Highlights in Chronic Lymphocytic Leukemia from the 2019 American Society of Clinical Oncology Annual Meeting
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July 2019 Volume 17, Issue 7, Supplement 11 A SPECIAL MEETING REVIEW EDITION Highlights in Chronic Lymphocytic Leukemia From the 2019 American Society of Clinical Oncology Annual Meeting A Review of Selected Presentations From the 2019 ASCO Annual Meeting • May 31-June 4, 2019 • Chicago, Illinois Special Reporting on: • Final Analysis From RESONATE: Six-Year Follow-Up in Patients With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma on Ibrutinib • Acalabrutinib With Obinutuzumab in Treatment-Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia: Three-Year Follow-Up • Long-Term Follow-Up of Previously Untreated Patients With Chronic Lymphocytic Leukemia Treated With Ofatumumab and Chlorambucil: Final Analysis of the Phase 3 COMPLEMENT 1 Trial • TRANSCEND CLL 004: Minimal Residual Disease Negative Responses After Lisocabtagene Maraleucel (JCAR017), a CD19-Directed CAR T-Cell Product, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma • Phase 1/2 Trial of Cirmtuzumab and Ibrutinib: Planned Analysis of Phase 1 CLL Cohorts • Effect of Fixed-Duration Venetoclax Plus Obinutuzumab on Progression-Free Survival, and Rates and Duration of Minimal Residual Disease Negativity in Previously Untreated Patients With Chronic Lymphocytic Leukemia and Comorbidities • Effect of Dose Modifications on Response to Duvelisib in Patients With Relapsed/Refractory CLL/SLL in the DUO Trial • Phase 2 Study of Acalabrutinib in Ibrutinib-Intolerant Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia • Outcomes in Chronic Lymphocytic Leukemia Patients With NOTCH1 Signaling Pathway Mutations PLUS Meeting Abstract Summaries With Expert Commentary by: Susan M. O’Brien, MD Associate Director for Clinical Sciences, Chao Family Comprehensive Cancer Center Medical Director, Sue and Ralph Stern Center for Clinical Trials & Research Professor of Medicine, Division of Hematology/Oncology, Department of Medicine University of California, Irvine Orange, California ON THE WEB: hematologyandoncology.net Indexed through the National Library of Medicine (PubMed/MEDLINE), PubMed Central (PMC), and EMBASE EDITORIAL ADVISORY BOARD Lee Schwartzberg, MD Andre Goy, MD John O. Mascarenhas, MD Editors-in-Chief The West Clinic Hackensack University Mount Sinai Medical Center Medical Center Richard R. Furman, MD George W. Sledge Jr, MD Ruben A. Mesa, MD Weill Cornell Medicine Stanford University Steven M. Horwitz, MD UT Health San Antonio New York Presbyterian Memorial Sloan Kettering Cancer Center Hospital COLORECTAL CANCER Cancer Center Edward Chu, MD Srdan Verstovsek, MD, PhD Daniel J. George, MD Brad S. Kahl, MD The University of Texas Duke University Medical Center UPMC Hillman Cancer Center University of Pittsburgh Washington University MD Anderson Cancer Center School of Medicine Section Editors John L. Marshall, MD NEUTROPENIA John P. Leonard, MD Georgetown University Hospital David C. Dale, MD Melanoma in Focus Weill Cornell Medicine New York Presbyterian Hospital University of Washington Sanjiv S. Agarwala, MD Mohamed E. Salem, MD St Luke’s Cancer Center and Carolinas Medical Center Craig H. Moskowitz, MD OVARIAN CANCER Temple University Leonard Saltz, MD University of Miami Maurie Markman, MD Sylvester Comprehensive Cancer Cancer Treatment Centers Prostate Cancer in Focus Memorial Sloan Kettering Cancer Center Center of America Andrew J. Armstrong, MD Duke University Medical Center MELANOMA ENDOCRINE CANCER PANCREATIC CANCER John M. Kirkwood, MD Ovarian Cancer in Focus Alexandria Phan, MD Margaret Tempero, MD University of Pittsburgh University of California, Robert L. Coleman, MD UT Health North Campus Tyler Cancer Institute San Francisco Comprehensive The University of Texas MD Anderson Cancer Center Cancer Center MD Anderson Cancer Center MULTIPLE MYELOMA HEAD AND NECK CANCER Kenneth C. Anderson, MD Colorectal Cancer in Focus Marshall R. Posner, MD PEDIATRIC HEM/ONC Dana-Farber Cancer Axel Grothey, MD Mount Sinai Medical Center Mitchell S. Cairo, MD Institute West Cancer Center New York Medical College University of Tennessee KIDNEY CANCER James R. Berenson, MD PROSTATE CANCER Robert A. Figlin, MD Institute for Myeloma Hematology Cedars-Sinai Comprehensive & Bone Cancer Research David B. Agus, MD Craig M. Kessler, MD Cancer Center University of Southern California Georgetown University Sundar Jagannath, MD Keck School of