Expert Analysis

CME

Key Studies in Lymphomas: CCO Independent Conference Highlights of the 2020 Virtual ASH Annual Meeting

Physicians: Maximum of 1.00 AMA PRA Category 1 Credit

Released: February 26, 2021

Expiration: February 25, 2022

John M. Burke
John M. Burke, MD
Jeffrey P. Sharman
Jeffrey P. Sharman, MD

Activity

Progress
1
Course Completed

  1. Mato AR, Pagel JM, Coombs CC, et al. LOXO-305, a next generation, highly selective, non-covalent BTK inhibitor in previously treated CLL/SLL: results from the phase 1/2 BRUIN study. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 542.
  2. Mato A, Flinn I, Pagel J, et al. Results from a first-in-human, proof-of-concept phase 1 trial in pretreated B-cell malignancies for Loxo-305, a next-generation, highly selective, non-covalent BTK inhibitor. Program and abstracts of the 2019 American Society of Hematology Annual Meeting; December 7-10, 2019. Orlando, Florida. Abstract 501.
  3. ClinicalTrials.gov. A phase 3 open-label, randomized study of LOXO-305 versus investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab in BTK inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (BRUIN CLL-321). Available at: https://clinicaltrials.gov/ct2/show/NCT04666038. Accessed February 18, 2021.
  4. Gribben JH, Jurczak W, Jacobs R, et al. 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. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 543.
  5. Wierda WG, Tam CS, Allan JN, et al. 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. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 123.
  6. Siddiqi T, Soumerai J, Dorritie K, et al. 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. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 546.
  7. Wierda WG, Dorritie KA, Munoz J, et al. Transcend CLL 004: phase 1 cohort of lisocabtagene maraleucel (liso-cel) in combination with ibrutinib for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 544.
  8. Shin N, Stubbs M, Koblish H, et al. Parsaclisib is a next-generation phosphoinositide 3-kinase δ inhibitor with reduced hepatotoxicity and potent antitumor and immunomodulatory activities in models of B-cell malignancy. J Pharmacol Exp Ther. 2020;374:211.
  9. Forero-Torres A, Ramchandren R, Yacoub A, et al. Parsaclisib, a potent and highly selective PI3Kδ inhibitor, in patients with relapsed or refractory B-cell malignancies. Blood. 2019;133:1742-1752.
  10. Phillips TJ, Corradini P, Gurion R, et al. Phase 2 study evaluating the efficacy and safety of parsaclisib in patients with relapsed or refractory marginal zone lymphoma (CITADEL-204). Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 338.
  11. Zinzani PL, Samaniego F, Jurczak W, et al. Umbralisib, the once daily dual inhibitor of PI3Kδ and casein kinase-1ε demonstrates clinical activity in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results from the phase 2 Global Unity-NHL Trial 2020. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 2934.
  12. Fowler NH, Samaniego F, Jurczak W, et al. Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: a multicenter, open-label, registration directed phase II study. Program and abstracts of the 2019 American Association for Cancer Research Annual Meeting; March 29 - April 3, 2019; Atlanta, Georgia. Abstract 132.
  13. Burris HA 3rd, Flinn IW, Patel MR, et al. Umbralisib, a novel PI3Kδ and casein kinase-1ε inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018;19:486-496.
  14. Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: a phase II study of duvelisib (IPI-145) in patients with refractory indolent non-Hodgkin lymphoma. J Clin Oncol. 2019;37:912-922.
  15. Ibrutinib [package insert]. Horsham, PA/Sunnyvale, CA: Janssen Biotech, Inc/Pharmacyclics LLC; 2020.
  16. Assouline SE, Kim WS, Sehn LH, et al. Mosunetuzumab shows promising efficacy in patients with multiply relapsed follicular lymphoma: updated clinical experience from a phase I dose-escalation trial. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 702.
  17. ClinicalTrials.gov. Phase III randomized, open-label, multicenter study evaluating efficacy and safety of mosunetuzumab in combination with lenalidomide in comparison to rituximab in combination with lenalidomide in patients with follicular lymphoma after at least one line of systemic therapy. Available at: https://clinicaltrials.gov/ct2/show/NCT04712097. Accessed February 18, 2021.
