Pfizer Inc. (NYSE:PFE) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion recommending approval
of BESPONSA® (inotuzumab ozogamicin) in the European Union (EU) as
monotherapy for the treatment of adults with relapsed or refractory
CD22-positive B-cell precursor Philadelphia chromosome negative
(Ph-) acute lymphoblastic leukemia (ALL) and Philadelphia
chromosome positive (Ph+) ALL, who have previously failed treatment
with at least one tyrosine kinase inhibitor (TKI). The CHMP’s
opinion will now be reviewed by the European Commission (EC). If
approved, BESPONSA will be the first antibody drug conjugate
available for patients with this type of leukemia.
“Relapsed or refractory ALL is a rapidly progressive and often
fatal disease. BESPONSA is an antibody-drug conjugate that has been
designed to bind to a receptor – CD22 – that is present on the
leukemia cells of most patients with ALL and deliver a potent toxin
– calicheamicin – into those cells,” said Mace Rothenberg, MD,
chief development officer, Oncology, Pfizer Global Product
Development. “The positive results of the INO-VATE 1022 Phase 3
trial provide strong evidence of the important role BESPONSA may
have versus commonly used chemotherapy regimens used in this
situation, and we believe BESPONSA could provide patients with
relapsed or refractory ALL with a much needed treatment
option.”
“Approximately 10,000 new adult cases of ALL are diagnosed in
Europe each year, and there is an urgent unmet need for patients
with relapsed or refractory adult ALL, as the reported long term
survival rates range from between less than 10 percent to
approximately 20 percent1,” said Professor Matthias Stelljes,
Department of Medicine A/Hematology and Oncology, University of
Münster, Germany. “Today’s decision by the CHMP to recommend
marketing authorization of BESPONSA is an important step forward
for patients in Europe, and the community looks forward to
potentially having a new treatment option available.”
ALL is an aggressive type of leukemia with a poor prognosis in
adults.2 The current foundational treatment is intensive,
long-term chemotherapy.3 ALL is uncommon in adults, representing
about 15 percent of leukemias, with about 10,000 new adult cases
diagnosed in Europe each year.4 Approximately 20 to 40 percent of
newly diagnosed adults with ALL are cured with current treatment
regimens,5 however about 20 percent of adult patients will be
refractory, or resistant, to treatment, and an additional 40 to 50
percent will relapse within months or years. For patients with
relapsed or refractory adult ALL, the five-year overall survival
rate is less than 10 percent.6
The Marketing Authorization Application (MAA) for BESPONSA was
based on results from the Phase 3 INO-VATE 1022 trial, which
enrolled 326 adult patients with relapsed or refractory B-cell ALL,
and compared BESPONSA to standard of care chemotherapy. The
INO-VATE 1022 study had two primary endpoints, complete response
with or without hematologic remission (CR/CRi) and overall survival
(OS). Results from the trial were published in The New England
Journal of Medicine in June 2016.
A Biologics License Application (BLA) for BESPONSA for the
treatment of adult patients with relapsed or refractory B-cell
precursor ALL has been accepted for filing and granted Priority
Review by the U.S. Food and Drug Administration (FDA). The
Prescription Drug User Fee Act (PDUFA) goal date for a decision by
the FDA is in August 2017. BESPONSA received Breakthrough Therapy
designation from the FDA in October 2015 for ALL.
With a growing hematology pipeline, Pfizer is committed to
extending therapeutic progress in acute and chronic leukemias that
leverage select pathways and mechanism of actions (MOAs).
Specifically, our investigational products aim to treat some of the
hardest to treat leukemias, including acute myeloid leukemia (AML),
acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML)
and mantle cell lymphoma (MCL).
About BESPONSA® (Inotuzumab Ozogamicin)
BESPONSA is an investigational antibody-drug conjugate (ADC)
comprised of a monoclonal antibody (mAb) targeting CD22, a
cell surface antigen found on cancer cells in almost all B-ALL
patients, linked to a cytotoxic agent.7 When BESPONSA binds to
the CD22 antigen on B-cells, it is internalized into the cell,
where the cytotoxic agent, calicheamicin, is released to destroy
the cell.8 The most common adverse events (AEs) observed in
clinical trials for BESPONSA were cytopenias, including febrile
neutropenia. Common nonhematologic treatment-emergent AEs with
BESPONSA included nausea, headache and pyrexia. Additionally,
veno-occlusive liver disease (VOD) was observed more frequently in
patients treated with BESPONSA, especially those who went on to
receive hematopoietic stem cell transplantation.
BESPONSA originates from a collaboration between Pfizer and
Celltech, now UCB. Pfizer has sole responsibility for all
manufacturing and clinical development activities for this
molecule.
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
world®
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 healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
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, Pfizer has worked to make a difference for
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DISCLOSURE NOTICE: The information contained in this
release is as of April 21, 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), an investigational oncology therapy,
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, the
uncertainties inherent in research and development, including,
without limitation, 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 the MAA,
the BLA and any such other applications for BESPONSA may be
approved by the European Commission, the FDA or other regulatory
authorities, respectively, 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.
________________________________1 Gokbuget N.
et al. Outcome of relapsed adult lymphoblastic leukemia depends on
response to salvage chemotherapy, prognostic factors, and
performance of stem cell transplantation. Blood. 2012; 120(10):
2032-2041.2 National Cancer Institute: Adult Acute Lymphoblastic
Leukemia Treatment (PDQ®) – General Information About Adult Acute
Lymphoblastic Leukemia (ALL). Available at:
http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1.
Accessed March 21, 2016.3 American Cancer Society: Typical
treatment of acute lymphocytic leukemia. Available at:
http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment.
Accessed March 21, 2016.4 Orphan Europe. Acute lymphoblastic
leukaemia. Available at:
http://www.orphan-europe.com/patients-and-families/acute-lymphoblastic-leukaemia.
Accessed March 1, 2017.5 Manal Basyouni A. et al. Prognostic
significance of surviving and tumor necrosis factor-alpha in adult
acute lymphoblastic leukemia.
doi:10.1016/j.clinbiochem.2011.08.1147.6 Fielding A. et al. Outcome
of 609 adults after relapse of acute lymphoblastic leukemia (ALL);
an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950.7 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: 5327-5334.8 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 (U.S.)212-733-6566orAndrew Widger
(Europe)+44-7970-149098orInvestors:Ryan Crowe, 212-733-8160
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