Presentation is loading. Please wait.

Presentation is loading. Please wait.

© MediPaper 2016 ASCO 2016 Ipilimumab Data - Melanoma MediPaper Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate.

Similar presentations


Presentation on theme: "© MediPaper 2016 ASCO 2016 Ipilimumab Data - Melanoma MediPaper Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate."— Presentation transcript:

1 © MediPaper 2016 ASCO 2016 Ipilimumab Data - Melanoma MediPaper Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate CheckMate-032I/IIAdv. & Met. Gastric Cancer ≧ 2 nd 59 49 52 N3 q2wk N1+I3 —> N3 q2wk N3+I1 —> N3 q2wk ORR 14% 26% 1 0% Overall: 16% 5.0 6.9 4.8 49, 36 54, 34 43, NA (6-Mo, 1-Yr) CA-184-162IIAdv. & Met. Gastric Cancer Maint.57 I10 q3wk x 4 doses —> I10 q12wk BSC irPFS2.9, 2.7 4.9, 4.9 (irPFS, PFS) 12.7 12.1 Keynote-006III BMa Adv. Melanoma1 st & 2 nd 667 PDL1+ 150 PDL1– 550 1st-line 284 2nd-line PDL1+, TNai Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 PFS & OS 39% 13% 25% 13% 40% 13% 29% 12% 43% 13% 51% (6-Mo) 25% (6-Mo) 32% (6-Mo) 28% (6-Mo) 52% (6-Mo) 28% (6-Mo) 38% (6-Mo) 23% (6-Mo) 55% (6-Mo) 28% (6-Mo) 87% (6-Mo) 74% (6-Mo) 81% (6-Mo) 73% (6-Mo) 87% (6-Mo) 76% (6-Mo) 83% (6-Mo) 71% (6-Mo) 88% (6-Mo) 75% (6-Mo) Keynote-006IIIAdv. Melanoma1 st & 2 nd 834Pembro 10 q2wk x 24mo Pembro 10 q3wk x 24mo Ipi 3mg/kg q3wk x 4 PFS & OS 36.9% 36.1% 13.3% 5.6 4.1 2.8 31.2% (24- Mo) 27.8% (24-Mo) 13.5% (24-Mo) NR NR 16.0 55.1% (24- Mo) 55.3% (24- Mo) 43.0% (24-Mo) Keynote-029IAdv. Melanoma ≧ 1 st 153Pembro 2 + I1 q3wk x4 —> Pembro 2 q3wkPFS & Safety 51% (IDMC) 57% (Inv.) Treatments: BSC = Best Supportive Care; HF10 = HF10 injected into single or multiple tumors (1 x 107 TCID50/mL/dose, up to 5mL depending on tumor size and number); HDI = High-Dose IFN-α 20 MU/m²/d IV x 5 days (d)/wk for 4 wk then 10 MU/m²/d SC every other d TIW for 48 wk; I1 = Ipilimumab 1 mg/kg; I3 = Ipilimumab 3 mg/kg; I10 = Ipilimumab 10 mg/kg; N1 = nivolumab 1 mg/kg; N3 = nivolumab 3 mg/kg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; Pbo = Placebo; Abbreviations: 1 o EP = Primary Endpoint; Adv. = Advanced; BMa = Biomarker; BRAFwt = BRAF Wild-type; IDMC = Independent Data Monitoring Committee; Inv. = Investigator; irAE = Immune-related Adverse Events; irPFS = Immune-related PFS; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; Maint. = Maintenance; Met. = Metastatic; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NE = Not Evaluable; Neoadj. = Neoadjuvant; NR = Not Reached; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate; OS; Overall Survival; pCR = pathological Complete Response; PFS: Progression Free Survival; Ph = Phase; qXwk = every X weeks; Rec. = Recurrent; SC = Substance; SCLC = small cell lung cancer; TIW = Twice per Week; TNai = Treatment Naive; UNK = Unknown; Wk = Weeks; Yr = Year.

