Highlights of Key Findings from ICML Lugano 2011 Conference

Highlights 11- ICML Lugano 15-18 June 2011 Anastasios Stathis, MD Oncology Institute of Southern Switzerland CH-6500 Bellinzona

Topics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

The role of the microenvironment in malignant lymphomas ,[object Object],[object Object],RD Gascoyne et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv47 (abs VII ) N=130

Hematological response to antiviral treatment in 94 patients with indolent B-NHL associated with HCV infection: studies of the FIL L. Arcaini et al. Ann Oncol 2011, 22 Suppl 4:iv129 (abs 138) 94 pts with iNHL and HCV infection 36 pts received IFN (in 26 with ribavirin) 57 received peg-IFN (in 53 plus ribavirin) 76 pts treated in 1st line 18 pts had AT in 2nd line CR 47%, PR 30 % in first line Lower response rate in 2nd line Similar responses between IFN and peg-IFN Better long term control of iNHL with peg-IFN PFS 5-yr OS 94%; 5-yr PFS 78% DOR > 3 yrs in 40% of pts

PET+ lesions at the end of chemotherapy for Hodgkin Lymphona Engert et al., Abstr. 45, ICML-11 728 advanced HL with residual disease after 6-8 BEACOPP 74% PET -  No RT  only 5% relapsed (NPV 94.6%) 26% PET +  RT Conclusion : PET - residual disease (after BEACOPP) do NOT need RT

HD16 R PET scan in low risk HL : The GHSD HD16 trial

PET scan in PMBCL: New IELSG protocol ,[object Object],[object Object],[object Object],RT 0 /

DA-EPOCH-R for Burkitt’s lymphoma and PMBCL 30 Burkitt at 5y median FU EFS 97%, OS 100% 40 PMBCL at 4y median FU EFS 95%, OS 100% only 3/40 needed RT/surgery for PET+ Dunleavy et al., Abstr. 71, ICML-11 Dunleavy et al., Abstr. 150, ICML-11

Centrocytic lymphoma -Described by K. Lennert more than 30 year ago -Accepted as a separate entity in the 1990s

The hallmark of mantle cell lymphoma is the t(11;14)(q13;q32) Mantle cell lymphoma

MCL frequency at the IOSI Diffuse Large B-cell Lymphoma 37% Follicular Lymphoma 20 % CLL/SLL 15 % MALT lymphoma 7% Mantle Cell Lymphoma 6.5 %

R-CHOP vs R-FC followed by maintenance with Rituximab or IFN First results of a RCT for elderly patients with Mantle cell lymphoma H Kluin-Nelemans et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv86 (abs 016 ) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],R-CHOP R-FC OS European MCL Network

R-CHOP vs R-FC followed by maintenance with Rituximab or IFN First results of a RCT for elderly patients with Mantle cell lymphoma ,[object Object],[object Object],[object Object],Abstract 16, 11-ICML

Oral lenalidomide plus 4 doses of rituximab induced prolonged remissions in relapsed/refractory MCL: a phase I/II clinical trial Wang M et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv119 (abs 109) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Response N=46 (%) ORR 26 (57) CR 15 (33) PR 11 (24) SD 10 (21.5) PD TTFR 10 (21.5) 2 (2-8)

Outcomes of patients (n =640) with MCL undergoing autologous versus RIC allogeneic transplantation ,[object Object],[object Object],[object Object],[object Object],[object Object],TS Fenske et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv87 (abs 018) „ Early MCL“

High response rates with Lenalidomide plus Rituximab for untreated indolent B cell NHL N Fowler et al. 11-ICML (Lugano 2011) – Ann Oncol 2011, 22 Suppl 4:iv128 (abs 137) PFS Lenalidomide 20mg Days 1-21 Cycles 1-6* 1 2 3 4 5 6 7 8 9 10 11 12 If clinical benefit, can proceed to 12 cycles R= RESTAGING Lenalidomide 20mg Days 1-21 Cycles 7-12 ,[object Object],[object Object],[object Object],Months Rituximab 375mg/M 2 Day 1 of Cycles 1-6 R Rituximab 375mg/M 2 Day 1 of Cycles 7-12 R R R

Inotuzumab Ozogamicin (CMC-544) in patients with indolent B-cell NHL refractory to Rituximab, Rituximab plus chemotherapy, or radioimmunotherapy ,[object Object],[object Object],42 SAEs were reported in 17 patients; the majority of SAEs (55%) were not considered to be related to the study treatment Goy A et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv105 (abs 069) 57% n = 35 26% n = 16 67% n = 35 31% n = 16

702 FL patients (EBMT + CIBMTR) Sureda et al., Abstr. 037, ICML-11 Half of relapsed FL are rescued by allo BMT Sibling Unrelated 3y PFS 60% 49% P= 0.02 3Y OS 69% 54% P < 0.01

Treatment of limited-stage DLBCL can be effectively tailored using a PET-based approach LH Sehn et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv91 (abs 028) N=134 Majority of limited stage patients will be PET negative after 3 cycles of R-CHOP and have excellent outcome with systemic therapy alone PET positive patients who complete treatment with IFRT have a high rate of distant relapse, and alternative approaches may be necessary OS N=134

R-CHOP 14 vs 21 x 8 in elderly (ASH 2009, Abstract 406, Delarue et al, GELA) ICML update: all 600 patients analysed, 2nd interim analysis. (interim analysis – 200/600 pat.) Delarue et al., Abstr. 106, ICML-11 R-CHOP 14 R-CHOP 21 RR 72% 75% 3y EFS 57% 60% 3y OS 70% 73%

