Article ; Online: Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
2022 Volume 41, Issue 3, Page(s) 528–540
Abstract: Purpose: The combination of talimogene laherparepvec (T-VEC) and pembrolizumab previously demonstrated an acceptable safety profile and an encouraging complete response rate (CRR) in patients with advanced melanoma in a phase Ib study. We report the ... ...
Abstract | Purpose: The combination of talimogene laherparepvec (T-VEC) and pembrolizumab previously demonstrated an acceptable safety profile and an encouraging complete response rate (CRR) in patients with advanced melanoma in a phase Ib study. We report the efficacy and safety from a phase III, randomized, double-blind, multicenter, international study of T-VEC plus pembrolizumab (T-VEC-pembrolizumab) versus placebo plus pembrolizumab (placebo-pembrolizumab) in patients with advanced melanoma. Methods: Patients with stage IIIB-IVM1c unresectable melanoma, naïve to antiprogrammed cell death protein-1, were randomly assigned 1:1 to T-VEC-pembrolizumab or placebo-pembrolizumab. T-VEC was administered at ≤ 4 × 10 Results: Overall, 692 patients were randomly assigned (346 T-VEC-pembrolizumab and 346 placebo-pembrolizumab). T-VEC-pembrolizumab did not significantly improve PFS (hazard ratio, 0.86; 95% CI, 0.71 to 1.04; Conclusion: T-VEC-pembrolizumab did not significantly improve PFS or OS compared with placebo-pembrolizumab. Safety results of the T-VEC-pembrolizumab combination were consistent with the safety profiles of each agent alone. |
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MeSH term(s) | Humans ; Melanoma/drug therapy ; Oncolytic Virotherapy/methods ; Herpesvirus 1, Human ; Double-Blind Method |
Chemical Substances | talimogene laherparepvec ; pembrolizumab (DPT0O3T46P) |
Language | English |
Publishing date | 2022-08-23 |
Publishing country | United States |
Document type | Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't |
ZDB-ID | 604914-x |
ISSN | 1527-7755 ; 0732-183X |
ISSN (online) | 1527-7755 |
ISSN | 0732-183X |
DOI | 10.1200/JCO.22.00343 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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