2 © MediPaper 2016 ASCO 2016 Ipilimumab Data - Melanoma Cont’d Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate CheckMate-067IIIAdv. Melanoma1 st 314 316 315 N1+I3 q3wk x 4 —> N3 q2wk N3 q2wk x 4 —> Pbo I3 q3wk x 4 —> Pbo PFS & OS 57.6% 43.7% 19.0% NR 22.3 14.4 11.5 6.9 2.9 CheckMate-064IIAdv. MelanomaUNK68 70 N3 q2wk x 6 —> I3 q3wk x 4 —> N3 q2wk I3 q3wk x 4 —> N3 q2wk x 6 —> N3 q2wk Safety54% 31% NR 16.9 76% (1-Yr) 54% (1-Yr) Checkmate-069 Checkmate-069 Discontinued pts (irAE) IIAdv. Melanoma1 st 44 10 72 (BRAFwt) 3 7 (BRAFwt) N1+I3 q3wk x 4 —> N3 q2wk or Pbo I3 + Pbo q3wk x 4 —> N3 q2wk or Pbo ORR (ND) NR 11.2 NR NR 79.5% (18-Mo) 40.0% (18-Mo) 73.2% (18-Mo) 56.0% (18-Mo) Abstract 9543 Abstract 9543 Preliminary Results IIAdv. Melanoma ≧ 1st 43HF10 q1wk x4 —> HF10 q3wk x15 and I3 q3wk x4 37.8% (irRC) Abstract 9585IMelanomaNeoadj.14 13 I3 q3wk x4 —> Sur—> I3 q12wk x 4 +HDI I10 q3wk x4 —> Sur—> I10 q12wk x 4 +HDI Safety35%, 35% (ORR, pCR) Treatments: BSC = Best Supportive Care; HF10 = HF10 injected into single or multiple tumors (1 x 107 TCID50/mL/dose, up to 5mL depending on tumor size and number); HDI = High-Dose IFN-α 20 MU/m²/d IV x 5 days (d)/wk for 4 wk then 10 MU/m²/d SC every other d TIW for 48 wk; I1 = Ipilimumab 1 mg/kg; I3 = Ipilimumab 3 mg/kg; I10 = Ipilimumab 10 mg/kg; N1 = nivolumab 1 mg/kg; N3 = nivolumab 3 mg/kg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; Pbo = Placebo; Abbreviations: 1 o EP = Primary Endpoint; Adv. = Advanced; BMa = Biomarker; BRAFwt = BRAF Wild-type; IDMC = Independent Data Monitoring Committee; Inv. = Investigator; irAE = Immune-related Adverse Events; irPFS = Immune-related PFS; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; Maint. = Maintenance; Met. = Metastatic; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NE = Not Evaluable; Neoadj. = Neoadjuvant; NR = Not Reached; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate; OS; Overall Survival; pCR = pathological Complete Response; PFS: Progression Free Survival; Ph = Phase; qXwk = every X weeks; Rec. = Recurrent; SC = Substance; SCLC = small cell lung cancer; TIW = Twice per Week; TNai = Treatment Naive; UNK = Unknown; Wk = Weeks; Yr = Year. MediPaper

