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FOCUS on NHL/CLL Thursday December 10, 2020 (3 Hrs)

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CONGRESS COVERAGE: ASH 2020 – FOCUS ON NHL/CLL Thursday December 10, 2020 (3 hrs) Agenda is tentative based on late-breakers. Abstracts in orange represent potentially lower-priority material; we will discuss with Dr Kahl about whether to include them. AGENDA Time Topic Presenter 5 min Welcome Brad Kahl, MD DLBCL • 597 “Safety and Efficacy of Induction and Maintenance Avelumab Plus R-CHOP in Patients with Diffuse Large B- Cell Lymphoma (DLBCL): Analysis of the Phase II Avr- CHOP Study”--Eliza A Hawkes • 598 “Phase 1b/2 Study of Vipor (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide) in Relapsed/Refractory B-Cell Lymphoma: Safety, Efficacy and Molecular Analysis”--Christopher Melani • 401 “Single-Agent Mosunetuzumab Is a Promising Safe and Efficacious Chemotherapy-Free Regimen for Elderly/Unfit Patients with Previously Untreated Diffuse Large B‑Cell Lymphoma”--Adam J Olszewski • 2099 “Interim Results of Loncastuximab Tesirine Combined with Ibrutinib in Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)”--Julien Depaus 10 min • 400 “Odronextamab (REGN1979), a Human CD20 x TBC CD3 Bispecific Antibody, Induces Durable, Complete Responses in Patients with Highly Refractory B-Cell Non- Hodgkin Lymphoma, Including Patients Refractory to CAR T Therapy”--Rajat Bannerji • 599 “Polatuzumab Vedotin Plus Venetoclax with Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Primary Efficacy Analysis of a Phase Ib/II Study”--Giuseppe Gritti • 33 “Double-Hit Signature with TP53 Abnormalities Predicts Poor Survival in Patients with Germinal Center Type Diffuse Large B-Cell Lymphoma Treated with R- CHOP”--Joo Y Song • 126 “A Once Daily, Oral, Triple Combination of BTK Inhibitor, mTOR Inhibitor and IMiD for Treatment of Relapsed/Refractory Richter’s Transformation and De Novo Diffuse Large B-Cell Lymphoma”--Anthony R. Mato • Any LBAs expected??? Moderator: Brad 20 min Discussion Kahl, MD Aptitude Health - US Aptitude Health - EU Page 1 of 68 5901-C Peachtree Dunwoody Road NE Schenkkade 50, Suite 17 Suite 200 2595 AR Atlanta, GA 30328, US The Hague, the Netherlands aptitude-health.com • Are these data likely to have any impact on the current treatment paradigms for DLBCL? If yes, how? • Are any of these data immediately practice- changing? • Which of the above targeted therapies show the most promise? • What combinations appear most promising? • Toxicities of the above therapies – are they tolerable? • What does the phenotype of CAR T-relapsed DLBCL patients look like? • How likely are CAR T-relapsed patients to be treated in a community setting? • What do academic centers do now for CAR T- relapsed patients? 5 min Key Takeaways CAR T • 737 ”Lines of Therapy before Autologous Stem Cell Transplant (ASCT) and CAR-T Infusion Affect Outcomes in Aggressive Non-Hodgkin’s Lymphoma (NHL)--Arushi Khurana • 601 “Improved Safety and Efficacy of a Multi-Target Chimeric Antigen Receptor Modified T Cell Therapy (4SCAR2.0) Against Relapsed or Refractory Lymphomas”--Rui Zhang • 600 “Phase 1 Alexander Study of AUTO3, the First CD19/22 Dual Targeting CAR T Cell Therapy, with Pembrolizumab in Patients with Relapsed/Refractory (r/r) DLBCL”--Aravind Ramakrishnan • 405 “Interim Analysis of ZUMA-12: A Phase 2 Study of 10 min Axicabtagene Ciloleucel (Axi-Cel) as First-Line Therapy TBC in Patients (Pts) With High-Risk Large B Cell Lymphoma (LBCL):--Sattva S. Neelapu • 118 “Safety and Preliminary Efficacy in Patients with Relapsed/Refractory Mantle Cell Lymphoma Receiving Lisocabtagene Maraleucel in Transcend NHL 001”-- Maria Lia Palomba • 546 “Updated Follow-up of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated with Lisocabtagene Maraleucel in the Phase 1 Monotherapy Cohort of Transcend CLL 004, Including High-Risk and Ibrutinib-Treated Patients”--Tanya Siddiqi • Any LBAs expected??? Discussion • Are these data likely to have any impact on the current treatment paradigms?If yes, how? • Are any of these data immediately practice- Moderator: Brad 20 min changing? Kahl, MD • How comfortable are you using CAR T-cell approaches in the different NHL subtypes? • What is the most common bridging therapy? Page 2 of 68 • How do approval of polatuzumab, tafasitimab, and selenexor affect bridging, salvage, and CAR T prescribing if at all? • What difference (efficacy and/or safety) do you see right now for the various CAR T-cellular products, and how will this influence your preference to use each of them? – How does RWD factor into your decision? – What factors affect which CAR T