- More than 10 oral and mini-oral presentations span Pfizer’s
extensive Oncology portfolio of approved and investigational
therapies
- Two late-breaking presentations include longer-term results
from BRAFTOVI® + MEKTOVI® PHAROS study in BRAF V600E-mutant
metastatic NSCLC and new Phase 2 ponsegromab data in cancer
cachexia
- Encouraging early results for PD-L1 vedotin ADC, disitamab
vedotin and the novel combination of CDK4 + CDK2 inhibitors
highlight rapidly advancing pipeline
Pfizer Inc. (NYSE: PFE) continues to showcase potential
practice-changing research and next-generation candidates across
its robust Oncology portfolio at the European Society for Medical
Oncology (ESMO) Congress 2024, being held September 13-17 in
Barcelona. Data from more than 50 company-sponsored,
investigator-sponsored and collaborative research abstracts,
including more than 10 oral and mini-oral presentations, will be
presented across the company’s tumor areas and core scientific
modalities, as well as a potential treatment for a cancer-related
condition.
“At this year’s ESMO, we are looking forward to demonstrating
our progress toward delivering next-generation biologics and novel
combinations that have the potential to be new standards of care
for patients,” said Chris Boshoff, Chief Oncology Officer and
Executive Vice President, Pfizer. “Our key data presentations
highlight our scientific leadership in developing targeted
therapies, including small molecules and antibody-drug conjugates,
across our core tumor areas, including breast, bladder and thoracic
cancers.”
“At ESMO, Pfizer will share important data highlighting our
commitment to transforming outcomes for patients living with lung
cancer, including longer-term follow-up results from the BRAFTOVI +
MEKTOVI PHAROS study in BRAF V600E-mutated metastatic non-small
cell lung cancer,” said Karin Tollefson, Chief Oncology Medical
Officer, Pfizer. “We are also looking forward to sharing progress
on our industry-leading pipeline of new molecules, including
encouraging early results for two novel, investigational
antibody-drug conjugates and preliminary data on a novel
combination of Pfizer’s next-generation CDK inhibitors.”
Key research includes a late-breaking presentation of updated
results from the pivotal Phase 2 PHAROS* study of BRAFTOVI
(encorafenib) + MEKTOVI (binimetinib) in patients with BRAF
V600E-mutant metastatic non-small cell lung cancer (mNSCLC).
Longer-term efficacy and safety data will be presented, following
the initial primary overall response results (ORR) that supported
the FDA approval for BRAFTOVI + MEKTOVI in this indication in 2023
and the recent approval by the European Commission in August 2024.
Further, Pfizer will share updated data from the safety lead-in of
the ongoing Phase 3 BREAKWATER trial, showing antitumor activity of
BRAFTOVI + cetuximab + FOLFIRI in patients with untreated BRAF
V600E-mutant metastatic colorectal cancer (mCRC) in a mini-oral
presentation.
Additionally, Pfizer will present a late-breaking Proffered
Paper Presentation on the Phase 2 efficacy and safety results for
its GDF-15 inhibitor, ponsegromab, in patients with
cancer-associated cachexia, highlighting the company’s commitment
to improving the treatment journey for people living with cancer.
Cancer cachexia is a common, life-threatening wasting condition
characterized by severe weight loss. The condition affects patients
with advanced cancers and can greatly impact a patient’s ability to
tolerate cancer treatment and quality of life. Despite its
severity, there are no FDA-approved treatments for
cachexia.i,ii
Pfizer will also present early clinical-stage research for a
number of priority pipeline areas, including encouraging Phase 1
results of the potential first-in-class antibody-drug conjugate
(ADC) candidate SGN-PDL1V (PF-08046054) in NSCLC and head and neck
squamous cell carcinoma (HNSCC); initial data for the
investigational ADC disitamab vedotin in combination with KEYTRUDA®
(pembrolizumab) in human epidermal growth factor receptor 2
(HER2)-expressing locally advanced or metastatic urothelial cancer
(la/mUC); and the first data combining atirmociclib, our
highly-selective cyclin-dependent kinase 4 (CDK4) inhibitor
(CDK4i), with a novel CDK2 inhibitor (CDK2i) in hormone
receptor-positive (HR+)/HER2-negative metastatic breast cancer
(MBC) from a Phase 1 dose-escalation study.