3 © MediPaper 2016 ASCO 2016 Ipilimumab Data - NSCLC / Other MediPaper Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate CheckMate-012IAdv. NSCLC1 st 31 40 38 39 N1 + I1 q2wk x 4 —> N3 q2wk N1 q2wk + I1 q6wk N3 q2wk + I1 x q12wk N3 q2wk + I1 x q6wk Safety13% 25% 39% 31% 10.6 4.9 8.0 8.3 55 (24-Wk) NC (24-Wk) 63 (24-Wk) NC (24-Wk) CheckMate-032I/IIRec. SCLC ≧ 2 nd 80 47 53 N3 q2wk N1+I3 —> N3 q2wk N3+I1 —> N3 q2wk ORR13% 31% 1.4 3.4 3.6 7.8 27% (1-Yr) 48% (1-Yr) CheckMate-142IIMSI-H mCRCMostly ≧ 3 rd 33 26 N3 q2wk N3+I1 q3wk x 4 —> N3 q2wk ORR (by Inv.) 9% 4%NR 5.3 NR 55% (4-Mo) 80% (4-Mo) 16.3 NR 75% (5-Mo) 100% (5-Mo) CheckMate-143IRec. Glioblastoma 2 nd 10 10 20 N3 q2wk x 4 —> N3 q2wk N1 + I3 q3wk x 4 —> N3 q2wk N3 + I1 q3wk x 4—> N3 q2wk 40% (1-Yr) 30% (1-Yr) 25% (1-Yr) Treatments: BSC = Best Supportive Care; HF10 = HF10 injected into single or multiple tumors (1 x 107 TCID50/mL/dose, up to 5mL depending on tumor size and number); HDI = High-Dose IFN-α 20 MU/m²/d IV x 5 days (d)/wk for 4 wk then 10 MU/m²/d SC every other d TIW for 48 wk; I1 = Ipilimumab 1 mg/kg; I3 = Ipilimumab 3 mg/kg; I10 = Ipilimumab 10 mg/kg; N1 = nivolumab 1 mg/kg; N3 = nivolumab 3 mg/kg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; Pbo = Placebo; Abbreviations: 1 o EP = Primary Endpoint; Adv. = Advanced; BMa = Biomarker; BRAFwt = BRAF Wild-type; IDMC = Independent Data Monitoring Committee; Inv. = Investigator; irAE = Immune-related Adverse Events; irPFS = Immune-related PFS; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; Maint. = Maintenance; Met. = Metastatic; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NE = Not Evaluable; Neoadj. = Neoadjuvant; NR = Not Reached; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate; OS; Overall Survival; pCR = pathological Complete Response; PFS: Progression Free Survival; Ph = Phase; qXwk = every X weeks; Rec. = Recurrent; SC = Substance; SCLC = small cell lung cancer; TIW = Twice per Week; TNai = Treatment Naive; UNK = Unknown; Wk = Weeks; Yr = Year.

4 © MediPaper 2016 ASCO 2016 Ipilimumab Data - Melanoma Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate CheckMate-032I/IIAdv. & Met. Gastric Cancer ≧ 2 nd 59 49 52 N3 q2wk N1+I3 —> N3 q2wk N3+I1 —> N3 q2wk ORR 14% 26% 1 0% Overall: 16% 5.0 6.9 4.8 49, 36 54, 34 43, NA (6-Mo, 1-Yr) CA-184-162IIAdv. & Met. Gastric Cancer Maint.57 I10 q3wk x 4 doses —> I10 q12wk BSC irPFS2.9, 2.7 4.9, 4.9 (irPFS, PFS) 12.7 12.1 Keynote-006III BMa Adv. Melanoma1 st & 2 nd 667 PDL1+ 150 PDL1– 550 1st-line 284 2nd-line PDL1+, TNai Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo Ipi 3 q3wk x 4 PFS & OS 39% 13% 25% 13% 40% 13% 29% 12% 43% 13% 51% (6-Mo) 25% (6-Mo) 32% (6-Mo) 28% (6-Mo) 52% (6-Mo) 28% (6-Mo) 38% (6-Mo) 23% (6-Mo) 55% (6-Mo) 28% (6-Mo) 87% (6-Mo) 74% (6-Mo) 81% (6-Mo) 73% (6-Mo) 87% (6-Mo) 76% (6-Mo) 83% (6-Mo) 71% (6-Mo) 88% (6-Mo) 75% (6-Mo) Keynote-006IIIAdv. Melanoma1 st & 2 nd 834Pembro 10 q2wk x 24mo Pembro 10 q3wk x 24mo Ipi 3mg/kg q3wk x 4 PFS & OS 36.9% 36.1% 13.3% 5.6 4.1 2.8 31.2% (24- Mo) 27.8% (24-Mo) 13.5% (24-Mo) NR NR 16.0 55.1% (24- Mo) 55.3% (24- Mo) 43.0% (24-Mo) Keynote-029IAdv. Melanoma ≧ 1 st 153Pembro 2 + I1 q3wk x4 —> Pembro 2 q3wkPFS & Safety 51% (IDMC) 57% (Inv.) Treatments: BSC = Best Supportive Care; HF10 = HF10 injected into single or multiple tumors (1 x 107 TCID50/mL/dose, up to 5mL depending on tumor size and number); HDI = High-Dose IFN-α 20 MU/m²/d IV x 5 days (d)/wk for 4 wk then 10 MU/m²/d SC every other d TIW for 48 wk; I1 = Ipilimumab 1 mg/kg; I3 = Ipilimumab 3 mg/kg; I10 = Ipilimumab 10 mg/kg; N1 = nivolumab 1 mg/kg; N3 = nivolumab 3 mg/kg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; Pbo = Placebo; Abbreviations: 1 o EP = Primary Endpoint; Adv. = Advanced; BMa = Biomarker; BRAFwt = BRAF Wild-type; IDMC = Independent Data Monitoring Committee; Inv. = Investigator; irAE = Immune-related Adverse Events; irPFS = Immune-related PFS; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; Maint. = Maintenance; Met. = Metastatic; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NE = Not Evaluable; Neoadj. = Neoadjuvant; NR = Not Reached; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate; OS; Overall Survival; pCR = pathological Complete Response; PFS: Progression Free Survival; Ph = Phase; qXwk = every X weeks; Rec. = Recurrent; SC = Substance; SCLC = small cell lung cancer; TIW = Twice per Week; TNai = Treatment Naive; UNK = Unknown; Wk = Weeks; Yr = Year.

