KML Experten berichten von der 14 ICML in Lugano

Transkript

1 KML Experten berichten von der 14 ICML in Lugano

2 Prof. Dr. med. Michael Hallek Chronische lymphatische Leukämie (CLL) Direktor der Klinik I für Innere Medizin der Uniklinik Köln Leiter Deutsche CLL Studiengruppe (DCLLSG) Vorstandsvorsitzender im Kompetenznetz Maligne Lymphome e.v.

3 INTEGRATED ANALYSIS: OUTCOMES OF IBRUTINIB TREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LEUKEMIA (CLL/SLL) WITH HIGH RISK PROGNOSTIC FACTORS Presenter: Tom Kipps, La Jolla, USA T.J. Kipps, G. Fraser, S.E. Coutre, J.R. Brown, J.C. Barrientos, P.M. Barr, J.C. Byrd, S.M. O'Brien, M. Dilhuydy, P. Hillmen, U. Jaeger, C. Moreno, P. Cramer, S. Stilgenbauer, A.A. Chanan Khan, M. Mahler, M. Salman, M. Cheng, A. Londhe, J. Ninomoto, A. Howes, D.F. James, M. Hallek Aim: Examine impact of prognostic factors other than del17p from three ibrutinib studies (Resonate 1, Resonate 2, Helios) Lugano, Juni 2017 Prof. Dr. med. Michael Hallek Seite 3 Klinik I für Innere Medizin Uniklinik Köln

4

5

6 CHARACTERISTICS, TREATMENT, AND OUTCOMES OF 80 YEAR OLD PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) ENROLLED TO PROSPECTIVE TRIALS OF THE GERMAN CLL STUDY GROUP Presenter: Othman Al Sawaf, Cologne, Germany O. Al Sawaf, J. Bahlo, K. Fischer, C. Herling, M. Bergmann, A.M. Fink, J. von Tresckow, P. Langerbeins, P. Cramer, S. Stilgenbauer, C.M. Wendtner, B. Eichhorst, M. Hallek, V. Goede Lugano, Juni 2017 Prof. Dr. med. Michael Hallek Seite 6 Klinik I für Innere Medizin Uniklinik Köln

7 Study population

8 Treatments

9 STUDY POPULATION All patients 152 Age (years), N 152 Median (range) 82 (80 90) Binet stage, N (%) 146 A 33 (22.6) B 52 (35.6) C 61 (41.8) Concomitant disease present, N (%) 146 No 1 (0.7) Yes 145 (99.3) Total CIRS score, N 145 Median (range) 8 (0 18) Creatinine clearance (ml/min), N 145 Median (range) 46.2 ( ) < (93.1) < (60.7) 15 th June 2017 ICML Lugano Othman Al-Sawaf 9

10 OVERALL SURVIVAL OS Pts Median months 4-yTFS, % GCLB / RCLB FCR / BR F / FC CLB th June 2017 ICML Lugano Othman Al-Sawaf 10

11 SAFETY AND ACTIVITY OF THE HIGHLY SPECIFIC BTK INHIBITOR, BGB 3111 PLUS OBINUTUZUMAB IN PATIENTS (PTS) WITH FOLLICULAR LYMPHOMA (FL) AND CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) Presenter: Constantine Tam, East Melbourne, Australia C.S. Tam, H. Quach, A. Nicol, X. Badoux, H. Rose, H. Prince, M.F. Leahy, R. Eek, N. Wickham, S. Patil, J. Huang, X. Zhang, L. Wang, E. Hedrick, W. Novotny, I. Flinn Lugano, Juni 2017 Prof. Dr. med. Michael Hallek Seite 11 Klinik I für Innere Medizin Uniklinik Köln

12

13

14

15 UBLITUXIMAB AND IBRUTINIB FOR PREVIOUSLY TREATED GENETICALLY HIGH RISK CHRONIC LYMPHOCYTIC LEUKEMIA: RESULTS OF THE GENUINE PHASE 3 STUDY Presenter: Anthony Mato, Pennsylvania, USA J.P. Sharman, D.M. Brander, A. Mato, S. Kambhampati, J.M. Burke, F. Lansigan, M.T. Schreeder, S.D. Lunin, N. Ghosh, A. Zweibach, M.I. Shtivelband, P.M. Travis, J. Chandler, K.S. Kolibaba, P. Sporteli, H.P. Miskin, M.S. Weiss, I.W. Flinn Lugano, Juni 2017 Prof. Dr. med. Michael Hallek Seite 15 Klinik I für Innere Medizin Uniklinik Köln

