OVERVIEW OF ACTIVITY
Each year, thousands of clinicians, basic scientists and other industry professionals sojourn to major international oncology conferences, like the American Society of Hematology (ASH) annual meeting, to hone their skills, network with colleagues and learn about recent advances altering state-of-the-art management in hematologic oncology. These events have become global stages where exciting science, cutting-edge concepts and practice-changing data emerge on a truly grand scale. This massive outpouring of information has enormous benefits for the hematologic oncology community, but the truth is it also creates a major challenge for practicing oncologists and hematologists.
Although original data are consistently being presented and published, the flood of information unveiled during a major academic conference is unmatched and leaves in its wake an enormous volume of new knowledge that practicing oncologists must try to sift through, evaluate and consider applying. Unfortunately and quite commonly, time constraints and an inability to access these data sets leave many oncologists struggling to ensure that they’re aware of crucial practice-altering findings. This creates an almost insurmountable obstacle for clinicians in community practice because they are not only confronted almost overnight with thousands of new presentations and data sets to consider but they are also severely restricted in their ability to review and interrogate the raw findings.
To bridge the gap between research and patient care, this CME activity will deliver a serial review of the most important emerging data sets on novel agents and therapeutic options for the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM) from the latest ASH meeting, including expert perspectives on how these new evidence-based concepts may be applied to routine clinical care. This activity will assist medical oncologists, hematologists, hematology-oncology fellows and other healthcare professionals in the formulation of optimal clinical management strategies and the timely application of new research findings to best-practice patient care.
LEARNING OBJECTIVES
Please see individual web programs for CME program-specific information.
ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT
Please see individual web programs for CME program-specific information.
HOW TO USE THIS CME ACTIVITY
Please see individual web programs for CME program-specific information.
CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.
FACULTY — Please see individual web programs for CME program-specific information.
EDITOR — Dr Love is president and CEO of Research To Practice, which receives funds in the form of educational grants to develop CME activities from the following commercial interests: AbbVie Inc, Amgen Inc, Astellas Pharma Global Development Inc, AstraZeneca Pharmaceuticals LP, Baxalta Inc, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Pharma Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, CTI BioPharma Corp, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Foundation Medicine, Genentech BioOncology, Genomic Health Inc, Gilead Sciences Inc, ImmunoGen Inc, Incyte Corporation, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Lilly, Medivation Inc, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, NanoString Technologies, Natera Inc, Novartis Pharmaceuticals Corporation, Novocure, Onyx Pharmaceuticals, an Amgen subsidiary, Pharmacyclics Inc, Prometheus Laboratories Inc, Regeneron Pharmaceuticals, Sanofi, Seattle Genetics, Sigma-Tau Pharmaceuticals Inc, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Teva Oncology, Tokai Pharmaceuticals Inc and VisionGate Inc.
RESEARCH TO PRACTICE STAFF AND EXTERNAL REVIEWERS — The scientific staff and reviewers for Research To Practice have no relevant conflicts of interest to disclose.
This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.
This activity is supported by educational grants from Celgene Corporation, CTI BioPharma Corp/Baxalta Inc, Jazz Pharmaceuticals Inc, Novartis Pharmaceuticals Corporation, Seattle Genetics and Takeda Oncology.
Hardware/Software Requirements:
A high-speed Internet connection
A monitor set to 1280 x 1024 pixels or more
Internet Explorer 7 or later, Firefox 3.0 or later, Chrome, Safari 3.0 or later
Adobe Flash Player 10.2 plug-in or later
Adobe Acrobat Reader
(Optional) Sound card and speakers for audio
Last review date: March/April 2016
Expiration date: March/April 2017
Overview This 4-part web program is part of an email series designed for dedicated but frenzied oncology professionals attempting to keep up with an exploding clinical research database. Subscribers to this program receive weekly emails that include links to slides from important data sets presented at ASH 2015 along with brief comments from clinical investigators about the significance of these results.
