Safe Implementation of Tumor-Infiltrating Lymphocyte Therapy at an Academic Cancer Center: A Multidisciplinary and Oncology Clinical Pharmacy Specialist–Driven Approach

BACKGROUND

Tumor-infiltrating lymphocyte (TIL) therapy is an emerging autologous cellular immunotherapy with demonstrated efficacy in patients with advanced solid tumors, particularly metastatic melanoma, highlighted by the 2024 FDA approval of lifileucel (Amtagvi). Lifileucel has shown promising clinical outcomes in patients with melanomas following progression on immune checkpoint inhibitors; however, its delivery requires a complex, multidisciplinary care model. Clinical pharmacists play a vital role in therapy coordination, medication safety, and supportive care management, in close collaboration with physicians, nurses, and other health care professionals. Here, we describe the safe implementation of a TIL program at an academic cancer center, with an emphasis on standardized workflows and pharmacy-led safety strategies. Clinical pharmacists developed electronic order sets with embedded safeguards (weight-based dosing, renal adjustment, duplication alerts), conducted drug interaction screening, and provided patient counseling. Standardized supportive care pathways (antimicrobial prophylaxis, electrolyte replacement, vasopressor guidance) were implemented. Nursing and pharmacy education emphasized early recognition and management of IL-2–related toxicities, with defined monitoring parameters, dose-hold criteria, and intensive care unit (ICU) escalation guidelines.

METHODS

We established a multidisciplinary TIL program for lifi leucel using standardized workfl ows across patient selection, tumor procurement, product handling, lymphodepletion, cell infusion, and high-dose interleukin-2 (IL-2) administration. Eligibility followed FDA criteria, with additional requirements for performance status and renal, cardiac, and pulmonary function. The cellular therapy and surgical teams led a coordinated eligibility review with pathology to ensure timely procurement and chain of custody–verifi ed transport. Lymphodepletion with cyclophosphamide and fl udarabine was protocolized with renal monitoring and predefi ned supportive care triggers, requiring dual independent verifi cation by oncology nurses and pharmacists. Cell infusion processes included standardized premedication, readiness checks, and continuous monitoring by trained oncology nurses. IL-2 administration was harmonized with defined dosing, toxicity thresholds, and escalation criteria.

RESULTS

We successfully operationalized a comprehensive TIL program, achieving seamless coordination across oncology, cellular therapy, critical care, pharmacy, and nursing teams. Standardized workflows streamlined treatment sequencing and ensured consistent execution of complex care processes from lymphodepletion through IL-2 administration. Pharmacy-led interventions strengthened medication safety through prospective verification, protocolized order sets, and real-time toxicity surveillance. Integrated toxicity monitoring and escalation pathways enabled rapid identification and management of IL-2–related adverse events, supporting safe and reliable therapy delivery across all phases of care. During initial program implementation (n = 8 patients), TIL therapy was delivered safely with high adherence to standardized protocols. The average hospital length of stay was 13 days (range, 10-20 days). Patients received a median of 5 IL-2 doses (range, 2-5 doses), with dose holds primarily due to hypotension or oliguria. ICU transfer rate was 25% (2/8 patients), most commonly for vasopressor support; all patients were successfully stabilized and returned to the oncology unit. No treatment-related mortality was observed. Pharmacy interventions included dose adjustments (25%), electrolyte management optimization (30%), and prevention of potential drug interactions (40%). No medication-related safety events were reported.

CONCLUSIONS

TIL therapy can be safely implemented at academic centers through a structured, multidisciplinary model with strong integration of clinical pharmacy. Standardized order sets, rigorous verifi cation processes, and proactive management of IL-2–related toxicities are essential to maintaining patient safety. These fi ndings demonstrate the feasibility of expanding TIL programs and underline the critical role of oncology clinical pharmacy specialists in the delivery of complex cellular therapies.

REFERENCES

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