Iovance Biotherapeutics Announces Clinical Data for Lifileucel in Advanced Mucosal Melanoma at the European Society for Medical Oncology (ESMO) Congress

SAN CARLOS, Calif., Oct. 16, 2023 (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, today announced the publication of an reporting clinical data for lifileucel which will be presented at the European Society for Medical Oncology , October 20-24, 2023 in Madrid, Spain.

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:

• 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)

About Iovance Biotherapeutics, Inc.

aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit .

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CONTACTS

Iovance Biotherapeutics, Inc.:

Sara Pellegrino, IRC

SVP, Investor Relations & Corporate Communications

650-260-7120 ext. 264

Jen Saunders

Director, Investor Relations & Public Relations

267-485-3119