Medicine Medical School Brian I. Rini, MD Mount Sinai Medical Center Lombardi Comprehensive Cleveland Clinic Taussig Michael A. Carducci, MD Cancer Center Cancer Institute Paul G. Richardson, MD The Sidney Kimmel Harvard Medical School Comprehensive Cancer Center Hematologic Malignancies LEUKEMIA Dana-Farber Cancer at Johns Hopkins Susan O’Brien, MD Jan A. Burger, MD, PhD Institute University of California, Irvine The University of Texas SARCOMAS/GISTs MD Anderson Cancer Center MYELOPROLIFERATIVE George D. Demetri, MD Drug Development NEOPLASMS Dana-Farber Cancer Institute Mark J. Ratain, MD Elihu H. Estey, MD Claire Harrison, MD, FRCP Harvard Medical School The University of Chicago Fred Hutchinson Cancer Center Guy’s and St Thomas’ Hospital Breast Cancer in Focus Elias Jabbour, MD Hope S. Rugo, MD The University of Texas UCSF Helen Diller Family MD Anderson Cancer Center Comprehensive Cancer Center Hagop M. Kantarjian, MD Lung Cancer in Focus The University of Texas Mark A. Socinski, MD MD Anderson Cancer Center Florida Hospital Neil E. Kay, MD Founding Editor Mayo Clinic, Rochester Bruce D. Cheson, MD CEO and Copublisher Georgetown University Hospital LUNG CANCER Lombardi Comprehensive Jeffrey Crawford, MD Steven H. Kurlander Cancer Center Duke University Medical Center President and Copublisher David S. Ettinger, MD Paul H. McDaniel The Sidney Kimmel aHUS, TTP Comprehensive Cancer Center Editorial Director at Johns Hopkins Jeffrey C. Laurence, MD Devon Schuyler Weill Cornell Medicine Richard J. Gralla, MD New York Presbyterian Albert Einstein College of Medicine Contributing Editor Hospital Jacquelyn Matos Roy S. Herbst, MD, PhD BREAST CANCER Yale Cancer Center Howard A. Burris III, MD Art Director The Sarah Cannon David H. Johnson, MD Vanessa Ray Cancer Center University of Texas Southwestern Medical Center William Gradishar, MD Indexed in PubMed/MEDLINE and EMBASE Northwestern University Corey J. Langer, MD, FACP University of Pennsylvania Kathy D. Miller, MD Hematology-Oncology Division Postmaster: Please send address changes (form 3579) to Clinical Indiana University Advances in Hematology & Oncology c/o DMD, 10255 West School of Medicine LYMPHOMA Higgins Road, Suite 280, Rosemont, IL 60018. Ruth O’Regan, MD George P. Canellos, MD ISSN: 1543-0790 University of Wisconsin Dana-Farber Cancer Institute Carbone Cancer Center Harvard Medical School ho0719_EABsingle.indd 365 6/19/19 12:15 PM B:8.375" T:8.125" S:7.625" A National Comprehensive Cancer Network® (NCCN®) Recommendation IBRUTINIB (IMBRUVICA®) IS THE ONLY NCCN CATEGORY 1 PREFERRED REGIMEN B:11.125" S:10.375" IN FIRST-LINE T:10.875" CLL/SLL* *As monotherapy for CLL/SLL without del 17p/TP53 mutation. Category 1: Based on high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Preferred intervention: Interventions that are based on superior effi cacy, safety, and evidence; and, when appropriate, affordability. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.5.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed May 23, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. INDICATIONS IMBRUVICA® (ibrutinib) is a kinase inhibitor indicated for the treatment of patients with: • Chronic lymphocytic leukemia (CLL)/ Small lymphocytic lymphoma (SLL) • CLL/SLL with 17p deletion IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) have occurred in 3% of patients, with fatalities occurring in 0.3% of 1,124 patients exposed to IMBRUVICA® in clinical trials. Bleeding events of any grade, including bruising and petechiae, occurred in 44% of patients treated with IMBRUVICA®. The mechanism for the bleeding events is not well understood. Please see additional Important Safety Information and Brief Summary on the following pages. Colors: Date: June 12, 2019 2:22 PM Brand: IMBRUVICA® CMYK File Name: PRC-05486a_829794_v1a Size: 8.125" x 10.875" – Page 1 - Right Hand Start Customer Code: PRC-05486a Description: IBRUTINIB (IMBRUVICA®) IS the ONLY NCCN category 1 ... Pub: Clinical Advances in Hematology and Oncology - supplement We Are Alexander #: 829794 (7/1/19 issue) B:8.375" T:8.125" S:7.625" IBRUTINIB (IMBRUVICA®) Is the Only NCCN Category 1 Preferred Regimen* *As monotherapy for CLL/SLL without del 17p/TP53 mutation. Suggested treatment regimens for first-line therapy in CLL/SLL without del 17p/TP53 mutation Other recommended regimens† Preferred regimens (alphabetical by category) ‡ Frail patients Ibrutinib • Bendamustine + an anti-CD20 monoclonal antibody (category 2A) with significant (IMBRUVICA®)