construct you would prescribe, and why? 5 min Key Takeaways MCL and FL • 121 “VLS-101, a ROR1-Targeting Antibody-Drug Conjugate, Demonstrates a Predictable Safety Profile and Clinical Efficacy in Patients with Heavily Pretreated Mantle Cell Lymphoma and Diffuse Large B-Cell Lymphoma”--Michael Wang • 702 “Mosunetuzumab Shows Promising Efficacy in Patients with Multiply Relapsed Follicular Lymphoma: Updated Clinical Experience from a Phase I Dose- Escalation Trial”--Sarit E Assouline • 122 “Venetoclax, Lenalidomide and Rituximab for Patients with Relapsed or Refractory Mantle Cell Lymphoma - Data from the Nordic Lymphoma Group NLG-MCL7 (VALERIA) Phase I Trial: Stopping Treatment in Molecular Remission Is Feasible”--Mats 10 min Jerkeman TBC • 117 “LOXO-305, A Next Generation, Highly Selective, Non-Covalent BTK Inhibitor in Previously Treated Mantle Cell Lymphoma, Waldenström's Macroglobulinemia, and Other Non-Hodgkin Lymphomas: Results from the Phase 1/2 BRUIN Study”--Michael Wang • 120 “Predictive Power of Early, Sequential MRD Monitoring in Peripheral Blood and Bone Marrow in Patients with Mantle Cell Lymphoma Following Autologous Stem Cell Transplantation with or without Rituximab Maintenance; Final Results from the LyMa- MRD Project, Conducted on Behalf of the Lysa Group”-- Mary B. Callanan • Any LBAs expected??? Discussion • Are these data likely to have any impact on the current treatment paradigms? If yes, how? • Are any of these data immediately practice- changing? • How do you decide on therapies in the frontline Moderator: Brad 20 min setting? • MRD in MCL – is it ready to be applied outside of Kahl, MD clinical trials? • Does induction regimen affect the use of maintenance, or not? • In chemo-free regimens for FL and MCL, how do we factor in cost of care and QOL data? 5 min Key Takeaways 15 min T-cell lymphoma and others TBC Page 3 of 68 • 40 “Multi-Center Phase II Study of Oral Azacitidine (CC- 486) Plus CHOP As Initial Treatment for Peripheral T- Cell Lymphoma (PTCL)”-- Jia Ruan • 645 “A Phase II Study of Pembrolizumab in Combination with Romidepsin Demonstrates Durable Responses in Relapsed or Refractory T-Cell Lymphoma (TCL)”--Swami P. Iyer • 44 “Duvelisib in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma from the Phase 2 Primo Trial: Dose Optimization Efficacy Update and Expansion Phase Initial Results”-- Barbara Pro • 374 “Effect of Pembrolizumab Monotherapy Versus Brentuximab Vedotin (BV) on Symptoms Associated with Health-Related Quality of Life (HRQoL) in Relapsed/Refractory (R/R) Classical Hodgkin Lymphoma (cHL) in the Randomized, Phase 3, Keynote-204 Study”-- Pier Luigi Zinzani • 338 “Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)”--Tycel J. Phillips • 474 “Preliminary Results of a Phase 2 Study of Camidanlumab Tesirine (Cami), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Patients with Relapsed or Refractory Hodgkin Lymphoma”-- Alex F. Herrera • 472 “Consolidation with Nivolumab and Brentuximab Vedotin after Autologous Hematopoietic Cell Transplantation in Patients with High-Risk Hodgkin Lymphoma”--Alex F. Herrera • 617 “Phase I Study of Yttrium-90 Labeled ANTI-CD25 (aTac) Monoclonal Antibody PLUS BEAM for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients with Mature T-Cell NON-Hodgkin Lymphoma, the "a-TAC-BEAM Regimen"”--Jasmine Zain • 42 “Safety and Efficacy of Mitoxantrone Hydrochloride Liposome in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma and Extranodal NK/T-Cell Lymphoma: A Prospective, Single-Arm, Open-Label, Multi-Center, Phase Ⅱ Clinical Trial”--Yan Gao • 39 “Analysis of the Ro-CHOP Phase III Study (Conducted by LYSA): Romidepsin Plus CHOP in Patients with Peripheral T-Cell Lymphoma”--Emmanuel Bachy • 41 “Successful Treatment of Mature T-Cell Lymphoma with Allogeneic Stem Cell Transplantation: The Largest Multicenter Retrospective Analysis”-- Neha Mehta-Shah • Any LBAs expected??? Discussion • Are these data likely to have any impact on the current treatment paradigms? If yes, how? Moderator: Brad 20 min • Are any of these data immediately practice- changing? Kahl, MD • HSCT in first CR in T-cell lymphoma – yes, no, and why? Page 4 of 68 • What is your assessment of other targeted or immunotherapeutic approaches in this field? Which agents show the biggest promise? 5 min Key Takeaways CLL • 543 “Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 Unity-CLL Study”-- John G. Gribben • 123 “Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): 1-Year Disease-Free Survival (DFS) Results From the MRD Cohort of the Phase 2 CAPTIVATE Study”-- William G. Wierda • 124 “Continued Long Term
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