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Cómo funciona la inmunoterapia
Mauricio Lema Medina
Clínica de oncología Astorga, Clínica SOMA, Medellín
2
Conflicts of interest for this talk
Mauricio Lema Medina
BMS/MSD
@Onconerd
2018
• Increased risk of cancer in immunosuppressed
• Increased risk of certain cancers with the use of
immunosuppressing agents
• Longer OS when Tumor-Infiltrating Lymphocytes present
Immunoediting
Elimination Equilibrium Escape
Complete
destruction of
cancer cells
Cancer growth
stalled
Cancer growth
unhindered
Disis ML, Semin Oncol, 2014
The goal of cancer immunotherapy is
to boost or restore the ability of the
immune system to detect and destroy
cancer cells by overcoming the
mechanisms by which tumors evade
and suppress the immune response,
Disis ML, Semin Oncol, 2014
The goal of cancer immunotherapy is
to boost or restore the ability of the
immune system to detect and destroy
cancer cells by overcoming the
mechanisms by which tumors evade
and suppress the immune response,
Disis ML, Semin Oncol, 2014
Immunoediting
Elimination Equilibrium Escape
Complete
destruction of
cancer cells
Cancer growth
unhindered
Disis ML, Semin Oncol, 2014
Immunotherapy
IL-2 discovery
1976
Gallo
(Science)
10,000 mouse T-
cells
300,000 mouse
T-cellsMurine IL-2
(Rosenberg)
recombinant IL-2
+ LAK
Destroyed Linda
Taylor’s
melanoma
1984
(Rosenberg)
NEJM
(Rosenberg)
Therapeutic cancer
vaccines
Long, tedious… of a largely INEFFECTIVE
strategy (as of today)
T-Cell activation
Discovery of the T-Cell Receptor
1984 (Nature)
A Cure Within, Neil Canavan, 2018
James Allison
Co-stimulatory signal
CD28 - B7
Ralph Steinmann
Dendritic cells
James Allison
Co-stimulatory signal
CD28 - B7
Accelerator
Ralph Steinmann
Dendritic cells
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Célula
Dendrítica
Antígeno tumoral
Linfocito T
CD8+/Citotóxico
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Célula
Dendrítica
Antígeno tumoral
Linfocito T
CD8+/Citotóxico
Receptor de célula T
(TCR)
MHC II y antígeno
MHC II: Major histocompatibility complex
T-Cell
activation
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Célula
Dendrítica
Linfocito T
CD8+/Citotóxico
Co-estimuladora CD28 Co-estimuladora B7.1
James Allison Ralph Steinmann
Dendritic cells
CTLA-4 is NOT produced
by resting T-Cells…
but only in T-Cells that
had been activated
…CTLA-4 appeared to bind
the same LIGANDS as CD28
James Allison
Co-inhibitory signal
CTLA4 - B7
Ralph Steinmann
Dendritic cells
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Célula
Dendrítica
Linfocito T
CD8+/Citotóxico
CTLA-4 Co-estimuladora B7.1
T-Cell brake
The primary role of immune
checkpoints is to protect tissues from
damage when the immune system is
responding to pathogens and to
maintain tolerance to self-antigens (ie,
prevent autoimmunity). This is
primarily achieved by downregulating
T-cell activation or effector functions
Disis ML, Semin Oncol, 2014
The primary role of immune
checkpoints is to protect tissues from
damage when the immune system is
responding to pathogens and to
maintain tolerance to self-antigens (ie,
prevent autoimmunity). This is
primarily achieved by downregulating
T-cell activation or effector functions
Disis ML, Semin Oncol, 2014
James Allison
Professor, Chair of Immunology
M.D. Anderson Cancer Center
Houston, Texas
Nobel Prize Medicine and Physiology - 2018
CTLA-4 was a brake
Protein structure of
the T-Cell receptor
(M.D. Anderson)
Born 1948, Alice, Tx
Co-stimulatory
signal
CD28
CTLA-4 and CD28
shared the same ligands
(B7-1, B7-2
in dendritic cells)
“((in cancer))… this all starts a
negative program as well by inducing
thE CLKA-4 gene, and that’s what’s
going to eventually turn the system
off.”
“I proposed treating cancer by ignoring it.”
