The Multiple Myeloma Research Foundation Webinar Series Improving the Overall Understanding of Immunotherapy in Multiple Myeloma

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1 Improving the Overall Understanding of Immunotherapy in Multiple Myeloma Webinar 1, August 13, 2015 Antibodies: The Body s Foot Soldiers in the Battle Against Disease Speakers Moderator: Joseph Mikhael, MD, FACP Mayo Clinic Scottsdale, Arizona Faculty: Don Benson, Jr., MD, PhD The Ohio State University Columbus, Ohio Sagar Lonial, MD, FACP Winship Cancer Institute of Emory University Atlanta, Georgia Antibodies: The Body s Foot Soldiers in the Battle Against Disease 1

2 The Four Pillars of Cancer Therapy Surgery Radiation therapy Chemotherapy Immunotherapy Monoclonal antibodies Vaccines Adoptive cell transfer Checkpoint inhibitors Immune System Basics Antibodies: The Body s Foot Soldiers in the Battle Against Disease 2

3 How The Immune System Works Defends you against various germs or foreign invaders that cause infection, illness, or disease Bacteria Viruses Fungi Parasites How Does the Body Fight Against Foreign Invaders? Immunity Innate (natural) Defender components are always ready to defend you Your first line of defense against invaders that get into your body Adaptive (acquired or specific) The invader awakens your immune cells to mount their defense Can have a longlasting effect against future invaders Antibodies: The Body s Foot Soldiers in the Battle Against Disease 3

4 Your Defense Team Line Up NK Cells Macrophages Dendritic Cells T Cells B Cells Innate Adaptive NK, natural killer. Immunotherapy Directing the immune system to fight cancer Antibodies: The Body s Foot Soldiers in the Battle Against Disease 4

5 Cancer Immunotherapies Already Available Checkpoint Inhibitors mabs Vaccine mabs 1990s 2000s mabs are used in a variety of solid and heme tumors eg, rituximab (Rituxan), trastuzumab (Herceptin), alemtuzumab (Campath) Vaccines are being used in prostate cancer eg, sipuleucel-t (Provenge) Checkpoint inhibitors are being used in melanoma eg, ipilimumab (Yervoy) mabs, monoclonal antibodies. Harnessing the Immune System to Fight Myeloma Types of Immunotherapy Monoclonal Antibodies Vaccines Chimeric Antigen Receptor (CAR) T Cells Antigen CDC C1q MAC Direct effects Monoclonal antibody ADCC Fc receptor Myeloma cell Lysis NK cell 1. Extract WBCs from patient 3. Infuse MM-targeted cells back to patient 2. Modify and expand cells in lab Cell death Webinar 1 Webinar 2 Webinar 3 Antibodies: The Body s Foot Soldiers in the Battle Against Disease 5

6 Monoclonal Antibodies Types of Monoclonal Antibodies Naked Nothing is attached Drugconjugates A toxin or radioactive isotope is attached Antibodies: The Body s Foot Soldiers in the Battle Against Disease 6

7 Monoclonal Antibody Therapy What is it? It is an injection of antibodies that can directly bind to the surface of a myeloma cell How does it work against myeloma? After the antibodies bind to myeloma cells they kill them by different mechanisms Monoclonal Antibodies Can Kill Myeloma Cells in Multiple Ways DIRECT EFFECT INDIRECT EFFECTS Interferes with survival or delivers myelomakilling substances Labels myeloma cells for killing by complement Labels myeloma cells for killing by NK cells Activates T cells by Taking the Brakes Off Monoclonal antibody Myeloma cell surface target NK cell toxins Checkpoint inhibitor Complement Fc receptor Antibodies: The Body s Foot Soldiers in the Battle Against Disease 7

8 Elotuzumab Elotuzumab Works in Two Ways A naked monoclonal antibody Binds to the cell surface molecule SLAMF7 Can kill myeloma cells in 2 ways 1. Activates NK cells directly 2. Marks myeloma cells for death by NK cells 1 2 NK cell Elotuzumab SLAMF7 MM SLAMF7 Myeloma cell death Antibodies: The Body s Foot Soldiers in the Battle Against Disease 8

9 Elotuzumab Farthest along in clinical development When used alone it is well tolerated, with mostly stable disease responses When combined with the immunomodulatory drug Revlimid there was a more robust response Phase 3 Trial of Elotuzumab ELOQUENT-2 Relapsed/Refractory Myeloma Patients n = 321 n = 325 R ELO + Rev + Dex Rev + Dex Compared to Revlimid and dexamethasone alone, the addition of elotuzumab significantly increased: Progression-free survival Overall response rates The triple combination resulted in a 30% reduction in the risk of disease progression or death Another phase 3 trial comparing the same combinations is underway in patients with newly diagnosed disease Lonial S. et al. N Engl J Med. 2015; Jun 2 [Epub ahead of print]. Antibodies: The Body s Foot Soldiers in the Battle Against Disease 9

10 Other Monoclonal Antibodies Anti-CD38 Monoclonal Antibodies Daratumumab Isatuximab (formerly SAR650984) These agents are highly active when used alone In patients with relapsed and refractory disease who had been treated previously with multiple therapies, when combined with Revlimid and dexamethasone Favorable safety profiles Promising activity Antibodies: The Body s Foot Soldiers in the Battle Against Disease 10

