دورية
Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB–IVM1a melanoma: a randomized, open-label, phase 2 trial
| العنوان: | Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB–IVM1a melanoma: a randomized, open-label, phase 2 trial |
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| المؤلفون: | 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. |
| المصدر: | Nature Medicine; October 2021, Vol. 27 Issue: 10 p1789-1796, 8p |
| مستخلص: | 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. |
| قاعدة البيانات: | Supplemental Index |
| تدمد: | 10788956 1546170X |
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| DOI: | 10.1038/s41591-021-01510-7 |