Linfoma de Hodgkin. Novos medicamentos. Otavio Baiocchi CRM-SP

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1 Linfoma de Hodgkin Novos medicamentos Otavio Baiocchi CRM-SP

2 Hodgkin Lymphoma Unique B-cell lymphoma HRS malignant cells Scattered malignant Hodgkin-Reed-Sternberg (RS) cells in a background of reactive T-cells infiltrate,.

3 HRS cells interaction with microenvironment Aldinucci et al. J Pathol 2010 Jul;221(3):248-63

4 Hodgkin lymphoma: treatment modalities

5 Hodgkin lymphoma: treatment modalities

6 Hodgkin Lymphoma: Depletion of malignant cells Chemotherapy and Radiotherapy approach Autologous stem-cell transplant Antibody-drug conjugate: Brentuximab vedotin ABVD BEACOPP

7 Hodgkin Lymphoma: Depletion of malignant cells Chemotherapy and Radiotherapy approach Autologous stem-cell transplant Antibody-drug conjugate: Brentuximab vedotin BEACOPP ABVD

8 Hodgkin Lymphoma - treatment Early favorable Early unfavorable Advanced stages

9 Current guidelines for HL treatment Treatment setting Frontline NCCN guidelines, 2016 Treatment ABVD + IFRT Stanford V BEACOPP BEACOPP followed by ABVD + RT ABVD alone Individualized treatment may be necessary for older patients and patients with concomitant disease (2A) ESMO guidelines, 2014 Treatment ABVD or BEACOPP ± RT (I II,A) Second-line Salvage chemotherapy + ASCT Salvage chemotherapy + ASCT Third line therapy Brentuximab vedotin Allo SCT No data to support superior outcomes with any treatment; individualized therapy recommended Clinical trial may be appropriate Brentuximab vedotin Allo SCT No data to support superior outcomes with any treatment; individualized therapy recommended Clinical trial may be appropriate

10 Current guidelines for HL treatment Treatment setting Frontline NCCN guidelines, 2016 Treatment ABVD + IFRT Stanford V BEACOPP BEACOPP followed by ABVD + RT ABVD alone Individualized treatment may be necessary for older patients and patients with concomitant disease (2A) ESMO guidelines, 2014 Treatment ABVD or BEACOPP ± RT (I II,A) Second-line Radiotherapy or second-line chemotherapy ± radiotherapy followed by high-dose chemotherapy + ASCT/allo-SCT Salvage chemotherapy + ASCT BEACOPP escalated or salvage radiotherapy alone Third line therapy Brentuximab vedotin Allo SCT No data to support superior outcomes with any treatment; individualized therapy recommended Clinical trial may be appropriate Brentuximab vedotin Allo SCT No data to support superior outcomes with any treatment; individualized therapy recommended Clinical trial may be appropriate

11 Current guidelines for HL treatment Treatment setting Frontline NCCN guidelines, 2016 Treatment ABVD + IFRT Stanford V BEACOPP BEACOPP followed by ABVD + RT ABVD alone Individualized treatment may be necessary for older patients and patients with concomitant disease (2A) ESMO guidelines, 2014 Treatment ABVD or BEACOPP ± RT (I II,A) Second-line Salvage chemotherapy + ASCT Salvage chemotherapy + ASCT Third line therapy Brentuximab vedotin Allo SCT No data to support superior outcomes with any treatment; individualized therapy recommended Clinical trial may be appropriate Brentuximab vedotin Allo SCT No data to support superior outcomes with any treatment; individualized therapy recommended Clinical trial may be appropriate

12 Why a biopsy is mandatory? 34 y/o white female with fever, night sweats and a newly diagnosed advanced stage HL Pcte sexo feminino, 34 anos Stage: IVB Interin PET After C2 ABVD PET + Partial Response After C4 ABVD PET + After C6 ABVD PET + Refractory HL? After 1 month Tb treatment Bx: Tuberculosis

13 2 nd line therapy for chl relapsed refractory disease High dose chemotherapy followed ASCT Which salvage chemotherapy? How to increase CR rate before ASCT? How to improve prognosis in high risk patients after ASCT?

14 2 nd line therapy for chl relapsed refractory disease High dose chemotherapy followed ASCT Which salvage chemotherapy? How to increase CR rate before ASCT? How to improve prognosis in high risk patients?

