BESPONSA is the first and only CD22-directed
antibody-drug conjugate indicated for the treatment of adults with
relapsed or refractory B-cell precursor acute lymphoblastic
leukemia
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and
Drug Administration (FDA) has approved BESPONSA® (inotuzumab
ozogamicin) for the treatment of adults with relapsed or refractory
B-cell precursor acute lymphoblastic leukemia (ALL).1 BESPONSA was
reviewed and approved under the FDA’s Breakthrough Therapy
designation and Priority Review programs.
“The approval of BESPONSA is an important step forward for adult
patients with relapsed or refractory B-cell acute lymphoblastic
leukemia, a rare disease that can be fatal within a matter of
months if left untreated,” said Liz Barrett, global president,
Pfizer Oncology. “BESPONSA will help address a significant need for
new treatment options in B-cell acute lymphoblastic leukemia, and
may help more patients reach stem cell transplant, which provides
the best chance for long term remission. We’re proud to build on
our continued commitment to patients with hematologic malignancies,
and will continue our work to find new treatments in acute
lymphoblastic leukemia and other blood cancers.”
The approval was based on results from the Phase 3 INO-VATE ALL
trial, a randomized, open-label, international, multicenter study
evaluating the safety and efficacy of BESPONSA compared with
Investigator’s choice of chemotherapy in 326 adult patients with
relapsed or refractory B-cell ALL.1
“Based on the results seen in the INO-VATE ALL trial, BESPONSA
improved multiple efficacy measures, including rates of hematologic
remission, MRD-negativity and stem cell transplantation,” said
Hagop M. Kantarjian, M. D., INO-VATE ALL lead study investigator
and professor, The University of Texas MD Anderson Cancer Center.
“I look forward to seeing the impact this important new therapy may
have on my patients.”
The complete remission rate (CR/CRi)* for patients treated with
BESPONSA was 81 percent [95% CI: 72%-88%] compared to 29 percent
with chemotherapy [95% CI: 21%-39%]. Among patients achieving
CR/CRi, those treated with BESPONSA also demonstrated a higher rate
of minimal residual disease (MRD) negativity (78% [95% CI:
68%-87%]) compared to those treated with chemotherapy (28% [95% CI:
14%-47%]). Forty-eight percent of patients treated with BESPONSA
proceeded to hematopoietic stem cell transplantation (HSCT)
compared to 22 percent treated with chemotherapy. The median
overall survival (OS) for patients treated with BESPONSA was 7.7
months [95% CI: 6.0, 9.2] and 6.2 months [95% CI: 4.7, 8.3] for
patients treated with chemotherapy. The analysis of OS for patients
treated with BESPONSA compared to chemotherapy did not meet the
pre-specified boundary for statistical significance (HR: 0.75
[97.5% CI: 0.57-0.99]).1
The U.S. labeling for BESPONSA includes a boxed warning for
hepatotoxicity, including hepatic veno-occlusive disease (VOD),
also known as sinusoidal obstruction syndrome (SOS), and increased
risk of post-HSCT non-relapse mortality. Veno-occlusive disease,
including fatal and life-threating VOD, occurred in 14 percent of
patients treated with BESPONSA. A higher post-HSCT non-relapse
mortality rate occurred in patients treated with BESPONSA (39%)
than chemotherapy (23%).1 In patients treated with BESPONSA, the
most common (≥20%) adverse reactions were thrombocytopenia,
neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage,
pyrexia, nausea, headache, febrile neutropenia, transaminases
increased, abdominal pain, gamma-glutamyltransferase increased, and
hyperbilirubinemia.1
Pfizer is committed to helping patients gain access to Pfizer
medicines, including BESPONSA, and related educational tools,
resources and services, regardless of their financial or health
insurance status through the company’s patient assistance programs.
Patients can call 1-877-744-5675 to learn more.
The full Prescribing Information, including BOXED WARNING, for
BESPONSA can be found at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf.
