Treatment with the autologous tumor-infiltrating lymphocyte (TIL) cell therapy lifileucel (Amtagvi) for pretreated metastatic non-small cell lung cancer was feasible, had a manageable safety profile, and induced responses, including in patients with profiles typically resistant to immunotherapy, according to findings from a small phase II trial.
Findings from the study, , were presented at the recent American Society of Clinical Oncology meeting and published in .
In this exclusive ľֱ video, Kai He, MD, PhD, of the Ohio State University in Columbus, discusses the background and takeaway from the study.
Following is a transcript of his remarks:
For the study COM-202 3B cohort -- so that was TIL therapy, namely tumor-infiltrating lymphocyte therapy -- sponsored by Iovance to test this drug in a phase II study, multicenter, in immunotherapy refractory/resistant stage IV non-small cell lung cancer population.
It's feasible and safe to deliver centrally-manufactured TIL cell product and deliver globally to multiple cancer centers and to treat the patient. The treatment is feasible, the safety profile is manageable, and we also demonstrate encouraging anti-tumor activity. More than 20% of the patients have either partial response or complete response, and we also observed long-sustained complete response in patients. And we also observed a response in patients with a general signature resistant [to] immunotherapy, for example, low tumor mutation burden, negative PD-L1, or with STK11 mutation.
I think overall, the safety profile is as expected and manageable because there's associated lymphodepletion and the cell infusion and [interleukin-2] treatment. I think the chemo-related bone marrow suppression is part of the manageable toxicity. Surprisingly, cytokine release syndrome was not obvious in this patient population. It's very encouraging.
The takeaway message is we know tumor-infiltrating therapy is approved in metastatic melanoma. That was the first ever cell therapy treatment in solid tumor, and currently we are expanding the utility of this novel immunotherapy into a lung cancer population. It is a very large population and with a huge unmatched medical need [for] how to treat stage IV non-small cell lung cancer [that progresses after] previous immunotherapy. So this new cell therapy with a TIL actually provides a very encouraging and novel approach to treat this patient population and the further study is ongoing.