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ASCO 2016 Nivolumab Data Study Ph Indication Line N Arms 1o EP ORR
mDR (Mo) mPFS (Mo) PFS rate mOS (Mo) OS rate CheckMate-017 III Adv. SQ-NSCLC 2nd 135
137 N3 q2wk
T q3wk OS 6.0 8% (2-Yr) CheckMate-057 Adv. NS-NSCLC 290 9.5 16% (2-Yr) CheckMate-012 I Adv. NSCLC 1st 39 N3 q2wk + I1 x q6wk Safety 31% 8.3 NC (24-Wk) CheckMate-032 I/II Rec. SCLC ≧2nd 53 N3+I1 —> N3 q2wk 31% 3.4 7.8 48% (1-Yr) CheckMate-205 Ib Cohort B: failed BV after ASCT 3rd 80 N3 q2wk 66% 79% (6-Mo) 99% (6-Mo) CheckMate-142 II MSI-H mCRC Mostly ≧3rd 26 N3+I1 q3wk x 4 —> N3 q2wk 4% NR NR 80% (4-Mo) NR 100% (5-Mo) CheckMate-067 Adv. Melanoma 315 I3 q3wk x 4 —> Placebo PFS & OS 19.0% 14.4 2.9 CheckMate-064 UNK 68
70 I3 q3wk x 4 —> N3 q2wk x 6 —> N3 q2wk 31% 16.9 76% (1-Yr)
54% (1-Yr) Treatments Legend: I1: ipilimumab 1 mg/kg; I3: ipilimumab 3 mg/kg; N1: nivolumab 1 mg/kg; N3: nivolumab 3 mg/kg; T: docetaxel 75 mg/m2. Abbreviations: 1o EP = Primary Endpoint; Adv. = Advanced; ASCT = Autologous Cell Transplant; BV = brentuximab vendotin; CHL = Classical Hodgkin Lymphoma; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NR = Not Reached; NSCLC = non-small cell lung cancer; NS-NSCLC = Non-squamous NSCLC; ORR = Overall Response Rate; Ph = Phase; PI = Principal Investigator; qXwk = every X weeks; Rec. = Recurrent; SQ-NSCLC = squamous NSCLC; UNK = Unknown; Wk = Weeks; Yr = Year. MediPaper
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Courtesy of MediPaper Medical Writers - Medi-Paper.com
ASCO 2016 Nivolumab Data Study Ph Indication Line N Arms 1o EP ORR mDR (Mo) mPFS (Mo) PFS rate mOS (Mo) OS rate CheckMate-017 III Adv. SQ-NSCLC 2nd 135
137 N3 q2wk
T q3wk OS 6.0 8% (2-Yr) CheckMate-057 Adv. NS-NSCLC 290 9.5 16% (2-Yr) CheckMate-012 I Adv. NSCLC 1st 39 N3 q2wk + I1 x q6wk Safety 31% 8.3 NC (24-Wk) CheckMate-032 I/II Rec. SCLC ≧2nd 53 N3+I1 —> N3 q2wk 31% 3.4 7.8 48% (1-Yr) CheckMate-205 Ib Cohort B: failed BV after ASCT 3rd 80 N3 q2wk 66% 79% (6-Mo) 99% (6-Mo) CheckMate-142 II MSI-H mCRC Mostly ≧3rd 26 N3+I1 q3wk x 4 —> N3 q2wk 4% NR NR 80% (4-Mo) NR 100% (5-Mo) CheckMate-067 Adv. Melanoma 315 I3 q3wk x 4 —> Placebo PFS & OS 19.0% 14.4 2.9 CheckMate-064 UNK 68
70 I3 q3wk x 4 —> N3 q2wk x 6 —> N3 q2wk 31% 16.9 76% (1-Yr)
54% (1-Yr) Treatments Legend: I1: ipilimumab 1 mg/kg; I3: ipilimumab 3 mg/kg; N1: nivolumab 1 mg/kg; N3: nivolumab 3 mg/kg; T: docetaxel 75 mg/m2. Abbreviations: 1o EP = Primary Endpoint; Adv. = Advanced; ASCT = Autologous Cell Transplant; BV = brentuximab vendotin; CHL = Classical Hodgkin Lymphoma; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NR = Not Reached; NSCLC = non-small cell lung cancer; NS-NSCLC = Non-squamous NSCLC; ORR = Overall Response Rate; Ph = Phase; PI = Principal Investigator; qXwk = every X weeks; Rec. = Recurrent; SQ-NSCLC = squamous NSCLC; UNK = Unknown; Wk = Weeks; Yr = Year. Courtesy of MediPaper Medical Writers - Medi-Paper.com
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