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Efficacy and safety of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in patients with stage IIIB/C and IVM1a melanoma: subanalysis of the Phase III OPTiM trial.

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Publication Date
2016-01
ICR Author
Harrington, Kevin
Author
Harrington, KJ
Andtbacka, RH
Collichio, F
Downey, G
Chen, L
Szabo, Z
Kaufman, HL
Type
Journal Article
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Abstract
<h4>Objectives</h4>Talimogene laherparepvec is the first oncolytic immunotherapy to receive approval in Europe, the USA and Australia. In the randomized, open-label Phase III OPTiM trial (NCT00769704), talimogene laherparepvec significantly improved durable response rate (DRR) versus granulocyte-macrophage colony-stimulating factor (GM-CSF) in 436 patients with unresectable stage IIIB-IVM1c melanoma. The median overall survival (OS) was longer versus GM-CSF in patients with earlier-stage melanoma (IIIB-IVM1a). Here, we report a detailed subgroup analysis of the OPTiM study in patients with IIIB-IVM1a disease.<h4>Patients and methods</h4>The patients were randomized (2:1 ratio) to intralesional talimogene laherparepvec or subcutaneous GM-CSF and were evaluated for DRR, overall response rate (ORR), OS, safety, benefit-risk and numbers needed to treat. Descriptive statistics were used for subgroup comparisons.<h4>Results</h4>Among 249 evaluated patients with stage IIIB-IVM1a melanoma, DRR was higher with talimogene laherparepvec compared with GM-CSF (25.2% versus 1.2%; <i>P</i><0.0001). ORR was also higher in the talimogene laherparepvec arm (40.5% versus 2.3%; <i>P</i><0.0001), and 27 patients in the talimogene laherparepvec arm had a complete response, compared with none in GM-CSF-treated patients. The incidence rates of exposure-adjusted adverse events (AE) and serious AEs were similar with both treatments.<h4>Conclusion</h4>The subgroup of patients with stage IIIB, IIIC and IVM1a melanoma (57.1% of the OPTiM intent-to-treat population) derived greater benefit in DRR and ORR from talimogene laherparepvec compared with GM-CSF. Talimogene laherparepvec was well tolerated.
URL
https://repository.icr.ac.uk/handle/internal/319
Collections
  • Cancer Biology
  • Radiotherapy and Imaging
Licenseref URL
https://creativecommons.org/licenses/by-nc/4.0
Version of record
10.2147/ott.s115245
Research team
Targeted Therapy
Language
eng
License start date
2016-01
Citation
OncoTargets and therapy, 2016, 9 pp. 7081 - 7093

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