ASH News Daily 2017 - Issue 2 - C-21
VISIT BOOTH #1340 TO LEARN MORE
ISATUXIMAB
An Investigational Agent in Phase 3
Isatuximab is an investigational anti-CD38 IgG1 monoclonal antibody1
Sanofi Genzyme is committed to advancing research and development in multiple myeloma. Learn more
about our clinical development program. Currently there are three active phase 3 trials for isatuximab:
A phase 3, randomized, open-label,
multicenter study comparing
Isatuximab in Combination with
pomalidomide And low-dose
dexamethasone veRsus pomalidomide
and low-dose dexamethasone In
patients with refractory or relapsed
And refractory multiple myeloma.
Patients
with RRMM
Isatuximab +
Pomalidomide/
Dexamethasone
R
Primary
Endpoint:
PFS
1:1
N=300
Pomalidomide/
Dexamethasone
Key secondary
endpoints: ORR, OS,
TTP, DOR
NCT02990338
DOR=duration of response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival;
RRMM=relapsed/refractory multiple myeloma; TTP=time to progression.
A phase 3, randomized, open-label,
multicenter study assessing the
clinical benefit of Isatuximab
combined with carfilzomib (Kyprolis®)
and dExamethasone versus carfilzomib
with dexamethasone in patients with
relapsed and/or refractory Multiple
myelomA previously treated with
1 to 3 prior lines.
180 pts
Patients
with RRMM
R
Isatuximab +
Carfilzomib/
Dexamethasone
Primary
Endpoint:
PFS
3:2
120 pts
Carfilzomib/
Dexamethasone
Key secondary
endpoints: ORR, OS,
TTP, DOR
DOR=duration of response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival;
RRMM=relapsed and/or refractory multiple myeloma; TTP=time to progression.
NCT03275285
INDUCTION
A phase 3, randomized, open-label,
multicenter study assessing the
clinical benefit of Isatuximab in
combination with bortezomib
(Velcade®), lenalidoMide (Revlimid®)
and dexamethasOne versus
borteZomib, lenalidomide and
dexamethasone in patients with
newly diagnosed multiple myeloma
not eligible for transplant.
R
Primary
Endpoint:
PFS
Lenalidomide/
Dexamethasone
CR=complete response; NDMM=newly diagnosed multiple myeloma; ORR=objective response rate; OS=overall survival;
PFS=progression-free survival; PFS2=progression-free survival on next line of therapy; SCT=stem cell transplant.
*Patients randomized to the lenalidomide and dexamethasone combination who exhibit progressive disease during continuous
treatment may cross over to receive the isatuximab, lenalidomide, and dexamethasone combination.
Isatuximab is an investigational agent and has not been
approved by the US Food and Drug Administration or any other
regulatory agency worldwide for the uses under investigation.
SAUS.ONP.17.10.7998 10/2017
Isatuximab +
Lenalidomide/
Dexamethasone
Crossover*
3:2
N=440
Bortezomib/
Lenalidomide/
Dexamethasone
NCT03319667
Reference: 1. Deckert J, et al. Clin Cancer Res. 2014;20(17):4574-4583.
Isatuximab +
Bortezomib/
Lenalidomide/
Dexamethasone
Patients
with NDMM not
eligible for SCT
CONTINUOUS TREATMENT
Key secondary
endpoints: OS,
PFS2, ORR, CR
Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 2
ASH News Daily 2017 - Issue 2 - A-1
ASH News Daily 2017 - Issue 2 - A-2
ASH News Daily 2017 - Issue 2 - A-3
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ASH News Daily 2017 - Issue 2 - A-13
ASH News Daily 2017 - Issue 2 - A-14
ASH News Daily 2017 - Issue 2 - A-15
ASH News Daily 2017 - Issue 2 - A-16
ASH News Daily 2017 - Issue 2 - A-17
ASH News Daily 2017 - Issue 2 - A-18
ASH News Daily 2017 - Issue 2 - A-19
ASH News Daily 2017 - Issue 2 - A-20
ASH News Daily 2017 - Issue 2 - A-21
ASH News Daily 2017 - Issue 2 - A-22
ASH News Daily 2017 - Issue 2 - A-23
ASH News Daily 2017 - Issue 2 - A-24
ASH News Daily 2017 - Issue 2 - A-25
ASH News Daily 2017 - Issue 2 - A-26
ASH News Daily 2017 - Issue 2 - A-27
ASH News Daily 2017 - Issue 2 - A-28
ASH News Daily 2017 - Issue 2 - B-1
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ASH News Daily 2017 - Issue 2 - B-20
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ASH News Daily 2017 - Issue 2 - B-22
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ASH News Daily 2017 - Issue 2 - B-56
ASH News Daily 2017 - Issue 2 - C-1
ASH News Daily 2017 - Issue 2 - C-2
ASH News Daily 2017 - Issue 2 - C-3
ASH News Daily 2017 - Issue 2 - C-4
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ASH News Daily 2017 - Issue 2 - C-6
ASH News Daily 2017 - Issue 2 - C-7
ASH News Daily 2017 - Issue 2 - C-8
ASH News Daily 2017 - Issue 2 - C-9
ASH News Daily 2017 - Issue 2 - C-10
ASH News Daily 2017 - Issue 2 - C-11
ASH News Daily 2017 - Issue 2 - C-12
ASH News Daily 2017 - Issue 2 - C-13
ASH News Daily 2017 - Issue 2 - C-14
ASH News Daily 2017 - Issue 2 - C-15
ASH News Daily 2017 - Issue 2 - C-16
ASH News Daily 2017 - Issue 2 - C-17
ASH News Daily 2017 - Issue 2 - C-18
ASH News Daily 2017 - Issue 2 - C-19
ASH News Daily 2017 - Issue 2 - C-20
ASH News Daily 2017 - Issue 2 - C-21
ASH News Daily 2017 - Issue 2 - C-22
ASH News Daily 2017 - Issue 2 - C-23
ASH News Daily 2017 - Issue 2 - C-24
ASH News Daily 2017 - Issue 2 - C-25
ASH News Daily 2017 - Issue 2 - C-26
ASH News Daily 2017 - Issue 2 - C-27
ASH News Daily 2017 - Issue 2 - C-28
ASH News Daily 2017 - Issue 2 - C-29
ASH News Daily 2017 - Issue 2 - C-30
ASH News Daily 2017 - Issue 2 - C-31
ASH News Daily 2017 - Issue 2 - C-32
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