LENALIDOMIDA EN EL SMD 5Q-
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1 LENALIDOMIDA EN EL SMD 5Q- EXPERIENCIA ESPAÑOLA 37 Diada Internacional 7 de Junio de 2013 M. Díez Campelo Hematología HOSPITAL UNIVERSITARIO
2 15-30% MDS Introduction Sole anomaly or in addition to 1 cytogenetics aberrations OS 1 Anemia 2 (78%) Transfusion dependency (40%): Lenalidomide Transfusion independency (60%) 1 Mallo et al, Germing et al, 2012
3 15-30% MDS Introduction Sole anomaly or in addition to 1 cytogenetics aberrations OS 1 Anemia 2 (78%) Transfusion dependency (40%): Lenalidomide and response Transfusion independency (60%) 1 Mallo et al, Germing et al, 2012
4 15-30% MDS Introduction Lenalidomide and predictors of response in MDS del(5q) Clinical predictors 1 : platelets, time from diagnosis to Lena Genetic: TP53 mutations 2, 3 and lower complete cytogenetic responses No other genetic predictors of response 1 Fenaux et al, Jädersten et al, Bally et al, 2012
5 Mallo et al, 2013 Predictors of response in Lena TD patients
6 Mallo et al, 2013 Predictors of response in Lena TD patients
7 Predictors of response in Lena TD patients (77%) (33%) (31%) Mallo et al, 2013
8 Mallo et al, 2013 Predictors of response in Lena TD patients
9 Mallo et al, 2013 Predictors of response in Lena TD patients
10 Mallo et al, 2013 Predictors of response in Lena TD patients
11 Mallo et al, 2013 Predictors of response in Lena TD patients
12 Mallo et al, 2013 Predictors of response in Lena TD patients
13 Predictors of response in Lena TD patients Tabla de Response y variables Mallo et al, 2013
14 Predictors of response in Lena TD patients Tabla de TI y variables Mallo et al, 2013
15 Predictors of response in Lena TD patients Multivariante analysis Mallo et al, 2013
16 Mallo et al, 2013 Predictors of response in Lena TD patients
17 15-30% MDS Introduction Sole anomaly or in addition to 1 cytogenetics aberrations OS 1 Anemia 2 (78%) Transfusion dependency (40%): Lenalidomide and outcome Transfusion independency (60%) 1 Mallo et al, Germing et al, 2012
18 Lena, impact on outcome in TD patients 15-30% MDS Lenalidomide and outcome in MDS del(5q) high rates of RBC transfusion independece 1 (TI) cytogenetic response 1 (CyR) Outcome? TI 1 : OS and AML evolution 1 Fenaux et al, Göhring et al, Adès et al, 2012 AML evolution 2 : if no erythroid or cytogenetic response Similar 3,4 OS and AML evolution to no Lena TD patients 4 Kuendgen et al, 2013
19 Sánchez-García & Sanz et al, submitted 2013 Lena, impact on outcome in TD patients
20 Sánchez-García & Sanz et al, submitted 2013 Lena, impact on outcome in TD patients
21 Sánchez-García & Sanz et al, submitted 2013 Lena, impact on outcome in TD patients
22 Sánchez-García & Sanz et al, submitted 2013 Lena, impact on outcome in TD patients
23 Sánchez-García & Sanz et al, submitted 2013 Lena, impact on outcome in TD patients
24 Sánchez-García & Sanz et al, submitted 2013 Lena, impact on outcome in TD patients
25 Sánchez-García et al, submitted 2013 Lena, impact on outcome in TD patients
26 Lena, impact on outcome in TD patients All patients Global Lena No Lena Median OS (mo) years 81% 92% 76% 5 years 48% 62% 42% Global Lena No Lena AML 19% 13% 23% 2 years 13% 6% 12% 5 years 32% 31% 25% Sánchez-García & Sanz et al, submitted 2013
27 Lena, impact on outcome in TD patients All patients Sánchez-García & Sanz et al, submitted 2013
28 Lena, impact on outcome in TD patients Transfusion dependent patients mfu mos* 2y AML evolution* 51 patients (78%) TI 26 mo NR 3% 14 patients (22%) TD 31 mo 23% p<0.001 p<0.001 Median TI duration 36 mo OS estimated at 18 mo after TI failure 51% *Desde inicio Lena, Sánchez-García & Sanz et al, submitted 2013