IMPORTANT BESPONSA® (inotuzumab ozogamicin)
SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE
DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and
INCREASED RISK OF POST–HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
NON-RELAPSE MORTALITY (NRM):
- Hepatotoxicity, including fatal and
life-threatening VOD, occurred in patients who received
BESPONSA. The risk of VOD was greater in patients who
underwent HSCT after BESPONSA treatment. Consider identified risk
factors. Monitor closely for signs and symptoms of VOD
- There was a higher post-HSCT
non-relapse mortality rate in patients receiving BESPONSA,
resulting in a higher Day 100 post-HSCT mortality rate
Hepatotoxicity, Including VOD: Hepatotoxicity, including
fatal and life-threatening VOD, occurred in patients who received
BESPONSA. The risk of VOD was greater in patients who underwent
HSCT after BESPONSA treatment. The use of HSCT conditioning
regimens containing 2 alkylating agents and last total bilirubin ≥
the upper limit of normal (ULN) before HSCT were significantly
associated with an increased risk of VOD. Other risk factors for
VOD in patients treated with BESPONSA included ongoing or prior
liver disease, prior HSCT, increased age, later salvage lines, and
a greater number of BESPONSA treatment cycles. Grade 3/4 increases
in aspartate aminotransferase (AST), alanine aminotransferase
(ALT), and total bilirubin have occurred.
Monitor closely for signs and symptoms of VOD; these may include
elevations in total bilirubin, hepatomegaly (which may be painful),
rapid weight gain, and ascites. Elevation of liver tests may
require dosing interruption, dose reduction, or permanent
discontinuation of BESPONSA. Permanently discontinue treatment if
VOD occurs. If severe VOD occurs, treat according to standard
medical practice.
Increased Risk of Post-HSCT Non-Relapse Mortality: There
was a higher post-HSCT non-relapse mortality rate in patients
receiving BESPONSA, resulting in a higher Day 100 post-HSCT
mortality rate. In the BESPONSA arm, the most common causes of
post-HSCT non-relapse mortality included VOD and infections.
Monitor closely for toxicities post HSCT, including signs and
symptoms of infection and VOD.
Myelosuppression: Myelosuppression, and severe,
life-threatening and fatal complications of myelosuppression,
including hemorrhagic events and infections, have occurred with
BESPONSA. Thrombocytopenia, neutropenia, and febrile neutropenia
were reported.
Monitor complete blood counts prior to each dose of BESPONSA and
monitor for signs and symptoms of infection, bleeding/hemorrhage,
or other effects of myelosuppression during treatment and provide
appropriate management. As appropriate, administer prophylactic
anti-infectives during and after treatment with BESPONSA. Dose
interruption, dose reduction, or permanent discontinuation may be
required.
Infusion-Related Reactions: Infusion-related reactions
have occurred in patients who received BESPONSA. 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. Interrupt the infusion and institute appropriate medical
management if an infusion-related reaction occurs. For severe or
life-threatening infusion reactions, permanently discontinue
BESPONSA.
QT Interval Prolongation: Increases in QT interval have
occurred. Administer BESPONSA with caution in patients who have a
history of or predisposition to QTc prolongation, who are taking
medicinal products that are known to prolong QT interval, and in
patients with electrolyte disturbances. Obtain electrocardiograms
and electrolytes prior to treatment and after initiation of any
drug known to prolong QTc, and periodically monitor as clinically
indicated during treatment.
Embryo-Fetal Toxicity and Nursing Mothers: BESPONSA can
cause embryo-fetal harm. 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 against breastfeeding while receiving BESPONSA and for
2 months after the last dose.
Adverse Reactions: The most common (≥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.
The most common (≥2%) serious adverse reactions were infection,
febrile neutropenia, hemorrhage, abdominal pain, pyrexia, VOD, and
fatigue.
Please see full Prescribing Information, including BOXED WARNING
here
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf.
