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Title: Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB-IVM1a melanoma: a randomized, open-label, phase 2 trial.
Austin Authors: Dummer, R;Gyorki, D E;Hyngstrom, J;Berger, A C;Conry, R;Demidov, L;Sharma, A;Treichel, S A;Radcliffe, H;Gorski, K S;Anderson, A;Chan, E;Faries, M;Ross, M I
Affiliation: Amgen Inc., Thousand Oaks, CA, USA
University of Alabama School of Medicine, Birmingham, AL, USA
The Angeles Clinic and Research Institute, Los Angeles, CA, USA
John Wayne Cancer Institute, Santa Monica, CA, USA
University Hospital of Zurich, Zurich, Switzerland
Amgen Inc., South San Francisco, CA, USA
University of Utah Huntsman Cancer Institute, Salt Lake City, UT, USA
Olivia Newton-John Cancer Wellness and Research Centre
University of Texas MD Anderson Cancer Center, Houston, TX, USA
Cancer Institute of New Jersey, New Brunswick, NJ, USA
Thomas Jefferson University Hospitals, Philadelphia, PA, USA
N.N. Blokhin Russian Cancer Research Center, Moscow, Russia
Amgen Inc., Uxbridge, UK
Issue Date: Oct-2021 2021-10-04
Publication information: Nature Medicine 2021; 27(10): 1789-1796
Abstract: Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1-based intralesional oncolytic immunotherapy approved for the treatment of unresectable melanoma. The present, ongoing study aimed to estimate the treatment effect of neoadjuvant T-VEC on recurrence-free survival (RFS) of patients with advanced resectable melanoma. An open-label, phase 2 trial (NCT02211131) was conducted in 150 patients with resectable stage IIIB-IVM1a melanoma who were randomized to receive T-VEC followed by surgery (arm 1, n = 76) or surgery alone (arm 2, n = 74). The primary endpoint was a 2-year RFS in the intention-to-treat population. Secondary and exploratory endpoints included overall survival (OS), pathological complete response (pCR), safety and biomarker analyses. The 2-year RFS was 29.5% in arm 1 and 16.5% in arm 2 (overall hazard ratio (HR) = 0.75, 80% confidence interval (CI) = 0.58-0.96). The 2-year OS was 88.9% for arm 1 and 77.4% for arm 2 (overall HR = 0.49, 80% CI = 0.30-0.79). The RFS and OS differences between arms persisted at 3 years. In arm 1, 17.1% achieved a pCR. Increased CD8+ density correlated with clinical outcomes in an exploratory analysis. Arm 1 adverse events were consistent with previous reports for T-VEC. The present study met its primary endpoint and estimated a 25% reduction in the risk of disease recurrence for neoadjuvant T-VEC plus surgery versus upfront surgery for patients with resectable stage IIIB-IVM1a melanoma.
DOI: 10.1038/s41591-021-01510-7
ORCID: 0000-0002-2279-6906
Journal: Nature Medicine
PubMed URL: 34608333
Type: Journal Article
Appears in Collections:Journal articles

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