15 2 nd line therapy for chl relapsed refractory disease High dose chemotherapy followed ASCT Salvage chemotherapy - UNIFESP 1. ICE Moskowitz et al. (2001) 2. DHAP Josting et al. (2005) 3. IGEV Santoro et al. (2007) Do not delay cycles DHAP 14, ICE 15 have shown the best 4. GDP Bartlett et al. (2007) results CR rate ICE, DHAP, IGEV, GDP %

16 Probability of OS (%) Response to salvage therapy predicts post-asct survival Survival correlates with depth of response prior to ASCT 1 n Complete response 53 Partial response 96 Resistant 46 5-year OS: 79% for patients in CR pre-asct 59% in patients with PR 17% in patients with resistant disease (p<0.0001) Complete remission is good, but not a pre-requisite! Time since transplant (years) 1. Sirohi B et al. Ann Oncol 2008;19:1312 9; 2. Majhail N et al. Biol Blood Marrow Transplant 2006;12: ;;

17 2 nd line therapy for chl relapsed refractory disease High dose chemotherapy followed ASCT Which salvage chemotherapy? How to increase CR rate before ASCT? How to improve prognosis in high risk patients? The role of Brentuximab vedotin

18 Is it possible to increase CR rate without increasing toxicity? The role of BV in savage therapy Use brentuximab vedotin (BV) with salvage chemotherapy BV-bendamustine Brentuximab vedotin 1.8 mg/kg D1 with bendamustine 90 mg/m2 on D1-2 q3w for 3 cycles ORR 92% 76 patients, 80% CR 30% used plerixafor LaCasce, et al. ASH 2016 CR rate ICE, DHAP, IGEV, GDP % Brentuximab Vedotin Plus ESHAP (BRESHAP) Garcia-Sans, et al. EBMT 2016 (poster) GELTAMO ORR 94% 39 patients, 85% CR

19 Is it possible to increase CR rate without increasing toxicity? The role of BV in savage therapy Brentuximab monotherapy 60 patients ORR 88% CR 65% Excellent stem-cell harvest Chen et al, EBMT 2016 (poster) B-ICE ASH 2017 preliminary results B-DHAP ISHL 2016 preliminary results CR 85% Hagenbeck et al, Oral ISHL 2016

20 2 nd line therapy for chl relapsed refractory disease High dose chemotherapy followed ASCT Which salvage chemotherapy? How to increase CR rate before ASCT? How to improve prognosis in high risk patients after ASCT?

21 AETHERA phase III trial of brentuximab vedotin vs placebo in relapsed or refractory HL pts at risk of relapse post ASCT Dose and schedule: Pts were randomized 1:1 to receive day cycles of brentuximab vedotin 1.8 mg/kg IV day 1 or placebo Pts who progressed on placebo could receive brentuximab vedotin HL, Hodgkin lymphoma; PFS, progression free survival; IRF, independent review facility; OS, overall survival; mos, months; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; ASCT, autologous stem cell transplantation; BV, brentuximab vedotin; pts, patients ; R/R, relapsed refractory Moskowitz C et al. Lancet Oncology 2016

22 AETHERA phase III trial of brentuximab vedotin vs placebo in relapsed or refractory HL pts at risk of relapse post ASCT PFS outcome Brentuximab vedotin (n=165) Moskowitz C et al. Lancet Oncology 2016 Placebo (n=164) Median PFS NR 16 mos HR (95% CI) 0.50 (0.36, 0.70) p-value NR 2-year PFS 65% 45% Moskowitz C et al. Lancet Oncology 2016

23 AETHERA phase III trial of brentuximab vedotin vs placebo in relapsed or refractory HL pts at risk of relapse post ASCT Consolidation after ASCT with brentuximab vedotin (BV) demonstrated improved PFS in patients with HL and risk factors for relapse or disease progression (HR = 0.57, p = 0.001) PFS benefit was sustained after 3 years f/u (EHA 2016) Consistent benefit observed across subgroups Analysis of overall survival did not show a significant difference between treatment arms. Moskowitz C et al. Lancet Oncology 2016

24 3 rd line therapy for chl relapsed after ASCT

25 Current guidelines for HL treatment Treatment setting Frontline NCCN guidelines, 2016 Treatment ABVD + IFRT Stanford V BEACOPP BEACOPP followed by ABVD + RT ABVD alone Individualized treatment may be necessary for older patients and patients with concomitant disease (2A) ESMO guidelines, 2014 Treatment ABVD or BEACOPP ± RT (I II,A) Second-line Radiotherapy or second-line chemotherapy ± radiotherapy followed by high-dose chemotherapy + ASCT/allo-SCT Salvage chemotherapy + ASCT BEACOPP escalated or salvage radiotherapy alone Third line therapy Brentuximab vedotin Allo SCT Clinical trial may be appropriate Brentuximab vedotin Allo SCT Clinical trial may be appropriate

26 Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma Chen et al, Blood 2016 Single agent brentuximab vedotin can induce durable remissions 5-year overall survival rate was 41% and 70% for those who achieved CR

27 Current guidelines for HL treatment Treatment setting Frontline NCCN guidelines, 2016 Treatment ABVD + IFRT Stanford V BEACOPP BEACOPP followed by ABVD + RT ABVD alone Individualized treatment may be necessary for older patients and patients with concomitant disease (2A) ESMO guidelines, 2014 Treatment ABVD or BEACOPP ± RT (I II,A) Second-line Radiotherapy or second-line chemotherapy ± radiotherapy followed by high-dose chemotherapy + ASCT/allo-SCT Salvage chemotherapy + ASCT BEACOPP escalated or salvage radiotherapy alone Third line therapy Brentuximab vedotin Allo SCT Clinical trial may be appropriate Brentuximab vedotin Allo SCT Clinical trial may be appropriate

