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NEW YORK, Nov 07, 2011 (BUSINESS WIRE) -- --Investigator Research
on Several Pfizer Compounds to be Presented Including an ASH
Plenary Presentation on Gemtuzumab Ozogamicin
Pfizer Oncology will present data on a number of investigational
compounds from its hematology portfolio, including new data from
bosutinib in chronic myeloid leukemia (CML),(1) inotuzumab in
non-Hodgkin lymphoma (NHL),(2) as well as the first presentation of
clinical data for PF-04449913,(3) which inhibits Smoothened (SMO),
a key component of the Hedgehog pathway.(4) In addition, ongoing
investigator-initiated research on gemtuzumab ozogamicin (Mylotarg)
will be presented in the plenary session.(5) These data will be
presented at the upcoming 53rd Annual Meeting of the American
Society of Hematology (ASH) in San Diego, December 10-13.
"Pfizer is committed to the evaluation and development of
innovative therapies for hematologic malignancies," said Dr. Mace
Rothenberg, senior vice president of clinical development and
medical affairs for Pfizer's Oncology Business Unit. "In addition
to important results from company-initiated trials, we also support
investigator-initiated research of compounds within our portfolio.
The positive data to be presented at this meeting on gemtuzumab
ozogamicin add to our understanding of this compound and the
potential role of antibody-drug conjugates in hematologic
malignancies. We are working closely with investigators to better
understand the findings from this study and will work with
regulatory authorities to determine next steps, as
appropriate."
Advancing a Robust Late-Stage Portfolio: Bosutinib and
Inotuzumab
Key investigational compounds bosutinib and inotuzumab, both with
ongoing Phase 3 trials,(6,7) will be featured in presentations at
the upcoming meeting.(1,2)
Analyses of data evaluating bosutinib, an investigational oral dual
Src and Abl kinase inhibitor,(1) as a single-agent in both newly
diagnosed and previously treated patients with CML will be
presented,(1,8) including:
-- Bosutinib Versus Imatinib in Newly Diagnosed Chronic Phase
Chronic Myeloid Leukemia -- BELA Trial: 24-month Follow-up (Oral
presentation, Abstract #455, December 12)(1)
-- Activity of Bosutinib by Baseline and Emergent Mutation Status
in Philadelphia Chromosome--Positive Leukemia Patients with
Resistance or Intolerance to Other Tyrosine Kinase Inhibitors
(Study 200) (Oral presentation, Abstract #110, December 11)(8)
-- In addition, multiple poster presentations for bosutinib in
newly diagnosed and previously treated patients with CML have been
accepted for presentation.(9,10,11)
Additionally, Phase 1 and 2 data will be presented on
inotuzumab,(12,2) an investigational antibody-drug conjugate (ADC)
comprised of a monoclonal antibody (mAb) targeting CD22, a cell
surface antigen expressed on approximately 90 percent of B-cell
malignancies, linked to a cytotoxic agent.(13,14) Inotuzumab is
currently being evaluated in a Phase 3 study in combination with
rituximab in patients with relapsed or refractory CD22-positive
aggressive NHL who are not candidates for intensive high-dose
chemotherapy.(7)
-- Anti-CD22 Immunoconjugate Inotuzumab Ozogamicin + Rituximab
Followed by Stem Cell Transplantation in Relapsed/Refractory DLBCL
Patients: Safety and Efficacy (Study 2005) (Poster, Abstract #2718,
December 11)(2)
-- An Open-label, Phase I Study of R-CVP in Combination with
Inotuzumab Ozogamicin in Patients with Relapsed/Refractory
CD22-positive B-cell Non-Hodgkin Lymphoma (Study 1105) (Poster,
Abstract #3715, December 12)(12)
New Pathways, New Promise in the Early-Stage Pipeline
For the first time, Pfizer will present clinical data for
PF-04449913, an oral inhibitor of SMO,(3) one of the key components
of the Hedgehog signaling pathway.(4) The study evaluates the
effectiveness of PF-04449913 across multiple hematologic cancers,
including CML, acute myeloid leukemia (AML), myelodysplatic
syndrome, and myelofibrosis.(3)
-- Phase 1 Dose-escalation Study of PF-04449913, an Oral Hedgehog
Inhibitor, in Patients with Select Hematologic Malignancies (Oral
presentation, Abstract #424, December 12)(3)
Abnormal activation of the Hedgehog pathway has been linked to
multiple human cancers.(15) Recent data suggest that disruption of
the hedgehog pathway or inhibition of its activity may provide a
new strategy for the treatment of hematologic disorders, including
multiple myeloma, lymphoma, and myeloid malignancies.(4,16)
Partnering to Gain a Better Understanding of our Cancer
Therapies
Data on a range of investigator-initiated research will also be
presented, including data on gemtuzumab ozogamicin to be featured
in the Plenary Scientific Session

5)
-- Fractionated doses of Gemtuzumab Ozogamicin combined to standard
chemotherapy improve event-free and overall survival in newly
diagnosed de novo AML patients aged 50-70 years old: A prospective
randomized Phase 3 trial from the Acute Leukemia French Association
(ALFA) (Sylvie Castaigne, Hopital Andre Mignot; Plenary
presentation, Abstract #6, December 11)(5)
Background on Mylotarg(R)
In October 2010, Pfizer voluntarily withdrew the new drug
application (NDA) for Mylotarg(R) (Gemtuzumab Ozogamicin for
Injection) for the treatment of relapsed AML.(17) The required
post-approval study (SWOG S0106) combining chemotherapy and
Mylotarg given 6 mg/m2 for induction and then as monotherapy in
doses of 5 mg/m2 (up to three doses given 28 days apart) for
post-consolidation did not demonstrate improved survival compared
with chemotherapy alone in patients aged 18-60 with previously
untreated AML. Additionally, among all patients evaluable for early
toxicity the fatal induction toxicity rate was significantly higher
in patients given the combination of conventional induction
chemotherapy and Mylotarg than in those treated with chemotherapy
alone.(18)
About Pfizer Oncology