Patterns of Clinical Response with Talimogene Laherparepvec T-VEC in Patients with Melanoma Treated in the OPTiM Phase III Clinical TrialReport as inadecuate

Patterns of Clinical Response with Talimogene Laherparepvec T-VEC in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial - Download this document for free, or read online. Document in PDF available to download.

Journal Title:

Annals of Surgical Oncology


Volume 23, Number 13


Springer Verlag Germany | 2016-12-01, Pages 4169-4177

Type of Work:

Article | Final Publisher PDF

Abstract: Purpose: Talimogene laherparepvec T-VEC is an oncolytic immunotherapy designed to induce tumor regression of injected lesions through direct lytic effects, and of uninjected lesions through induction of systemic antitumor immunity. In this study, we describe the patterns and time course of response to T-VEC from the phase III OPTiM trial of 436 patients with unresected stages IIIB–IV melanoma.Methods: Lesion-level response analyses were performed based on the type of lesion injected or uninjected cutaneous, subcutaneous, or nodal lesions; or visceral lesions uninjected, and the best percentage change from baseline of the sum of products of the longest diameters was calculated. Patients randomized to T-VEC n = 295 who experienced a durable response continuous partial or complete response for ≥6 months were evaluated for progression prior to response PPR, defined as the appearance of a new lesion or >25 % increase in total baseline tumor area.Results: T-VEC resulted in a decrease in size by ≥50 % in 64 % of injected lesions N = 2116, 34 % of uninjected non-visceral lesions N = 981, and 15 % of visceral lesions N = 177. Complete resolution of lesions occurred in 47 % of injected lesions, 22 % of uninjected non-visceral lesions, and 9 % of visceral lesions. Of 48 patients with durable responses, 23 48 % experienced PPR, including 14 who developed new lesions only. No difference in overall survival was observed, and median duration of response was not reached in patients with PPR versus those without PPR.Conclusions: Responses in uninjected lesions provide validation of T-VEC-induced systemic immunotherapeutic effects against melanoma. PPR did not negatively impact the clinical effectiveness of T-VEC.

Subjects: Health Sciences, Medicine and Surgery - Health Sciences, Oncology - Health Sciences, Pharmacology - Keywords: Science and Technology - Life Sciences and Biomedicine - Oncology - Surgery - IMMUNE-RELATED RESPONSE - HERPES-SIMPLEX-VIRUS - SOLID TUMORS - CRITERIA -

Author: Robert H.I. Andtbacka, Merrick Ross, Igor Puzanov, Mohammed Milhem, Frances Collichio, Keith Delman, Thomas Amatruda, Jonathan S.



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