-Results of INO-VATE ALL Trial Published in The
New England Journal of Medicine-
-Overall Survival Data Also Presented as a
Late-Breaking Oral Presentation at EHA 2016-
Pfizer Inc. (NYSE:PFE) today announced the publication of
findings from the Phase 3 INO-VATE ALL study in the online issue of
The New England Journal of Medicine. The study, also known as Study
1022, is an open-label, randomized, Phase 3 study evaluating the
safety and efficacy of inotuzumab ozogamicin as compared with
investigator-choice chemotherapy in 326 adult patients with
relapsed or refractory CD22-positive acute lymphoblastic leukemia
(ALL). Results showed improvement over chemotherapy on a number of
measures including complete hematologic remission and
progression-free survival (PFS). Updated results and newly
available overall survival (OS) data were also presented as a
late-breaking oral presentation (#LB2233) today at the 21st
Congress of the European Hematology Association (EHA) 2016 Annual
Meeting in Copenhagen, Denmark.
“Relapsed or refractory ALL is an aggressive leukemia in urgent
need of new treatment options as about half of adult patients will
not respond to chemotherapy or will see their disease return,” said
Hagop M. Kantarjian, M. D., lead study investigator and professor,
The University of Texas MD Anderson Cancer Center. “The efficacy
results seen in patients treated with inotuzumab ozogamicin in this
study are impressive, particularly median progression-free
survival, high rates of hematological remission and absence of
minimal residual disease. These results suggest inotuzumab
ozogamicin, if approved, could be a valuable new addition to
currently available treatment options for ALL patients, including
as a bridge to stem cell transplantation, which is the best chance
for a cure at this stage of the disease.”
The INO-VATE ALL study had two independent primary endpoints,
complete response with or without hematologic remission and OS.
INO-VATE ALL met its first primary endpoint of complete response,
which was significantly better with inotuzumab ozogamicin compared
to chemotherapy (80.7% [95% CI, 72%-88%] vs. 29.4% [95% CI,
21%-39%], P<0.001). Inotuzumab ozogamicin also significantly
extended PFS compared to chemotherapy (HR: 0.45 [97.5% CI,
0.34-0.61], P<0.001; median PFS, 5.0 vs. 1.8 months, in their
respective arms). The second primary endpoint of OS showed a strong
trend toward longer OS for patients treated with inotuzumab
ozogamicin compared to chemotherapy, but did not reach the level of
statistical significance (p < 0.0104) for the trial (HR: 0.77
[97.5% CI, 0.58-1.03], one-sided P=0.0203; median OS, 7.7 months
[95% CI, 6.0-9.2] vs. 6.7 months [95% CI, 4.9-8.3]). The two-year
OS rate for inotuzumab ozogamicin was 23 percent (95% CI, 16%‒30%)
compared to chemotherapy at 10 percent (95% CI, 5%‒16%).
“Adult patients with relapsed or refractory ALL have a five-year
survival rate of less than 10 percent, making these patients
particularly difficult to treat. To see remission rates and
two-year survival rates that are more than doubled compared to
standard of care chemotherapy is very gratifying. We believe these
data add to the growing body of evidence that supports inotuzumab
ozogamicin as an important potential treatment option in adults
with relapsed or refractory ALL,” said Mace Rothenberg, MD, Chief
Development Officer, Oncology, Pfizer Global Product
Development.
Results from INO-VATE ALL also showed patients treated with
inotuzumab ozogamicin achieved high rates of minimal residual
disease (MRD) negativity (78.4% [95% CI, 68%-87%; P<0.001]), and
experienced a duration of response (DOR) of 4.6 months (95% CI,
3.9-5.4; HR: 0.55; P<0.034). In comparison, 28.1 percent (95%
CI, 14%-47%; P<0.001) of patients treated with chemotherapy
achieved MRD negativity and median DOR was 3.1 months (95% CI,
1.4-4.9; HR: 0.55; P<0.034). More patients also proceeded to
stem-cell transplant with inotuzumab ozogamicin compared to
standard chemotherapy (41% vs. 11%, P<0.001).
The most common adverse events (AEs) observed for both
inotuzumab ozogamicin and chemotherapy were cytopenias, including
febrile neutropenia (16% vs. 22%). Common nonhematologic
treatment-emergent AEs with inotuzumab ozogamicin included nausea
(32%), headache (28%) and pyrexia (27%). Patients in the
chemotherapy arm experienced nausea (47%), pyrexia (43%) and
diarrhea (40%).
Additionally, any-grade veno-occlusive liver disease (VOD)
occurred more frequently in patients treated with inotuzumab
ozogamicin compared to chemotherapy (11% vs. 1%). Five patients
taking inotuzumab ozogamicin developed VOD during treatment and 10
patients developed VOD after subsequent stem cell transplant. Among
those taking chemotherapy, one patient developed VOD after
transplant; no cases of VOD occurred during treatment with
chemotherapy.
Inotuzumab ozogamicin received Breakthrough Therapy designation
from the U.S. Food and Drug Administration (FDA) for ALL in October
2015. Pfizer is working closely with the FDA and other regulatory
authorities with the aim of making inotuzumab ozogamicin available
for adult patients with relapsed or refractory CD22-positive
ALL.
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is an aggressive type of
leukemia with a poor prognosis in adults.1 The current
foundational treatment is intensive, long-term
chemotherapy.2 In 2016, it is estimated that 6,590 cases of
ALL will be diagnosed in the United States, with about 2 in 5 cases
in adults.3 Approximately 20 to 40 percent of newly diagnosed
adults with ALL are cured with current treatment
regimens.4 For patients with relapsed or refractory adult ALL,
the five-year overall survival rate is less than 10 percent.5
About Inotuzumab Ozogamicin
Inotuzumab ozogamicin 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. 1,6 When
inotuzumab ozogamicin binds to the CD22 antigen on malignant
B-cells, it is thought to be internalized into the cell, where the
cytotoxic agent calicheamicin is released to destroy the cell.7
Inotuzumab ozogamicin 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 the discovery, investigation and
development of innovative treatment options to improve the outlook
for cancer patients worldwide. Our strong pipeline of biologics and
small molecules, 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 breakthrough medicines, to
deliver the right drug for each patient at the right time. For more
information, please visit www.pfizer.com.
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
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Consistent with our responsibility as one of the world's premier
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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 June 12, 2016. 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
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 the
ability to meet anticipated 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 new drug applications may be filed
in any jurisdictions for inotuzumab ozogamicin; whether and when
any such applications 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 inotuzumab ozogamicin;
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, 2015 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information 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 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.
2 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.
3 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
(link is external). Accessed March 21, 2016.
4 Manal Basyouni A. et al. Prognostic significance of survivin
and tumor necrosis factor-alpha in adult acute lymphoblastic
leukemia. doi:10.1016/j.clinbiochem.2011.08.1147.
5 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.
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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