Issue 4 — Current Issue
Read Dr Love’s original email (June 1, 2016)
Novel Agents and Therapeutic Options for Acute and Chronic Leukemias, Myelodysplastic Syndromes and Myeloproliferative Neoplasms
Program Description: A summary of recent data on the safety and efficacy of novel therapeutic options in the management of acute and chronic leukemias, myelodysplastic syndromes and myeloproliferative neoplasms, including antibody-based therapies, multikinase and tyrosine kinase inhibitors, histone deacetylase and Bcl-2 inhibitors and other targeted agents.
Full Abstracts:
Efficacy and Safety of Midostaurin-Based Induction and Maintenance Therapy for Newly Diagnosed AML
Stone RM et al. The multi-kinase inhibitor midostaurin (M) prolongs survival compared with placebo (P) in combination with daunorubicin (D)/cytarabine (C) induction (ind), high-dose C consolidation (consol), and as maintenance (maint) therapy in newly diagnosed acute myeloid leukemia (AML) patients (pts) age 18-60 with FLT3 mutations (muts): an international prospective randomized (rand) P-controlled double-blind trial (CALGB 10603/RATIFY [Alliance]). Proc ASH 2015; Abstract 6.
Schlenk R et al. Midostaurin in combination with intensive induction and as single agent maintenance therapy after consolidation therapy with allogeneic hematopoietic stem cell transplantation or high-dose cytarabine (NCT01477606). Proc ASH 2015; Abstract 322.
Alliance C11001 Trial of Sorafenib with Chemotherapy for Older Adults with FLT3-ITD-Mutated AML
Uy GL et al. Addition of sorafenib to chemotherapy improves the overall survival of older adults with FLT3-ITD mutated acute myeloid leukemia (AML) (Alliance C11001). Proc ASH 2015; Abstract 319.
Phase I/II Trial of Gilteritinib (ASP2215) in FLT3-Mutated Relapsed/Refractory AML
Altman JK et al. Antileukemic activity and tolerability of ASP2215 80mg and greater in FLT3 mutation-positive subjects with relapsed or refractory acute myeloid leukemia: Results from a Phase 1/2, open-label, dose-escalation/dose-response study. Proc ASH 2015; Abstract 321.
Phase 1b Study of Venetoclax with Decitabine or Azacitidine for Elderly Patients with Untreated AML
DiNardo C et al. A Phase 1b study of venetoclax (ABT-199/GDC-0199) in combination with decitabine or azacitidine in treatment-naive patients with acute myelogenous leukemia who are ≥ to 65 years and not eligible for standard induction therapy. Proc ASH 2015; Abstract 327.
Phase I/II Studies of Azacitidine Alone or with Pracinostat for Patients with AML
Garcia-Manero G et al. Final results from a Phase 2 study of pracinostat in combination with azacitidine in elderly patients with acute myeloid leukemia (AML). Proc ASH 2015; Abstract 453.
Savona MR et al. CC-486 (oral azacitidine) monotherapy in patients with acute myeloid leukemia (AML). Proc ASH 2015; Abstract 452.
Phase III BMT CTN 0901 Trial of Allogeneic Stem Cell Transplant After High- versus Reduced-Intensity Conditioning for Patients with MDS or AML
Scott BL et al. Results of a Phase III randomized, multi-center study of allogeneic stem cell transplantation after high versus reduced intensity conditioning in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML): Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0901. Proc ASH 2015; Abstract LBA-8.
Phase I/II Trial of AG-221 in Advanced Hematologic Cancer
Stein EM et al. Safety and efficacy of AG-221, a potent inhibitor of mutant IDH2 that promotes differentiation of myeloid cells in patients with advanced hematologic malignancies: Results of a Phase 1/2 trial. Proc ASH 2015; Abstract 323.
SWOG-S1117: Azacitidine Alone or in Combination with Lenalidomide or Vorinostat for MDS and Chronic Myelomonocytic Leukemia
Sekeres MA et al. Additional analyses of a randomized Phase II study of azacitidine combined with lenalidomide or with vorinostat vs azacitidine monotherapy in higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML): North American Intergroup study SWOG S1117. Proc ASH 2015; Abstract 908.
