State of the Art Therapy and Monitoring of CML Hagop Kantarjian, M.D. Grand Rounds Hackensack, New Jersey. September 22, 2010
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1 State of the Art Therapy and Monitoring of CML Hagop Kantarjian, M.D. Grand Rounds Hackensack, ew Jersey September 22,
2 CML. Historical vs. Modern Perspective Parameter Historical Modern Course Fatal Indolent Prognosis Poor Excellent 10-yr survival 10% 84-90% Frontline Rx Allo SCT; IF-α Imatinib; nilotinib; dasatinib Second line Rx? ew TKIs; 2 allo SCT
3 Today, CML is an indolent disease. Patients can be functionally cured and live their normal expected life span, provided they continue treatment with oral TKIs (imatinib). CML is now a condition like diabetes, hypertension, CASHD, which, treated appropriately, should result in a normal life Hagop Kantarjian; Somewhere,
4
5 CML in US. The Changing Demographics of CML allosct later 4% resistant 250,000=10,000 allosct at Dx 30% of 5,000=1,500 5
6 Why Do We eed Bone Marrow At Dx? Assess % of blasts and basos (10-15% have CML transformation at Dx) Confirm Ph by CG; detect clonal evolution FISH can be falsely positive QPCR can be falsely positive or negative 6
7 ew Tests for Monitoring in CML
8 Monitoring CML Course Cytogenetics Fluorescent in situ hybridization (FISH) Quantitative PCR (QPCR):real time, competitive Abl mutations 8
9 Monitoring CML in Stable CGCR. My (Simple) Approach FISH and QPCR q 6 mos (ensure concordance and stability of high quality CGCR; both tests can be false positive or false negative) Marrow CG q 2-3 yrs; more often if abnormalities in Ph-negative diploid cells (eg chromosome 5 or 7 abn) Mutation analysis only if imatinib failure or change of Rx Do not order imatinib plasma levels
10 How Do I Use FISH and QPCR Monitoring in CGCR? FISH QPCR Interpretation eg <0.1% Excellent response; FU 6 mos Pos <0.1% FISH and QPCR false + or eg >1% false -; FU 3 mos eg 0.1-1% FU 6 mos, FU 3 mos if one log Pos >1% Check marrow + CG;? relapse
11 Therapy of CML in 2010 Frontline Imatinib 400mg/D 800(?) ilotinib mg BID; dasatinib 100 mg/d Imatinib failure - ilotinib, dasatinib, bosutinib Allogeneic SCT Investigational T315I inhibitors, (AP24534, DCC2036) omacetaxine, decitabine, TKIs combos 11 Combining TKIs + old standards (HU, ara-c)
12 CML. Survival after Allogeneic BMT PROBABILITY : Sib + CP1 (=3,372) 2: Sib + ot CP1 (=1,141) 3: Other Donor + CP1 (=1,302) 4: Other Donor + ot CP1 (=725) 5: All Patients (=6,548) YEARS 12 LTO03_5.ppt
13 CML. Survival after Allogeneic BMT 1.0 PROBABILITY % 45% 15% mortality over 15 yrs YEARS 13
14 CML Survival after Allogeneic BMT PROBABILITY Imatinib 60% 1: Sib + CP1 (=3,372) 2: Sib + ot CP1 (=1,141) 3: Other Donor + CP1 (=1,302) 4: Other Donor + ot CP1 (=725) 5: All Patients (=6,548) 45% YEARS 14
15 P190 Ph-positive CML 14 of 1292 pts with Ph-positive CML had e1a2/p190 disease 5/9 pts presenting in chronic phase progressed to CML BP (4- myeloid 3, lymphoid 1) or CML AP (1)-median follow up 48 mos 5 received imatinib frontline; 1 CGCR Verma. Blood 2009; in press 15
16 TKI Imatinib Available TKIs in CML Target Potency vs. IM Bcr- Abl Dose (mg/d) FDA Approval in CML 400 post IF; frontline Unique AEs ilotinib Bcr- Abl Dasatinib Src- Abl BID post IM CP, AP frontline post IM all phases pancreas; LFT; rash PLT; effusions Bosutinib Src- Abl diarrhea; LFT 16
