Pioneering trial of immunotherapy against triple negative breast cancer

The Hospital Clínic de Barcelona has launched the TILs001 study, a pioneering study of tumor-infiltrating lymphocyte-based immunotherapy in triple negative breast cancer. The study is led by Dr. Aleix Prat, funded by the Spanish Cancer Association (AECC) and sees the participation of Vall d’Hebron, the University Clinic of Navarra and the 12 de Octubre Hospital in Madrid. Coordination is entrusted to the SOLTI Oncology Academic Research Group. Eight patients with triple negative metastatic breast cancer participate. The procedure has shown promise in patients with metastatic melanoma and other cancers, and now the researchers want to test its feasibility in this type.

Metastatic triple negative breast cancer (mTNBC) is the most aggressive type of breast cancer, accounting for approximately 10-15% of all breast cancers. It is a little known disease that affects around 5,000 women in the Spanish state every year. Among those who develop this aggressive type, the five-year survival rate is 12%, while it rises to 28% in other types of metastatic breast cancer. Furthermore, the treatment options are much more limited.

Cell therapy-based immunotherapy using tumor-infiltrating lymphocytes (TILs) is a heterogeneous mixture of T-lymphocytes, directed primarily against cancer cells. These lymphocytes are immune system cells involved in function and regulation and are responsible for the destruction of cancer or infected cells. TILs form naturally in the inflammatory infiltrates of some solid tumors, explains the head of the Immunology service of the Clinic and of the Immunogenic and Immunotherapy group in the immune and autoinflammatory response, Dr. Manuel Juan.

Adoptive T cell transfer or TIL therapy in solid tumors is a program jointly launched by the Clinic’s Medical Oncology and Immunology services. It is a type of cell therapy conceptually similar to CART, selecting the T lymphocytes with antitumor activity present in the tumor.

The process begins with a preselection to choose the tumors most likely to be enriched for TIL, determining the PD1 biomarker. Then, T lymphocytes that have the ability to act against cancer cells (PD1-positive TILs) are isolated and selected, and many copies are made in the laboratory. Finally, the lymphocytes are injected back into the patient intravenously. The final infusion product is manufactured by the Clinic under the name NUMARZU-001. It has been shown that it is possible to obtain it from patients in a reproducible way, a fundamental step in obtaining authorization from the Medicines Agency to start the trial.

It will be the first time that this type of immunotherapy treatment for breast cancer has been administered in the Spanish state. The trial also received funding from the FERO Foundation and other anonymous campaigns and donations through the Clínic-IDIBAPS “Cancer Immunotherapy” project.

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