Initial Results from Phase II Trials of Eltrombopag or Luspatercept for Myelosuppression in Low- and Intermediate-1-Risk MDS
Oliva EN et al. Eltrombopag for the treatment of thrombocytopenia of low and intermediate-1 IPSS risk myelodysplastic syndromes: Interim results on efficacy, safety and quality of life of an international, multicenter prospective, randomized, trial. Proc ASH 2015; Abstract 91.
Giagounidis A et al. Luspatercept treatment leads to long term increases in hemoglobin and reductions in transfusion burden in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS): Preliminary results from the Phase 2 PACE-MDS extension study. Proc ASH 2015; Abstract 92.
STIM1 Trial: Update of the Stop Imatinib Study in CML
Etienne G et al. Long-term follow-up of the French 1 Stop Imatinib study (STIM1) in chronic myeloid leukemia patients. Proc ASH 2015; Abstract 345.
OPTIM-Imatinib Trial: Imatinib Dose Optimization in CML
Rousselot P et al. Personalized daily doses of imatinib by therapeutic drug monitoring increase the rates of molecular responses in patients with chronic myeloid leukemia. Final results of the randomized OPTIM Imatinib study. Proc ASH 2015; Abstract 133.
TIDEL II Substudy: Early Imatinib-Induced ABCB1 Overexpression in Chronic-Phase CML
Eadie LN et al. The clinical significance of early imatinib induced ABCB1 overexpression in chronic phase CML patients: A TIDEL II sub-study. Proc ASH 2015; Abstract 348.
Final Results from the ENESTxtnd Study of Dose-Optimized Nilotinib in Newly Diagnosed CML
Hughes TP et al. Dose-optimized nilotinib (NIL) in patients (Pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Final results from ENESTxtnd study. Proc ASH 2015; Abstract 344.
ENEST1st Subset Analysis: Impact of Age on Efficacy and Toxicity of Nilotinib in Chronic-Phase CML
Giles FJ et al. Impact of age on efficacy and toxicity of nilotinib in patients with chronic myeloid leukemia in chronic phase (CML-CP): ENEST1st sub-analysis. Proc ASH 2015; Abstract 479.
Phase II Trial of Dasatinib and Peginterferon Alpha-2b as First-Line Treatment for Chronic-Phase CML
Roy L et al. Combination of dasatinib and peg-interferon alpha 2b in chronic phase chronic myeloid leukemia (CP-CML) first line: Preliminary results of a Phase II trial, from the French Intergroup of CML (Fi-LMC). Proc ASH 2015; Abstract 134.
Ponatinib versus Allogeneic Stem Cell Transplant for Patients with CML or Ph+ ALL with the T315I Mutation
Nicolini FE et al. The impact of ponatinib versus allogeneic stem cell transplant (SCT) on outcomes in patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with the T315I mutation. Proc ASH 2015; Abstract 480.
Next-Generation Sequencing for BCR-ABL Mutations in Patients Receiving First- and Second-Line Tyrosine Kinase Inhibitors for CML
Soverini S et al. BCR-ABL mutations in chronic myeloid leukemia (CML) patients (pts) with failure and warning to first- and second-line tyrosine kinase inhibitor (TKI) therapy: What is the advantage of next-generation sequencing (NGS) over conventional sequencing? Proc ASH 2015; Abstract 346.
5-Year Analysis of the Phase III COMFORT-II Study Comparing Ruxolitinib to Best Available Therapy for the Treatment of Myelofibrosis
Harrison CN et al. Long-term efficacy and safety in COMFORT-II, a Phase 3 study comparing ruxolitinib with best available therapy for the treatment of myelofibrosis: 5-year final study results. Proc ASH 2015; Abstract 59.
Phase III PERSIST-1 Trial Subgroup Analysis: Pacritinib versus Best Available Therapy for Myelofibrosis
Vannucchi AM et al. Analysis of outcomes by patient subgroups in patients with myelofibrosis treated with pacritinib vs best available therapy (BAT) in the Phase III Persist-1 trial. Proc ASH 2015; Abstract 58.
