Pfizer Inc. (NYSE: PFE) will highlight the latest advancements
from its growing hematology and breast cancer portfolios at the
American Society of Hematology (ASH) Annual Meeting &
Exposition (December 7-10) and the San Antonio Breast Cancer
Symposium (SABCS, December 10-13). Data from more than 100
company-sponsored, investigator-sponsored, and collaborative
research abstracts, including 13 oral presentations and four poster
spotlights, will be shared across the company’s approved medicines
and expanding portfolio of potential breakthroughs for patients
with blood and breast cancers, as well as rare blood disorders.
“Our robust presence at ASH and SABCS reinforces Pfizer’s legacy
of scientific innovation for people living with blood disorders and
breast cancer,” said Chris Boshoff, Chief Oncology Officer and
Executive Vice President, Pfizer. “We are pleased to share the
latest updates for some of our key approved medicines, including
ADCETRIS, ELREXFIO, and IBRANCE, which continue to generate
compelling data as foundations of care in their respective
indications. We are also excited to present new results in
hemophilia and from our expanding pipeline of innovative,
next-generation therapy candidates for both blood and breast
cancers, including new data on combination approaches across our
core scientific modalities.”
Key ASH Presentations
Data from more than 75 company-sponsored,
investigator-sponsored, and collaborative research abstracts will
be presented at ASH, including updated analyses from the pivotal
ECHELON-3 trial supporting the clinical benefit of ADCETRIS®
(brentuximab vedotin) in patients with relapsed/refractory diffuse
large B-cell lymphoma (DLBCL). New data for ELREXFIO®
(elranatamab-bcmm) in relapsed/refractory multiple myeloma (RRMM)
will also be presented from the pivotal MagnetisMM-3 trial, as well
as Phase 1 combination data from the MagnetisMM-20 trial. Pfizer
will also present updates from its growing Hematology-Oncology
pipeline, which includes next-generation CD30 antibody-drug
conjugates and other novel and differentiated molecules, including
the first presentation of combination data for SEA-CD70 in
high-risk myelodysplastic syndromes.
Additionally, Pfizer will present results across its portfolio
of investigational and approved medicines in benign hematology.
- ADCETRIS: Additional analyses from the Phase 3 ECHELON-3
trial will be presented, highlighting the durability of complete
responses and consistent benefit of ADCETRIS in combination with
lenalidomide and rituximab in patients with relapsed/refractory
DLBCL, including enrollment of elderly patients, those who are
refractory to most recent treatment, and those who have received
prior CAR-T therapy. These findings also underscore the overall
survival (OS) advantage over lenalidomide and rituximab plus
placebo in patients who have received at least two prior lines of
therapy. In addition, updated two-year follow-up data from a Phase
2 study investigating the combination of ADCETRIS, nivolumab,
doxorubicin, and dacarbazine in newly diagnosed early-stage
classical Hodgkin lymphoma (cHL) will be presented highlighting
promising efficacy and safety of this investigational novel
combination.
- ELREXFIO: A post hoc analysis of the Phase 2
MagnetisMM-3 trial continues to show deep and durable responses
after longer-term follow-up of nearly three years, and these
responses were also maintained with a reduction to once-monthly
dosing in RRMM. Data will also be shared from the ongoing Phase 1b
MagnetisMM-20 trial that indicate encouraging clinical efficacy and
predictable safety signals with ELREXFIO in combination with
carfilzomib and dexamethasone after a median of two prior lines of
therapy (range: one to three).
- SEA-CD70 (PF-08046040): Encouraging preliminary data
from the ongoing Phase 1 study with PF-08046040, also known as
SEA-CD70, a nonfucosylated monoclonal antibody targeting CD70 that
is designed to enhance effector function, will be shared for the
first time from the combination dose-optimization cohort with
azacitidine in patients with higher-risk myelodysplastic syndromes
(MDS). SEA-CD70 is being developed with the goal of being a
best-in-class foundational medicine either alone or as combination
treatment in myeloid malignancies.
Key SABCS Presentations
Data from 30 company-sponsored, investigator-sponsored, and
collaborative research abstracts will be presented at SABCS,
including nine real-world analyses affirming IBRANCE® (palbociclib)
as a first-line standard-of-care treatment for hormone
receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-) metastatic breast cancer (MBC). The company will
also present new data from its expanding pipeline of innovative,
next-generation therapy candidates that have the potential to
address critical unmet patient needs across all subtypes and stages
of breast cancer, including new and updated Phase 1 data for
atirmociclib, vepdegestrant, and the novel KAT6 inhibitor,
PF-07248144.
- IBRANCE: In P-VERIFY, the largest-ever real-world
comparative overall survival analysis of first-line CDK4/6
inhibitors plus aromatase inhibitor (AI) therapy in HR+/HER2- MBC,
numerically similar overall survival rates were observed across
CDK4/6 inhibitor groups at 12, 24, and 30 months.