16 Primary endpoint: ORR

17 Efficacy: IRC Assessed ORR, CR, & MRD Negativity

18 Efficacy: PFS

19 CHEMO FREE TRIPLET COMBINATION OF TGR 1202, UBLITUXIMAB, AND IBRUTINIB IS WELL TOLERATED AND HIGHLY ACTIVE IN PATIENTS WITH ADVANCED CLL AND NHL. Presenter: Loretta Nastoupil, Houston, USA L. Nastoupil, M.A. Lunning, J.M. Vose, M.T. Schreeder, T. Siddiqi, C.R. Flowers, J.B. Cohen, J.A. Burger, W.G. Wierda, S. O'Brien, P. Sportelli, H.P. Miskin, M.A. Purdom, M.S. Weiss, N.H. Fowler TGR 1202/Umbralisib: Next generation PI3Kdelta inhibitor Ublituximab: Glycoengineered, Type I CD20 antibody Lugano, Juni 2017 Prof. Dr. med. Michael Hallek Seite 19 Klinik I für Innere Medizin Uniklinik Köln

20

21

22 BENDAMUSTINE (B), FOLLOWED BY OBINUTUZUMAB (G) AND VENETOCLAX (A) IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): CLL2 BAG TRIAL OF THE GERMAN CLL STUDY GROUP (GCLLSG) Presenter: Paula Cramer, Cologne, Germany P. Cramer, J. von Tresckow, J. Bahlo, S. Robrecht, O. Al Sawaf, P. Langerbeins, A. Engelke, A.M. Fink, K. Fischer, T. Seiler, L.Fischer von Weikersthal, H. Hebart, K.A. Kreuzer, M. Ritgen, M. Kneba, C.M. Wendtner, S. Stilgenbauer, B. Eichhorst, M. Hallek Lugano, Juni 2017 Prof. Dr. med. Michael Hallek Seite 22 Klinik I für Innere Medizin Uniklinik Köln

23 CLL2-BAG: Bendamustine, ABT-199 (venetoclax), GA101 (obinutuzumab) DEBULKING INDUCTION MAINTENANCE (MRD tailored) Bendamustine GA101 (Obinutuzumab) ABT-199 (Venetoclax)

24 Induction with obinutuzumab and venetoclax IWCLL response: Responses -CR -unconfirmed/clinical CR/CRi* -PR -SD -Progression all patients (n=63) 5 pts (8%) 20 pts (32%) 35 pts (56%) - 3 pts (5%) treatment-naїve (n=34) 3 (9%) 14 (41%) 17 (50%) - - relapsed/refractory (n=29) 2 (7%) 6 (21%) 18 (62%) - 3 (10%) Overall response rate 60 pts (95%) 34 (100%) 26 (90%) *) missing CT scan and/or bone marrow biopsy

25 Induction with obinutuzumab and venetoclax MRD negativity: all patients (n=63) treatment-naїve (n=34) relapsed/refractory (n=29) MRD in peripheral blood - negative (< 10-4 ) - intermediate ( 10-4 and < 10-2 ) - positive ( 10-2 ) - missing 55 pts (87%) 2 pts (3%) 4 pts (6%) 2 pts (3%) 31 (91%) 2 (6%) 1 (3%) - 24 (83%) - 3 (10%) 2 (7%) MRD in bone marrow - negative (< 10-4 ) - intermediate ( 10-4 and < 10-2 ) - positive ( 10-2 ) - missing 8 pts (13%) pts (87%) 4 (12%) (88%) 4 (14%) (86%)

26 Die Kurzpräsentationen sind online unter ICML Für den Inhalt verantwortlich: Prof. Dr. med. Dr. Michael Hallek Klinik I für Innere Medizin Uniklinik Köln

27 Das Informationsprojekt wird unterstützt von den Firmen Diese hatten keinen Einfluss auf die Inhalte.