The recent US FDA approvals of lifileucel (a TIL therapy for advanced melanoma) and afamitresgene autoleucel (a TCR therapy targeting MAGE-A4 in synovial sarcoma) mark the first regulatory recognition of cell therapies for solid tumours and signal a new era for oncology...Emphasis is placed on emerging innovations like gene-edited and allogeneic therapies, as well as future directions for integrating cell therapies into mainstream oncology. We conclude with recommendations for overcoming barriers related to cost, toxicity management, and equitable access across Europe.

P1/2, N=208, Recruiting, Obsidian Therapeutics, Inc. | Trial completion date: Jun 2028 --> Jun 2029 | Trial primary completion date: Jun 2028 --> Jun 2029

P2, N=11, Completed, University of Kansas Medical Center | Trial completion date: Nov 2025 --> Jul 2025 | Trial primary completion date: Nov 2025 --> Jul 2025 | Recruiting --> Completed

P3, N=670, Recruiting, Iovance Biotherapeutics, Inc. | N=290 --> 670

Our institutional real-world data show that only about half of TIL therapy referrals will proceed with the actual TIL infusions. While TIL therapy seeks to achieve the approximately 32% response rate observed in the registrational trial, real-world outcomes in an intent-to-treat population are anticipated to be inferior. Advanced melanoma affords a narrow time window from referral to completion of TIL manufacturing and infusion, necessitating efficient workflows to enable early treatment and optimize patient outcomes.

P2, N=100, Active, not recruiting, Iovance Biotherapeutics, Inc. | Recruiting --> Active, not recruiting

P1, N=32, Completed, Baylor College of Medicine | Active, not recruiting --> Completed | Trial completion date: Oct 2033 --> Jan 2026

All individuals received cyclophosphamide/fludarabine lymphodepletion, lifileucel, and 6 or fewer IL-2 infusions. In this cohort study, lifileucel treatment was frequently complicated by purpuric morbilliform eruptions, which were prognostically favorable and associated with short-term response. The lifileucel-associated eruption may be a peritreatment efficacy marker, assessable during the TIL treatment hospitalization prior to traditional 42-day restaging.

P1, N=40, Active, not recruiting, Iovance Biotherapeutics, Inc. | Recruiting --> Active, not recruiting

P1/2, N=208, Recruiting, Obsidian Therapeutics, Inc. | N=52 --> 208

TIL-based adoptive cell therapy is now a promising, personalized treatment for advanced melanoma after anti-PD-1 therapy has failed. Future studies should focus on identifying reliable biomarkers, improving TIL products, combining therapies to change the tumor environment, and making manufacturing more efficient to ensure more patients can safely access TIL therapy.

P1/2, N=5, Completed, National Cancer Institute (NCI) | N=70 --> 5 | Recruiting --> Completed