Chronic Myeloid Leukemia A Disease of Young at Heart but Not of Body

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1 Chronic Myeloid Leukemia A Disease of Young at Heart but Not of Body Jeffrey H Lipton, PhD MD FRCPC Staff Physician, Princess Margaret Cancer Centre Professor of Medicine University of Toronto POGO November, 2016

2 Disclosure Research Support/P.I. Employee Consultant Stockholder Speakers Bureau Scientific Advisory Board Other BMS, Novartis, Roche, Pfizer (Wyeth), Merck (Schering), Teva (ChemGenex), Ariad BMS, Novartis, Roche, Merck, Teva, Pfizer, Alexion, Ariad, CSL Behring BMS, Novartis, Roche, Pfizer, Ariad BMS, Novartis, Roche. Pfizer, Teva, Alexion, Ariad, CSL Behring

3 Regional Incidence of CML

4 CML in the Third World Bansal S, Prabhash K, Parikh P. Chronic myeloid leukemia data from India. Indian J Med Paediatr Oncol 2013;34:154-8.

5 Age-Dependent Incidence of CML Swedish Registry

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7 Historical Incidence of CML Swedish Registry

8 Prevalence of CML in the USA

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16 A walk through history Arsenic Lissauer, 1865 Radiotherapy Pusey, 1902 Busulfan Galton, 1953 Hydroxyurea Fishbein et al, 1964 Autografting Buckner et al, 1974 Allogeneic BMT (SD) Doney et al, 1978 Interferon Talpaz et al, 1983 Allogeneic BMT (UD) Beatty et al, 1989 Donor Leukocytes Kolb et al, 1990

17 CML Survival After Allogeneic HCT (FHCRC) Probability of Survival Chronic phase (n = 576) Accelerated phase (n = 125) Blast crisis/remission (n = 62) Blast crisis (n = 44) Yrs After Transplantation *Includes both matched related and unrelated donors. Patients allografted at FHCRC from 1995 to the present. Courtesy of Dr. Ted Gooley.

18 PMH CML Transplant Results Zaretsky 2007 Zaretsky, BMT (2007)

19 CML Milestones 1 st description of pts w/ CML features Philadelphia chromosome identified Translocation identified as 22q to distal end of 9 BCR-ABL Kinase activity characterized TKI efficacy against BCR-ABL characterized Arsenic RT Busulfan IFNα Allogeneic SCT Imatinib Nilotinib, Dasatinib Bosutinib, OM, 19 ponatinib

20 OS on First-Line Imatinib (IRIS Study) 90 Alive % Estimated overall survival at 8 years was 85% (93%, considering only CML-related deaths) Survival: deaths associated with CM L Overall Survival Months Since Randomization Deininger M, et al. ASH Annual Meeting Abstracts. 2009;114:1126.

21 % with event IRIS 8-year update: majority of events occur early Event Loss of CHR, Loss of MCyR, AP/BP, Death during treatment AP/BP UK SPIRIT 2 IM vs DAS 814 patients randomised 1:1 13 progressions: 12 in first 12 months Year Patients with newly diagnosed CML-CP treated with imatinib 400 mg/day (n=553) Deininger M, et al. ASH 2009, abstract 1126 (poster)

22 Larson, ASH 2014 ENESTnd at 6 years

23 Cumulative MMR Rates Over Time % With MMR N Dasatinib 100 mg QD 259 Imatinib 400 mg QD 260 By 5 years By 4 years p= By 3 years 76% 73% By 2 years 67% 64% 64% 60% By 1 year 55% 46% 46% 28% Months Since Randomization Cortes, ASH 2014

24 Correlation Between Response and Disease Burden: Molecular Response Number of leukaemic cells Haematologic CHR (<1-log reduction) Cytogenetic BCR-ABL1 transcripts (log 10 ) CCyR (2-log reduction) MMR (3-log reduction) 4.5-log reduction RQ-PCR Diagnosis Time Baccarani M, et al. Blood. 2006;108: ; Radich JP. Blood. 2009;114: RT-qPCR, reverse transcription - quantitative polymerase chain reaction

25 Therapeutic Milestones NCCN vs. ELN Baccarani et al. Blood. 2013;122(6): Radich et al. J Natl Compr Canc Netw. 2014;12(11):

26 Tyrosine Kinase Sensitivity in CML bcr-abl Mutations

27 Currently Drugs approved in Canada for front line therapy include: Imatinib brand plus 6 generics Nilotinib Dasatinib Drugs approved in Canada for salvage therapy include: Nilotinib Dasatinib Bosutinib Ponatinib Other options: Interferon Stem cell allografting Hydroxyurea

28 So many drugs So many choices!

29 Efficacy Data from Studies Using Second Generation Drugs First Line Jabbour and Lipton,

30 STIM 1 : Molecular Recurrence Free Survival (N = 100) The median molecular follow-up after treatment discontinuation is 77 months (range, 9 to 95 months). Etienne G, et al. JCO in press

31 Moving treatment-free remission into mainstream clinical practice in CML Hughes TP, Ross DM. Blood Mar 24. pii: blood

32 Life Expectancy of Swedish CML Patients Compared to General Population Bower et al (JCO) 2016

33 Drug Costs Kantarjian and Lipton (2015) JAMA Oncology

34 Microelectronic Monitoring System (MEMS 6 Trackcap) Records the time of opening the container Most reliable method of measuring adherence Our patients: not told about the chip Marin et al, Blood 2008

35 Lack of Adherence is a Major Cause of Failure P< Cumulative CCyR Loss Probability of Failure P< Ibrahim et al. Blood. 2011;117(14):3733-6

36 Compliance Failure Jabbour (2012) Clin Lymph Myel Leuk

37 Conclusions -1 There are many choices for what to do when a patient fails initial TKI therapy Decisions are made on the basis of reasons for failure, co-morbidities, previous adverse events, life-style implications, physician familiarity Complete review of the patient and the disease are necessary before deciding

38 Conclusions - 2 Mistakes are made when: Patients are not monitored for response and toxicity Changes in therapy are not initiated in the face of obvious failure Appropriate referral at a time of uncertainty about management is not done

39 Conclusions -3 Mistakes are not made by choosing one drug over another, but by persisting when the outcome of the choice is not appropriate There are multiple options Stem cell allografting is still on the table In rare cases, hydroxyurea is still on the table

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