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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe phase 2b results of the randomized, double-blind, placebo-controlled TIME study provide evidence of activity with TG4010, a therapeutic cancer vaccine, when added to first-line chemotherapy for stage IV non\u2013small cell lung cancer, especially for nonsquamous histology and low levels of triple-positive activated lymphocytes. These data suggest that normal levels of triple-positive activated lymphocytes may be a predictive biomarker of TG4010 efficacy.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eadvanced non\u2013small cell lung cancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eimmunotherapy\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETG4010\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecancer vaccine, triple-positive activated lymphocytes\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epredictive biomarkers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETIME study\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eoncology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003ELung cancer is emerging as a promising target for immunotherapy, with the PD-1 inhibitor nivolumab just recently approved by the FDA. Two categories of novel immunotherapies being evaluated include cancer vaccines and checkpoint inhibitors [Guibert N et al. \u003Cem\u003ETher Adv Respir Dis.\u003C\/em\u003E 2015]. Elisabeth Quoix, MD, The University Hospitals of Strasbourg, Strasbourg, France, and colleagues shared phase 2b results from TIME, a phase 2b\/3 randomized, double-blind, placebo-controlled study comparing the efficacy of adding TG4010, a therapeutic cancer vaccine, to first-line treatment for stage IV non\u2013small cell lung cancer (NSCLC) [Quoix E et al. \u003Cem\u003EAnn Oncol.\u003C\/em\u003E 2015]. TG4010 is a modified attenuated poxvirus (Ankara strain) coding for MUC1 tumor-associated antigen and interleukin-2. The aim of the phase 2b study was to validate a normal level of triple-positive activated lymphocytes (TrPALs; including CD16\u003Csup\u003E+\u003C\/sup\u003E, CD56\u003Csup\u003E+\u003C\/sup\u003E, and CD69\u003Csup\u003E+\u003C\/sup\u003E) as a predictive biomarker for TG4010 efficacy. The primary end point was progression-free survival (PFS) assessed by RECIST 1.1, while the secondary end points included overall response rates, safety, overall survival (OS), and subgroup analysis.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EThe trial enrolled 221 patients with untreated NSCLC and an \u003Cem\u003EMUC1\u003C\/em\u003E mutation. Patients were stratified by TrPAL levels (normal vs high) and then randomized 1:1 to receive TG4010 (subcutaneous injection, 10\u003Csup\u003E8\u003C\/sup\u003E PFU weekly over 6 weeks, once every 3 weeks thereafter until progression) or placebo in combination with chemotherapy (21-day cycles for 4-6 cycles). Bayesian analysis of PFS in patients with normal TrPAL levels (n\u2005=\u2005170) treated with TG4010 (n\u2005=\u200585) or placebo (n\u2005=\u200585) was conducted after 144 events of disease progression.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EIn the patients with normal TrPAL levels, the primary end point of PFS was achieved in 70 patients (82.4%) receiving TG4010 and 74 patients (87.1%) receiving placebo. The observed hazard ratio (HR) for PFS was 0.74 (95% CI, 0.53 to 1.02), which corresponded to a 98.6% Bayesian probability that the true HR was \u0026lt;\u20051 and thus passed the necessary threshold of 95% to have met the efficacy end point in the normal TrPAL patient population. In patients with normal TrPAL levels, median PFS favored the TG4010 treatment arm compared with standard chemotherapy alone (5.7 vs 5.1 months, respectively; HR, 0.78; 95% CI, 0.53 to 1.02; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.078). The overall response rate was 37.6% in the TG4010 treatment arm compared and 30.6% in the placebo arm of the patients with a normal TrPAL level. The analysis of patients with high TrPAL levels is still pending.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EMost grade 3\/4 adverse events were similar between the treatment arms and included neutropenia, thrombocytopenia, fatigue, anemia, and febrile neutropenia with higher TG4010-related adverse events at the injection site (31.4% vs 4%).\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003ESubgroup analyses in patients with nonsquamous NSCLC (n\u2005=\u2005195) showed a significant improvement in PFS when treated with TG4010 (HR, 0.71; 95% CI, 0.51 to 0.97; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.016), with an increase in OS (HR, 0.73; 95% CI, 0.50 to 1.07). In the 75% of patients with the lowest baseline TrPAL levels (low TrPAL; n\u2005=\u2005152), the HR for PFS was 0.66 (95% CI, 0.46 to 0.96; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.014). In the patients with nonsquamous NSCLC and low TrPAL levels (n\u2005=\u2005131), PFS was significantly increased in the TG4010 arm vs placebo (HR, 0.60; 95% CI, 0.41 to 0.88) and OS was increased with TG4010 vs placebo (HR, 0.70; 95% CI, 0.45 to 1.10). Forest plots of PFS and OS in the stratified subgroups are shown in \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigures 1\u003C\/a\u003E and \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003E2\u003C\/a\u003E.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Progression-Free Survival by SubgroupThe HR is from the unstratified Cox proportional hazards model. The P value (one-sided) is from the unstratified log-rank test.TrPAL, triple-positive activated lymphocyte.Reproduced with permission from E Quoix, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-265059429\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Progression-Free Survival by SubgroupThe HR is from the unstratified Cox proportional hazards model. The \u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt; value (one-sided) is from the unstratified log-rank test.TrPAL, triple-positive activated lymphocyte.Reproduced with permission from E Quoix, MD.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16305\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EProgression-Free Survival by Subgroup\u003C\/p\u003E\n               \u003Cp id=\u0022p-8\u0022\u003EThe HR is from the unstratified Cox proportional hazards model. The \u003Cem\u003EP\u003C\/em\u003E value (one-sided) is from the unstratified log-rank test.\u003C\/p\u003E\n               \u003Cp id=\u0022p-9\u0022\u003ETrPAL, triple-positive activated lymphocyte.\u003C\/p\u003E\n               \u003Cp id=\u0022p-10\u0022\u003EReproduced with permission from E Quoix, MD.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Overall Survival by SubgroupThe HR is from the unstratified Cox proportional hazards model. The P value (one-sided) is from the unstratified log-rank test.TrPAL, triple-positive activated lymphocyte.Reproduced with permission from E Quoix, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-265059429\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Overall Survival by SubgroupThe HR is from the unstratified Cox proportional hazards model. The \u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt; value (one-sided) is from the unstratified log-rank test.TrPAL, triple-positive activated lymphocyte.Reproduced with permission from E Quoix, MD.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/8\/11.2\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16306\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-11\u0022 class=\u0022first-child\u0022\u003EOverall Survival by Subgroup\u003C\/p\u003E\n               \u003Cp id=\u0022p-12\u0022\u003EThe HR is from the unstratified Cox proportional hazards model. The \u003Cem\u003EP\u003C\/em\u003E value (one-sided) is from the unstratified log-rank test.\u003C\/p\u003E\n               \u003Cp id=\u0022p-13\u0022\u003ETrPAL, triple-positive activated lymphocyte.\u003C\/p\u003E\n               \u003Cp id=\u0022p-14\u0022\u003EReproduced with permission from E Quoix, MD.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EProf Quoix concluded that the results of the phase 2b portion of the TIME study provided evidence of the efficacy and safety of TG4010 in stage IV NSCLC, especially in patients with nonsquamous tumors and low TrPAL levels.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/8\/11.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzl741\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzl741\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}