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Onco Targets Ther. 2016 Nov 16;9:7081-7093. eCollection 2016.

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.

Author information

1
The Institute of Cancer Research/The Royal Marsden Hospital NIHR Biomedical Research Centre, London, UK.
2
Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
3
Division of Hematology and Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
4
Amgen Ltd, Cambridge, UK.
5
Amgen Inc, Thousand Oaks, CA, USA.
6
Amgen GmbH, Zug, Switzerland.
7
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.

Abstract

OBJECTIVES:

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.

PATIENTS AND METHODS:

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.

RESULTS:

Among 249 evaluated patients with stage IIIB-IVM1a melanoma, DRR was higher with talimogene laherparepvec compared with GM-CSF (25.2% versus 1.2%; P<0.0001). ORR was also higher in the talimogene laherparepvec arm (40.5% versus 2.3%; P<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.

CONCLUSION:

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.

KEYWORDS:

benefit–risk; clinical trial; durable response rate; immunotherapy; oncolytic virus; talimogene laherparepvec

Conflict of interest statement

Kevin J Harrington discloses membership of scientific advisory boards for Amgen, AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer and Viralytics and discloses a consulting role with Amgen, AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer and Viralytics. Kevin J Harrington acknowledges support from the The Institute of Cancer Research/The Royal Marsden Hospital NIHR Biomedical Research Centre. Robert HI Andtbacka discloses a consulting role with Amgen. Frances Collichio discloses a consulting role with Amgen; the University of North Carolina School of Medicine receives clinical trials funding from Amgen. Gerald Downey, Lisa Chen and Zsolt Szabo are employees of Amgen. Howard L Kaufman discloses membership of scientific advisory boards for Alkermes, Amgen, EMD Serono, Merck, Prometheus and Sanofi and involvement in a speaker’s bureau for Merck. The authors report no other conflicts of interest in this work.

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