Amtagvi (lifileucel)

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.

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

P3, N=360, Recruiting, Immatics US, Inc. | N=108 --> 360

P3, N=108, Recruiting, Immatics US, Inc.

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.

P3, N=360, Recruiting, Immatics US, Inc. | N=96 --> 360

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

P3, N=96, Recruiting, Immatics US, Inc.

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.

The recent U.S. FDA approval of lifileucel, a non-engineered, autologous tumor-infiltrating lymphocyte (TIL) therapy, for unresectable or metastatic melanoma represents a major milestone for cellular therapies in solid tumors...OBX-115, designed with regulatable membrane-bound IL-15 expression, eliminates the need for IL-2 infusion and has shown early clinical activity. KSQ-001EX uses CRISPR/Cas9 to inactivate SOCS1, while KSQ-004EX additionally targets Regnase-1 to enhance TIL function...TIL therapy remains among the most promising strategies in melanoma and solid tumors after immunotherapy failure. Ongoing research aims to optimize cell dose, phenotype, tumor procurement, treatment sequencing, and rational combinations to improve durable benefit.

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