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Cryopreserved Lifileucel in Advanced Refractory Metastatic Melanoma

By: Melissa E. Fryman, MS
Posted: Tuesday, September 17, 2019

Cryopreserved lifileucel, an autologous tumor-infiltrating lymphocyte therapy, seems to be safe and effective in patients with advanced refractory metastatic melanoma. The adoptive cell transfer therapy was tested in several cohorts as a cryopreserved, or noncryopreserved, product. Results from the ongoing C-144-01 trial were presented by Amod Sarnaik, MD, of the Moffitt Cancer Center, Tampa, Florida, and colleagues at the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 2518).

In cohort 2 of this phase II, multicenter, open-label study, 55 patients with stage IIIC/IV unresectable melanoma underwent nonmyeloablative lymphodepletion, then received infusion of cryopreserved lifileucel followed by interleukin-2. On average, patients had received 3.1 prior therapies. All patients had a high tumor burden and had received prior anti–PD-1 therapy. Almost all patients experienced disease progression on previous anti—PD-1 therapy. In addition, 80% of patients had received anti–CTL4A-4, and 24% of patients had received BRAF/MEK inhibitors.

After a median follow-up of 7.4 months, the overall response rate in cohort 2 was 38%, with 2, 18, and 1 patient having complete, partial, and unconfirmed partial responses, respectively. Patients with negative PD-L1 status, with a tumor proportion score less than 5, were among the responders. Of the 21 patients who responded to treatment, four patients experienced disease progression. The overall rate of disease control was 76%. The authors noted that “improved responses in some patients were observed with longer follow-up.”

“Based on these data, a new cohort 4 in C-144-01 has been initiated to support lifileucel registration,” concluded the authors.

Disclosure: The study authors’ disclosure information may be found at coi.asco.org.



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