11 Daratumumab The most clinically advanced of the anti-cd38 monoclonal antibodies A phase 2 study in patients who had already received multiple lines of therapy showed: The majority of patients had reduction in their paraprotein levels compared to their baseline levels Between 21% and 29% overall response rates were observed even in patients who were refractory to: Kyprolis (carfilzomib) Pomalyst (pomalidomide) Velcade (bortezomib) + Revlimid (lenalidomide) Or all 4 agents Summary of Monoclonal Antibody Treatment of Myeloma Each Combined With Revlimid (lenalidomide) + Dexamethasone No. of Patients Studied Data from ASH 2014 reports Overall Response Rate* Target Monoclonal Antibody Progression- Free Survival SLAMF7 Elotuzumab 73 84% 28 months CD38 Daratumumab 32 87% Too early CD38 Isatuximab 31 58% 6.2 months *Patients who achieve a partial response or better Antibodies: The Body s Foot Soldiers in the Battle Against Disease 11

12 Monoclonal Antibodies and Their Targets in MM MM-directed Cell Surface Target CD38 CD40 CD56 CD74 CD138 CXCR4 ICAM-1 Monoclonal Antibody in Clinical Development Daratumumab Isatuximab Lucatumumab Dacetuzumab Lorvotuzumab Milatuzumab Indatuximab Ravtansine Ulocuplumab BI-505 Pembrolizumab PD-1 Nivolumab Host effector cell-directed Pidilizumab KIR Lirilumab CD137 Urelumab Both SLAMF7 Elotuzumab Current Clinical Trials of Monoclonal Antibodies in MM mab Target Combination Patient Types Phase Elotuzumab SLAMF7 Rev/dex New, relapsed 3 Daratumumab CD38 Rev/dex Vel/dex New, relapsed 3 Tabalumab BAFF Relapsed/refractory 2 Isatuximab CD38 Rev/dex Kyprolis (carfil) Relapsed/refractory 1 Pom/dex Indatuximab* CD138 Rev/dex Relapsed/refractory 1/2 Milatuzumab CD74 Relapsed/refractory 1/2 MOR03087 CD38 Relapsed/refractory 1/2 Pidilizumab PD-1 Rev Relapsed/refractory 1/2 Pembrolizumab PD-1 Pom Rev/dex Relapsed/refractory 1/2 Nivolumab PD-1 Ipilimumab Lirilumab Relapsed/refractory 1 Atezolizumab PD-L1 Rev Relapsed/refractory 1 Lirilumab KIR Elotuzumab Relapsed/refractory 1 Urelumab CD137 Elotuzumab Relapsed/refractory 1 *Immunotoxin conjugate Antibodies: The Body s Foot Soldiers in the Battle Against Disease 12

13 Monoclonal Antibodies: Further Directions Elotuzumab Two phase 3 trials Daratumumab Four phase 3 trials Immune Checkpoint Blockade PD-1 PD-L1 KIR Continuing Evolution of Multiple Myeloma Treatment: New Classes and Targets Novel Therapy Novel Therapies and Immunotherapy Atezolizumab * Revlimid Kyprolis Ixazomib* Nivolumab* Thalomid Vaccines* Pomalyst Daratumumab* CAR-T* Velcade Doxil Farydak Elotuzumab* Isatuximab* IMiD Proteasome inhibitor HDAC inhibitor Chemotherapy Monoclonal antibody Adoptive T cell therapy Vaccines Checkpoint inhibitors IMiD, immunomodulatory drug; HDAC, histone deacetylase; KSP, kinesin spindle protein, SINE, selective inhibitor of nuclear export *Not yet FDA-approved for MM; only available in clinical trials Treatments studied in MMRC trials Antibodies: The Body s Foot Soldiers in the Battle Against Disease 13

14 Questions & Answers Question Are there side effects with the use of immunotherapy? Antibodies: The Body s Foot Soldiers in the Battle Against Disease 14

15 Question How do you feel about intravenous immunoglobulin (IVIG) on a monthly basis for smoldering myeloma to support the immune system? Question Is there a way to deliver immunotherapy with less dexamethasone? Antibodies: The Body s Foot Soldiers in the Battle Against Disease 15

16 Question When is immunotherapy going to become available? Question If someone gets treated with one type of immunotherapy, does that mean they can t receive another one of the other immunotherapies later? Antibodies: The Body s Foot Soldiers in the Battle Against Disease 16

17 Question Why do we have to wait for refractory disease situations before we can use immunotherapy? Closing Antibodies: The Body s Foot Soldiers in the Battle Against Disease 17

18 We wish to thank the faculty for their contributions and Bristol-Myers Squibb for providing an educational grant in support of this activity. Additional Information Speak to an MMRF Nurse Specialist Call Monday Friday, 9:00AM 7:00PM EST MMCT (6628) Need information about clinical trials? Go to: myelomatrials.org Join the MMRF CoMMunity Gateway to Share and Connect with other Members of the Myeloma Community Go to: mmrfcommunitygateway.org Antibodies: The Body s Foot Soldiers in the Battle Against Disease 18

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