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is an aggressive type of
leukemia with a poor prognosis in adults.2 The current foundational
treatment is intensive, long-term chemotherapy.3 In 2017, it is
estimated that 5,970 cases of ALL will be diagnosed in the United
States.4 About 4 in 10 cases occur in adults.4 While about 80-90%
of adult patients will have a complete remission at some point
during initial treatment, the remainder (approximately 10%-20%)
will be refractory, meaning they no longer respond to treatment.3
Additionally, about half of patients who achieve remission will
relapse.3 The post relapse median survival is 4.5 to 6 months.5
About BESPONSA® (inotuzumab ozogamicin)
BESPONSA is an antibody-drug conjugate (ADC) composed of a
monoclonal antibody (mAb) targeting CD22, a cell surface antigen
expressed on cancer cells in almost all B-ALL patients, linked to a
cytotoxic agent.6 When BESPONSA binds to the CD22 antigen on
B-cells, it is internalized into the cell, where the cytotoxic
agent calicheamicin is released causing cell death.7 BESPONSA is
administered as a one-hour intravenous infusion that can be given
in the outpatient setting of care for appropriate patients.
BESPONSA originates from a collaboration between Pfizer and
Celltech, now UCB. Under the terms of this agreement, Pfizer has
sole responsibility for all commercialization, manufacturing and
clinical development activities for this molecule. Pfizer also
collaborated with SFJ Pharmaceuticals Group on the registrational
program (INO-VATE ALL) for BESPONSA.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on those living with cancer. As a
leader in oncology speeding cures and accessible breakthrough
medicines to patients, Pfizer Oncology is helping to redefine life
with cancer. Our strong pipeline of biologics, small molecules and
immunotherapies, one of the most robust in the industry, is studied
with precise focus on identifying and translating the best
scientific breakthroughs into clinical application for patients
across a wide range of cancers. By working collaboratively with
academic institutions, individual researchers, cooperative research
groups, governments and licensing partners, Pfizer Oncology strives
to cure or control cancer with its breakthrough medicines. Because
Pfizer Oncology knows that success in oncology is not measured
solely by the medicines you manufacture, but rather by the
meaningful partnerships you make to have a more positive impact on
people’s lives.
Pfizer Inc.: Working together for a healthier
worldTM
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
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addition, to learn more, please visit us on www.pfizer.com and
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DISCLOSURE NOTICE: The information contained in this release is
as of August 17, 2017. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about BESPONSA
(inotuzumab ozogamicin), and an approval by the FDA for the
treatment of adults with relapsed or refractory B-cell precursor
acute lymphoblastic leukemia, including its potential benefits,
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, uncertainties regarding the commercial success of BESPONSA;
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; whether and when applications for BESPONSA may be
filed in any other jurisdictions; whether and when any such
applications that may be pending or filed for BESPONSA may be
approved by regulatory authorities, which will depend on the
assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the efficacy and safety
information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of BESPONSA; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
*CR/CRi includes complete remission (<5% blasts in the bone
marrow and the absence of peripheral blood leukemic blasts, full
recovery of peripheral blood counts and resolution of any
extramedullary disease) and complete remission with incomplete
recovery of peripheral blood counts.
1 BESPONSA (inotuzumab ozogamicin) Prescribing Information. New
York. NY: Pfizer Inc: 2017.
2 National Cancer Institute: Adult Acute Lymphoblastic Leukemia
Treatment (PDQ®) – General Information About Adult Acute
Lymphoblastic Leukemia (ALL). Available at:
https://www.cancer.gov/types/leukemia/hp/adult-all-treatment-pdq#section/all.
Accessed March 23, 2017.
3 American Cancer Society: Typical treatment of acute
lymphocytic leukemia. Available at:
https://www.cancer.org/cancer/acute-lymphocytic-leukemia/treating/typical-treatment.html.
Accessed March 21, 2017.
4 American Cancer Society: What are the key statistics about
acute lymphocytic leukemia? Available
at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics.
Accessed March 21, 2017.
5 National Comprehensive Cancer Network. NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines®): Acute Lymphoblastic
Leukemia. Version 2.2016. National Comprehensive Cancer Network;
2016. http://www.nccn.org/professionals/physician_gls/pdf/all.pdf.
Accessed April 26, 2017.
6 Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody,
in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial
Results. Clinical Cancer Research. 2004; 10: 5327-5334.
7 DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544
(Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate
of Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell
Lymphoma. Clin Cancer Res. 2006; 12: 242-250.
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Pfizer Inc.Media:Sally Beatty, 212-733-6566orInvestor:Ryan
Crowe, 212-733-8160
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