Efficacy and Safety of PRM-151 in Myelofibrosis
Verstovsek S et al. PRM-151 in myelofibrosis: Durable efficacy and safety at 72 weeks. Proc ASH 2015; Abstract 56.
Activity and Safety of Ruxolitinib-Based Combination Therapies for Patients with Myelodysplastic Syndromes/Myeloproliferative Neoplasms
Daver N et al. 5-azacytidine (AZA) in combination with ruxolitinib (RUX) as therapy for patients (pts) with myelodysplastic/myeloproliferative neoplasms (MDS/MPNs). Proc ASH 2015; Abstract 823.
Gupta V et al. Phase 1b/2 study of the efficacy and safety of sonidegib (LDE225) in combination with ruxolitinib (INC424) in patients with myelofibrosis. Proc ASH 2015; Abstract 825.
Stegelmann F et al. A Phase-Ib/II study of ruxolitinib plus pomalidomide in myelofibrosis. Proc ASH 2015; Abstract 826.
Durrant ST et al. An open-label, multicenter, 2-arm, dose-finding, Phase 1b study of the combination of ruxolitinib and buparlisib (BKM120) in patients with myelofibrosis: Results from HARMONY study. Proc ASH 2015; Abstract 827.
Phase II COMBI Trial of Interferon Alpha-2 with Ruxolitinib for Chronic Myeloproliferative Neoplasms
Mikkelsen SU et al. Safety and efficacy of combination therapy of interferon-alpha2 + JAK1-2 inhibitor in the Philadelphia-negative chronic myeloproliferative neoplasms. Preliminary results from the Danish Combi-Trial — An open label, single arm, non-randomized multicenter Phase II study. Proc ASH 2015; Abstract 824.
Phase III GRAALL-R 2005 Study of Rituximab in CD20-Positive, Ph-Negative, B-Cell Precursor ALL
Maury S et al. Addition of rituximab improves the outcome of adult patients with CD20-positive, Ph-negative, B-cell precursor acute lymphoblastic leukemia (BCP-ALL): Results of the randomized Graall-R 2005 study. Proc ASH 2015; Abstract 1.
DFCI ALL Consortium Trial: Pegylated Asparaginase Pediatric Regimen in Adults with Untreated ALL
DeAngelo DJ et al. A multicenter Phase II study using a dose intensified pegylated-asparaginase pediatric regimen in adults with untreated acute lymphoblastic leukemia: A DFCI ALL Consortium trial. Proc ASH 2015; Abstract 80.
Phase II ALCANTRA Trial of Blinatumomab in Relapsed/Refractory Ph-Positive B-Precursor ALL
Martinelli G et al. Complete molecular and hematologic response in adult patients with relapsed/refractory (R/R) Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia (ALL) following treatment with blinatumomab: Results from a Phase 2 single-arm, multicenter study (ALCANTARA). Proc ASH 2015; Abstract 679.
Inotuzumab Ozogamicin and Mini-Hyper-CVD as Front-Line Therapy for Older Patients with B-Cell ALL
Jabbour E et al. Frontline inotuzumab ozogamicin in combination with low-intensity chemotherapy (mini-hyper-CVD) for older patients with acute lymphoblastic leukemia (ALL). Proc ASH 2015; Abstract 83.
Issue 3
Read Dr Love’s original email (March 30, 2016)
Novel Agents and Therapeutic Options for Newly Diagnosed and Relapsed/Refractory Hodgkin and Non-Hodgkin Lymphomas
Program Description: A summary of recent data on the safety and efficacy of novel therapeutic options in the management of Hodgkin lymphoma and B- and T-cell lymphomas, including checkpoint inhibitors, antibody-drug conjugates and targeted agents.
Key Abstracts of Interest in Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle-Cell Lymphoma and T-Cell Lymphoma at ASH 2015
Full Abstracts:
Phase I Studies of Nivolumab and Pembrolizumab in Relapsed/Refractory Classical Hodgkin Lymphoma
Ansell S et al. Nivolumab in patients (pts) with relapsed or refractory classical Hodgkin lymphoma (R/R cHL): Clinical outcomes from extended follow-up of a phase 1 study (CA209-039). Proc ASH 2015; Abstract 583.