5 © MediPaper 2016 ASCO 2016 Ipilimumab Data - Melanoma Cont’d Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate CheckMate-067IIIAdv. Melanoma1 st 314 316 315 N1+I3 q3wk x 4 —> N3 q2wk N3 q2wk x 4 —> Pbo I3 q3wk x 4 —> Pbo PFS & OS 57.6% 43.7% 19.0% NR 22.3 14.4 11.5 6.9 2.9 CheckMate-064IIAdv. MelanomaUNK68 70 N3 q2wk x 6 —> I3 q3wk x 4 —> N3 q2wk I3 q3wk x 4 —> N3 q2wk x 6 —> N3 q2wk Safety54% 31% NR 16.9 76% (1-Yr) 54% (1-Yr) Checkmate-069 Checkmate-069 Discontinued pts (irAE) IIAdv. Melanoma1 st 44 10 72 (BRAFwt) 3 7 (BRAFwt) N1+I3 q3wk x 4 —> N3 q2wk or Pbo I3 + Pbo q3wk x 4 —> N3 q2wk or Pbo ORR (ND) NR 11.2 NR NR 79.5% (18-Mo) 40.0% (18-Mo) 73.2% (18-Mo) 56.0% (18-Mo) Abstract 9543 Abstract 9543 Preliminary Results IIAdv. Melanoma ≧ 1st 43HF10 q1wk x4 —> HF10 q3wk x15 and I3 q3wk x4 37.8% (irRC) Abstract 9585IMelanomaNeoadj.14 13 I3 q3wk x4 —> Sur—> I3 q12wk x 4 +HDI I10 q3wk x4 —> Sur—> I10 q12wk x 4 +HDI Safety35%, 35% (ORR, pCR) Treatments: BSC = Best Supportive Care; HF10 = HF10 injected into single or multiple tumors (1 x 107 TCID50/mL/dose, up to 5mL depending on tumor size and number); HDI = High-Dose IFN-α 20 MU/m²/d IV x 5 days (d)/wk for 4 wk then 10 MU/m²/d SC every other d TIW for 48 wk; I1 = Ipilimumab 1 mg/kg; I3 = Ipilimumab 3 mg/kg; I10 = Ipilimumab 10 mg/kg; N1 = nivolumab 1 mg/kg; N3 = nivolumab 3 mg/kg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; Pbo = Placebo; Abbreviations: 1 o EP = Primary Endpoint; Adv. = Advanced; BMa = Biomarker; BRAFwt = BRAF Wild-type; IDMC = Independent Data Monitoring Committee; Inv. = Investigator; irAE = Immune-related Adverse Events; irPFS = Immune-related PFS; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; Maint. = Maintenance; Met. = Metastatic; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NE = Not Evaluable; Neoadj. = Neoadjuvant; NR = Not Reached; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate; OS; Overall Survival; pCR = pathological Complete Response; PFS: Progression Free Survival; Ph = Phase; qXwk = every X weeks; Rec. = Recurrent; SC = Substance; SCLC = small cell lung cancer; TIW = Twice per Week; TNai = Treatment Naive; UNK = Unknown; Wk = Weeks; Yr = Year.

