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DEVELOPMENTAL THERAPEUTICS AND TRANSLATIONAL RESEARCH Antibody-Drug Conjugates: New Horizons to Maximize Efficacy and Minimize Toxicity CHAIR Beverly A. Teicher, PhD National Cancer Institute at the National Institutes of Health Bethesda, MD SPEAKERS Francisco J. Esteva, MD, PhD NYU Langone Medical Center New York, NY Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center Indianapolis, IN
ANTIBODY-DRUG CONJUGATES AND T-DM1 What Can We Learn about Antibody-Drug Conjugates from the T-DM1 Experience? Francisco J. Esteva, MD, PhD, Kathy D. Miller, MD, and Beverly A. Teicher, PhD OVERVIEW Antibody conjugates are a diverse class of therapeutics that consist of a cytotoxic agent linked covalently to an antibody or antibody fragment directed toward a specific cell surface target expressed by tumor cells. The notion that antibodies directed toward targets on the surface of malignant cells could be used for drug delivery is not new. The history of antibody conjugates has been marked by hurdles identified and overcome. Early conjugates used mouse antibodies, drugs that either were not sufficiently potent, were immunogenic (proteins), or were too toxic, and linkers that were not sufficiently stable in circulation. Four main avenues have been explored using antibodies to target cytotoxic agents to malignant cells: antibody-protein toxin (or antibody fragment–protein toxin fusion) conjugates, antibody-chelated radionuclide conjugates, antibody-small molecule conjugates, and antibody-enzyme conjugates administered along with small molecule prodrugs that require metabolism by the conjugated enzyme to release the activated species. Technology is continuing to evolve regarding the protein and small molecule components, and it is likely that single chemical entities soon will be the norm for antibody-drug conjugates. Only antibodyradionuclide conjugates and antibody-drug conjugates have reached the regulatory approval stage, and there are more than 40 antibody conjugates in clinical trials. The time may have come for this technology to become a major contributor to improving treatment for patients with cancer. The challenges posed by the development of therapeutic antibody-drug conjugates (ADCs) are formidable. Over the past 30 years, many cell surface proteins that have selective aberrant expression on malignant cells or are aberrantly highly expressed on the surface of malignant cells have been identifıed. In many cases, specifıc antibodies that bind tightly to malignant cell surface proteins were developed. However, these antibodies often were not active antitumor agents. ADCs provide an opportunity to make use of antibodies that are specifıc to cell surface proteins. 1 Successful ADCs have improved tumor specifıcity and potency compared with traditional drugs. 2,3 Heterogeneity of antibody target expression on the tumor surface, and expression of the antigen by normal tissues, can limit the effectiveness of ADCs. For some hematologic malignancies, antigen expression is specifıc and homogeneous. Early ADCs were composed of tumor-specifıc murine monoclonal antibodies covalently linked to anticancer drugs, such as doxorubicin, vinblastine, and methotrexate. These early conjugates were evaluated in human clinical trials but had limited success because of immunogenicity, lack of potency, and insuffıcient selectivity for tumor versus normal tissue. The lessons learned from these early explorations led to improvements in all aspects of antibody conjugate therapeutics and, hence, to renewed interest in ADC technology. 4 Immunogenicity was overcome by replacing murine antibodies with humanized or fully human antibodies. Potency was improved by using drugs that were 100- to 1,000-fold more potent than previously used drugs. Selectivity was addressed by performing more careful target and antibody selection. As a result of such improvements, gemtuzumab ozogamicin (Mylotarg; Pfızer, New York, NY) was granted accelerated U.S. Food and Drug Administration (FDA) approval for the treatment of acute myelogenous leukemia in 2000, becoming the fırst commercially available ADC. However, gemtuzumab ozogamicin was withdrawn from the market in 2010 because, in postmarketing follow-up clinical trials, it failed to meet the prospective effıcacy targets. Two ADCs, trastuzumab emtansine (T-DM1, Kadcyla; Genentech/Roche, South San Francisco, CA) and brentuximab vedotin (SGN-35; Adcetris, Seattle Genetics, Seattle, WA; Millennium/Takeda, Boston, MA), reached FDA approval in 2014 and 2011, respectively, for treatment of metastatic breast cancer and refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma, respectively. More than 40 ADCs are in clinical trials (Table 1). From the Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; National Cancer Institute at the National Institutes of Health, Bethesda, MD. Disclosures of potential conflicts of interest are found at the end of this article. Corresponding author: Beverly A. Teicher, PhD, Molecular Pharmacology Branch, National Cancer Institute, 9609 Medical Center Dr., Room 4-W602, MSC 9735, Bethesda, MD 20892; email: beverly.teicher@nih.gov. © 2015 by American Society of Clinical Oncology. asco.org/edbook | 2015 ASCO EDUCATIONAL BOOK e117
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AMERICAN SOCIETY OF CLINICAL ONCOLO
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American Society of Clinical Oncolo
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Controversies in Neoadjuvant Therap
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Clinical Trials of Precision Medici
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Managing Ovarian Cancer in the Olde
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Updates in the Multimodality Manage
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PEDIATRIC ONCOLOGY Real-Time Molecu
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2015 ASCO Annual Meeting Disclosure
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2015 Educational Book Expert Panel
