Choroby krwi i układu krwiotwórczego najnowsze doniesienia z EHA

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1 Choroby krwi i układu krwiotwórczego najnowsze doniesienia z EHA Krzysztof Giannopoulos Centrum Onkologii Ziemi Lubelskiej Uniwersytet Medyczny w Lublinie

2 XXI zjazd Europejskiego Towarzystwa Hematologicznego w Kopenhadze 4 dni (9-12 czerwca 2016) ponad uczestników ponad 240 sesji ponad 2500 zgłoszonych prac

3 Najważniejsze doniesienia z EHA Daratumumab Shows Remarkable Benefit in Relapsed or Refractory Multiple Myeloma in the POLLUX Study Immunotherapy delivered by Blinatumomab improves survival in acute lymphoblastic leukaemia patients. STOPPING TYROSINE KINASE INHIBITORS IN A VERY LARGE COHORT OF EUROPEAN CHRONIC MYELOID LEUKEMIA PATIENTS: RESULTS OF THE EUROSKI TRIAL EFFICACY AND SAFETY OF IMATINIB GENERICS; A REPORT FROM POLISH (PALG) IMATINIB GENERICS REGISTRY CHECKMATE 205: A PHASE 2 STUDY OF NIVOLUMAB IN PATIENTS WITH CLASSICAL HODGKIN LYMPHOMA FOLLOWING AUTOLOGOUS STEM CELL TRANSPLANTATION AND BRENTUXIMAB VEDOTIN

4 BLINATUMOMAB IMPROVED OVERALL SURVIVAL IN PATIENTS WITH RELAPSED OR REFRACTORY PHILADELPHIA NEGATIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA IN A RANDOMIZED, OPEN-LABEL PHASE 3 STUDY (TOWER)

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12 Szpiczak plazmocytowy zmiana modelu leczenia Krzysztof Giannopoulos Centrum Onkologii Ziemi Lubelskiej Uniwersytet Medyczny w Lublinie

13 Immunochemioterapia, immunoterapia u chorych na szpiczaka plazmocytowego Pierwsze przeciwciała monoklonalne w leczeniu szpiczaka plazmocytowego Daratumumab FDA 2015 Elotuzumab EMA 2016

14 AN OPEN-LABEL, RANDOMISED PHASE 3 STUDY OF DARATUMUMAB, LENALIDOMIDE, AND DEXAMETHASONE (DRD) VERSUS LENALIDOMIDE AND DEXAMETHASONE (RD) IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM): POLLUX

15 POLLUX wyniki EHA 2016 Primary endpoint was met at interim analysis 63% reduction in risk of progression/death for DRd vs Rd Deep and durable responses were reported for DRd vs Rd: Overall response rate: 93% vs 76% (P<0.0001) VGPR: 76% vs 44% (P <0.0001) Complete Response (CR) rate: 43% vs 19% (P <0.0001)

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18 Model przebiegu szpiczaka plazmocytowego 10 Choroba bezobjawowa Choroba objawowa Choroba aktywna 5 Nawrót Nawrót oporny na leczenie 2 Trwająca remisja czas Durie BGM. :

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21 Aktualizacja wyników year PFS 2-year PFS 3-year PFS % % 41% 27% 26% 18% E-Ld Ld 0.0 No. of patients at risk: E-Ld Ld PFS (months) Eloquent-2 Update: A Phase 3, Randomized, Open-Label Study of Elotuzumab in Combination with Lenalidomide/Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma - 3-Year Safety and Efficacy Follow-up. ASH 2015

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23 Friday, June 10, 2016, 11:45 12:00 S101. Improved Efficacy after Incorporating Autologous Stem Cell Transplant (ASCT) into KRd Treatment with Carfilzomib (K), Lenalidomide (R), and Dexamethasone (d) in Newly Diagnosed Multiple Myeloma Andrzej Jakubowiak, Noopur Raje, Ravi Vij, Donna Reece, Jesus Berdeja, David Vesole, Sundar Jagannath, Craig Cole, Malek Faham, Jennifer Nam, Leonor Stephens, Erica Severson, Andrea Revethis, Brittany Wolfe, Shaun Rosebeck, Sandeep Gurbuxani, Cara Rosenbaum, Jagoda Jasielec, Dominik Dytfeld, Kent Griffith, Todd Zimmerman

24 Phase 2 trial of KRd combined with ASCT in NDMM Abstract S101, EHA 2016 KRd + ASCT KRd + ASCT KRd + ASCT KRd + ASCT NDMM 4 x 28 day cycles (C) of K i.v. 36 mg/m 2 on days (D) 1-2*, 8-9, 15-16; R - D 121 at 25 mg, oral; d - 40 mg/week, oral Stem cell collection, melphalan 200 mg/m 2 and ASCT Consolidation** 4 cycles Maintenance*** 10 cycles Primary endpoint KRd + ASCT (end C8) Aim: Evaluate whether extended KRd can be further improved by incorporating ASCT Primary endpoint: scr at the end of C8 A previous phase 1 trial with a similar dosing schema but no stem cell transplant ( KRd w/o ASCT ) served as historical comparator *20 mg/m 2 on Days 1, 2, Cycle 1 only; **same doses and schedule except (R) 15 mg in C5 with the option to escalate to prior dose and (d) reduced to 20 mg/wk; *** same doses as C8 except (K) on D1-2 and D15-16 only. ASCT, autologous stem cell transplant; C, cycle; D, day; d, dexamethasone; i.v., intravenous; K, carfilzomib; KRd, carfilzomib + lenalidomide + dexamethasone; NDMM, newly diagnosed multiple myeloma; R, Lenalidomide; scr, stringent complete response; w/o, without.

25 KRd combined with ASCT in NDMM: Patient characteristics and status 72 out of 76 enrolled patients were evaluated Baseline characteristics were comparable between KRd + ASCT and KRd w/o ASCT populations Status of KRd + ASCT patients at data cutoff: Abstract S101, EHA 2016 Proceeded to ASCT n = 69 Completed KRd consolidation n = 50 KRd maintenance n = 26 + remaining patients on treatment (except 1 patient who progressed prior to transplant) ASCT, autologous stem cell transplant; KRd, carfilzomib + lenalidomide + dexamethasone; NDMM, newly diagnosed multiple myeloma; w/o, without.

26 KRd + ASCT shows superior scr compared with KRd w/o ASCT Abstract S101, EHA 2016 scr at end of C8 and C18 2-year PFS 100 KRd + ASCT KRd w/o ASCT n= 50 n= 44 End of C8 n= 26 n= 41 End of C KRd + ASCT (median f/u 17.8 months) Types and rates of AEs pre- and post- ASCT were comparable to AEs in KRd w/o ASCT KRd w/o ASCT (median f/u 47.5 months) AE, adverse event; ASCT, autologous stem cell transplant, C, cycle; f/u, follow-up; KRd, carfilzomib + lenalidomide + dexamethasone; PFS, progression-free survival; scr, stringent complete response; w/o, without.

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