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graphic of lungs with a tumor in one
graphic of lungs with a tumor in one

A new combination immunotherapy approach is showing promising results for patients with advanced lung cancer who have not yet received immunotherapy treatment. New data from a phase 2 clinical trial presented at the Society for Immunotherapy of Cancer annual meeting show that combining lifileucel, a tumor-infiltrating lymphocyte (TIL) therapy, with the immunotherapy drug pembrolizumab led to tumor shrinkage in nearly half of the patients with metastatic non-small cell lung cancer.

Lifileucel, approved by the FDA earlier this year for the treatment of advanced melanoma, is being explored for its potential in other cancer types. TIL therapy works by harvesting immune cells that have already infiltrated a patient’s tumor, expanding them in the laboratory and then reinfusing them into the patient in large numbers to boost the immune system’s ability to fight cancer.

The phase 2 study included 22 patients with advanced non-small cell lung cancer who had not previously received immunotherapy. After receiving the combination treatment, 45.5% of patients saw their tumors shrink, and two patients had a complete response. Importantly, the treatment appeared effective even in patients whose tumors lacked high levels of the PD-L1 protein, which is often used to predict response to immunotherapy.

headshot of Dr. Ben Creelan

Ben Creelan, MD

“These results are very encouraging, especially for patients who may not typically respond well to standard immunotherapy,” said the study’s lead investigator, Ben Creelan, MD, a medical oncologist in Mofffit Cancer Center’s Thoracic Oncology Department. “We’re seeing durable responses in some patients that are ongoing after two years of follow-up.”

The treatment process involves several steps. First, a small tumor sample is surgically removed to collect TILs. These cells are then grown and multiplied in a laboratory over several weeks. Before reinfusion, patients undergo conditioning chemotherapy to make room for the new TILs. The expanded TILs are then infused back into the patient, followed by doses of a protein that plays a key role in immune response to further stimulate the TILs’ growth and activity.

Side effects were generally manageable and consistent with those seen with pembrolizumab and the TIL therapy process. The most common severe side effects included low oxygen levels, fever, low white blood cell counts and low phosphate levels.

While larger studies are needed to confirm the findings, these early results suggest this combination approach could potentially offer a new treatment option for some patients with advanced lung cancer. The researchers plan to continue investigating the therapy in larger clinical trials.