scout
News|Articles|February 6, 2026

Single-Center, Retrospective Data Show Low Rate of Lifileucel Infusion Following Referral in Advanced Melanoma

Author(s)Chris Ryan
Fact checked by: Jax DiEugenio
Listen
0:00 / 0:00

Key Takeaways

  • Referral-to-infusion conversion was limited, with 63.4% completing tumor harvest and 56.1% receiving lifileucel; progression-related deaths occurred before lymphodepletion, emphasizing narrow therapeutic windows.
  • Eligibility barriers included sub-1.5 cm tumor size, unresectable harvest sites, comorbidity burden, autoimmune colitis post–checkpoint inhibition, patient refusal, and rapid progression precluding therapy delivery.
SHOW MORE

Only a proportion of patients with advanced melanoma proceeded to TIL therapy following referral in a real-world setting.

Findings from a single-center, retrospective study demonstrated that among patients with advanced melanoma referred for treatment with lifileucel (Amtagvi), only a proportion proceeded to tumor infiltrating lymphocyte (TIL therapy); furthermore, patients treated with the TIL therapy experienced improved overall survival (OS) outcomes compared with those receiving other treatments.1

Data presented at the 2026 Transplantation & Cellular Therapy Meetings showed that among 41 patients with unresectable or metastatic melanoma referred to Oregon Health & Science University for consideration of TIL therapy, 63.4% of patients complete surgical tumor harvest, and 56.1% received TIL infusion. Disease progression led to death in 2 patients prior to the administration of lymphodepleting chemotherapy. Notably, TIL products were out of specification for 28.5% of patients.

Real-World Data for Lifileucel Referrals and Infusions in Advanced Melanoma

  • Findings from a single-center, retrospective study showed inconsistent infusion rates among patients with advanced melanoma referred for TIL therapy.
  • Those who underwent successful infusion experienced improved OS compared with those treated with other therapies following referral.
  • Workflow changes helped improve the rates of patients undergoing infusion with lifileucel and the time between referral and infusion.

Eighteen patients did not receive lifileucel; 10 patients (58.8%) were deemed ineligible due to small tumors under 1.5 cm, 10 had comorbidities or an unresectable site, 4 died due to rapid disease progression, 2 had autoimmune colitis stemming from prior immune checkpoint inhibitor therapy, and 1 patient elected not to undergo treatment with the TIL therapy. The outcome for 1 patient was pending as of data cutoff.

Among all patients in this retrospective study, the median OS was 12.2 years following their initial diagnosis. Patients treated with lifileucel achieved a 1-year OS rate of 78.9% compared with 46.8% for those who did not receive TIL therapy (P = .05).

“Advanced melanoma confers a narrow time window to complete TIL manufacturing and infusion from the time of referral, necessitating efficient workflow processes to improve patient outcomes,” lead study author Amrita Desai, MD, and colleagues wrote in a poster presentation of the data. Desai is an assistant professor of Medicine, in the Division of Hematology/Medical Oncology, at Oregon Health & Science University.

How did workflow changes help improve TIL infusion rates and speed?

Desai and colleagues also highlighted outcomes stemming from workflow changes made in an effort to improve efficiency following referrals for TIL therapy. In this study, 22 referrals were made prior to the workflow change, and 19 occurred after. Prior to the change, 13 of 22 patients were seen within 14 days of referral; 11 complete resection to harvest TILs; and 6 underwent lifileucel infusions. The mean time from referral to cell therapy consult was 16.36 days. Following the workflow change, 16 of 19 patients were seen within 14 days of referral; 14 underwent surgical resection for TIL harvesting; and 13 received lifileucel. The mean time from referral to cell therapy consult was 11.1 days.

Furthermore, prior to the workflow change, the average times between cellular therapy consult and surgical consult, surgical consult to resection, and resection to lifileucel infusion were 20.6 days, 20.8 days, and 58.3 days, respectively. These respective rates were 21.7 days, 21.9 days, and 58.03 days following the workflow changes. The average time from initial referral to lifileucel infusion was 184.8 days prior to the workflow change and 109.3 days following the change.

How was the retrospective study conducted?

Investigators at Oregon Health & Science University gathered data for 41 patients with unresectable or metastatic melanoma who were referred to the institution for lifileucel between February 1, 2024, and September 30, 2025. Lifileucel received FDA accelerated approval in February 2024 for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.2

Electronic medical records were used to obtain demographic and clinical data, along with the timeline of various visits and procedures.1

The 41 patients had a median age of 66 years (range, 27-83), and 51.2% of patients were female. Most patients (85.3%) had stage IV, BRAF wild-type disease. Additionally, 34.1% had central nervous system disease.

References

  1. Desai A, Valenzuela C, Hayes-Lattin B, et al. Real world outcomes of a single-center tumor infiltrating lymphocyte (TIL) melanoma therapy program with commercial lifileucel. Presented at: 2026 Transplantation & Cellular Therapy Meetings; February 4-7, 2026; Salt Lake City, UT. Abstract 231.
  2. FDA approves first cellular therapy to treat patients with unresectable or metastatic melanoma. FDA. February 16, 2024. Accessed February 6, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-unresectable-or-metastatic-melanoma

Newsletter

Stay up to date on the most recent and practice-changing oncology data


Latest CME