Armand P et al. PD-1 blockade with pembrolizumab in patients with classical Hodgkin lymphoma after brentuximab vedotin failure: Safety, efficacy, and biomarker assessment. Proc ASH 2015; Abstract 584.
Brentuximab Vedotin-Based Combination Regimens in Hodgkin and T-Cell Lymphomas
Diefenbach CS et al. 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). Proc ASH 2015; Abstract 585.
Sawas A et al. The combination of brentuximab vedotin (Bv) and bendamustine (B) demonstrates marked activity in heavily treated patients with relapsed or refractory Hodgkin lymphoma (HL) and anaplastic large T-cell lymphoma (ALCL): Results of an international multi center phase I/II experience. Proc ASH 2015; Abstract 586.
Yasenchak CA et al. Brentuximab vedotin in combination with dacarbazine or bendamustine for frontline treatment of Hodgkin lymphoma in patients aged 60 years and above: Interim results of a multi-cohort phase 2 study. Proc ASH 2015; Abstract 587.
Chen R et al. Post transplant outcome of a multicenter phase II study of brentuximab vedotin as first line salvage therapy in relapsed/refractory HL prior to AHCT. Proc ASH 2015; Abstract 519.
Garcia-Sanz R et al. Evaluation of the regimen brentuximab vedotin plus ESHAP (BRESHAP) in refractory or relapsed Hodgkin lymphoma patients: Preliminary results of a phase I-II trial from the Spanish Group of Lymphoma and Bone Marrow Transplantation (GELTAMO). Proc ASH 2015; Abstract 582.
Clinical Outcomes for Patients with Advanced Classical HL with a Negative PET Scan after ABVD
Savage KJ et al. Advanced stage classical Hodgkin lymphoma patients with a negative PET-scan following treatment with ABVD have excellent outcomes without the need for consolidative radiotherapy regardless of disease bulk at presentation. Proc ASH 2015; Abstract 579.
Phase I Study of Denintuzumab Mafodotin in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Moskowitz CH et al. A phase 1 study of denintuzumab mafodotin (SGN-CD19A) in relapsed/refractory B-lineage non-Hodgkin lymphoma. Proc ASH 2015; Abstract 182.
Updated Results of the Phase II S1106 Trial of R-hyper-CVAD versus Bendamustine/ Rituximab Followed by ASCT in MCL
Chen R et al. Pre-transplant R-bendamustine induces high rates of minimal residual disease in MCL patients: Updated results of S1106: US Intergroup study of a randomized phase II trial of R-HCVAD Vs R-bendamustine followed by autologous stem cell transplants for patients with mantle cell lymphoma. Proc ASH 2015; Abstract 518.
Dose-Adjusted TEDDI-R and Ibrutinib in Untreated Relapsed/Refractory Primary CNS Lymphoma
Dunleavy K et al. Phase I study of dose-adjusted-Teddi-R with ibrutinib in untreated and relapsed/refractory primary CNS lymphoma. Proc ASH 2015; Abstract 472.
Additional Abstracts of Interest in Hodgkin and Non-Hodgkin Lymphomas at ASH 2015
Johnston PB et al. Everolimus plus RCHOP-21 is safe and highly effective for new untreated diffuse large B-cell lymphoma (DLBCL): Results of the phase I trial NCCTG1085 (Alliance). Proc ASH 2015; Abstract 813.
Rule S et al. Ibrutinib vs temsirolimus: Results from a phase 3, international, randomized, open-label, multicenter study in patients with previously treated mantle cell lymphoma (MCL). Proc ASH 2015; Abstract 469.
Dreyling M et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: An international, randomised, open-label, phase 3 study. Lancet 2016;387(10020):770-8. Abstract
Fujiwara H et al. Multicenter phase II study of lenalidomide in patients with relapsed adult T-cell leukemia-lymphoma. Proc ASH 2015; Abstract 181.