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James Marshall, PhD Roswell Park Ca
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2015 Annual Meeting Supporters* MIS
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David Yurman Corporate Allies Conqu
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INVITED ARTICLES This year’s invi
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WONG, CAPASSO, AND ECKHARDT terize
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STEPHEN T. SONIS portantly, patient
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INVITED ARTICLES HEAD AND NECK CANC
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GROSS AND COHEN treatments are poor
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GILBERT ET AL tional scholars, lead
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ENG ET AL colorectal cancer. Indeed
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WILLIAM M. SIKOV gational treatment
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BREAST CANCER Individualizing the A
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CAN DIET AND LIFESTYLE PREVENT BREA
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ZARDAVAS AND PICCART-GEBHART TABLE
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MICHAEL A. POSTOW Managing Immune C
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MICHAEL A. POSTOW diarrhea symptoms
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MICHAEL A. POSTOW nitis during ipil
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PRECISION THERAPY FOR RECTAL CANCER
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PRECISION THERAPY FOR RECTAL CANCER
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CERCEK, CUSACK, AND RYAN Treatment
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GASTROINTESTINAL (NONCOLORECTAL) CA
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ABOU-ALFA ET AL sess liver function
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ABOU-ALFA ET AL HCC (Anti-Programme
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AHN ET AL Making Sense of Current a
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AHN ET AL Pancreatic cancer has bee
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AHN ET AL Disclosures of Potential
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EGIDIO DEL FABBRO tion of precachex
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EGIDIO DEL FABBRO FIGURE 3. Mechani
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EGIDIO DEL FABBRO II RCT of ghrelin
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THE SPECTRUM OF NEUROENDOCRINE TUMO
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STAGE I TESTICULAR GERM CELL CANCER
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STAGE I TESTICULAR GERM CELL CANCER
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GERM CELL TUMORS: LOOKING TO THE FU
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SALVAGE CHEMOTHERAPY Salvage Therap
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SALVAGE CHEMOTHERAPY References 1.
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EARLY CHEMOTHERAPY IN MEN WITH META
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RADIUM 223 AND METASTATIC CASTRATIO
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RADIUM 223 AND METASTATIC CASTRATIO
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IMMUNOTHERAPY FOR PROSTATE TUMORS I
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IMMUNOTHERAPY FOR PROSTATE TUMORS a
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EVOLVING IMMUNOTHERAPY STRATEGIES I
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NOVEL IMMUNOTHERAPY AGENTS IN METAS
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PROMISING STRATEGIES IN BLADDER CAN
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GYNECOLOGIC CANCER Cervical Cancer
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MACKAY, WENZEL, AND MILESHKIN In th
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MACKAY, WENZEL, AND MILESHKIN 59. F
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GYNECOLOGIC CANCER Managing Ovarian
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DUSKA, TEW, AND MOORE KEY POINTS A
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DUSKA, TEW, AND MOORE 10. Griffıth
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GYNECOLOGIC CANCER Treatment of the
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CHEMOTHERAPY FOR PATIENTS WITH BMOC
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PROGRESS IN HEAD AND NECK SQUAMOUS
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HEAD AND NECK CANCER PI3-Kinase: Ge
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ISAACSSON VELHO, CASTRO JR, AND CHU
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SHARON H. GIORDANO Comparative Effe
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HEALTH SERVICES RESEARCH AND QUALIT
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INDUSTRY AND ONCOLOGY KEY POINTS F
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INDUSTRY AND ONCOLOGY has been “l
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INDUSTRY AND ONCOLOGY by (covered)
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INDUSTRY AND ONCOLOGY 42. World Hea
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CANCER CARE QUALITY: CURRENT STATE
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MANAGING OLDER PATIENTS WITH ALL Th
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MANAGING OLDER PATIENTS WITH ALL TA
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MANAGING OLDER PATIENTS WITH ALL FI
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MANAGING OLDER PATIENTS WITH ALL FI
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MANAGING OLDER PATIENTS WITH ALL ra
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TREATMENT OF PHILADELPHIA CHROMOSOM
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CD19 CAR THERAPY FOR ALL FIGURE 1.
