 , 2021. Highlights include : • CARTITUDE - 1 updated results from the Phase 1b / 2 study of cilta - cel in patients with relapsed or refractory multiple myeloma ( RRMM ) • Adjusted indirect comparisons of patient outcomes in CARTITUDE - 1 versus therapies from real - world clinical practice from the prospective LocoMMotion study • CARTITUDE - 1 subgroup analysis data • CARTITUDE - 2 first data in patients with multiple myeloma and early relapse after initial therapy ( Cohort B ) and updated data in lenalidomide - refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy ( Cohort A )