Yasenchak CA et al. Brentuximab vedotin with RCHOP as frontline therapy in patients with high-intermediate/high-risk diffuse large B cell lymphoma (DLBCL): Results from an ongoing Phase 2 study. Proc ASH 2015; Abstract 814.
Issue 2
Read Dr Love’s original email (March 15, 2016)
Novel Agents and Therapeutic Options for Newly Diagnosed and Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL)
Program Description: A summary of recent data on the safety and efficacy of novel therapeutic options with targeted agents, including ibrutinib, idelalisib, venetoclax and the checkpoint inhibitor pembrolizumab, for patients with CLL and FL.
Key Abstracts of Interest in Chronic Lymphocytic Leukemia and Follicular Lymphoma at ASH 2015
Full Abstracts:
RESONATE-2 Trial of Ibrutinib in Older Patients with Untreated CLL/SLL and the Importance of Pharmacovigilance During Ibrutinib Therapy for CLL
Tedeschi A et al. Results from the international, randomized Phase 3 study of ibrutinib versus chlorambucil in patients 65 years and older with treatment-naïve CLL/SLL (RESONATE-2TM). Proc ASH 2015; Abstract 495.
Finnes HD et al. The importance of pharmacovigilance during ibrutinib therapy for chronic lymphocytic leukemia (CLL) in routine clinical practice. Proc ASH 2015; Abstract 717.
Phase I/II Study of the Bruton Tyrosine Kinase Inhibitor Acalabrutinib in Relapsed/Refractory CLL
Byrd JC et al. The Bruton tyrosine kinase (Btk) inhibitor ACP-196: Marked activity in relapsed/refractory CLL with a favorable safety profile. Proc ASH 2015; Abstract 831.
Byrd JC et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med 2016;374(4):323-32. Abstract
Idelalisib in Combination with Bendamustine/Rituximab or Ofatumumab for CLL
Zelenetz AD et al. Idelalisib plus bendamustine and rituximab (BR) is superior to BR alone in patients with relapsed/refractory chronic lymphocytic leukemia: Results of a Phase 3 randomized double-blind placebo-controlled study. Proc ASH 2015; Abstract LBA-5.
Lampson BL et al. Idelalisib given front-line for the treatment of chronic lymphocytic leukemia results in frequent and severe immune-mediated toxicities. Proc ASH 2015; Abstract 497.
Venetoclax Alone or as Combination Therapy for CLL
Stilgenbauer S et al. Venetoclax (ABT-199/GDC-0199) monotherapy induces deep remissions, including complete remission and undetectable MRD, in ultra-high risk relapsed/refractory chronic lymphocytic leukemia with 17p deletion: Results of the pivotal international Phase 2 study. Proc ASH 2015; Abstract LBA-6.
Salles GA et al. Updated safety and preliminary efficacy data from a Phase 1b study combining venetoclax (GDC-0199, ABT-199) with bendamustine/rituximab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia. Proc ASH 2015; Abstract 829.
Ma S et al. Deep and durable responses following venetoclax (ABT-199/GDC-0199) combined with rituximab in patients with relapsed/refractory chronic lymphocytic leukemia: Results from a Phase 1b study. Proc ASH 2015; Abstract 830.
Flinn IW et al. Safety and efficacy of a combination of venetoclax (GDC-0199/ABT-199) and obinutuzumab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia — Results from a Phase 1b study (GP28331). Proc ASH 2015; Abstract 494.
Subgroup Analysis of the Green Study: Obinutuzumab and Bendamustine in Patients with Untreated CLL
Stilgenbauer S et al. Safety and efficacy of obinutuzumab plus bendamustine in previously untreated patients with chronic lymphocytic leukemia: Subgroup analysis of the Green study. Proc ASH 2015; Abstract 493.
Results from a Phase II Trial of Pembrolizumab in Relapsed/Refractory CLL, Including in Patients with Richter’s Transformation
Ding W et al. PD-1 blockade with pembrolizumab (MK-3475) in relapsed/refractory CLL including Richter transformation: An early efficacy report from a Phase 2 trial (MC1485). Proc ASH 2015; Abstract 834.
