Dr Kirtane on an Investigation of TILs Plus Pembrolizumab in Advanced HNSCC

Kedar Kirtane, MD, assistant member, Department of Head and Neck-Endocrine Oncology, medical director, Solid Tumor Cellular Therapy, Moffitt Cancer Center, discusses a phase 1b study investigating TBio-4101, which isolates autologous selected and expanded tumor-infiltrating lymphocytes (TILs), plus pembrolizumab (Keytruda) in patients with PD-1 inhibitor–resistant, advanced head and neck squamous cell carcinoma (HNSCC). This trial’s rationale and design were shared at the 2024 ASCO Annual Meeting.

Currently, patients with recurrent metastatic head and neck cancers have limited treatment options, with the standard of care being everolimus (Afinitor), with or without chemotherapy, Kirtane begins. Unfortunately, most of these patients experience disease progression despite receiving this treatment, he says, adding that as of now, there is no effective second-line therapy available to manage their condition. Ongoing research efforts aim to address this unmet need, particularly for patients who do not respond to PD-1 inhibition and subsequent treatments, Kirtane reports.

The primary objective of this phase 1b trial is to develop a readily available second-line treatment for patients with advanced HNSCC whose cancers progress after standard therapies, he expands. TIL therapy offers a promising approach, Kirtane states. This therapy involves extracting lymphocytes from a patient’s tumor, enhancing the cancer-fighting capabilities of these lymphocytes, and reintroducing them into the patient’s body, he elucidates.

TBio-4101 stands out because it uses a selection process to isolate lymphocytes that are more likely to reduce tumors effectively, Kirtane explains. This selective process contrasts with those of other TIL products that do not differentiate between more and less effective lymphocytes, according to Kirtane. By focusing on the most potent lymphocytes, TBio-4101 aims to provide a more effective treatment option for patients with recurrent metastatic HNSCC, he states.

The rationale behind this trial is to fill the critical gap in treatment options for these patients, offering a new line of defense against their disease, Kirtane says. By leveraging the unique properties of TIL therapy combined with advanced selection techniques, investigators hope to significantly improve outcomes for patients who have exhausted other treatment avenues, Kirtane concludes.