17 Imatinib Mesylate (STI571; Gleevec) H H O Phenylaminopyrimidine 17
18 ormal Bcr-Abl Signaling The kinase domain activates a substrate protein, eg, PI3 kinase, by phosphorylation This activated substrate initiates a signaling cascade culminating in cell proliferation and survival Bcr-Abl ADP P P P P ATP Substrate P P P Effector ADP = adenosine diphosphate; ATP = adenosine triphosphate; P = phosphate. Savage and Antman. Engl J Med. 2002;346:683 Scheijen and Griffin. Oncogene. 2002;21:3314. SIGALIG 18
19 Imatinib Mesylate: Mechanism of Action Imatinib mesylate occupies the ATP binding pocket of the Abl kinase domain This prevents substrate phosphorylation and signaling A lack of signaling inhibits proliferation and survival Bcr-Abl Imatinib mesylate P ATP P P P SIGALIG Savage and Antman. Engl J Med. 2002;346:
20 IRIS - Patient Status at 6 years R A D O M I Z E Imatinib n = 553 IF-α + Ara-C n = (3%) 359 (65%) Crossover Discontinued study treatment 181 (33%) 364 (66%) 13 (2%) Druker et al. EJM 355:2408, 2006; Hochhaus. Blood 110:abst 25,
21 IRIS Update. Cumulative Best Response % responding % 85% 69% Druker et al. EJM 355:2408, % 84% CGCR at 5 yrs 67% CHR MCyR CCyR Months since randomization to Imatinib 98% 92% 87% 21
22 IRIS in Chronic Phase CML at 8 Yrs 553 pts randomized to imatinib 400 mg/d. Transformation to AP/BP at Yr 4-8: 0.9%, 0.5%, 0%, 0%, 0.4% Only 15 pts in CGCR (3%) progressed to AP/BP o pts in MMR at 12 mos progressed to AP/BP Outcome at 8 yrs Percent On study 55 EFS 81 PFS 92 OS 85 OS (CML deaths) 93 MMR 86 Deininger. Blood 114:abst 1126; 2009
23 Annual Event Rates on IRIS EFS at 8 years = 81% - 1 progression to AP/BC and 2 non-cml related deaths in year 8 Freedom from progression to AP/BC at 8 years = 92% Deininger et al; Blood 2009; 114: Abst# 1126
24 IRIS 8-Year Update. Outcome After Imatinib 37% Deininger et al; Blood 2009; 114: Abst# 1126
25 IRIS. Survival % Without Event Estimated overall survival at 7 years is 86% (94% considering only CMLrelated deaths) Survival: deaths associated with CML Overall Survival Months Since Randomization O Brien SG. Blood 112: Abst 186, 2008.
26 CG Abnormalities in Ph-negative Metaphases with IM Frontline Therapy 21/258 (9%) patients developed CG abnormalities in Phmetaphases after median 36 mo Most common abnormalities: -Y (n=9; 43%), +8 (n=9; 43%), -7 (n=5; 17%) 1 (5%; 0.4% overall) developed AML [-7] Overall Survival Progression-Free Survival Warning? Warning? Jabbour. Blood 110:2991-5, 2007
27 Imatinib and Pregnancy 180 women, outcome available in 125 (69%) Outcomes: 50% normal infants 28% elective termination (3 abnormalities) 12 infants (9%) with abnormalities 3/12 similar complex malformations (exomphalos, kidneys, bones) Conclusion: Women on imatinib should be advised not to become pregnant Pye. Blood 111:5505,
28 Course of CML in CGCR on Imatinib Highly Stable and Predictable Historical fear of sudden blastic transformation On imatinib, sudden transformation may still occur, but: rare, usually in first 2 yrs, usually lymphoid BP in younger pts, usually responsive to HCVAD + TKI Closer monitoring in first 2 yrs Monitoring in stable durable CGCR Q 6 mo (I like FISH + QPCR check for concordance)
29 QPCR Monitoring in CR o definite role for pre Rx/pre CR QPCR monitoring In CGCR, monitor QPCR Q 3-6 mos Use same reliable labs, same source of specimen (PB) Aim for QPCR <0.1% = major molecular response In CGCR, do not react to QPCR variations in major way Kantarjian. Blood 111: ,