- Atirmociclib (PF-07220060): Updated data will be
presented from a Phase 1/2a study of atirmociclib, a
next-generation, highly selective CDK4 inhibitor, in combination
with letrozole as a potential first-line treatment for patients
with HR+/HER2- MBC. Atirmociclib is being developed as a potential
future CDK inhibitor backbone therapy in HR+ MBC, and a Phase 3
study in the first-line setting is anticipated to start by early
2025.
- Vepdegestrant: For the first time, initial Phase 1b data
will be shared from the Phase 1b/2 TACTIVE-U trial evaluating the
combination of vepdegestrant, a potential first-in-class
PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER)
degrader, in combination with abemaciclib in patients with
ER+/HER2- locally advanced or MBC. These data reinforce the
potential of vepdegestrant as a new backbone endocrine therapy, and
Pfizer and Arvinas anticipate topline Phase 3 data evaluating
vepdegestrant as a monotherapy in the first quarter of 2025.
- KAT6 (PF-07248144): Updated efficacy and safety data
will be presented from a Phase 1 dose-expansion study of
PF-07248144, a novel KAT6 inhibitor, in heavily pretreated
ER+/HER2- MBC. These early data continue to provide strong clinical
proof of concept for this novel target as a potential new treatment
approach for ER+/HER2- MBC, and Pfizer anticipates initiating a
Phase 3 study for PF-07248144 in the post-CDK4/6 inhibitor setting
in mid-2025.
Additional information on key Pfizer-sponsored abstracts at ASH
and SABCS, including date and time of presentation, follow in the
chart below. A complete list of Pfizer-sponsored accepted abstracts
is available here:
https://www.pfizer.com/ASH_and_SABCS_2024_Sponsored_Abstracts.
Blood Cancers
Updated Analysis of Brentuximab Vedotin,
Nivolumab, Doxorubicin, and Dacarbazine for Nonbulky, Early-Stage
Classical Hodgkin Lymphoma (Abstract #460)
Abramson J
Oral Presentation
Sunday, December 8, 9:30-11:00 AM PST
Presentation Time: 10:15 AM PST
Efficacy of Elranatamab (ELRA) in
Combination with Carfilzomib (CFZ) and Dexamethasone (DEX) in the
Phase 1b MagnetisMM-20 Trial in Relapsed or Refractory Multiple
Myeloma (RRMM) (Abstract #1024)
Tomasson MH
Oral Presentation
Monday, December 9, 4:30-5:30 PM PST
Presentation Time: 5:15 PM PST
PF-08046040 (SEA-CD70), a Nonfucosylated
CD70-Directed Antibody, in Combination with Azacitidine for
Patients with Myelodysplastic Syndromes (MDS): A Phase 1
Dose-Finding and Dose Expansion Study (Abstract #1840)
Poster Presentation
Saturday, December 7, 5:30-7:30 PM PST
Durability of Complete Responses in
Patients from the ECHELON-3 Study (Abstract #3101)
Yasenchak C
Poster Presentation
Sunday, December 8, 6:00-8:00 PM PST
MagnetisMM-3: Long-Term Update and
Efficacy and Safety of Less Frequent Dosing of Elranatamab in
Patients with Relapsed or Refractory Multiple Myeloma (Abstract
#4738)
Prince M
Poster Presentation
Monday, December 9, 6:00-8:00 PM PST
Outcomes in Older Patients with
Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
from the ECHELON-3 Study (Abstract #4483)
Bartlett N
Poster Presentation
Monday, December 9, 6:00-8:00 PM PST
Outcomes by Refractory Status and Prior
Therapies Received in Patients with Relapsed/Refractory (R/R)
Diffuse Large B-Cell Lymphoma (DLBCL) from the ECHELON-3 Study
(Abstract #4489)
Hahn U
Poster Presentation
Monday, December 9, 6:00-8:00 PM PST
Hemophilia
Efficacy and Safety of Giroctocogene
Fitelparvovec in Adults with Moderately Severe to Severe Hemophilia
Α: Primary Analysis Results from the Phase 3 AFFINE Gene Therapy
Trial (Abstract #1053)
Leavitt AD
Oral Presentation
Monday, December 9, 4:30-6:00 PM PST
Presentation Time: 5:00 PM PST
Descriptive Characterization of Bleeding
Events in Participants with Severe Hemophilia Α or B without
Inhibitors, Receiving Prophylactic Marstacimab Treatment (Abstract
#716)
Matino D
Oral Presentation
Monday, December 9, 10:30 AM-12:00 PM
PST
Presentation Time: 10:45 AM PST
Sickle Cell Disease
Qualitative Interview Study to
Characterize the Treatment Experiences of Participants with Sickle
Cell Disease and Assess Perceptions of Red Blood Cell Transfusions
(Abstract #3691)
Kosa K
Poster Presentation
Sunday, December 8, 6:00-8:00 PM PST
Breast Cancer
Comparative overall survival of CDK4/6is
plus an aromatase inhibitor (AI) in HR+/HER2- MBC in the US
real-world setting
Rugo et al
Poster Spotlight Presentation (PS2-03)
Thursday, December 12, 7:00-8:30 AM
CST
PF-07248144, a first-in-class KAT6
inhibitor, in patients with HR+ HER2− metastatic breast cancer:
Updated results from phase 1 dose expansion study
Mukohara et al
Poster Presentation (P4-10-28)
Thursday, December 12, 5:30-7:00 PM
CST
Vepdegestrant, a PROteolysis TArgeting
Chimera (PROTAC) Estrogen Receptor (ER) Degrader, Plus Abemaciclib
in ER-Positive/Human Epidermal Growth Factor Receptor 2
(HER2)-Negative Advanced or Metastatic Breast Cancer: TACTIVE-U
Preliminary Phase 1b Results
Hilton et al
Poster Presentation (P4-12-03)