29 Lena, impact on outcome in TD patients Transfusion dependent patients Sánchez-García & Sanz et al, submitted 2013
30 Lena, impact on outcome in TD patients Transfusion dependent patients, impact of TI Sánchez-García & Sanz et al, submitted 2013
31 Lena, impact on outcome in TD patients Cytogenetic response 49 patients assessed: 19 (39%) complete cytogenetic response 10 (20%) partial cytogenetic response 20 (41%) no response Sánchez-García & Sanz et al, submitted 2013
32 Lena, impact on outcome in TD patients CONCLUSIONS Lena in TD patients improve OS AML evolution among patients who reach TI Lena in the overall population improve, OS among patients who reach TI and CyR Poor prognosis after relapse/no response to Lena Sánchez-García & Sanz et al, submitted 2013
33 15-30% MDS Introduction Sole anomaly or in addition to 1 cytogenetics aberrations OS 1 Anemia 2 (78%) Transfusion dependency (40%): Lenalidomide Transfusion independency (60%): Lenalidomide? 1 Mallo et al, Germing et al, 2012
34 RE-SMD SINTRA-REV SPANISH STUDY WITH LENALIDOMIDE IN 5Q- MDS PATIENTS WITH TRANSFUSION INDEPENDENT ANEMIA María Díez Campelo MD, PhD Hematología HOSPITAL UNIVERSITARIO
35 SINTRA-REV: TOPICS Rationale of the study Spanish MDS Registry data on del(5q) patients Clinical trial
36 SINTRA-REV: TOPICS Rationale of the study Spanish MDS Registry data on del(5q) patients Clinical trial
37 SINTRA-REV: RATIONALE MDS and del(5q) Low risk MDS Anemia Poor response to ESAs Transfusion requirements LENALIDOMIDE Adés et al. Haematologica 2012 Kelaidi et al, Leuk Res 2008 Le Bras et al, Leuk Res 2011 Fenaux, Blood 2011
38 SINTRA-REV: RATIONALE MDS and del(5q) at presentation, 381 untreated patients 68% developed anemia 42% transfusion requirements LENALIDOMIDE? Germing et al. Leukemia 2012
39 SINTRA-REV: RATIONALE MDS and del(5q) at presentation, 381 untreated patients Germing et al. Leukemia 2012
40 SINTRA-REV: RATIONALE TRANSFUSION DEPENDENCY IN MDS Poor prognosis (WPSS) Advanced Disease Risk of AML evolution Could prolong the time until transfusion dependency? LENALIDOMIDE? SINTRA-REV
41 RE-SMD SINTRA-REV: TOPICS Rationale of the study Spanish MDS Registry data on del(5q) patients Clinical trial
42 RE-SMD SINTRA-REV: SPANISH MDS REGISTRY MDS and del(5q) at presentation Spanish Registry on 150 MDS patients AT DIAGNOSIS: 94% developed anemia (Hb<12 g/dl) Median 10.4 g/dl ( g/dl) N=84 with information available on TD 73% developed transfusion requirements (61/84)
43 RE-SMD SINTRA-REV: SPANISH MDS REGISTRY MDS and del(5q) evolution Proportion of anemic patients with transfusion indepe endecy 1,0 0,8 0,6 0,4 0,2 0,0 N = Time (days) from diagnosis
44 SINTRA-REV: TOPICS Rationale of the study Spanish MDS Registry data on del(5q) patients Clinical trial
45 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: Title Multicenter, randomized, double-blind, phase III study of REVLIMID (Lenalidomide) versus placebo in patients with low risk myelodysplastic syndrome (low and intermediate-1 IPSS) with alteration in 5q- and anemia without transfusion dependency
46 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: Objectives The main objective of the study is efficacy: To assess if treatment with Revlimid (Lenalidomide) prolongs the period until disease progression (transfusion dependency). Revlimid will be compared to current standard treatment for patients with low risk MDS associated with the loss of 5q with transfusion independent anamia, which is observation and monitoring until disease progression.
