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© MediPaper 2016 ASCO 2016 Palbociclib (Ibrance™) Data MediPaper Study / AbstractPhIndicationLineNN BiomarkerMethodologyArms1 o EPORRCBRDCRmPF S (Mo) PFS.

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Presentation on theme: "© MediPaper 2016 ASCO 2016 Palbociclib (Ibrance™) Data MediPaper Study / AbstractPhIndicationLineNN BiomarkerMethodologyArms1 o EPORRCBRDCRmPF S (Mo) PFS."— Presentation transcript:

1 © MediPaper 2016 ASCO 2016 Palbociclib (Ibrance™) Data MediPaper Study / AbstractPhIndicationLineNN BiomarkerMethodologyArms1 o EPORRCBRDCRmPF S (Mo) PFS rate PALOMA-2IIIAdv. Post-meno. ER+/HER2– BC 1 st 666P125 + L2.5 PLB + L2.5 PFS (Inv.)42.1% 34.7% 84.9% 70.3% 24.8 14.5 PALOMA-3IIIHR+/HER2– Met Breast Cancer ≧ 1 st 108 (Pre- & Peri- menopausal subgroup) P125 + F500 PLB + F500 PFS69% 44% 9.5 5.6 PALOMA-3IIIHR+/HER2– Met Breast Cancer ≧ 1 st 395106 ESR1-mu 289 ESR1-wt ND ESR1-wt ND ESR1-mu ctDNA P125 + F500 or PLB + F500 P125 + F500 PLB + F500 P125 + F500 PLB + F500 PFS5.7 9.2 9.5 3.8 9.4 4.1 Abstract 533EAPMet. Breast Cancer ≧ 1 st 175 ESR1-mu 12 ESR1-wtcfDNAP125 + L2.5 NA 4.6 6.3 Abstract 5557IIRec. Ovarian Carcinoma ≧ 2 nd 30 by RECIST by CGIG CA125* P125 6-mo PFS rate4% 13% 3.7 4.0 30% Abstract 2589IRb+ solid tumoursND26P50-100 + 5FURP2D4%27%10 Treatments: 5FU = 5-Fluorouracil 2400mg/m 2 continuous infusion Days 8-10, on an every 2 week cycle; F500 = Fulvestrant 500 mg intramuscularly on D1 & D15 of Cycle 1 —> D1 of each subsequent 28 day cycle; L2.5 = letrozole 2.5 mg qd; PX= Palbociclib X mg q3wk in 4wk cycles; PLB = Placebo. Abbreviations: Adv. = Advanced; AE = Adverse Event; BC = Breast Cancer; CBR = Clinical Benefit Rate (CR, PR and SD ≧ 24 wk); cfDNA or ctDNA = Liquid Biopsy; DCR = Disease Control Rate; DFS = Disease Free Survival; DLT = Dose-Limiting Toxicity; EAP = Extended Access Protocol; ESR1 = estrogen receptor 1; EP = Endpoint; ER+ = Estrogen Receptor Positive; HER2- = Human Epidermal Growth Factor Receptor 2; HR+ = Hormone Receptor Positive; Inv. = Investigator; mDR = median Duration Response; met. = Metastatic; Mo = Month; mOS = median Overall Survival; mPFS = median Progression Free Survival; mTTR = median Time to Recurrence; mu = mutation; NA = Not Applicable; ND = Not Disclosed; NR = Not Reached; ORR = Overall Response Rate; OS = Overall Survival; PFS = Progression Free Survival; Ph = Phase; Rb+ = retinoblastoma-positive (by IHC); Rec. = Recurrent; SOC = Standard of Care; SQ = Squamous Histology; qXwk = every X weeks; wk = Week; wt = wildtype.

2 © MediPaper 2016 ASCO 2016 Palbociclib Data Courtesy of MediPaper Medical Writers - Medi-Paper.comMedi-Paper.com Study / AbstractPhIndicationLineNN BiomarkerMethodologyArms1 o EPORRCBRDCRmPF S (Mo) PFS rate PALOMA-2IIIAdv. Post-meno. ER+/HER2– BC 1 st 666P125 + L2.5 PLB + L2.5 PFS (Inv.)42.1 % 34.7 % 84.9 % 70.3 % 24.8 14.5 PALOMA-3IIIHR+/HER2– Met Breast Cancer ≧ 1 st 108 (Pre- & Peri- menopausal subgroup) P125 + F500 PLB + F500 PFS69% 44% 9.5 5.6 PALOMA-3IIIHR+/HER2– Met Breast Cancer ≧ 1 st 395106 ESR1-mu 289 ESR1-wt ND ESR1-wt ND ESR1-mu ctDNA P125 + F500 or PLB + F500 P125 + F500 PLB + F500 P125 + F500 PLB + F500 PFS5.7 9.2 9.5 3.8 9.4 4.1 Abstract 533EAPMet. Breast Cancer ≧ 1 st 175 ESR1-mu 12 ESR1-wtcfDNAP125 + L2.5 NA 4.6 6.3 Abstract 5557IIRec. Ovarian Carcinoma ≧ 2 nd 30 by RECIST by CGIG CA125* P125 6-mo PFS rate4% 13% 3.7 4.0 30% Abstract 2589IRb+ solid tumoursND26P50-100 + 5FURP2D4%27%10 Treatments: 5FU = 5-Fluorouracil 2400mg/m 2 continuous infusion Days 8-10, on an every 2 week cycle; F500 = Fulvestrant 500 mg intramuscularly on D1 & D15 of Cycle 1 —> D1 of each subsequent 28 day cycle; L2.5 = letrozole 2.5 mg qd; PX= Palbociclib X mg q3wk in 4wk cycles; PLB = Placebo. Abbreviations: Adv. = Advanced; AE = Adverse Event; BC = Breast Cancer; CBR = Clinical Benefit Rate (CR, PR and SD ≧ 24 wk); cfDNA or ctDNA = Liquid Biopsy; DCR = Disease Control Rate; DFS = Disease Free Survival; DLT = Dose-Limiting Toxicity; EAP = Extended Access Protocol; ESR1 = estrogen receptor 1; EP = Endpoint; ER+ = Estrogen Receptor Positive; HER2- = Human Epidermal Growth Factor Receptor 2; HR+ = Hormone Receptor Positive; Inv. = Investigator; mDR = median Duration Response; met. = Metastatic; Mo = Month; mOS = median Overall Survival; mPFS = median Progression Free Survival; mTTR = median Time to Recurrence; mu = mutation; NA = Not Applicable; ND = Not Disclosed; NR = Not Reached; ORR = Overall Response Rate; OS = Overall Survival; PFS = Progression Free Survival; Ph = Phase; Rb+ = retinoblastoma-positive (by IHC); Rec. = Recurrent; SOC = Standard of Care; SQ = Squamous Histology; qXwk = every X weeks; wk = Week; wt = wildtype.

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