An expert told CURE that the recently-approved TIL therapy may lead to years of monitoring without the need for more treatment.
The Food and Drug Administration’s (FDA) approved Amtagvi (lifileucel), not only marked the first tumor-infiltrating lymphocyte (TIL) therapy for patients with solid tumors but also may set patients up for years before needing more treatment for their advanced melanoma, according to an expert.
Amtagvi was approved on Feb. 16 for the treatment of patients with advanced melanoma whose disease progressed on or after an immunotherapy and targeted therapy agent. Treatment with the TIL therapy, which works by extracting patients’ T cells and training them to find and fight cancer, comes with a lengthy process.
CURE® recently sat down with Dr. Rodabe N. Amaria, professor of medical oncology at The University of Texas MD Anderson Cancer Center, to discuss what patients can expect.
“There’s a lot of work involved in [administering Amtagvi], but once you get the treatment — and as long as it works — we’re potentially buying years and years without ever having to get more treatment,” Amaria said.
Pretreatment Discussions and Screening
Amaria explained that when she and her team are considering someone for Amtagvi treatment, they must first decide if the patient is a good candidate: are they healthy and fit enough to undergo the intensive treatment and will they logistically be able to spend a couple of weeks in the hospital?
“The first thing we decide is … does this patient really meet the criteria under which the FDA has given the approval, and number two, are they going to be healthy enough to sustain the rigors of this therapy?” she said. “So there’s a lot of pretreatment, a screening tests: lung function, test stress tests, infectious disease labs. So there’s a lot of preliminary hoops that have to be jumped through to make sure that the patient is healthy enough.”
Amaria had one of these discussions with Nina McDonald, a patient who was diagnosed with melanoma in 2013 that eventually spread to her liver, which became stage 4 disease in 2018.
“My wonderful oncologist, Dr. Amaria, told me about TIL therapy when the targeted therapy I was on stopped working. I thought it sounded like an amazing opportunity to receive TIL cells — ones trained to fight my cancer,” McDonald said in an interview with CURE®.
Surgery, Cell Manufacturing and Lymphodepletion
Next, patients must prepare for and undergo surgery.
The resected tumor is then sent back to the manufacturing facility where the TIL cells are engineered to find and destroy tumor cells. This process, according to Amaria, takes approximately 28 days.
Meanwhile, patients will undergo lymphodepleting chemotherapy — a process that is not intended to fight cancer, but rather to make patients’ blood counts “go essentially to nothing,” Amaria said. During this time, patients are at high risk for infection and may need to undergo blood or platelet transfusions.
Amtagvi and Interleukin-2 Treatment
After seven days of lymphodepleting chemotherapy, patients will get the TIL infusion, which is administered intravenously over the course of a few hours, Amaria explained.
Then, patients undergo treatment with interleukin-2, which, according to Moffitt Cancer Center, expands and stimulates the TIL cells. At this point, patients are monitored for side effects from interleukin-2.
“The [interleukin-2] is something that is potentially very toxic; it can cause stress and strain to the heart and lungs. That’s why we mandate those stress tests, the multifunction tests,” Amaria said. “People can gain lots of fluid weight, you know, it can be potentially an uncomfortable period. But that’s just for a couple of days, couple doses up to six doses.”
Recovery and Side Effect Monitoring
Finally, patients continue their hospital stay as they recover and are monitored for additional side effects and build up their blood cell counts.
McDonald mentioned that she experienced side effects from both the chemotherapy and the TIL treatment itself.
“The chemotherapy made me nauseous, and I did not feel like eating for about two weeks. The TIL therapy triggered an expected immune system response of fevers, chills, and fatigue. I also got a rash on my hands, arms and feet as a result of the TILs infiltrating my skin,” she explained.
Amaria added that recovery is a gradual process.
“After three weeks in the hospital, people will gradually improve day by day in terms of strength and stamina, but I don’t expect people to really start to feel 100% normal until potentially weeks after the treatment is done,” Amaria said.
Following up After TIL Therapy
After being treated with Amtagvi, patients may be able to go a long time where they have follow-ups with their doctors but do not need further treatment, according to Amaria.
“The true beauty is that for responders — those that are benefiting from the treatment — they don’t need to come in and get an infusion every three weeks or four weeks. That three weeks in the hospital will hopefully set them up for years and years where they don’t need any more treatment,” Amaria said.
Now, McDonald encourages anyone eligible for TIL therapy to seriously consider it.
“TIL therapy is an amazing opportunity for melanoma treatment that I would recommend to any melanoma patient for whom other therapies have not worked,” she said. “It was a tough process being in the hospital that long and dealing with the side effects, but the side effects lasted a short period of time and were less difficult than some side effects I experienced with other treatments. It is helpful to have family and/or friends nearby to support you, if possible.”
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