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Interest in Topics Related to the Treatment of Patients with CML (Percent Responding 9 or 10). Efficacy and tolerability of TKIs*. 42%. TKI-refractory CML. 39%. Sequencing of TKIs. 38%. New agents/regimens. 38%. Monitoring patients during therapy. 36%. Resistance mutations in BCR-ABL.

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interest in topics related to the treatment of patients with cml percent responding 9 or 10

Interest in Topics Related to the Treatment of Patients with CML (Percent Responding 9 or 10)

Efficacy and tolerability of TKIs*

42%

TKI-refractory CML

39%

Sequencing of TKIs

38%

New agents/regimens

38%

Monitoring patients during therapy

36%

Resistance mutations in BCR-ABL

36%

32%

34%

36%

38%

40%

42%

44%

*Tyrosine kinase inhibitors: Imatinib, dasatinib, nilotinib

slide2

Chronic Myeloid Leukemia (CML)

Susan M O’Brien, MD

iris 8 year update outcome after imatinib
IRIS 8-Year Update: Outcome After Imatinib

37%

Deininger M et al; Blood 2009;114(22):462.

nilotinib vs imatinib in newly dx cml enestnd
Nilotinib vs Imatinib in Newly Dx CML (ENESTnd)

R

A

N

DOMI

Z

ED

*

Nilotinib 300 mg BID (n = 282)

  • N = 846
  • 217 centers
  • 35 countries

Nilotinib 400 mg BID (n = 281)

Imatinib 400 mg QD (n = 283)

Follow-up

5 years

  • Primary endpoint: MMR at 12 months
  • Key secondary endpoint: Durable MMR at 24 months
  • Other endpoints: CCyR by 12 months, time to MMR and CCyR, EFS, PFS, time to AP/BC on study treatment, OS including follow-up

*Stratification by Sokal risk score

Hughes et al. ASH 2010; abst #207

slide5
Nilotinib vs Imatinib in Newly Dx CML-CP (ENESTnd). Primary Endpoint - MMR Rate at 12 Months (ITT Population)

P < .0001

P < .0001

Patients with MMR (%)

Larson RA et al. JClin Oncol 2010;28; Abstract 6501. Saglio G et al. N Engl J Med 2010;362; Abstract 2251.

iris 8 year results annual rate of events on imatinib
IRIS 8-Year Results: Annual Rate of Events on Imatinib

AP/BC

  • EFS = 81%
  • Freedom from progression to AP/BC = 92%
    • 1 progression to AP/BC and 2 non-CML related deaths in year 8

Deininger et al. ASH 2009. Abs # 1126.

dasatinib versus imatinib study in treatment na ve cml dasision ca180 056 study design

Dasatinib 100 mg QD (n = 259)

Imatinib 400 mg QD (n = 260)

Dasatinib versus Imatinib Study in Treatment-Naïve CML: DASISION (CA180-056) Study Design
  • Primary endpoint: Confirmed CCyR by 12 months
  • Secondary/other endpoints: Rates of CCyR and MMR; times to confirmed CCyR, CCyR and MMR; time in confirmed CCyR and CCyR; PFS; overall survival
  • N = 519
  • 108 centers
  • 26 countries

Follow-up

5 years

Randomized*

*Stratified by Hasford risk score

Shah et al. ASH 2010; abst #206.

dasision first line dasatinib vs imatinib in cml cp ccyr rate by 12 months itt
DASISION: First-Line Dasatinib vs Imatinib in CML-CP CCyR Rate by 12 Months (ITT)

P = 0.0011

P = 0.0067

CCyR

(%)

CCyRby 12 months

Confirmed CCyRby 12 months

Kantarjian. N Engl J Med 362: 2260, 2010.

dasision progression to ap bp itt
DASISION: Progression to AP-BP (ITT)

100

n/N6/259 9/260

  • No patient who achieved MMR progressed to AP/BP CML
  • 5 patients who achieved a CCyR progressed to AP/BP CML (2 dasatinib, 3 imatinib)
  • Rates of progression-free survival at 18 mos: 94.9% for dasatinib and 93.7% for imatinib

Shah N et al. Blood 2010;116: Abstract 206.

dasision confirmed ccyr itt
DASISION: Confirmed CCyR (ITT)

P = 0.0366

P = 0.0086

Shah N et al. Blood 2010;116: Abstract 206.

definitions of pfs efs in cml
Definitions of PFS-EFS in CML

Kantarjian et al. Blood 2010:116; Abst #672.

slide14

Outcome According to Different Definitions of EFS/PFS

- Because EFS and PFS are important in determining whether new TKIs are better than imatinib in front-line therapy, precise and common definitions of these endpoints are needed.

Kantarjian et al. Blood 2010:116;Abst #672.

dasision grade 3 4 cytopenia

100

DASISION: Grade 3/4 Cytopenia
  • Grade 3/4 bleeding occurred in 2 patients on dasatinib and 3 patients on imatinib
  • 6 patients on dasatinib and 3 patients on imatinib D/C Rx due to cytopenia

Shah N et al. Blood 2010;116: Abstract 206.

common nonhematologic drug related aes 10
Common Nonhematologic Drug-Related AEs (≥10%)

*Includes 11 MedDRA preferred terms

† Includes myalgia, muscle inflammation and musculoskeletal pain

slide22

What Clinicians Want to KnowA Live CME Event Addressing the Most Common Questions and Controversies in the Current Clinical Management of Select Hematologic CancersSunday, June 5, 20117:00 PM – 9:30 PMChicago, Illinois

Moderator

Neil Love, MD

Faculty

Sergio Giralt, MDJohn P Leonard, MD Lauren C Pinter-Brown, MD

Antonio Palumbo, MDSusan M O’Brien, MDProfessor Michael Hallek

slide24
Have you discontinued imatinib, dasatinib or nilotinib for patients responding with sustained molecular CR?
slide25

What Clinicians Want to KnowA Live CME Event Addressing the Most Common Questions and Controversies in the Current Clinical Management of Select Hematologic CancersSunday, June 5, 20117:00 PM – 9:30 PMChicago, Illinois

Moderator

Neil Love, MD

Faculty

Sergio Giralt, MDJohn P Leonard, MD Lauren C Pinter-Brown, MD

Antonio Palumbo, MDSusan M O’Brien, MDProfessor Michael Hallek

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