Dr Banks on the Feasibility of Lifileucel in Select Metastatic Sarcomas

What actually fell out was a pretty strong efficacy signal in a small number of patients. And so the next question is to formally evaluate the efficacy of this in the phase 2 trial.

Lauren Banks, MD, PhD, a sarcoma medical oncologist and assistant attending physician in the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center, discussed feasibility findings from a phase 1 pilot trial (NCT05607095) evaluating the tumor-infiltrating lymphocyte (TIL) therapy lifileucel (Amtagvi) in patients with metastatic or unresectable dedifferentiated liposarcoma (DDLPS) or undifferentiated pleomorphic sarcoma (UPS), which were presented at the 2026 SITC Annual Meeting.

The investigator-initiated pilot trial enrolled patients with DDLPS or UPS who had received at least 1 prior line of systemic therapy. Following surgical tumor harvest, patients received lymphodepleting chemotherapy, followed by TIL infusion and interleukin-2 (IL-2). The primary end point was feasibility, defined as infusion of at least 6 of the first 10 patients, along with safety.

As of the updated data cutoff, 11 of the 13 patients who underwent surgery were infused, Banks said. Nine of those 11 patients received product manufactured within specification, although the clinical relevance of that designation in sarcoma is unclear, she noted. The 2 patients whose product was out of specification were still infused after shared risk-benefit discussions with the patients and the study team, and the trial met its feasibility end point, Banks explained.

Although the study was not designed to assess efficacy, an efficacy signal emerged in a small number of patients, according to Banks. The multicenter phase 2 SARATOGA trial (NCT07741877) will formally evaluate the efficacy of lifileucel in these patient populations, she said.

Banks emphasized that TIL therapy can be toxic, as it requires surgery, lymphodepleting chemotherapy, and an infusion, making it important to identify who will benefit. Key open questions include why some patients respond while others do not, and why some responses are lost, she added. Investigators are analyzing correlative data to identify biomarkers of response, Banks said.