Ibrutinib in Combination with Rituximab or Lenalidomide/Rituximab for Untreated FL
Fowler N et al. Ibrutinib plus rituximab in treatment-naive patients with follicular lymphoma: Results from a multicenter, Phase 2 study. Proc ASH 2015; Abstract 470.
Ujjani CS et al. Phase I study of rituximab, lenalidomide, and ibrutinib in previously untreated follicular lymphoma (Alliance 051103). Proc ASH 2015; Abstract 471.
Venetoclax Alone and in Combination with Bendamustine/Rituximab for Relapsed/Refractory NHL
Gerecitano JF et al. A Phase 1 study of venetoclax (ABT-199/GDC-0199) monotherapy in patients with relapsed/refractory non-Hodgkin lymphoma. Proc ASH 2015; Abstract 254.
de Vos S et al. A dose-escalation study of venetoclax (ABT-199/GDC-0199) in combination with bendamustine and rituximab in patients with relapsed or refractory non-Hodgkin's lymphoma. Proc ASH 2015; Abstract 255.
Issue 1
Read Dr Love’s original email (March 4, 2016)
Novel Agents and Therapeutic Options for Newly Diagnosed and Relapsed/Refractory Multiple Myeloma
Program Description: A summary of recent data on proteasome inhibitor and immunomodulatory agent combination regimens as first- or later-line therapy for newly diagnosed or relapsed/refractory multiple myeloma. The program also includes recent clinical research on investigational immunotherapies and recently approved monoclonal antibodies for the treatment of multiple myeloma. The role of autologous stem cell transplant for young patients and treatment options for special populations of patients, including those with high-risk cytogenetics, renal impairment and amyloidosis will also be discussed.
Key Abstracts of Interest in Multiple Myeloma at ASH 2015
Full Abstracts:
IFM/DFCI 2009 Trial: Role of ASCT, Implications of MRD Status and Comparison of MRI to PET-CT
Attal M et al. Autologous transplantation for multiple myeloma in the era of new drugs: A phase III study of the Intergroupe Francophone du Myelome (IFM/DFCI 2009 trial). Proc ASH 2015; Abstract 391.
Avet-Loiseau H et al. Evaluation of minimal residual disease (MRD) by next generation sequencing (NGS) is highly predictive of progression free survival in the IFM/DFCI 2009 trial. Proc ASH 2015; Abstract 191.
Moreau P et al. Prospective evaluation of MRI and PET-CT at diagnosis and before maintenance therapy in symptomatic patients with multiple myeloma included in the IFM/DFCI 2009 trial. Proc ASH 2015; Abstract 395.
Phase III SWOG-S0777 Trial of Bortezomib/Lenalidomide/Dexamethasone versus Lenalidomide/Dexamethasone for Untreated MM without Intent for Immediate ASCT
Durie B et al. Bortezomib, lenalidomide and dexamethasone vs lenalidomide and dexamethasone in patients (pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT): Results of the randomized phase III trial SWOG S0777. Proc ASH 2015; Abstract 25.
Updated Results from the Phase I/II CHAMPION-1 Study of Weekly Carfilzomib with Dexamethasone for Relapsed/Refractory MM
Berenson J et al. Weekly carfilzomib with dexamethasone for patients with relapsed or refractory multiple myeloma: Updated results from the phase 1/2 study Champion-1 (NCT01677858). Proc ASH 2015; Abstract 373.
Ixazomib in Combination with Cyclophosphamide/Dexamethasone or Lenalidomide/Dexamethasone
Dimopoulos MA et al. Randomized phase 2 study of the all-oral combination of investigational proteasome inhibitor (PI) ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) in patients (pts) with newly diagnosed multiple myeloma (NDMM) who are transplant-ineligible (NCT02046070). Proc ASH 2015; Abstract 26.
Moreau P et al. Ixazomib, an investigational oral proteasome inhibitor (PI), in combination with lenalidomide and dexamethasone (IRd), significantly extends progression-free survival (PFS) for patients (pts) with relapsed and/or refractory multiple myeloma (RRMM): The phase 3 Tourmaline-MM1 study (NCT01564537). Proc ASH 2015; Abstract 727.
