MD Conference Express - ELCC 2015 - (Page 12)

CLINICAL TRIAL HIGHLIGHTS Figure 1. Progression-Free Survival by Subgroup Subgroup Overall No. of Patients HR (95% CI) P Value 110 vs 111 0.75 (0.56 to 1.01) .0303 Nonsquamous 97 vs 98 0.71 (0.51 to 0.97) .0155 Nonsquamous, no bevacizumab 81 vs 83 0.65 (0.46 to 0.92) .0069 85 vs 85 0.73 (0.52 to 1.01) .0295 Nonsquamous 72 vs 73 0.66 (0.46 to 0.95) .0115 Nonsquamous, no bevacizumab 61 vs 62 0.62 (0.42 to 0.92) .0077 75 vs 77 0.68 (0.47 to 0.96) .0141 Nonsquamous 64 vs 67 0.60 (0.41 to 0.88) .0040 Nonsquamous, no bevacizumab 54 vs 57 0.52 (0.34 to 0.79) .0008 Normal TrPAL Low TrPAL 0.0 0.5 ←TG4010 better 1.0 1.5 2.0 Placebo better→ The 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. Figure 2. Overall Survival by Subgroup Subgroup No. of Patients HR (95% CI) P Value 110 vs 111 0.78 (0.55 to 1.10) .0796 Nonsquamous 97 vs 98 0.73 (0.50 to 1.07) .0515 Nonsquamous, no bevacizumab 81 vs 83 0.71 (0.47 to 1.07) .0486 85 vs 85 0.81 (0.56 to 1.19) .1436 Nonsquamous 72 vs 73 0.74 (0.49 to 1.13) .0834 Nonsquamous, no bevacizumab 61 vs 62 0.75 (0.48 to 1.18) .1020 75 vs 77 0.77 (0.51 to 1.15) .0969 Nonsquamous 64 vs 67 0.70 (0.45 to 1.10) .0581 Nonsquamous, no bevacizumab 54 vs 57 0.65 (0.40 to 1.06) .0408 Overall Normal TrPAL Low TrPAL 0.0 0.5 ←TG4010 better 1.0 1.5 2.0 Placebo better→ The 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. cancer vaccines and checkpoint inhibitors [Guibert N et al. Ther Adv Respir Dis. 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, placebocontrolled study comparing the efficacy of adding TG4010, a therapeutic cancer vaccine, to first-line treatment for stage IV non-small cell lung cancer (NSCLC) [Quoix E et al. Ann Oncol. 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 12 May 2015 CD16+, CD56+, and CD69+) as a predictive biomarker for TG4010 efficacy. The primary end point was progressionfree survival (PFS) assessed by RECIST 1.1, while the secondary end points included overall response rates, safety, overall survival (OS), and subgroup analysis. The trial enrolled 221 patients with untreated NSCLC and an MUC1 mutation. Patients were stratified by TrPAL levels (normal vs high) and then randomized 1:1 to receive TG4010 (subcutaneous injection, 108 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 = 170) treated with www.mdce.sagepub.com http://mdc.sagepub.com/

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MD Conference Express - ELCC 2015