Tumor lysate particle only vaccine (TLPO) vs. Tumor lysate particle-loaded, dendritic cell vaccine (TLPLDC) to prevent recurrence in resected stage III/IV melanoma patients: Results of a phase I/IIa trial
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: The autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is produced from dendritic cells (DC) loaded ex vivo with autologous tumor lysate (TL). TLPLDC has been shown to decrease recurrence in resected Stage III/IV melanoma patients in a Phase IIb trial. The TL particle only (TLPO) vaccine is produced by loading of yeast cell wall particles with autologous TL and direct injection allowing for in vivo DC loading. We have compared the TLPO and TLPLDC vaccines in an embedded Phase I/IIa trial of a larger Phase IIb trial of the TLPLDC vaccine. METHODS: Patients rendered clinically disease-free after surgery were randomized 2:1 to receive the TLPO or TLPLDC vaccine and followed for recurrence and death. Patients had scheduled intradermal inoculations at 0, 1, 2, 6, 12, and 18 months after enrollment. Kaplan-Meier and log-rank analysis were used to compare disease-free survival (DFS) and overall survival (OS) in an intention-to-treat (ITT) analysis. RESULTS: Sixty-three patients were randomized, 43 TLPO and 20 TLPLDC. Patients randomized to the TLPO arm were more likely to be female (37.2% vs. 10.0 %, p = 0.026), but otherwise no significant clinicopathological differences were identified. No differences in related adverse events (AE) were found between treatment arms. At a median follow-up of 20.5 months, the DFS (60.8% vs. 58.7 %, p = 0.714) and OS (94.6% vs. 93.8 %, p = 0.966) were equivalent between the TLPO and TLPLDC groups, respectively. No statistical differences were found in subgroup analyses between vaccine types, which accounted for receipt of immunotherapy and the use of G-CSF pre-blood draw. CONCLUSIONS: In a randomized, double-blind Phase I/IIa trial, there were no differences in DFS or OS in resected Stage III/IV melanoma patients receiving adjuvant TLPO versus TLPLDC vaccines. Given manufacturing advantages, further efficacy testing of TLPO is warranted in a Phase III trial.
Authors: Spencer G. Van Decar, Elizabeth L. Carpenter, Alexandra M. Adams, Robert C. Chick, Guy T. Clifton, Alex Stojadinovic, Timothy J. Vreeland, Franklin A. Valdera, Ankur Tiwari, Anne E. O'Shea, Patrick M. McCarthy, Diane F. Hale, Phillip M Kemp Bohan, Annelies T. Hickerson, Jessica L. Cindass, John Hyngstrom, Adam C. Berger, James W. Jakub, Jeffrey J. Sussman, Montaser Shaheen, Xianzhong Yu, Thomas Wagner, Mark B. Faries, George E. Peoples
Institutions: Brooke Army Medical Center, The University of Texas at San Antonio Health Science Center, Huntsman Cancer Institute, Rutgers, The State University of New Jersey, Rutgers Cancer Institute, Mayo Clinic in Florida, University of Cincinnati, University of Arizona, Clemson University, Orbis Health Solutions (United States)
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $2,410
OpenAlex ID: W4402493826