28 Hodgkin lymphoma: treatment modalities

29 New medications: Cancer immunotherapy 29

30 WHEN A T-LYMPHOCYTE MEETS AN ANTIGEN 1. T cells recognize antigens presented on the MHC by the TCR (SIGNAL 1) APC CD4 Lymphocyte

31 WHEN A T-LYMPHOCYTE MEETS AN ANTIGEN 1. T cells recognize antigens presented on the MHC by the TCR (SIGNAL 1) APC CD4 Lymphocyte 2. The activation or inhibition of T cells is determined by the additional ligand receptor interactions between T cells and APCs (or tumour cells) (SIGNAL 2) 1. Release of cytokines (SIGNAL 3)

32 WHEN A T-LYMPHOCYTE MEETS AN ANTIGEN 1. T cells recognize antigens presented on the MHC by the TCR (SIGNAL 1) APC CD4 Lymphocyte 2. The activation or inhibition of T cells is determined by the additional ligand receptor interactions between T cells and APCs (or tumour cells) (SIGNAL 2) 1. Release of cytokines (SIGNAL 3)

33 Hodgkin Lymphoma: Immune activation Allogeneic SCT Immune checkpoint inhibitors (inhibitory effect) Immune checkpoint activators (activation effect)

34 Activating or inhibitory receptors 34

35 Hodgkin Lymphoma: Immune activation Immune checkpoint inhibitors (inhibitory effect) Immune checkpoint activators (activation effect)

36 Immune checkpoints in HL Teach your body to fight tumor Haematologica cover July 2016

37 Inhibitory receptors 37

38 Regulatory T-cells in Hodgkin Lymphoma Regulatory T-cells surround HRS cells (Assis et al, Med Oncol, 2012) EBV increases Tregs in tumor microenvironment (Assis et al, Leukemia & Lymphoma, 2014) Increased Tregs in peripheral blood of patients with chl at diagnosis. (Silva et al, Clin Leuk, Lymph and Myel, 2015)

39 Regulatory T-cells in Hodgkin Lymphoma Regulatory T-cells downregulate anti-tumor immune response

40 CTLA-4 Inhibitors: Ipililumab mechanism of action

41 Activating or inhibitory receptors 41

42 PD-1 Inhibitors in Hodgkin Lymphoma: Pembrolizumab and nivolumab

43 PD-1 Inhibitors in Hodgkin Lymphoma: Pembrolizumab and nivolumab

44 Results of PD1 Blocking Antibodies in Relapsed HL (all pts received BV) Drug Dose/Sche dule N % ORR % CR ORR in BV treated HL 1 st Author Pembrolizumab (humanized IgG4) 10 mg/kg IV Q 2wks 15 53% 20% 53% (n=15) Moskowitz C Nivolumab (Fully human IgG4) 3 mg/kg IV Q 2wks 23 87% 17% 89% (n=18) Armand P Phase 2 trials on going

45 Preliminary Safety and Efficacy of the Combination of Brentuximab Vedotin and Ipilimumab in Relapsed / Refractory Hodgkin Lymphoma: A Trial of the ECOG-ACRIN Cancer Research Group (E4412) Stephen Ansell et al, Poster, ASH 2016 E4412 is a phase 1 study of the combination of BV and the checkpoint inhibitors ipilimumab (anti-ctla-4) (IPI) and nivolumab (NIVO) 23 patients have been treated with BV + IPI (first cohort) BV + IPI was well tolerated Overall response BV + IPI was 87% with a CR rate of 62% Optimization of this combination strategy is planned with ongoing accrual to cohorts receiving BV + NIVO and BV + IPI + NIVO. 45

46 PD1 Blocking Antibodies: potential serious side effects

47 PD1 Blocking Antibodies: potential serious side effects Fulminant type 1 diabetes mellitus with Nivolumab J Diabetes, 2016 Fatal GVHD following Pembrolizumab Bone Marrow Transplant AIHA after nivolumab treatment Oncotarget, 2016 Vitiligo induced by nivolumab Cancer reviews, 2016 Myasthenia gravis induced by nivolumab JAMA Oncol, 2016

48 Single agent activity of novel agents in relapsed chl: update CR PR 25 0

49 Current and Future Treatment Paradigms of Hodgkin Lymphoma Strategy A Strategy B PD1/PDL1 an bodies Chemo therapy Brentuximab Vedo nn PI3Ki/ mtori Chemo therapy Brentuximab Vedo nn + PD1/PDL1 an body PI3Ki/ mtori HDACi HDACi Courtesy: Prof. Anas Younes

50 Obrigado

51 Current and Future Treatment Paradigms of Hodgkin Lymphoma ABVD ABVD 2020? No response/relapse No response/relapse No response/relapse Platinum-based salvage Platinum-based salvage? And/or And/or And/or Gemcitabine-based salvage Gemcitabine-based salvage? ASCT ASCT? No response/relapse No response/relapse No response/relapse? Brentuximab AlloSCT?

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