A Phase IIb Randomized Controlled Trial of the TLPLDC Vaccine as Adjuvant Therapy After Surgical Resection of Stage III/IV Melanoma: A Primary Analysis

Autor: Jessica L. Cindass, Thomas E. Wagner, Annelies T. Hickerson, Jeffrey J. Sussman, Alexandra M Adams, Adam C. Berger, Robert C. Chick, Alicia M. Terando, Timothy J. Vreeland, Robert H.I. Andtbacka, Guy T. Clifton, Diane F. Hale, Phillip M. Kemp Bohan, Mark B. Faries, James W. Jakub, George E. Peoples
Rok vydání: 2021
Předmět:
Zdroj: Annals of Surgical Oncology
ISSN: 1534-4681
1068-9265
DOI: 10.1245/s10434-021-09709-1
Popis: Background Melanoma therapy has changed dramatically over the last decade with improvements in immunotherapy, yet many patients do not respond to current therapies. This novel vaccine strategy may prime a patient’s immune system against their tumor and work synergistically with immunotherapy against advanced-stage melanoma. Methods This was a prospective, randomized, double-blind, placebo-controlled, phase IIb trial of the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine administered to prevent recurrence in patients with resected stage III/IV melanoma. Patients were enrolled and randomized 2:1 to the TLPLDC vaccine or placebo (empty yeast cell wall particles and autologous dendritic cells). Both intention-to-treat (ITT) and per treatment (PT) analyses were predefined, with PT analysis including patients who remained disease-free through the primary vaccine/placebo series (6 months). Results A total of 144 patients were randomized (103 vaccine, 41 control). Therapy was well-tolerated with similar toxicity between treatment arms; one patient in each group experienced related serious adverse events. While disease-free survival (DFS) was not different between groups in ITT analysis, in PT analysis the vaccine group showed improved 24-month DFS (62.9% vs. 34.8%, p = 0.041). Conclusions This phase IIb trial of TLPLDC vaccine administered to patients with resected stage III/IV melanoma shows TLPLDC is well-tolerated and improves DFS in patients who complete the primary vaccine series. This suggests patients who do not recur early benefit from TLPLDC in preventing future recurrence from melanoma. A phase III trial of TLPLDC + checkpoint inhibitor versus checkpoint inhibitor alone in patients with advanced, surgically resected melanoma is under development. Trial Registration NCT02301611. Supplementary information The online version contains supplementary material available at (10.1245/s10434-021-09709-1).
Databáze: OpenAIRE
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