47 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: Objectives The secondary objectives of the study are: Erythroid response according to IWG 2006 criteria. Duration of RBC-TI. Change in Hb concentration. Cytogenetic response according IWG 2006 criteria. Bone marrow response according to IWG 2006 criteria. Variation in absolute platelet count. Variation in absolute neutrophil count. To assess the safety and tolerability of Lenalidomide, measured according to the incidence of clinical and laboratory toxicity. OS, EFS and transformation to AML.
48 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: Design 60 patients with low risk del(5q-) MDS +/- other additional abnormality Anemia (Hb 12g/dL) but without TD Randomized in a 2:1 ratio Treatment for 108 weeks or until disease progression: transfusion dependency (at least 2 RBC units/56 days with a minimum follow-up of 112 days), or unacceptable toxicity
49 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: Scheme Treatment phase 5 mg/day on days 1 to 28 of every 28-day cycle 108 weeks of treatment Follow-up phase Observation and monitoring 108 weeks of follow-up Screening Treatment Phase 108w Follow-up Phase 108w
50 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: Schedule/planning Beginning years for recruitment: years of follow-up: Duration of the trial: 4 years Screening Treatment Phase 108w Follow-up Phase 108w
51 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENTS INCLUDED: N=10 3 YEARS IN RECRUITMENT: DATE OF INCLUSION Age (years) /15/ /18/10 83 H. Clínico de Salamanca /29/ /31/ /30/12 85 H. Son Llàtzer H. Cruces H. La Paz H. Clínic de Barcelona H. Germans Trias i Pujol /22/ /14/ /7/ /25/ /30/10 80
52 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results DISEASE CHARACTERISTICS: CLASSIFICATION AND PROGNOSIS FAB OMS 2008 IPSS RA RCMD 0 RA RCMD 1 RA RCMD 0 RA MDS with 5q- abnormality 0 RA MDS with 5q- abnormality 0 RARS MDS with 5q- abnormality 0 RARS RARS 0 RA RCMD 1 RA RCUD 0 RA RARS 0
53 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results STATUS OF THE PATIENTS ACTIVE TREATMENT N=6 Week of treatment TRANSFUSION DEPENDENCY N=2 Week 8 and 36 WITHDRAWL N=5 ADVERSE EVENTS N=3 Exanthema, week 2 Elevated lipase level, week 24 Solid tumor, week 40
54 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results Haemoglobin level evolution (g/dl) Basal V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V13 V14 V15 V16 V17 V18 V19 V20 V21 V22 V23 V24 V25 V26 V27 V29 Visita Final EOT tto W12 W108
55 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results ADVERSE EVENTS SERIOUS ADVERSE EVENTS N=3 Exhantema N=1, grade 2 Increase in lipase level N=1, grade 3 Solid tumor N=1, grade 3 ADVERSE EVENTS N=13 Neutropenia N=3, grades 1-3 Thrombocytopenia N=1, grade 1 Asthenia N=2, grades 1 and 2 Dyspnoea N=1, grade 1 Constipation N=2, grades 1 and 2 Vomiting N=1, grade 2 Depression N=1, grade 1 Dental N=1, grade 2 Hypothyroidism N=1, grade 2 NCI CTCAE version 3,0
56 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 1 RA, RCMD, IPSS 0, 74 year-old, woman 46 XX (del 5q) [20], FISH 45% +
57 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 1 RA, RCMD, IPSS 0, 74 year-old, woman 46 XX (del 5q) [20], FISH 45% + Haemoglobin level W12 W108
58 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 1 RA, RCMD, IPSS 0, 74 year-old, woman 46 XX (del 5q) [20], FISH 45% + Haemoglobin level Leukocytes 3 2,5 2 1,5 1 0,5 0 W12 W108