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CD19 CAR THERAPY FOR ALL 5. Zhou G,
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NEW TARGETED THERAPIES FOR iNHL New
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NEW TARGETED THERAPIES FOR iNHL TAB
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HEMATOPOIETIC CELL TRANSPLANTATION
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LEUKEMIA, MYELODYSPLASIA, AND TRANS
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MICHAEL W. DEININGER TABLE 1. Defin
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MICHAEL W. DEININGER broad range ef
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MICHAEL W. DEININGER 30. Hughes T,
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PEMMARAJU AND MOLITERNO TABLE 1. Ac
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PEMMARAJU AND MOLITERNO drome (BCS)
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PEMMARAJU AND MOLITERNO 13. Xing S,
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THERAPIES AND INDICATIONS FOR PH-NE
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BEYOND SECOND-LINE TREATMENT FOR LU
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BEYOND SECOND-LINE TREATMENT FOR LU
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GERBER, PAIK, AND DOWLATI a tumor t
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GERBER, PAIK, AND DOWLATI squamous
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GERBER, PAIK, AND DOWLATI FIGURE 2.
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GERBER, PAIK, AND DOWLATI gression
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GERBER, PAIK, AND DOWLATI Disclosur
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GERBER, PAIK, AND DOWLATI receptor
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BERNARDO H.L. GOULART The Value of
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BERNARDO H.L. GOULART every 6 month
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BERNARDO H.L. GOULART lung-cancer/l
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LUNG CANCER Updates in the Multimod
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WOODARD AND JABLONS section, becaus
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NASSER HANNA Current Standards and
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NASSER HANNA At the 2014 ASCO Annua
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NASSER HANNA culty of this task. Va
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LYMPHOMA AND PLASMA CELL DISORDERS
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NOWAKOWSKI AND CZUCZMAN sociated wi
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DAVID W. SCOTT Cell-of-Origin in Di
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DAVID W. SCOTT FIGURE 2. Immunohist
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DAVID W. SCOTT FIGURE 3. The Lymph2
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DAVID W. SCOTT 10. Shaffer AL 3rd,
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CHEAH, OKI, AND FANALE Novel Treatm
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CHEAH, OKI, AND FANALE TABLE 3. Sel
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STEPHEN ANSELL Disclosures of Poten
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MATEOS AND SAN MIGUEL Smoldering Mu
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MATEOS AND SAN MIGUEL TABLE 2. Risk
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MOREAU AND TOUZEAU Multiple Myeloma
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LYMPHOMA AND PLASMA CELL DISORDERS
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MANAGEMENT OF CLL Up-Front Manageme
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MANAGEMENT OF CLL than 17p-/TP53mut
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MANAGEMENT OF CLL could be associat
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MANAGEMENT OF CLL tion by nonmalign
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MANAGEMENT OF CLL lymphocytic leuke
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PROGNOSTIC FACTORS AND ADJUVANT RAD
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MERKEL CELL CARCINOMA Merkel Cell C
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MERKEL CELL CARCINOMA tions in PIK3
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MERKEL CELL CARCINOMA treating MCC
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MERKEL CELL CARCINOMA 32. Leonard J
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MELANOMA/SKIN CANCERS Locoregional
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PERFUSION AND INFUSION IN THE ERA O
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NEOADJUVANT THERAPY OF MELANOMA Neo
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NEOADJUVANT THERAPY OF MELANOMA ity
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NEOADJUVANT THERAPY OF MELANOMA 4.