30 Sensitivity of Mutations to TKI IC50-Fold Increase Imatinib Bosutinib Dasatinib ilotinib WT L248V G250E Q252H Y253F E255K E255V D276G E279K V299L T315I F317L M351T F359V L384M H396P H396R G398R F486S Redaelli et al, Highly Resistant / Resistant / Sensitive
31 Analysis of Mutations in CML Over emphasized; results produce more false therapeutic leads than benefits o role for mutation studies pre-rx or in imatinib responding patients If CG or hematologic relapse, mutations studies help T315I: no role for new TKIs; allo SCT or others (HU, ara-c, HHT, T315I inhibitors ) ilotinib IC50>150nM Dasatinib IC50>3nM Dasatinib (e.g. P-loop; ilotinib (e.g. F317L) Y253H, E255V) Kantarjian. Blood 111: ,
32 CML. Criteria For Failure On Imatinib o CG response at 6 mos (Ph 100%) o major CG response at 12 mos (Ph>35%) o CGCR in Year 2+ CG relapse or hematologic relapse ot failure criteria - suboptimal CG response - QPCR in CGCR Baccarani. Blood 108: ,
33 Chemical Structures of Approved BCR-ABL Tyrosine Kinase Inhibitors C H 3 H 3 H C H O C H 3 H 3 H C O H F F F Imatinib ilotinib Imatinib Dasatinib 33
34 Phase II Studies of Dasatinib After Imatinib Failure Response CP n=387 Percent by Disease Stage AP n=174 MyBP n=109 LyBP n=48 ALL n=46 Hematologic CHR EL Cytogenetic Complete Partial Blood 110:abst 470 and 734,
35 Dasatinib in CML Chronic Phase After Imatinib Failure (START-C) 387 pts; IM resistance 74%; median CML duration 61 mos; dasatinib 70 mg BID Parameter Percent CHR 91 CG major/cr 62/53 MMR mo PFS/Surv. 80/94 Dose reductions 73%; median dose 101mg/D; grade 3-4 plts/pm 48%; pleural effusions 26% (severe 9%) Baccarani. Blood 112:abst 450, 2008
36 Dasatinib 100 mg QD in CML-CP 662 treated 670 randomized 100 mg once daily (n=165) 100 mg CML-CP with resistance suboptimal response intolerance to imatinib 50 mg BID (n=167) 140 mg once daily (n=163) 140 mg 70 mg BID (n=167) Shah. Blood 112:3225, 2008
37 Overall Survival With Dasatinib After 100 Imatinib Failure Median age: 56 yrs Median time from Dx: 55 mo 100 mg once daily: 24-month overall survival = 91% % alive Overall survival rate (95% CI) n 12 months 24 months 100 mg once daily % 91% (86 96) 70 mg BID % 88% (82 93) 140 mg once daily % 94% (90 97) 50 mg BID % 90% (86 95) Months Shah et al. Hematologica 2010 [E-pub ahead of print]
38 ilotinib in CML-CP. Chemical Structures C H 3 H H C H 3 C H 3 O H O F C H 3 H F F Imatinib ilotinib 38
39 ilotinib in CML Chronic Phase Post Imatinib Failure 321 pts with imatinib resistance (71%) or intolerance (29%) Median age 58 yrs; median exposure 19 mo ilotinib 400 mg PO BID 6 mos Outcome Percent - CHR 85 - MCyR / CCyR 59 / 44 Resistant 56 / 41 Intolerant 66 / month OS / PFS 87 / 64 Median dose intensity 789 mg/d Grade 3-4 plts 31%, neut 31%; lipase elevation 17% (pancreatitis <1%), bilirubin 8% Kantarjian. Blood 114:abst 1129, 2009
40 ilotinib in CML Chronic Phase. Survival and PFS % 91% 88% % Progression-free survival % 73% 64% Kantarjian. Blood 110:354, Time in mos
41 Bosutinib in CML post-imatinib failure 294 pts; bosutinib mg in phase I, 500 mg in phase II Median age 52 yrs; median CML 4 yrs; median prior imatinib 2.3 yrs; imatinib resistance 69%; mutations 45% CHR 78%; CG major 58%; CGCR 46%; MMR 49%; CMR 30% Estimated 12-mo survival 95% Cortes. JCO 28 (15S): abst 6502, 2010.
