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Title:
Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial | Annals of Surgical Oncology
Description:
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. 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. 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. 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.
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Keywords {🔍}
lesions, patients, response, tvec, ppr, tumor, injected, uninjected, treatment, melanoma, months, responses, visceral, article, treated, progression, size, fig, analysis, phase, study, baseline, weeks, supplementary, pubmed, electronic, nonvisceral, systemic, time, durable, appendix, google, scholar, amgen, area, lesion, median, gmcsf, evaluable, due, usa, optim, trial, individual, patient, cancer, oncolytic, immunotherapies, cas, patterns,
Topics {✒️}
granulocyte-macrophage colony-stimulating factor-encoding f-fdg pet/ct interpretation anti-cytotoxic t-lymphocyte antigen-4 anti-tumour properties herpes simplex virus stage iiib–iv melanoma generation oncolytic herpesvirus immune-mediated tumor responses positron emission tomography/ct article download pdf lesion-level response analyses anti-pd-1 based immunotherapy enhance t-vec activity immune-related response criteria oncolytic immunotherapy designed tumor-derived antigens institutional review boards receive intralesional t-vec recurrent stage iiib cell responses vertical axis depicts mark shilkrut md clinical trial design received t-vec treatment merrick ross md phase iii study privacy choices/manage cookies lesion-level response analysis lisa chen phd t-vec-treated patients t-vec treated patients 48 t-vec-treated patients t-vec-treated patient phase ii study thomas amatruda md receiving t-vec full access gm-csf arm assigned body-site area immune stimulating distant immunity induced durable tumor remission eddy hsueh md frances collichio md surgical oncology aims residual pigmented areas unresectable metastatic melanoma durable response rate distinguishing true progression mohammed milhem md
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headline:Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial
description: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. 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. 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. 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.
datePublished:2016-06-24T00:00:00Z
dateModified:2016-06-24T00:00:00Z
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Ipilimumab
Overall Response Rate
Durable Response
Oncolytic Virus
Visceral Lesion
Surgical Oncology
Oncology
Surgery
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headline:Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial
description: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. 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. 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. 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.
datePublished:2016-06-24T00:00:00Z
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Ipilimumab
Overall Response Rate
Durable Response
Oncolytic Virus
Visceral Lesion
Surgical Oncology
Oncology
Surgery
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