6 © MediPaper 2016 ASCO 2016 Ipilimumab Data - NSCLC / Other Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate CheckMate-012IAdv. NSCLC1 st 31 40 38 39 N1 + I1 q2wk x 4 —> N3 q2wk N1 q2wk + I1 q6wk N3 q2wk + I1 x q12wk N3 q2wk + I1 x q6wk Safety13% 25% 39% 31% 10.6 4.9 8.0 8.3 55 (24-Wk) NC (24-Wk) 63 (24-Wk) NC (24-Wk) CheckMate-032I/IIRec. SCLC ≧ 2 nd 80 47 53 N3 q2wk N1+I3 —> N3 q2wk N3+I1 —> N3 q2wk ORR13% 31% 1.4 3.4 3.6 7.8 27% (1-Yr) 48% (1-Yr) CheckMate-142IIMSI-H mCRCMostly ≧ 3 rd 33 26 N3 q2wk N3+I1 q3wk x 4 —> N3 q2wk ORR (by Inv.) 9% 4%NR 5.3 NR 55% (4-Mo) 80% (4-Mo) 16.3 NR 75% (5-Mo) 100% (5-Mo) CheckMate-143IRec. Glioblastoma 2 nd 10 10 20 N3 q2wk x 4 —> N3 q2wk N1 + I3 q3wk x 4 —> N3 q2wk N3 + I1 q3wk x 4—> N3 q2wk 40% (1-Yr) 30% (1-Yr) 25% (1-Yr) Treatments: BSC = Best Supportive Care; HF10 = HF10 injected into single or multiple tumors (1 x 107 TCID50/mL/dose, up to 5mL depending on tumor size and number); HDI = High-Dose IFN-α 20 MU/m²/d IV x 5 days (d)/wk for 4 wk then 10 MU/m²/d SC every other d TIW for 48 wk; I1 = Ipilimumab 1 mg/kg; I3 = Ipilimumab 3 mg/kg; I10 = Ipilimumab 10 mg/kg; N1 = nivolumab 1 mg/kg; N3 = nivolumab 3 mg/kg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; Pbo = Placebo; Abbreviations: 1 o EP = Primary Endpoint; Adv. = Advanced; BMa = Biomarker; BRAFwt = BRAF Wild-type; IDMC = Independent Data Monitoring Committee; Inv. = Investigator; irAE = Immune-related Adverse Events; irPFS = Immune-related PFS; mCRC = Metastatic Colorectal Cancer; mDR = median Duration Response; Maint. = Maintenance; Met. = Metastatic; mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MSI-H = High Micro Satellite Instability; NC = Not Calculated; NE = Not Evaluable; Neoadj. = Neoadjuvant; NR = Not Reached; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate; OS; Overall Survival; pCR = pathological Complete Response; PFS: Progression Free Survival; Ph = Phase; qXwk = every X weeks; Rec. = Recurrent; SC = Substance; SCLC = small cell lung cancer; TIW = Twice per Week; TNai = Treatment Naive; UNK = Unknown; Wk = Weeks; Yr = Year.


Download ppt "© MediPaper 2016 ASCO 2016 Ipilimumab Data - Melanoma MediPaper Study / AbstractPhIndicationLineNArms1 o EPORRmDR (Mo) mPFS (Mo) PFS ratemOS (Mo) OS rate."

Similar presentations


Ads by Google