Iovance Starts BLA Submission of Lifileucel for Advanced Melanoma


The tumor-infiltrating lymphocyte therapy has shown efficacy in the phase 2 C-144-01 trial.

Iovance Biotherapeutics has initiated a rolling biologics license application (BLA) submission for its tumor-infiltrating lymphocyte (TIL) therapy intended to treat unresectable or metastatic melanoma that progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy.1

Lifileucel is being evaluated in the phase 2 C-144-01 clinical study (NCT02360579). The study has enrolled 178 participants and is evaluating overall response rate (ORR) as the primary endpoint and other safety and efficacy measures as secondary endpoints, including duration of response, disease control rate, progression-free survival, overall survival, and adverse events (AEs).

“Initiating our rolling BLA submission for lifileucel is a significant step towards our goal to deliver the first individualized, one-time cell therapy for melanoma patients with significant unmet need. In parallel, we are executing our on-boarding and personnel training at authorized treatment centers, education and awareness initiatives, internal capacity planning, and launch readiness activities to prepare for commercialization. The FDA is supportive of our regulatory approach, and we look forward to continuing this collaboration throughout the submission and review process,” Frederick Vogt, PhD, JD, interim president and chief executive officer, Iovance, said in a statement.1

The rolling submission allows the FDA to review supporting materials as Iovance submits them and is available as part of an expedited program for serious conditions. The company expects the BLA to be completed in the fourth quarter of 2022. Lifileucel has previously received regenerative medicine advanced therapy designation from the FDA.

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“Lifileucel represents hope and a new treatment for thousands of people with advanced melanoma who have very limited options after they progress on available standard of care,” Kyleigh LiPira, chief executive officer, Melanoma Research Foundation, added to the statement.1 “Cell immunotherapies are revolutionizing cancer treatment, and we are excited about the potential for the first FDA-approved TIL cell therapy for the treatment of melanoma, which helps us take another step towards finding a cure.”

Iovance previously announced positive data on lifileucel in May 2022 from cohort 4 of the C-144-01 study that enrolled patients with a higher baseline disease burden than other cohorts.2 The 87 patients in cohort 4 had a 29% ORR (95% CI, 19.5-39.4). Cohort 4 had 3 complete responses and 22 partial responses. An independent review committee determined median duration of response to be 10.4 months with a median follow-up of 23.5 months.

“Treatment of melanoma patients after failure of anti-PD-1 therapy remains a critical unmet medical need without an approved therapeutic option. Available care for metastatic melanoma patients in this setting is chemotherapy, which has been reported to offer a four to ten percent response rate with a very short median duration of response. We are excited about the results from registrational Cohort 4 of the C-144-01 study and the potential of lifileucel as a new treatment option for these patients,” Friedrich Graf Finckenstein, MD, chief medical officer, Iovance, said in a statement at that time.2

Lifileucel was well-tolerated, with a treatment-emergent AE profile consistent with underlying disease. Other AEs were consistent with non-myeloablative lymphodepletion and interleukin-2 therapy and were consistent between cohorts. Iovance plans to present additional data from C-144-01 at a medical meeting later this year.1

1. Iovance Biotherapeutics initiates biologics license application (BLA) submission for lifileucel in advanced melanoma. News release. Iovance Biotherapeutics. August 25, 2022.
2. Iovance Biotherapeutics Announces Positive Clinical Data for Lifileucel in Advanced Melanoma. News release. Ioveance Biotherapeutics. May 26, 2022.
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