On October 16, 2023 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, reported the publication of an abstract reporting clinical data for lifileucel which will be presented at the European Society for Medical Oncology ESMO (Free ESMO Whitepaper) Congress 2023, October 20-24, 2023 in Madrid, Spain (Press release, Iovance Biotherapeutics, OCT 16, 2023, View Source [SID1234636003]).
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The abstract reports outcomes of a subset of 12 patients with advanced mucosal melanoma treated with lifileucel in the pooled consecutive cohorts from the C-144-01 trial. All patients had progressed on or after immune checkpoint inhibitor therapy. Patients with mucosal melanoma, which is rare and difficult to treat, have worse outcomes after anti–PD-1 therapy compared to patients with other melanoma subtypes.
The ORR assessed by an independent review committee (IRC) using RECIST v1.1 was 50% (95% CI: 21%–79%). At median study follow-up of 35.7 months, median duration of response (DOR) was not reached (NR; 95% CI: 12.5 months–NR), median progression free survival (PFS) was NR (95% CI: 1.4 months–NR), and median overall survival (OS) was 19.4 months (95% CI: 7.9 months–NR). Treatment emergent adverse events (TEAEs) were consistent with known safety profiles of lymphodepleting chemotherapy and interleukin-2 (IL-2).
The clinically meaningful and durable activity for lifileucel in the subgroup of patients with the rare and difficult-to-treat mucosal melanoma subtype, as well as in the total population of 153 patients treated in the C-144-01 trial, support the potential benefit of lifileucel as a one-time treatment that is differentiated from other immunotherapies for advanced melanoma.
Additional details will be presented in a mini-oral presentation at ESMO (Free ESMO Whitepaper):
Mini Oral Session – Melanoma and Other Skin Tumours: 1086MO – Lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts) with advanced mucosal melanoma after progression on immune checkpoint inhibitors (ICI): Results from the phase 2 C-144-01 study
Saturday, October 21, 3:15 PM – 3:20PM CEST (9:15 AM – 9:20 AM EDT)