42 Bosutinib in CP CML (2 nd Line) Overall Survival Probability of OS (%) IM resistant IM intolerant Time to death (months) n Median OS Patients who died, n (%) IM resistant 191 ot reached 20 (10) IM intolerant 81 ot reached 2 (1) Cortes. JCO 28 (15S): abst 6502, 2010
43 ilotinib vs Imatinib in ewly Dx CML. Endpoints and Design Primary: MMR at 12 mos Secondary: CCyR by 12 mos Other: time/duration of MMR and CGCR, EFS, PFS, time to AP/BP, OS ewly Diagnosed CML-CP: = centers;35 countries R A D O M I Z E D ilotinib 300 BID (n=282) ilotinib 400 BID (n=281) Imatinib 400 QD (n=283) Stratification by Sokal risk; MMR defined as 0.1% BCR- ABL(/ABL ratio) on International Scale Saglio. EJM 362: 2251,
44 ilotinib vs Imatinib in ewly Dx CML-CP (EESTnd). Primary Endpoint - MMR Rate at 12 Months (ITT Population) P <.0001 P <.0001 Patients with MMR (%) Larson. JCO 28: abstr 6501; 2010 and Saglio. EJM 362: 2251, 2010.
45 ilotinib vs Imatinib in CML-CP (EESTnd). Confirmed CCyR Rates by 12 Months P <.0001 P <.0001 % CCyR Larson. JCO 28: abstr 6501; 2010
46 ilotinib vs Imatinib in CML-CP (EESTnd). Progression to AP/BC umber of Patients P =.006 P = % 0.7% 0.4% 4 patients who achieved CCyR on imatinib progressed to AP/BC * ITT Population, median follow-up of 18.5 months ** P values are based on log-rank test stratified by Sokal risk group vs imatinib for time to AP/BC. Larson. JCO 28: abstr 6501; 2010
47 ilotinib vs Imatinib in CML-CP (EESTnd). Overall Survival ilotinib 300 n = 282 ilotinib 400 n = 281 Imatinib 400 n = 283 umber deaths CML-unrelated CML-related (after SCT) Estimated 18-mo OS 98.5% 99.3% 96.9% 2 (1) 1 (0) 8 (2) Stratified log-rank test vs. imatinib Larson. JCO 28: abstr 6501; 2010
48 ilotinib vs Imatinib in CML-CP (EESTnd). Grade 3/4 Myelosuppression % of Patients Larson. JCO 28: abstr 6501; 2010
49 ilotinib vs Imatinib in CML-CP (EESTnd). Study Drug-Related Adverse Events ( 10% in Any Group) % of patients treated ilotinib 300 mg BID = 279 All Grade Grades 3/4 ilotinib 400 mg BID = 277 All Grade Grades 3/4 Imatinib 400 mg QD = 280 All Grade Grades 3/4 ausea 12 < Muscle spasms <1 26 <1 Diarrhea 8 < Vomiting Edema peripheral Eyelid edema <1 0 2 <1 14 <1 Periorbital edema <1 0 < Rash 32 < Headache Pruritus 15 <1 13 <1 5 0 Alopecia Fatigue <1 9 <1 Myalgia 10 < Larson. JCO 28: abstr 6501; 2010
50 Dasatinib Versus Imatinib Study In Treatmentnaïve CML: DASISIO (CA ). Design = centers 26 countries Dasatinib 100 mg QD (n=259) Randomized* Imatinib 400 mg QD (n=260) *Stratified by Hasford risk score Follow-up 5 years 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 Kantarjian. EJM 362: 2260, 2010.