Thursday, December 12, 5:30-7:00 PM
CST
The next-generation CDK4-selective
inhibitor atirmociclib (PF-07220060) in combination with letrozole
as first-line treatment in patients with HR+/HER2+ metastatic
breast cancer
Giordana et al
Poster Presentation (P5-07-28)
Friday, December 13, 12:30-2:00 PM CST
About Pfizer Oncology
At Pfizer Oncology, we are at the forefront of a new era in
cancer care. Our industry-leading portfolio and extensive pipeline
includes three core mechanisms of action to attack cancer from
multiple angles, including small molecules, antibody-drug
conjugates (ADCs), and bispecific antibodies, including other
immune-oncology biologics. We are focused on delivering
transformative therapies in some of the world’s most common
cancers, including breast cancer, genitourinary cancer,
hematology-oncology, and thoracic cancers, which includes lung
cancer. Driven by science, we are committed to accelerating
breakthroughs to help people with cancer live better and longer
lives.
About Pfizer Rare Disease
There are over 10,000 known rare diseases that affect
approximately 400 million people worldwide. 80% of these diseases
have genetic origins and 50% affect children. Collectively, people
living with a rare disease represent one of the largest underserved
patient communities in the world, with less than 10% of known rare
diseases having one or more approved treatments.
At Pfizer, we believe that people living with a rare disease,
along with the untold number of family members and caregivers who
support them, deserve more. For more than 40 years, we have
provided critical treatment options for patients with rare diseases
including 11 Pfizer Rare Disease medicines that have received
regulatory approval.
Prescribing Information for Pfizer Medicines
Please read full Prescribing Information, including BOXED
WARNING, for ADCETRIS.
Please read full Prescribing Information, including BOXED
WARNING, for ELREXFIO.
Please read full Prescribing Information for HYMPAVZI.
Please see full Prescribing Information for IBRANCE®
(palbociclib) tablets and IBRANCE® (palbociclib) capsules.
About Pfizer: Breakthroughs That Change Patients’ Lives
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, including innovative medicines and vaccines. 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 healthcare
providers, governments, and local communities to support and expand
access to reliable, affordable healthcare around the world. For 175
years, we have worked to make a difference for all who rely on us.
We routinely post information that may be important to investors on
our website at www.Pfizer.com. In addition, to learn more, please
visit us on www.Pfizer.com and follow us on X at @Pfizer and
@Pfizer_News, LinkedIn, YouTube, and like us on Facebook at
www.facebook.com/Pfizer/.
Disclosure notice
The information contained in this release is as of December 5,
2024. 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 Pfizer’s
hematology and breast cancer portfolio and pipeline, ADCETRIS
(brentuximab vedotin), ELREXFIO (elranatamab-bcmm), SEA-CD70
(PF-08046040), IBRANCE (palbociclib), atirmociclib (PF-07220060),
vepdegestrant, and the novel KAT6 inhibitor, PF-07248144, including
their 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 Pfizer’s breast cancer and hematology
products and product candidates; the uncertainties inherent in
research and development, including the ability to meet anticipated
clinical endpoints, commencement and/or completion dates for our
clinical trials, regulatory submission dates, regulatory approval
dates and/or launch dates, as well as the possibility of
unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from our clinical studies; whether and
when any applications may be filed with any regulatory authorities
for any potential indications for brentuximab vedotin,
elranatamab-bcmm, PF-08046040, palbociclib, PF-07220060,
vepdegestrant, and PF-07248144, or any other product candidates;
whether and when any applications that may be pending or filed for
brentuximab vedotin, elranatamab-bcmm, PF-08046040 or any such
other product candidates may be approved by regulatory authorities,
which will depend on myriad factors, including making a
determination as to whether the product’s benefits outweigh its
known risks and determination of the product’s efficacy and, if
approved, whether brentuximab vedotin, elranatamab-bcmm,
PF-08046040, palbociclib, PF-07220060, vepdegestrant, and
PF-07248144, or any such other product candidates will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of brentuximab vedotin, elranatamab-bcmm, PF-08046040, palbociclib,
PF-07220060, vepdegestrant, and PF-07248144, or any such other
product candidates; uncertainties regarding the impact of COVID-19
on our business, operations and financial results; 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, 2023 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.
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