  18. Jacobson C, Chavez JC, Sehgal AR, et al. Primary analysis of Zuma-5: a phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL). Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 700.
  19. Bacac M, Colombetti S, Herter S, et al. CD20-TCB with obinutuzumab pretreatment as next-generation treatment of hematologic malignancies. Clin Cancer Res. 2018;24:4785-4797.
  20. Morschhauser F, Carlo-Stella C, Offner F, et al. Dual CD20-targeted therapy with concurrent CD20-TCB and obinutuzumab shows highly promising clinical activity and manageable safety in relapsed or refractory B-cell non-Hodgkin lymphoma: preliminary results from a phase Ib trial. Program and abstracts of the 2019 American Society of Hematology Annual Meeting; December 7-10, 2019. Orlando, Florida. Abstract 1584.
  21. Hutchings M, Iacoboni G, Morschhauser F, et al. CD20-Tcb (RG6026), a novel “2:1” format T-cell-engaging bispecific antibody, induces complete remissions in relapsed/refractory B-cell non-Hodgkin’s lymphoma: preliminary results from a phase I first in human trial. Program and abstracts of the 2018 American Society of Hematology Annual Meeting; December 1-4, 2018; San Diego, California. Abstract 226.
  22. Hutchings M, Carlo-Stella C, Bachy E, et al. Glofitamab step-up dosing induces high response rates in patients with hard-to-treat refractory or relapsed non-Hodgkin lymphoma. Program and abstracts of the 2020 American Society of Hematology; December 5-8, 2020. Abstract 403.
  23. Dickinson M, Morschhauser F, Iacoboni G, et al. CD20-TCB in relapsed or refractory non-Hodgkin lymphoma: durable complete responses and manageable safety observed at clinically relevant doses in phase i dose escalation. Program and abstracts of the 2020 European Hematology Association Annual Meeting; June 11-21, 2020. Abstract S241.
  24. Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EbioMedicine. 2020;52:102625.
  25. Chiu C, Hiemstra IH, Johnson P, et al. Evaluation of pharmacodynamic biomarkers of epcoritamab (gen3013; cd3xcd20): results from a phase 1/2 dose-escalation study in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Program and abstracts of the 2020 European Hematology Association Annual Meeting; June 11-21, 2020. Abstract EP1330.
  26. Hutchings M, Mous R, Clausen MR, et al. Subcutaneous epcoritamab induces complete responses with an encouraging safety profile across relapsed/refractory B-cell non-Hodgkin lymphoma subtypes, including patients with prior CAR-T therapy: updated dose escalation data. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 402.
  27. Moskowitz AJ, Shah G, Shoder H, et al. Phase II study of pembrolizumab plus GVD as second-line therapy for relapsed or refractory classical Hodgkin lymphoma. Program and abstracts of the 2020 American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 402.
  28. ClinicalTrials.gov. A phase III, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of polatuzumab vedotin in combination with rituximab and CHP (R-CHP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with diffuse large B-cell lymphoma. Available at: https://clinicaltrials.gov/ct2/show/NCT03274492. Accessed February 18, 2021.
  29. ClinicalTrials.gov. A randomized, open-label, phase 3 study of the combination of ibrutinib plus venetoclax versus chlorambucil plus obinutuzumab for the first-line treatment of subjects with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Available at: https://clinicaltrials.gov/ct2/show/NCT03462719. Accessed February 18, 2021.
  30. ClinicalTrials.gov. A phase 3 multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinutuzumab (GA101) plus venetoclax (GVe) versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation. Available at: https://clinicaltrials.gov/ct2/show/NCT02950051. Accessed February 18, 2021.
  31. ClinicalTrials.gov. A randomized, multicenter, open-label, non-inferiority, phase III study of acalabrutinib (ACP-196) versus ibrutinib in previously treated subjects with high risk chronic lymphocytic leukemia. Available at: https://clinicaltrials.gov/ct2/show/NCT02477696. Accessed February 18, 2021.