A multi-institutional clinical trial conducted at the UNC Lineberger Comprehensive Cancer Centre and 21 other U.S. sites found that a single administration of autologous tumour-infiltrating lymphocyte (TIL) cell therapy helped stabilise metastatic head and neck squamous cell carcinoma (HNSCC) in some patients. 

This finding is significant, as many of these patients had previously undergone multiple treatments without success—making this one of the first therapies to demonstrate disease stabilisation in such cases.

Autologous TIL cell therapy uses a patient’s own immune cells to fight cancer. Doctors collect lymphocytes, a type of white blood cell, from the patient’s tumour, grow hundreds of millions of these cells in a lab, and then infuse them back into the patient to help the immune system better recognise and attack the cancer.

The findings from the phase 2 clinical trial appeared Aug. 24, in the Journal for the ImmunoTherapy of Cancer.

“This study demonstrated the feasibility of consistently generating TILs from recurrent and or metastatic head and neck squamous cell carcinoma tumours to stabilise a patient’s disease,” said Robert L. Ferris, MD, PhD, corresponding author and executive director of UNC Lineberger.

“This is a group of patients with a short life expectancy, many of whom have already undergone chemotherapy, radiation, surgery and/or immunotherapy, and there are no other known treatments that would have extended life by about nine months as our TIL therapy did.”

Metastatic HNSCC forms in cells lining the oral cavity, pharynx, larynx and sinuses. In the U.S., HNSCC accounts for approximately 3.6% of all cancers, with an estimated 59,660 new diagnoses and 12,770 deaths expected in 2025, according to the National Cancer Institute.

The study was designed to capitalise on an earlier finding that HNSCC patients with high levels of TILs are less likely to have disease recurrence than those with low or moderate TIL levels.

It assigned 53 patients to one of four treatment groups: 8 received non-cryopreserved TILs (cryopreservation usually involves freezing cells at low temperatures using liquid nitrogen); 17 received cryopreserved lifileucel, an FDA-approved one-time autologous T-cell immunotherapy for metastatic melanoma; 16 received lifileucel (non-cryopreserved); and 12 received a cryopreserved therapy targeting PD-1 positive TIL cells. PD-1 is a cell surface marker linked to better outcomes in cancers expressing this marker.

Most patients were men with a median age of 57, and all but one had late-stage metastatic disease. The median treatment was 17.9 months. The median response duration to the therapy was 7.6 months, with the longest lasting nearly two years. Additionally, 64% of patients experienced cancer stabilisation, and median overall survival was 9.5 months.

The investigators noted that it was difficult to compare results across the 4 patient groups due to the small patient populations.

Treatment side effects were mostly manageable. The most common non-blood related side effects were chills (60%), low blood pressure (53%) and fever (47%). The most common blood-related side effects were low platelet counts (74%) and anaemia (53%).

Ferris conducted the trial while on faculty at UPMC Hillman Cancer Centre, Pittsburgh, then undertook the analysis of results after being appointed as the executive director of UNC Lineberger and system chief of oncology services at UNC Health in June 2024.

Looking ahead, Ferris emphasised the need to optimise cell expansion methods, decide between fresh or cryopreserved cells, identify effective combination therapies since TIL therapy alone may be insufficient, and design a randomised trial comparing TIL therapy against the current standard of care.

“This trial has been a crucial step in not only finding a way to stabilise a patient’s disease but also to help guide us to the next stage of discovery, which is how to further prolong these patients’ lives while providing them with the best possible quality of life,” Ferris concluded.

The study was sponsored by Iovance Biotherapeutics, San Carlos, CA, which manufactures and markets lifileucel.

Article: Efficacy and safety of one-time autologous tumor-infiltrating lymphocyte cell therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma

Source: University of North Carolina Health Care