ASH Clinical News ACN_5.3_web | Page 3

In the INO-VATE ALL study, more patients achieved MRD-negative complete
remission and proceeded to HSCT after CD22-directed treatment with BESPONSA1• 2
Standard Chemotherapy
BESPONSA
CR/CRi rate
P<0.0001•
M RD-negative
CR/CRi rate
Overall
HSCT rate
80 7 0/ 10
e
78 • 4 0/ 10
48 0 0/ 10
e
(88/109) - 29.4%
(69/88) - 28.1%
95% Cl, 72.1-87.7
95% Cl, 68.4-86.5
(79/164)
95% Cl, 40.3-56.1
-
-
•
22.0%
(32/109)
95% Cl, 21.0-38.8
(9/32)
95% Cl, 13.7-46.7
(35/162)
95% Cl, 15.5-28.7
Median OS in patients treated with BESPONSA was 7.7 months (95% Cl, 6.0-9.2) vs
6.2 months (95% Cl, 4.7-8.3) in patients treated with SC (HR=0.75; P=0.0105). 6 The analysis
of OS did not meet a prespecified boundary for statistical significance of P=0.0104. 1• 2
The most common (>2%) serious adverse events were infection (23%), febrile neutropenia (11%), hemorrhage (5%),
abdominal pain (3%), pyrexia (3%), VOD (2%), and fatigue (2%) 1 •
2
Study design: INO-VATE ALL was a Phase 3, open-label, randomized (1 :1) study of BESPONSA vs investigator's choice of SC in 326 adult patients with relapsed or
refracto ry B-cell precursor ALL. SC included FLAG, HiDAC, or Ara-C + MXN. All patients were required to have :2!5% bone marrow blasts and to have received 1 or
2 previous induction chemotherapy regimens for ALL. Patients with Ph+ B-cell precursor ALL were required to have failed treatment with :2!1 TKI and SC. Single-agent
BESPONSA was given by 1-hour IV infusion in 3 fractionated doses at 1.8 mg/m 2 each 3- to 4-week cycle, reduced to 3 fractionated doses at 1.5 mg/m 2 per cycle after
achieving CR/CRi, for up to 6 cycles. For patients proceeding to HSCT, the recommended treatment duration with BESPONSA is 2 cycles. Patients who do not achieve
a CR or CRi within 3 cycles should discontinue treatment. 1•
3
Ara-C + MXN=cytarabine + mitoxantrone; Cl=confidence interval; CR=complete remission; CRi=CR with incomplete hematologic recovery; FLAG=fludarabine, Ara-C,
and granulocyte colony-stimulating factor; HiDAC=high-dose cytarabine; HR=hazard ratio; HSCT =hematopoietic stem cell transplant; MRD=minimal residual disease;
OS=overall survival; Ph+=Philadelphia chromosome-positive; SC=standard chemotherapy; TKl=tyrosine kinase inhibitor; VOD=hepatic veno-occlusive disease.
Response assessments were performed in the first 218 patients randomized, and survival analyses were completed in the full study population of 326 patients.
•1-sided P value using chi-square test.
b1-sided P value using log-rank test.
Learn more at BesponsaHCP.com
Infusion-Related Reactions: Infusion-related reactions (all Grade 2) were
reported in 4/164 patients (2%). Premedicate with a corticosteroid, antipyretic,
and antihistamine prior to dosing. Monitor patients closely during and for
at least 1 hour after the end of the infusion for the potential onset of
infusion-related reactions including symptoms such as fever, chills, rash,
or breathing problems. Interrupt the infusion and institute appropriate
medical management if an infusion-related reaction occurs. Depending on
the severity, consider discontinuation of the infusion or administration of
steroids and antihistamines. For severe or life-threatening infusion reactions,
permanently discontinue BESPONSA.
QT Interval Prolongation: Increases in OT interval corrected for heart rate
using Fridericia's formula of 2'.60 msec from baseline were measured in
4/162 patients (3%). Administer BESPONSA with caution in patients who
have a histo ry of or predisposition to OTc prolongation, who are taking
medicinal products that are known to prolong OT interval, and in patients
with electrolyte disturbances. Obtain electrocardiograms and electrolytes
prior to treatment and after initiation of any drug known to prolong OTc, and
periodically monitor as clinically indicated during treatment.
Emb ry o-Fetal Toxicity: BESPONSA can cause emb ry o-fetal harm. Apprise
pregnant women of the potential risk to the fetus. Advise males and females of
reproductive potential to use effective contraception during BESPONSA
treatment and for at least 5 and 8 months after the last dose, respectively.
Advise women to contact their healthcare provider if they become pregnant
or if pregnancy is suspected during treatment with BESPONSA.
Adverse Reactions: T he most common (2'.20%) adverse reactions observed
with BESPONSA were thrombocytopenia, neutropenia, infection, anemia,
leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia,
transaminases increased, abdominal pain, gamma-glutamyltransferase increased,
and hyperbilirubinemia. T he most common (2'.2%) serious adverse reactions
were infection, febrile neutropenia, hemorrhage, abdominal pain, pyrexia,
VOD, and fatigue.
Nursing Mothers: Advise women against breastfeeding while receiving
BESPONSA and for 2 months after the last dose.
INDICATION
BESPONSA is indicated for the treatment of adults with relapsed or refracto ry
B-cell precursor acute lymphoblastic leukemia (ALL).
Please see brief summa ry of full Prescribing Information, including
BOXED WARNING, on adjacent pages.
References: 1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
2. Data on file. Pfizer Inc, New York, NY. 3. Kantarjian HM, DeAngelo DJ, Stelljes M,
et al. lnotuzumab ozogamicin versus standard therapy for acute lymphoblastic
leukemia. N Engl J Med. 2016;375(8):740-753.
(/1/; Oncology
PP-I NO-USA-0183-02
© 2018 Pfizer Inc.
All rights reserved.
April 2018
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