Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma

Talimogene laherparepvec is an oncolytic immunotherapy approved in the US, Europe, Australia and Switzerland. We report the final planned analysis of OPTiM, a randomized open-label phase III trial in patients with unresectable stage IIIB-IVM1c melanoma. Patients were randomized 2:1 to receive intrat...

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Bibliographic Details
Published in:Journal for immunotherapy of cancer 2019-06, Vol.7 (1), p.145-145, Article 145
Main Authors: Andtbacka, Robert H I, Collichio, Frances, Harrington, Kevin J, Middleton, Mark R, Downey, Gerald, Ӧhrling, Katarina, Kaufman, Howard L
Format: Article
Language:English
Subjects:
Analysis
Cancer
Care and treatment
Clinical trials
Efficacy
Final analysis
Immunotherapy
Labels
Macrophage colony stimulating factor
Macrophages
Medical research
Melanoma
Metastasis
Operating systems (Software)
Overall survival
Population
Response rates
Short Report
Talimogene laherparepvec
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Summary:Talimogene laherparepvec is an oncolytic immunotherapy approved in the US, Europe, Australia and Switzerland. We report the final planned analysis of OPTiM, a randomized open-label phase III trial in patients with unresectable stage IIIB-IVM1c melanoma. Patients were randomized 2:1 to receive intratumoral talimogene laherparepvec or subcutaneous recombinant GM-CSF. In addition to overall survival (OS), durable response rate (DRR), objective response rate (ORR), complete responses (CR), and safety are also reported. All final analyses are considered to be descriptive and treatment responses were assessed by the investigators. Of 436 patients in the intent-to-treat population, 295 were allocated to talimogene laherparepvec and 141 to GM-CSF. Median follow-up in the final OS analysis was 49 months. Median OS was 23.3 months (95% confidence interval [CI], 19.5-29.6) and 18.9 months (95% CI, 16.0-23.7) in the talimogene laherparepvec and GM-CSF arms, respectively (unstratified hazard ratio, 0.79; 95% CI, 0.62-1.00; p = 0.0494 [descriptive]). DRR was 19.0 and 1.4% (unadjusted odds ratio, 16.6; 95% CI, 4.0-69.2; p 
ISSN:2051-1426
2051-1426
DOI:10.1186/s40425-019-0623-z