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Ann Surg Oncol. 2016 Dec;23(13):4169-4177. Epub 2016 Jun 24.

Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial.

Author information

1
Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Robert.Andtbacka@hci.utah.edu.
2
University of Texas MD Anderson Cancer Center, Houston, TX, USA.
3
Vanderbilt University Medical Center, Nashville, TN, USA.
4
University of Iowa Hospitals and Clinics, Iowa City, IA, USA.
5
University of North Carolina, Chapel Hill, NC, USA.
6
Emory University, Atlanta, GA, USA.
7
Minnesota Oncology, Fridley, MN, USA.
8
Moffitt Cancer Center, Tampa, FL, USA.
9
University of Washington School of Medicine, Seattle, WA, USA.
10
Saint Louis University Cancer Center, St Louis, MO, USA.
11
Amgen Inc., Thousand Oaks, CA, USA.
12
Rutgers Cancer Institute of New Jersey, Rutgers, NJ, USA.

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.

PMID:
27342831
PMCID:
PMC5090012
DOI:
10.1245/s10434-016-5286-0
[Indexed for MEDLINE]
Free PMC Article

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