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Cell therapy improves progression-free survival in advanced melanoma, first phase 3 study shows

Cell therapy improves progression-free survival in advanced melanoma, first phase 3 study shows
Lead author Professor John Haanen. Credit: European Society for Medical Oncology

A novel treatment strategy with personalized cell therapy significantly improves progression-free survival in comparison to standard immunotherapy in patients with advanced melanoma, in accordance with ground-breaking results reported at the ESMO Congress 2022 from the phase 3 M14TIL trial.

“This study shows for the very first time in a randomized, controlled trial that could be efficacious and good for with solid cancers,” said lead author John Haanen, Netherlands Cancer Institute, Amsterdam, Netherlands. “For patients with melanoma, we visit a 50% decrease in the opportunity of progression of the condition or dying from the condition, that is absolutely practice changing. This is actually the first time a TIL-based approach has been compared right to standard-of-care treatment, in this instance ipilimumab. So we have been now in a position to position TIL treatment far better in the management landscape for patients with .”

“TIL therapy can be an extraordinary therapy,” commented George Coukos, Lausanne University Hospital and the Ludwig Institute for Cancer Research, Lausanne, Switzerland, who was simply not mixed up in study. “TIL is really a new paradigm for treating cancers and, as these results clearly demonstrate, it’s efficacious and feasible most importantly scale. The findings raise hopes for the management and potential cure of metastatic solid tumors.”

The procedure essentially involves going for a small sample from the patient’s resected tumor, growing immune T cells from the tumor in the laboratory and infusing the personalized TIL therapy back to the individual following chemotherapy. TILs recognize as abnormal, penetrate them and work to kill them.

The phase 3 M14TIL trial randomized 168 patients with unresectable stage IIIC-IV melanoma to immunotherapy with the anti-CTLA-4 antibody ipilimumab or even to TIL treatment; most patients had failed prior anti-PD-1 treatment. Results reported for the very first time at the ESMO Congress 2022 showed that patients treated with TIL therapy had significantly longer median of 7.2 months in comparison to 3.1 months in those receiving ipilimumab; the entire response rate to TILs was 49% versus 21% for ipilimumab; median overall survival was 25.8 months versus 18.9 months. Patients remain being followed up for overall survival.

Treatment plans for patients with metastatic melanoma have changed considerably during the last 10 years with the development of checkpoint inhibitors, like the PD-1 inhibitors nivolumab and pembrolizumab and the CTLA-4 inhibitor ipilimumab. These drugs to push out a natural brake on the so the body’s own immune cells can recognize and attack tumor cells. “They will have a good safety profile and quite high efficacy and so are now often given as first-line therapy. But if patients fail first-line treatments then your options become very scarce, particularly for patients failing anti-PD-1 drugs so there exists a real unmet need,” explained Haanen. He added: “Inside our study, 89% of patients had failed anti-PD-1 treatment.” The rest of the patients joined the trial before anti-PD-1 therapies were licensed.

Exploring the possible mechanism where TIL therapy works well in patients who’ve failed anti-PD-1 treatment, Haanen suggested: “We believe the mechanism of resistance to anti-PD-1 treatment is mainly delivered by the tumor microenvironment. When we take these cells out of these environment, reactivate them in the laboratory, grow them around large numbers and present them back again to the patients we are able to overcome a few of the escape mechanisms. And that is what we have been seeingotherwise TILs wouldn’t work in this setting.”

Despite the fact that grade 3 or more adverse events occurred in every patients treated with TIL therapy and 57% of these randomized to ipilimumab, Haanen specified: “The are well manageable & most resolve by enough time patients leave a healthcare facility after their TIL therapy”. He also added that a lot of side-effects are linked to another therapies, including chemotherapy and interleukin-2, that patients receive within the TIL regimen. Concerning the impact of TIL therapy, Haanen concluded: “TIL gets the potential to benefit patients with an array of solid tumors and trials are underway in lots of cancer types, including lung, cervical and head and neck cancers.”

Haanen explained that the trial was run by academics in holland and Denmark, without industry involvement. The researchers are actually attempting to obtain EMA approval because of their TIL therapy to attempt to make sure that it remains affordable, clear of commercial pressures.

“The outcomes out of this phase 3 study may potentially result in regulatory approval that might be practice changing,” said Coukos. “It could enable countries that could consider this way to establish centers that may deliver TIL for patients and establish this a potential second-line in advanced melanoma.”

More info: LBA3 ‘Treatment with tumor infiltrating lymphocytes (TIL) versus ipilimumab (IPI) for advanced melanoma: results from the multicenter, randomized phase 3 trial’ will undoubtedly be presented by John Haanen during Presidential Symposium 1 on Saturday, 10 September, 16: 30 to 18: 00 CEST in Paris Auditorium. Annals of Oncology, Volume 33 Supplement 7, September 2022.

Citation: Cell therapy improves progression-free survival in advanced melanoma, first phase 3 study shows (2022, September 11) retrieved 12 September 2022 from

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