5 Questions on TIL Therapy for Melanoma

By Patrick Hwu, M.D. - September 02, 2021

Skin cancer is the most common of all cancers, and melanoma is the most serious form. Although it accounts for only 1% of all skin cancers, it is responsible for a large majority of skin cancer deaths.

Dr. Amod Sarnaik, surgical oncologist
Dr. Amod Sarnaik, surgical oncologist

One of the revolutionary ways we’re treating some cases of advanced melanoma is through cell therapy using tumor infiltrating lymphocytes (TIL) to enhance a patient's own immune system. I recently sat down with Dr. Amod Sarnaik, a surgical oncologist in Moffitt’s Department of Cutaneous Oncology, to discuss the latest advances in this area.

Hwu: What is the latest in T-cell therapy for melanoma?

Sarnaik:  These are exciting times to be in T-cell immunotherapy and Moffitt was actually the lead pilot flagship center for a registration trial conducted for patients with metastatic melanoma who have progressed upon standard front-line therapy. And I’m pleased to report that not only did Moffitt put the most patients on this trial, but we reported a 38% response rate, which far exceeded my expectations. The data is currently under review at the FDA for regulatory approval.

Hwu: How will T-cell therapy be used in the regimen for melanoma patients?

Sarnaik: Well like I said, this is really an exciting time for those of us who are taking care of patients with advanced melanoma, because from 1976 up until 1998 there really weren't any new treatments for these patients and unfortunately the response rates weren't good for traditional therapy and patient didn’t really live very long. But since 1998, there's been a series of novel mechanisms of action uncovered that allow the clinician multiple options in our armamentarium to treat patients. And as you mentioned, that includes targeted inhibitor therapy like BRAF-MEK inhibitor therapy for patients whose tumors are mutated with the BRAF gene. In addition to that, there's been immune checkpoint blockade IV infusions of drugs that can rev up the body's immune system to attack the cancer. While these are great therapies, you know unfortunately, probably about half the patients have disease that ultimately becomes resistant and as of right now, T-cell therapy is going to be used or is in development to be used to rescue patients whose disease is refractory to these current front-line therapy options. About half the patients will need some sort of salvage therapy.

Hwu: How are T cells extracted from the patient?

Sarnaik: I think that this plays to one of the strengths of Moffitt, is that you have multiple disciplines – surgery, medicine and immunology – they all have to work together in concert. It's almost like assembling a symphony, and if the wind instruments are kind of out of tune, then the whole thing does not sound very good. So as a surgeon, we are responsible for securing the tumor material. These are the tumors that we take out of patients that are sent to the immunology lab for the immune cells to grow. So, it's really important to have a surgeon who understands which tumors are able to be reasonably removed, and will the patients recover in time to get the treatment? We’re also looking at the scans in order to determine “is this tumor going to yield high quality or is this tumor going to be necrotic, meaning broken down tumor cells with blood and not really yield a TIL product?”

Moffitt was very smart, they involved all three disciplines – surgery, medicine and immunology right from the very inception when we tried to develop this treatment at our cancer center. I think that's what led Moffitt to be very successful and put us in a great position to be the flagship institution to really anchor the registration trial that that has just been completed and is under FDA review.

Hwu: How are T cells processed at Moffitt?

Sarnaik: In our center what the surgeon does is actually resects the tumor right in the operating room, so it's fresh out of the patient and then dropped right into a transport media. We have exceptional personnel from Total Cancer Care, they pick up the specimen right away and immediately carry it to our cell therapy facility, where the cell therapy technologist then processes the tumor. I think this is important because the tumor is not sitting around, it has a very low chance of getting contamination, and I think the surgeon being able to pick and choose the best part of the tumor for TIL propagation is really important to get the maximum quality of resulting TIL.

Hwu: When will this T-cell therapy be approved by the FDA?

Sarnaik: As you may know the FDA is a little bit encumbered with various problems that relate to the to the COVID-19 pandemic as well as the vaccine issue, so I think that's distracted attention somewhat and probably caused a little bit of a regulatory delay in the review of TIL, but I am happy to report that the FDA does an extremely thorough vetting of each and every product that comes across their desk. What we're hoping for is a final answer sometime in the spring of 2022.

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