Sajeve Thomas, MD, an oncologist and hematologist at the Orlando Health Cancer Institute speaks about Using A Patient"™s Own Tumor Cells As Ammunition To Fight Their Cancer.
Link to Article:
http://oh.multimedia-newsroom.com/index.php/2021/08/04/using-a-patients-own-tumor-cells-as-ammunition-to-fight-their-cancer/
Intent:
Patients with advanced (metastatic or unresectable) melanoma who do not respond to immune checkpoint inhibitors or targeted treatments have limited therapeutic choices. In metastatic melanoma, adoptive cell treatment with tumor-infiltrating lymphocytes has shown to be effective. Lifileucel is a tumor-infiltrating lymphocyte product that is autologous and produced centrally.
Methodologies:
In patients with metastatic melanoma who had previously been treated with checkpoint inhibitors and BRAF 6 MEK targeted therapies, we undertook a phase II open-label, single-arm, multicenter trial.
Lifileucel was created utilizing a simplified 22-day procedure from collected tumor tissues in central Good Manufacturing Practice facilities. A nonmyeloablative lymphodepletion regimen, a single lifileucel infusion, and up to six doses of high-dose interleukin-2 were given to the patients. The investigator-assessed objective response rate (ORR) per RECIST, version 1.1 was the major endpoint.
Outcomes:
Sixty-six patients had undergone an average of 3.3 previous treatments (100 percent anti-programmed death 1 [PD-1] or programmed death-ligand 1 [PD-L1], 80 percent anticytotoxic T-lymphocyte-associated protein-4, and 23% BRAF 6 MEK inhibitor). With two complete replies and 22 partial responses, the ORR was 36 percent (95 percent CI, 25 to 49). The disease control rate was about 80%. (95 percent CI, 69 to 89). After a median study follow-up of 18.7 months, the median duration of response was not attained (range, 0.2-34.1 months). The ORR and disease control rate in the main refractory to anti"“PD-1 or PD-L1 treatment category were 41 percent (95 percent CI, 26 to 57) and 81 percent (95 percent CI, 66 to 91), respectively. The safety profile was consistent with established interleukin-2 and nonmyeloablative lymphodepletion side effects.
Conclude:
Lifileucel showed long-lasting responses and fills a significant gap in therapeutic choices for patients with metastatic melanoma who have exhausted all other alternatives after receiving authorized therapy, including those who are resistant to anti"“PD-1 or PD-L1 therapy.