TIL therapy clinical trial gives lung cancer patients a shot at long-term remission

This is a dramatic shift from the way we’ve treated solid tumors."

Do you have a patient who has had one line of treatment that is no longer working, and is still motivated and healthy? This trial may be for them.

“For almost every solid tumor type, there is now a role for immunotherapy in some way, shape or form,” said Garrett Sherwood, MD, medical oncologist at Novant Health Cancer Institute. “It’s the biggest thing that’s happened in solid tumor oncology in the last 30 years.”

As the principal investigator for a phase 2 clinical trial through a partnership between Iovance Biotherapeutics and Novant Health, Dr. Sherwood is testing tumor infiltrating lymphocyte (TIL) therapy on non-small cell lung cancer. This type of immunotherapy uses the patient’s own T-cells to stimulate a greater immune response against their cancer.

“This is a strategy to overcome acquired resistance — to treat patients who responded to treatment with immunotherapy initially, but stopped responding,” Dr. Sherwood said.

The study is open at sites internationally and is enrolling 100 patients. Some have already been infused. At Novant Health, the study will be open through 2023 in Winston-Salem and Charlotte.

“This is a dramatic shift from the way we’ve treated solid tumors,” Dr. Sherwood said. “There’s really nothing like it.”

Here are key details of the clinical trial.

Despite successful outcomes in many tumors, most patients treated with immunotherapy drugs will eventually stop responding. Researchers are starting to better understand why — and this trial is working to change that outcome.

Dr. Sherwood: “The lymphocytes recognize the tumor as something foreign and bad and something the immune system needs to kill. The reason people stop responding is not necessarily because the lymphocyte no longer recognizes the tumor as foreign, but because the tumor has engaged multiple mechanisms in which it can evade those lymphocytes, or the lymphocytes can get exhausted. The constant stimulation creates a situation where they are no longer able to effectively kill the cancer cells. By extracting the T-cells that have already located the tumor and exponentially expanding them, we believe we can overcome these resistance mechanisms.”

Clinical trial patients can expect a six-to-eight-week therapy process, with two weeks in the hospital.

Dr. Sherwood: “Patients will have a surgery to acquire the tissue where those lymphocytes live. Then we send the tissue specimen to a special lab where they extract the lymphocytes and grow them. The patient goes through chemo, then we reinfuse the lymphocytes. In the ICU and under intense monitoring, we have to give high dose IL-2, an immunotherapy drug, to facilitate the TIL activity.”

After therapy, the patient is simply observed.

Dr. Sherwood: “After that intense process, all we do is follow those patients. We let them recover, check on them every few weeks to see how they’re doing. But there are no more infusions, and there’s no more chemo. At that point, we’re hoping we’ve retrained the immune system to attack and control the cancer.”

TIL therapy is already working for melanoma, with the medical community anticipating an FDA-approved drug by early 2023.

Dr. Sherwood: “This is something that is very quickly going from hypothetical and experimental to standard of care, and that’s why Novant Health wanted to get involved. This TIL treatment is something that the majority of otherwise healthy melanoma patients who stopped responding to treatment are going to need at some point in their cancer journey. There are patients that have been treated with TILs that have been treated successfully. Lung cancer is just one step behind melanoma.”

Eligible patients can be referred as clinical trial candidates.

Dr. Sherwood: “We’re looking for someone who has non-small cell lung cancer but is otherwise healthy, and who has had one line of treatment that is no longer working. It’s a high-risk, high-reward scenario. But for patients who are motivated and healthy enough to take this chance, we’re in a position to try this with them.”

TIL therapy shows a lot of promise.

Dr. Sherwood: “With TIL therapy, if we can regenerate that initial immune-versus-tumor response, then those patients can go into prolonged, sustained remission. The early data shows the promise of long-term disease control without ongoing infusions.”