Elotuzumab in Combination with Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone for Relapsed/Refractory MM
Dimopoulos MA et al. 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. Proc ASH 2015; Abstract 28.
Palumbo A et al. Elotuzumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma: 2-year follow-up. Proc ASH 2015; Abstract 510.
Daratumumab Alone or in Combination with Lenalidomide/Dexamethasone or Pomalidomide/Dexamethasone for Relapsed/Refractory MM
Usmani S et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Proc ASH 2015; Abstract 29.
Plesner T et al. Daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: Updated results of a phase 1/2 study (GEN503). Proc ASH 2015; Abstract 507.
Chari A et al. Open-label, multicenter, phase 1b study of daratumumab in combination with pomalidomide and dexamethasone in patients with at least 2 lines of prior therapy and relapsed or relapsed and refractory multiple myeloma. Proc ASH 2015; Abstract 508.
Pembrolizumab in Combination with Lenalidomide/Dexamethasone or Pomalidomide/Dexamethasone for Relapsed/Refractory MM
San Miguel J et al. Pembrolizumab in combination with lenalidomide and low-dose dexamethasone for relapsed/refractory multiple myeloma (RRMM): Keynote-023. Proc ASH 2015; Abstract 505.
Badros AZ et al. A phase II study of anti PD-1 antibody pembrolizumab, pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM). Proc ASH 2015; Abstract 506.
First-in-Human Phase I Study of B-Cell Maturation-Targeted Chimeric Antigen Receptor T Cells in Advanced MM
Ali SA et al. Remissions of multiple myeloma during a first-in-humans clinical trial of T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor. Proc ASH 2015; Abstract LBA-1.
Phase I/II Trial of Panobinostat with Lenalidomide/Bortezomib/Dexamethasone for Transplant-Eligible Patients with Newly Diagnosed MM
Shah JJ et al. Phase I/II trial of the efficacy and safety of combination therapy with lenalidomide/bortezomib/dexamethasone (RVD) and panobinostat in transplant-eligible patients with newly diagnosed multiple myeloma. Proc ASH 2015; Abstract 187.
Additional Abstracts of Interest in Multiple Myeloma at ASH 2015
Moreau P et al. Bortezomib, thalidomide and dexamethasone (VTD) is superior to bortezomib, cyclophosphamide and dexamethasone (VCD) prior to autologous stem cell transplantation for patients with de novo multiple myeloma. Results of the prospective IFM 2013-04 trial. Proc ASH 2015; Abstract 393.
Avet-Loiseau H et al. Impact of cytogenetics on outcomes of transplant-ineligible patients with newly diagnosed multiple myeloma treated with continuous lenalidomide plus low-dose dexamethasone in the FIRST (MM-020) trial. Proc ASH 2015; Abstract 730.
Avet-Loiseau H et al. Efficacy and safety of carfilzomib, lenalidomide, and dexamethasone vs lenalidomide and dexamethasone in patients with relapsed multiple myeloma based on cytogenetic risk status: Subgroup analysis from the phase 3 study Aspire (NCT01080391). Proc ASH 2015; Abstract 731.
Ramasamy K et al. Safety of treatment (Tx) with pomalidomide (POM) and low-dose dexamethasone (LoDEX) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) and renal impairment (RI), including those on dialysis. Proc ASH 2015; Abstract 374.
Cook G et al. A salvage autologous stem cell transplant (ASCT2) induces superior overall survival following bortezomib-containing re-induction therapy for relapsed multiple myeloma (MM): Results from the Myeloma X (Intensive) trial. Proc ASH 2015; Abstract 394.
Shah JJ et al. Oprozomib, pomalidomide, and dexamethasone (OPomd) in patients (pts) with relapsed and/or refractory multiple myeloma (RRMM): Initial results of a phase 1b study (NCT01999335). Proc ASH 2015; Abstract 378.
Wechalekar A et al. Oral doxycycline improves outcomes of stage III AL amyloidosis — A matched case control study. Proc ASH 2015; Abstract 732.
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