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Iovance Biotherapeutics Appoints Marc R. Theoret, M.D. as Senior Vice President, Regulatory Strategy
GlobeNewswire· 2025-07-10 20:01
SAN CARLOS, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the appointment of Marc. R Theoret, M.D. to assume the newly created position of Senior Vice President, Regulatory Strategy, where he will focus on clinical regulatory strategy for Iovance’s pipeline. Effective immediately ...
Iovance Announces Five-year Results of Amtagvi® (lifileucel) in Patients with Advanced Melanoma at ASCO Annual Meeting
Globenewswire· 2025-05-22 21:31
Core Insights - Iovance Biotherapeutics announced five-year results from the Phase 2 C-144-01 clinical trial for Amtagvi, demonstrating a five-year overall survival rate of 20% in patients with advanced melanoma previously treated with immune checkpoint inhibitors [1][2][3] Clinical Trial Results - The C-144-01 trial involved 153 patients with advanced melanoma, showing a median overall survival (OS) of 13.9 months and an objective response rate of 31.4%, with complete responses in 5.9% and partial responses in 25.5% of patients [3][7] - Among responders, the median duration of response was 36.5 months, with 31.3% of responders maintaining ongoing responses at the five-year assessment [3][5] Safety Profile - Adverse events were consistent with known safety profiles of nonmyeloablative lymphodepletion and interleukin-2 administration, with a rapid decrease in incidence within the first two weeks post-infusion and no new or late-onset treatment-related adverse events reported [4][5] Regulatory Approval - The U.S. FDA granted accelerated approval to Amtagvi in February 2024 for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, marking it as the first one-time T cell therapy for solid tumors [7][11] Future Developments - Iovance is conducting the TILVANCE-301 Phase 3 trial to confirm the clinical benefit of Amtagvi in frontline advanced melanoma [7][10]
Iovance Biotherapeutics Reports Financial Results and Corporate Updates for First Quarter 2025
Globenewswire· 2025-05-08 20:01
1Q25 Total Product Revenue of $49.3M FY25 Total Product Revenue Guidance Revised to $250M-$300M FY25 Operating Expenses Reduced and 2H26 Cash Runway Guidance Maintained 2025 Regulatory Approvals for Amtagvi® Expected in the UK, EU, and Canada On Track to Report Updated Clinical Data for Registrational Trialin Previously Treated Advanced NSCLC in 2H25 SAN CARLOS, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, ...
Iovance Biotherapeutics to Host First Quarter 2025 Financial Results and Corporate Updates Webcast on Thursday, May 8, 2025
GlobeNewswire News Room· 2025-05-02 20:01
SAN CARLOS, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will report its first quarter 2025 financial results and corporate updates on Thursday, May 8, 2025. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update on May 8, 2025 at 4:30 p.m. ET. ...