59 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 1 RA, RCMD, IPSS 0, 74 year-old, woman 46 XX (del 5q) [20], FISH 45% + Haemoglobin level Leukocytes Platelets Bas al V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V13 V14 V15 V16 V17 V18 V19 V20 V21 V22 V23 V24 V25 V26 V27 V28 V29 EOT W12 W108
60 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 1 RA, RCMD, IPSS 0, 74 year-old, woman 46 XX (del 5q) [20], FISH 45% + Haemoglobin level Leukocytes Platelets NO other adverse events
61 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 1 RA, RCMD, IPSS 0, 74 year-old, woman 46 XX (del 5q) [20], FISH 45% + Haemoglobin level Leukocytes Platelets Adverse Events Response at week 12 Erythroid response Complete response in bone marrow FISH negative WITHDRAL at w108 6 mo FU
62 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 4 RA, MDS 5q-, IPSS 0, 74 year-old, man, SEVERE COMORBIDITY (ISHCHEMIC CARDIOMIOPATHY) 46 XY (del 5q) [20], FISH 17% + Haemoglobin level Basal V1 V2 V3 V4 V5 V6 V7 W12
63 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 4 RA, MDS 5q-, IPSS 0, 74 year-old, man, SEVERE COMORBIDITY (ISHCHEMIC CARDIOMIOPATHY) 46 XY (del 5q) [20], FISH 17% + Haemoglobin level NO cytopenias or adverse events
64 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 4 RA, MDS 5q-, IPSS 0, 74 year-old, man, SEVERE COMORBIDITY (ISHCHEMIC CARDIOMIOPATHY) 46 XY (del 5q) [20], FISH 17% + Haemoglobin level NO cytopenias or adverse events Response at week 12 Erythroid response Complete response in bone marrow Cytogenetic response: 46 XY [21], FISH negative(4% +) w24
65 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 10 RA, MDS 5q-, IPSS 0, 80 year-oldwoman 46 XY (del 5q) [20], FISH NA Haemoglobin level 14 13, , , ,5 Basal V1 V2 V3 V4 V5 V6 V7 V8 V9 W12
66 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 10 RA, MDS 5q-, IPSS 0, 80 year-oldwoman 46 XY (del 5q) [20], FISH NA Haemoglobin level No cytopenias
67 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 10 RA, MDS 5q-, IPSS 0, 80 year-old, woman 46 XY (del 5q) [20], FISH NA haemoglobin level No cytopenias Adverse events G3 increase in lipase level, at w24 WITHDRAWL
68 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results PATIENT 10 RA, MDS 5q-, IPSS 0, 80 year-oldwoman 46 XY (del 5q) [20], FISH NA Haemoglobin level No cytopenias Adverse Events Response Erythroid response at w12 Complete bone marrow response at w12 Complete cytogenetic response at w12 w108
69 CLINICAL TRIAL: SINTRA-REV SINTRA-REV: preliminary results RESPONSE EVOLUTION HEMATOLOGICAL BONE MARROW CYTOGENETIC Week evaluable 8 Erythroid responses 6 CR 1 PR 3 CCyR 2 parcial CyR Week 36 4 evaluable 2 Erythroid responses* 1 No response 1 Progression 2 CR* 1 Progression 2 CCyR* 1 Progression Week 60 2 evaluable 2 Erythroid response* 2 CR* 2 CyCR* Week evaluable 2 Erythroid response* 2 CR* 2 CyCR* * Patient withdrawal on week 24 due to elevated lipase level
70 SINTRA-REV: CONCLUSION ON GOING STUDIES Further investigation is needed on the natural evolution on MDS and del(5q) patients with no transfusion dependency The treatment in this clinical trial seems to be effective and safe RE-SMD Grupo Español de SMD Registro Español de SMD
71 TAKE HOME MESSAGES Investigación clínica Mejorar resultados Ensayos clínicos
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