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MELANOMA/SKIN CANCERS Targeted Mole
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SULLIVAN ET AL FIGURE 1. Relevant S
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SULLIVAN ET AL Resistance to BRAF i
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SULLIVAN ET AL TABLE 1. Clinical Tr
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SULLIVAN ET AL 17. Halait H, Demart
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SULLIVAN ET AL NRAS-mutant melanoma
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KLEPIN, RODIN, AND HURRIA Treating
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KLEPIN, RODIN, AND HURRIA plication
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KLEPIN, RODIN, AND HURRIA plan was
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KLEPIN, RODIN, AND HURRIA patient-s
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KLEPIN, RODIN, AND HURRIA 62. Blanc
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PERIPHERAL NEUROTOXICITY IN CANCER
Page 766 and 767:
Page 768 and 769:
Page 770 and 771:
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PARTRIDGE, JACOBSEN, AND ANDERSEN C
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PARTRIDGE, JACOBSEN, AND ANDERSEN c
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PARTRIDGE, JACOBSEN, AND ANDERSEN w
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PARTRIDGE, JACOBSEN, AND ANDERSEN v
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LESLIE R. SCHOVER Sexual Healing in
Page 782 and 783:
LESLIE R. SCHOVER tinuous ADT in pr
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LESLIE R. SCHOVER 12. Potosky AL, H
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CATHERINE H. VAN POZNAK TABLE 1. Wo
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CATHERINE H. VAN POZNAK (tamoxifen,
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CATHERINE H. VAN POZNAK TABLE 3. FD
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CATHERINE H. VAN POZNAK premenopaus
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SHARI GOLDFARB KEY POINTS Brea
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SHARI GOLDFARB and friction with va
Page 798 and 799:
SHARI GOLDFARB importance both duri
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PATIENT AND SURVIVOR CARE Moving Su
Page 802 and 803:
MAYER ET AL TABLE 1. Quality Metric
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MAYER ET AL to enhance the quality
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MAYER ET AL FIGURE 2. (A) Infertili
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MAYER ET AL efıcial suggests that
Page 810 and 811:
PATIENT AND SURVIVOR CARE The Chall
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BRUERA AND PAICE Choice of Opioid a
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BRUERA AND PAICE toxicity and proce
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BRUERA AND PAICE effective. Basic s
Page 818 and 819:
PEDIATRIC ONCOLOGY Real-Time Molecu
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CARROLL, RAETZ, AND MEYER KEY POINT
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CARROLL, RAETZ, AND MEYER most are
Page 824 and 825:
CARROLL, RAETZ, AND MEYER markers a
Page 826 and 827:
PEDIATRIC ONCOLOGY Translating Surv
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REDUCING THE BURDEN OF LATE EFFECTS
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Page 832 and 833:
Page 834 and 835:
Page 836 and 837:
PROFESSIONAL DEVELOPMENT The Challe
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ADVANCES IN WEBSITE INFORMATION RES
Page 840 and 841:
Page 842 and 843:
Page 844 and 845:
Page 846 and 847:
COMMUNICATION AND TECHNOLOGY: IT’
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Page 850 and 851:
Page 852 and 853:
PATIENT-REPORTED OUTCOMES IN ONCOLO
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PATIENT-REPORTED OUTCOMES IN ONCOLO
Page 856 and 857:
PROFESSIONAL DEVELOPMENT Trends, An
Page 858 and 859:
CLINICAL ONCOLOGY PRACTICE 2015 FIG
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CLINICAL ONCOLOGY PRACTICE 2015 (6.
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CLINICAL ONCOLOGY PRACTICE 2015 Pro
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ADJUVANT/NEOADJUVANT MEDICAL THERAP
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Page 868 and 869:
Page 870 and 871:
INDICATIONS FOR ADJUVANT RADIATION
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Page 874 and 875:
Page 876 and 877:
Page 878 and 879:
SARCOMA Latest Advances in Systemic
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SYSTEMIC THERAPY FOR OSTEOSARCOMA A
Page 882 and 883:
SYSTEMIC THERAPY FOR OSTEOSARCOMA A
Page 884 and 885:
RETHINKING TREATMENT FOR CHONDROSAR
Page 886 and 887:
Page 888 and 889:
Page 890 and 891:
Page 892 and 893:
BONE SARCOMAS IN ADULTS local disea
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BONE SARCOMAS IN ADULTS structure a
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SARCOMA Well-Differentiated and Ded
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ABBAS MANJI ET AL ticular region. 7
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ABBAS MANJI ET AL MYXOID (ROUND CEL
Page 902 and 903:
ABBAS MANJI ET AL versus doxorubici
Page 904 and 905:
SHLUSH AND HERSHKOVITZ Clonal Evolu
Page 906 and 907:
SHLUSH AND HERSHKOVITZ FIGURE 1. Ti
Page 908 and 909:
TUMOR BIOLOGY New Strategies to Und
Page 910 and 911:
KNAPP, DHAWAN, AND OSTRANDER in dog
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KNAPP, DHAWAN, AND OSTRANDER TABLE
Page 914 and 915:
KNAPP, DHAWAN, AND OSTRANDER 14. Fe
Page 916 and 917:
SOURBIER, SRINIVASAN, AND LINEHAN M
Page 918 and 919:
SOURBIER, SRINIVASAN, AND LINEHAN F
Page 920 and 921:
SOURBIER, SRINIVASAN, AND LINEHAN T
Page 922:
Author Index Abbas Manji, Gulam ...
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