A randomized multicentre Phase III study for first-line treatment of young patients with high risk (AAIPI 2-3) Diffuse Large B-Cell Lymphoma: Rituximab plus Dose-Dense chemotherapy CHOP14/ MegaCHOP14 with or without intensified HDC and ASCT. Results of DLCL04 FIL Trial Vitolo U et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv106 (abs 072) CR/PR CR/PR Off study R-MegaCHOP14 x 4 R-CHOP14 x 4 R-MAD x 2 + BEAM + ASCT NR RANDOMIZATION R-MegaCHOP14 x 4 R-CHOP14 x 4 R E S T A G I N G 188 Pts 188 Pts R-MegaCHOP14x2 R-CHOP14 x 4 Off study NR *Patients at risk of CNS recurrence (SIE guidelines 2006): IT Mtx 4 or 6 doses

Vitolo U et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv106 (abs 072) 2-year PFS: median follow-up 24 months ,[object Object],[object Object],[object Object],[object Object],p=0.0128 0.00 0.25 0.50 0.75 1.00 0 12 24 36 48 Months R-HDC+ASCT R-dose dense 71% 59% p=0.0762 0.00 0.25 0.50 0.75 1.00 0 12 24 36 48 Months R -CHOP+HDC+ASCT R -megaCHOP+HDC+ASCT R-CHOP R-megaCHOP

Randomized Phase II study of R-CHOP+ Enzastaurin vs R-CHOP in the first-line treatment of patients with intermediate and high-risk DLBCL. Preliminary analysis Hainsworth JD et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv107 (abs 074) ,[object Object],[object Object],First-line Therapy Maintenance Therapy Randomization (3:2) Single-agent ENZ 500 mg daily up to 3 years Observation Arm A: R-CHOP + ENZ 500 mg daily × 6 cycles of 21 days N=57 Arm B: R-CHOP alone × 6 cycles of 21 days N=43 CR, CRu or PR Stratified by IPI (2 vs 3, 4, 5) and age (≤60 vs >60 years)

Combination of Lenalidomide with R-CHOP (R2CHOP) as an initial therapy for aggressive B cell lymphomas - a Phase I/II study Nowakowski GS et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv119 (abs 110) ,[object Object],[object Object],[object Object],Overall response rate 100% Complete response rate 83% The clinical benefit appears to be equal in non-GCB vs GCB (lenalidomide overcomes poor outcome in non-GCB?) Agent Dose Route Day of Cycle Lenalidomide daily po 1-10 R-CHOP 375 mg/m 2 IV over 4-8 hours 1 Pegfilgrastin 6 mg SC 2 Aspirin 81 mg po daily Toxicity Grade 3 4 Hematological Neutropenia Thrombocytopenia 13% 16% 75% 25% Infection Neutropenic fever 9% 0% Vascular Venous Thrombosis 6% 0% Constitutional Fatigue Dehydration 6% 6% 0% 0%

Immunotoxin: brentuximab vedotin SGN-35 = anti CD30 AB + monomethyl auristatin E (anti-microtubule) 58 ALCL relapsed or refractory (50%) 72% ALK negative ORR 86% CR 53% Duration of response (1wk - 1 year), median not reached Shustov et al., Abstr. 125, ICML-11

Preliminary results from a multicenter, Phase II study of Bendamustine in refractory or relapsed T-cell Lymphoma „The BENTLY Trial“ ,[object Object],[object Object],[object Object],[object Object],G Damay et al 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv125 (abs 126)

Further interesting new antibodies Abstracts, 66, 144, 67, 145, 64, 68 Name Target Activity GA101 CD20 indolent + aggressive NHL lucatumumab CD40 FL dacetuzumab CD40 DLBCL KW-0761 CCR4 ATL blinatumomab CD3/CD19 DLBCL + MCL

Phase I study of SB1518, a novel oral JAK2 inhibitor, in relapsed lymphoma: clinical and biologic activity in multiple lymphoma subtypes A. Younes et al. 11-ICML (Lugano 2011) - Ann Oncol 2011, 22 Suppl 4:iv136 (abs 157) ,[object Object],[object Object],[object Object],[object Object],[object Object]

JP Leonard et al. 11-ICML (Lugano 2011) – Ann Oncol 2011, 22 Suppl 4:iv137 (abs 158 ) Kahl, Abstract 350, 11-ICML) ,[object Object],[object Object],[object Object],[object Object],A Phase I study of CAL-101, an Isoform-selective inhibitor of Phosphatidylinositol 3‑Kinase P110  , in combination with anti-CD20 monoclonal antibody therapy and/or Bendamustine in previously treated B-NHL N=49 Progression-Free Survival 0 2 4 6 8 10 12 0 10 20 30 40 50 60 70 80 90 100 iNHL: CAL-101 + B (N=15) iNHL: CAL-101 + R (N=12) CLL: CAL-101 + B (N= 9) CLL: CAL-101 + R (N=13) Cycle (28 days) % Progression Free

12-ICML June 19-22, 2013 12th INTERNATIONAL CONFERENCE ON MALIGNANT LYMPHOMA Lugano, Switzerland Deadlines : ABSTRACT SUBMISSION: February 28, 2013 EARLY REGISTRATION: or on before March 15, 2013 LATE REGISTRATION: from March 16, 2013 (up to 3000 attendees) For information and on-line registration: www.lymphcon.ch

Highlights of Key Findings from ICML Lugano 2011 Conference

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Highlights of Key Findings from ICML Lugano 2011 Conference

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