CTLA-4 wild type
CTLA-4 -/-
Slide uploaded by J Gulley
Hippilimumab
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Célula
Dendrítica
Linfocito T
CD8+/Citotóxico
CTLA-4 Co-estimuladora B7.1
T-Cell brake
Anti-CTLA-4
James Allison
Professor, Chair of Immunology
M.D. Anderson Cancer Center
Houston, Texas
Nobel Prize Medicine and Physiology - 2018
Search for a biotech
company interested in
an anti-CTLA-4 in cancer
Born 1948, Alice, Tx
Medarex synthesis
of Ipilimumab
“medarex thought that mdx-010
was an activating molecule”
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Célula
Dendrítica
Linfocito T
CD8+/Citotóxico
CTLA-4 Co-estimuladora B7.1
Restablishes T-Cell functionality
Anti-CTLA-4
Célula
dendrític
a
Célula
T
MHC TCR
B7
CD28
CTLA-4
Célula
T
Células
Dendrítica
s
Interacción de
Células
Presentadoras de
antígeno – Células T
Anti-
CTLA-4
Bloqueo del CTLA-4
Los anticuerpos anti CTLA-4
restablecen la respuesta antitumoral
de linfocitos T
Ipilimumab
Tremelimumab
James Allison
Professor, Chair of Immunology
M.D. Anderson Cancer Center
Houston, Texas
Nobel Prize Medicine and Physiology - 2018
Clinical Trials
Melanoma
Search for a biotech
company interested in
an anti-CTLA-4 in cancer
Born 1948, Alice, Tx
Medarex synthesis
of Ipilimumab
Phase I trial
of Ipi: 3 objective
responses
Jedd Wolchok
First clinical trials with
Ipilimumab by
MSKCC/Medarex
Worked in immunology
with Dr. Houghton
(MSKCC)
Born 1965, Staten Island, NY
Heard about Allison’s
anti-CTLA-4 ab
Jedd Wolchok
Chief, Melanoma and Immunotherapeutics Service
Memorial Sloan Kettering Cancer Center
New York, New York
First clinical trials with
Ipilimumab by
MSKCC/Medarex
Worked in immunology
with Dr. Houghton
(MSKCC)
Born 1965, Staten Island, NY
Heard about Allison’s
anti-CTLA-4 ab
Despite the bad test results, the patient said he felt better
Initial studies looked for
Response Rates using
RECIST
One patient with
melanoma had
progressed, by
RECIST, but said “I feel
better”
That same patient came
back with LESS disease
Jedd Wolchok
Chief, Melanoma and Immunotherapeutics Service
Memorial Sloan Kettering Cancer Center
New York, New York
Born 1965, Staten Island, NY
Despite the bad test results, the patient said he felt better
For Phase III trial the CHOSEN
primary endpoint was Overall
Survival, not PFS
Precedent: Another anti-CTLA-4
(tremelimumab) chose PFS as the primary
endpoint, and the trial was negative
Clinical Trials
Melanoma
Search for a biotech
company interested in
an anti-CTLA-4 in cancer
James Allison, MD Anderson/MSKCC
Medarex synthesis
of Ipililimumab
Phase I trial
of Ipi: 3 objective
responses
FDA approval of
Ipilimumab
in Metastatic Melanoma
(2011)
Jedd Wolchok, MSKCC Axel Hoos, BMS
James Allison
Axel Hoos
Born 1969, Hesse, Germany
James Allison
Born 1948, Alice, Tx
T-Cell/Drugs Ligands Where Action
CTLA-4 B7.1 (CD80) APC
Immune response
inhibited
CTLA-4 B7.2 (CD86) APC
Immune response
inhibited
Ipilimumab anti-CTLA-4 T-Cells
Immune response
restored
Tremelimumab anti-CTLA-4 T-Cells
Immune response
restored
Effector T-Cells
Tumor
Cell
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
MHC class I + Ag
Tumor
Cell
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
CD8+
T-Cell
MHC class I + Ag
T-Cell receptor)
+++
Effector T-
Cell
activation
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
CD8+ T-Cell
MHC class I + Ag
T-Cel receptor
+++
Tasuku Honjo
Professor, Department of Immunology
and Genomic Medicine
Kyoto University
Kyoto, Japan
PD-1Worked in AICDA
Born 1942, Kyoto, Japan
Looking for thymic
Selection mechanisms
Curiosity, a challenge, and courage… patience
Knock-out (PD-1) mice
Unlike CTLA-4 mice,
PD-1 mice did survive
After a while… PD-1
mice developed
diseases…
2002
1994
PD1 is broadly expressed: T-Cells, B-Cells, NK-Cells
Tasuku Honjo
Born 1942, Kyoto, Japan
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Linfocito T
CD8+/Citotóxico
IFN-γ
IFN-γR
PD-1
+++
Tumor PD-L1 (PD-
L2) expression
occurs when there
is continuous
Gamma IFN
exposure
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Linfocito T
CD8+/Citotóxico