51 DASISIO: First-Line Dasatinib vs. Imatinib in CML-CP. CCyR Rate by 12 Mos (ITT) P= P= CCyR (%) CCyR by 12 months Confirmed CCyR by 12 months Kantarjian. EJM 362: 2260, 2010.
52 DASISIO: First-Line Dasatinib vs. Imatinib in CML-CP. MMR Rates (ITT) P< P< MMR (%) Mo 3 Mo 6 Mo 9 Mo 12 Any time Kantarjian. EJM 362: 2260, 2010.
53 DASISIO: First-Line Dasatinib vs. Imatinib in CML-CP. Progression to AP/BP Dasatinib 100 mg QD Imatinib 400 mg QD Progressed to AP/BP (n) 1.9% 3.5% o patient who achieved MMR progressed to accelerated or blast phase 2 patients who achieved CCyR progressed to accelerated or blast phase (1 with dasatinib, 1 with imatinib) Kantarjian. EJM 362: 2260, 2010.
54 DASISIO: First-Line Dasatinib vs. Imatinib in CML-CP. Forest Plots Comparing Differences in AE Rates Anemia, grade 3/4 eutropenia, grade 3/4 Thrombocytopenia, grade 3/4 Myalgia* ausea Vomiting Rash Diarrhea Fatigue Headache Fluid retention Superficial edema Pleural effusion Rate difference (dasatinib imatinib) with exact 95% CI *Myalgia = myalgia, muscle inflammation and MSK pains Favors dasatinib Favors imatinib Kantarjian. EJM 362: 2260, 2010.
55 Frontline Rx with Imatinib vs. Second Generation TKIs Parameter Imatinib 2 nd TKIs Efficacy excellent even better %12-mo CGCR MMR AP- BP Tolerances excellent even better Follow up (yrs) Cost ($/yr) 54,000 90,000 96,000
56 Inhibition of Bcr-Abl ATP-binding Bcr-Abl Abl & Src T315I-active on-kinase Inhibition Imatinib Dasatinib AP24534 DAC ilotinib Bosutinib DCC-2036 HHT IO-406 XL228 PHA KW-2449
57 AP24534 (T315I inhibitor) in CML Oral multi-kinase inhibitor, active against WT and mutants BCR-ABL including T315I 48 pts ; AP 2-60 mg daily; 42 CML (31CP) Prior Rx: imatinib 100%, dasatinib 88%, nilotinib 65%; 97% failed 2 TKIs and 81% failed 3 TKIs 18 with T315I mutations CHR 85%, CG major 48%, CGCR 33% T315I: CG major 71%, CGCR 57% DLT pancreatitis at 60mg/D Talpaz. JCO 28 (15S): abst 6511, 2010.
58 Cephalotaxus fortunei Hook Chinese Plum Yew Homoharringtonine
59 Omacetaxine for CML with T315I Response to Therapy Response CP =40 o. (%) AP =16 Data independently adjudicated by Data Monitoring Committee BP =10 Hematologic 34 (85) 8 (50) 4 (40) CHR 34 (85) 5 (31) 2 (20) HI A 2 (13) 1 (10) RCP A 1 (6) 1 (10) Cytogenetic 11 (28) 1 (6) - MCyR 6 (15) - - CCyR 4 (10) 1 (6) - PCyR 2 (5) - - Minimal 5 (13) - -
60 Omacetaxine for CML with T315I Overall Survival =10 Median: 1.81 =16 Median: =40 Median: A Survival Time in Months Chronic Phase Accelerated Phase Blast Phase
61 CML in 2010 Imatinib,nilotinib,dasatinib are standard frontline Rx (except p190 CML) Dose optimization and adequate monitoring Sub-optimal response dose imatinib (400mg 800mg) ew TKI Failure Dasatinib, nilotinib, bosutinib Allogeneic SCT T315I: AP24534, DCC2036, omacetaxine
62 Hematologic Malignancies Houston 2010 October 13 16, 2010 For informa<on: Go online to Contact Heather ewton at Call or fax Organizer Phone (281) x111 Fax (281)
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