Iovance Biotherapeutics’ TIL Therapy Lifileucel Approved for Advanced Melanoma in Canada

Iovance Biotherapeutics’ lifileucel (Amtagvi), a tumor-derived autologous tumor-infiltrating lymphocyte therapy (TIL), has received a Notice of Compliance with conditions (NOC/c) from Health Canada for advanced melanoma.¹

Specifically, the market authorization applies to adults with unresectable or metastatic melanoma who have no satisfactory alternative treatment options and whose disease has progressed after or during treatment with at least 1 previous line of systemic therapy that included a PD-1–blocking antibody. Furthermore, if the patient’s disease is positive for a BRAF V600 mutation, they must also have received a BRAF inhibitor.

The NOC/c was issued based on results of the completed phase 2 C-144-01 clinical trial (NCT02360579). Notably, lifileucel’s market authorization in Canada is conditional and depends upon future trial data confirming clinical benefit of the therapy. An ongoing phase 3 clinical trial referred to as TILVANCE-301 (NCT05727904), which was initiated on March 30, 2023, is evaluating lifileucel in frontline advanced melanoma and some other solid tumor indications.

“This approval in Canada is our first marketing authorization outside the US and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers,” Frederick Vogt, PhD, JD, the interim CEO and president of Iovance, said in a statement.¹ “We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-US strategy for Amtagvi in additional markets.”

Lifileucel has been approved in the US since February 2024 and is indicated by the FDA for adults with unresectable or metastatic melanoma previously treated with a PD-1–blocking antibody or treated with a BRAF inhibitor in the instance that the patient has BRAF V600–positive disease.^2,3 It was the first cellular therapy to have received the aforementioned indication. Notably, the therapy was granted accelerated approval by the FDA. Iovance Biotherapeutics had previously noted that if lifileucel received accelerated approval in the US, TILVANCE-301 may transition into a confirmatory trial to support the therapy’s full approval.⁴ The FDA’s announcement of the approval decision reiterated that data from TILVANCE-301 would be utilized as such.³

Earlier this year, a 5-year analysis of data from patients with advanced melanoma treated in C-144-01 showing that lifileucel had produced durable responses was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30 to June 3, in Chicago, Illinois, and was simultaneously published in the Journal of Clinical Oncology.^5,6 The analysis included 153 patients with a median follow-up of 57.8 months who had completed or discontinued participation in C-144-01, of whom 28 (18.3%) had completed the 5-year study follow-up. The objective response rate was 31.4%, with a partial response rate of 25.5% and a complete response rate of 5.9%, and the patients achieved a median duration of response of 36.5 months (95% CI, 8.3-not reached).

“This 5-year analysis of the C-144-01 trial is the longest follow-up of the largest group of patients with melanoma treated with TILs in a single study,” first author Theresa Medina, MD, a medical oncologist at the University of Colorado Cancer Center on the Anschutz Medical Campus, and colleagues wrote in the ASCO abstract.⁵ “This study illustrates lifileucel’s continued durability of response and survival benefit up to 5 years after a single administration without any long-term safety concerns.”

REFERENCES
1. Iovance’s Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma. News release. Iovance Biotherapeutics Inc. August 18, 2025. Accessed August 19, 2025. https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvir-lifileucel-receives-health-canada-approval
2. FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma. FDA. February 16, 2024. Accessed August 19, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma
3. FDA approves first cellular therapy to treat patients with unresectable or metastatic melanoma. News release. FDA. February 16, 2024. Accessed August 19, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-unresectable-or-metastatic-melanoma
4. Iovance’s AMTAGVI (lifileucel) receives U.S. FDA accelerated approval for advanced melanoma. News release. Iovance Biotherapeutics Inc. February 16, 2024. Accessed August 19, 2025. https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvitm-lifileucel-receives-us-fda-accelerated
5. Medina T. Lifileucel in patients with advanced melanoma: five-year outcomes of the C-144-01 study. Abstract presented at: 2025 American Society of Clinical Oncology Annual Meeting; May 30-June 3, 2025; Chicago, IL. Abstract 9515.
6. The Journal of Clinical Oncology publishes five-year analysis of Amtagvi (lifileucel) in patients with advanced melanoma. News release. Iovance Biotherapeutics Inc. June 2, 2025. Accessed August 19, 2025. https://ir.iovance.com/news-releases/news-release-details/journal-clinical-oncology-publishes-five-year-analysis-amtagvir