IFN-γ
IFN-γR
PD-L1
PD-1
- - -
Anti tumor immunity
Stalled
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Linfocito T
CD8+/Citotóxico
PD-L1
PD-1
- - -
Anti-PD1
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Linfocito T
CD8+/Citotóxico
PD-L1
PD-1
+++
Anti-PD1
T-Cell action restored
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Linfocito T
CD8+/Citotóxico
PD-L1
PD-1
- - -
Anti-PD-L1
Célula
tumoral
PD-1
PD-L1
PD-L2
Receptor de
células T
MHC-1
CD28
Shp-2
B7.1
Linfocito T
CD8+/Citotóxico
PD-L1
PD-1
+++
Anti-PD-L1
T-Cell action restored
Droga Mecanismo de acción
Pembrolizumab Anti-PD1
Nivolumab Anti-PD1
Avelumab Anti-PD-L1
Durvalumab Anti-PD-L1
Atezolizumab Anti-PD-L1
Célula
T
Célula
tumoral
MHCTCR
PD-1
PD-L1
Cancer
cell
T-cell
T-Cell/Drugs Ligands Where (Ligands) Action
CTLA-4 B7.1 (CD80) APC
Immune response
inhibited
CTLA-4 B7.2 (CD86) APC
Immune response
inhibited
Ipilimumab anti-CTLA-4 T-Cells
Immune response
restored
Tremelimumab anti-CTLA-4 T-Cells
Immune response
restored
PD1 PD-L1 Tumor cells
Immune response
inhibited
PD1 PD-L2 Tumor cells
Immune response
inhibited
Nivolumab PD1 T-Cell
Immune response
restored
Pembrolizumab PD1 T-Cell
Immune response
restored
Atezolizumab PD-L1 Tumor cells…
Immune response
restored
Avelumab PD-L1 Tumor cells
Immun response
restored
Immune response
CAR-T-Cells
Tisagenlecleucel
Vairy S, Drug Des Devel Ther, 2018
Leukapheresis
Vairy S, Drug Des Devel Ther, 2018
Leukapheresis
CD3+ T-Cell
Vairy S, Drug Des Devel Ther, 2018
Morris Plains - NJ Leipzig, Germany
Day 1
CD3+ T-Cells
Metallic beads covered with Anti CD3 / Anti CD28
Vairy S, Drug Des Devel Ther, 2018
Anti CD3 / Anti CD28
CD3+ T-Cells
Metallic beads covered with Anti CD3 / Anti CD28
CD3+ T-Cells
CD3+ T-Cells
Vairy S, Drug Des Devel Ther, 2018
Anti CD3
Anti CD137 (agonist)
CD3+ T-Cells
Metallic beads covered with Anti CD3 / Anti CD28
CD3+ T-Cells
CD3+ T-Cells
Selective expansion and
priming of CD3+ T-Cells
Vairy S, Drug Des Devel Ther, 2018
CD3+ T-Cells
Transduction begins
Lentiviral Vector coding CAR
(Chimeric antigen receptor)
Vairy S, Drug Des Devel Ther, 2018
Tisagenlecleucel
CTL019
CD3ζ
CD-137
CD8-α hinge region
anti-CD19 scFv
Extracellular
Intracellular
Vairy S, Drug Des Devel Ther, 2018
Antigen
recognition (CD19)
Better
CD19-anti CD19
interactions (steric)
Better cytokine production
and proliferation, and
enhances persistence of
CAR-T cells
Institution
Antigen
recognition
Signaling
domain
Co-
stimulatory
Vector
CHOP/UPenn,
Novartis
FMC63-
CD8𝛼
CD3𝜁 CD137 LV
FHCR
FMC63-
IgG4
CD3𝜁 CD28 𝛾RV
NCI/NIH FMC63-28z CD3𝜁 CD28 𝛾RV
MSKCC;
Juno
FMSJ25C1-
28z
CD3𝜁 CD28 𝛾RV
MDACC;
NCI
FMC63-
IgG4
CD3𝜁 CD28 SBT
Baylor; Bluebird;
Celgene
FMC63-
IgG1
CD3𝜁 CD28 𝛾RV
Vairy S, Drug Des Devel Ther, 2018
Second generation CD19 CAR T Cells for B-ALL
LV: Lentivirus, SBT: Sleeping beauty transposon, 𝛾RV: Gamma retrovirus
CD3+ T-Cells
T-Cell lymphocytes transduced with CAR
Vairy S, Drug Des Devel Ther, 2018
Chimeric T-Cells with CAR
Vairy S, Drug Des Devel Ther, 2018
CAR T-Cell
Vairy S, Drug Des Devel Ther, 2018
Characteristics
Highly activated T-Cell
Ability to seek and
destroy CD19+ cells
(B-Cell leukemia or
DLBCL)
Morris Plains - NJ Leipzig, Germany
Day 15
CAR T-Cells
Vairy S, Drug Des Devel Ther, 2018
Infusion to the patient
CAR T-Cells
CD19+
Tumor cell
CTL019
CD19+
Tumor cell
CTL019
CTL019
Tumor-cell
apoptosis
T-Cell/Drugs Ligands Where (Ligands) Action
CTLA-4 B7.1 (CD80) APC
Immune response
inhibited
CTLA-4 B7.2 (CD86) APC
Immune response
inhibited
Ipilimumab anti-CTLA-4 T-Cells
Immune response
restored
Tremelimumab anti-CTLA-4 T-Cells
Immune response
restored
PD1 PD-L1 Tumor cells
Immune response
inhibited
PD1 PD-L2 Tumor cells
Immune response
inhibited
Nivolumab PD1 T-Cell
Immune response
restored
Pembrolizumab PD1 T-Cell
Immune response
restored
Atezolizumab PD-L1 Tumor cells…
Immune response
restored
Avelumab PD-L1 Tumor cells
Immun response
restored
Immune response
Modern cancer immunotherapy
Anti CTLA-4
Anti-PD(L)1
CAR T-Cells
But, many more are being studied…

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