Key ESMO Presentations
Genitourinary Cancer
- PADCEV + KEYTRUDA**: additional analysis from the
pivotal EV-302 trial continues to support the combination as a new
standard of care for patients with previously untreated la/mUC. An
exploratory analysis shows PADCEV + KEYTRUDA® showed consistent
progression free survival (PFS), overall survival (OS), and ORR
versus chemotherapy regardless of Nectin-4 or PD-L1
expression.
- Disitamab Vedotin: preliminary efficacy and safety data
for disitamab vedotin in combination with KEYTRUDA highlights
Pfizer’s continued commitment to developing novel therapeutics to
meet the needs of patients with bladder cancer. Results from the
safety run-in of the ongoing Phase 2 trial showed encouraging early
efficacy and a safety profile consistent with previously presented
data in treatment-naive patients with HER2-expressing la/mUC.
Thoracic Cancer
- SGN-PDL1V (PF-08046054): encouraging Phase 1 results
will be presented for PDL1V, a novel, investigational vedotin ADC
directed to PD-L1-expressing solid tumors. Data from the
dose-escalation and dose optimization cohorts of the ongoing Phase
1 study show PDL1V as monotherapy was generally well tolerated with
no unexpected adverse events, and encouraging antitumor activity
was observed in patients with heavily pretreated NSCLC and
HNSCC.
Breast Cancer
- Atirmociclib (PF-07220060) + PF-07104091: initial data
from a dose-escalation study evaluating the innovative combination
of atirmociclib, a potential first-in-class CDK4-selective
inhibitor, with PF-07104091, a novel CDK2-selective inhibitor,
showed a manageable safety profile and encouraging efficacy in
patients with heavily pretreated HR+/HER2- breast cancer. These
early results highlight the potential of Pfizer's strategy to
advance atirmociclib as a future CDK inhibitor backbone therapy
that may address treatment resistance with first generation
CDK4/6i, subject to clinical success and regulatory approval. The
CDK4i+2i combination is continuing to be explored in an ongoing
Phase 1b/2 dose escalation and dose expansion study
(NCT05262400).
Additional information on the Pfizer-sponsored abstracts,
including date and time of presentation, follow in the chart
below.
Pfizer is continuing its commitment to help non-scientists
understand the latest findings with the development of abstract
plain language summaries (APLS) for company-sponsored research
being presented at ESMO, which are written in non-technical
language. Those interested in learning more can visit
www.Pfizer.com/apls to access the summaries starting September 16,
2024.
BREAST CANCER
Mini Oral Presentation (Abstract 618MO)
Saturday, September 14, 2:45 PM-4:15 PM CEST Phase 1b/2
first-in-class novel combination trial of next generation
CDK4-selective inhibitor PF-07220060 and next generation
CDK2-selective inhibitor PF-07104091 in HR+ HER2- metastatic breast
cancer and advanced solid tumors Yap et al
Poster Presentation (Abstract 413P)
Monday, September 16, 9:00 AM-5:00 PM CEST Longitudinal circulating
tumor DNA (ctDNA) dynamics in Phase 1/2a study of the
first-in-class CDK4-selective inhibitor, PF-07220060, in
combination with endocrine therapy in patients with HR+/HER2−
metastatic breast cancer (mBC) who progressed on prior CDK4/6
inhibitors Yap et al
Poster Presentation (Abstract 359P)
Monday, September 16, 9:00 AM-5:00 PM CEST Overall survival of
palbociclib (PAL) + endocrine therapy (ET) in Japanese patients
with hormone receptor-positive (HR+)/ human epidermal growth factor
receptor 2-negative (HER2-) advanced breast cancer (ABC) in the 1st
line (1L) or 2nd line (2L) setting: A multicenter observational
study Nakayama et al
Poster Presentation (Abstract 354P)
Monday, September 16, 9:00 AM-5:00 PM CEST Synergistic preclinical
efficacy through combination of the CDK4 and CDK2 selective
inhibitors, PF-07220060 and PF-07104091, respectively, in HR+ HER2-
breast cancer Anders et al
Poster Presentation (Abstract 356P)
Monday, September 16, 9:00 AM-5:00 PM CEST Real-world effectiveness
in subgroups of palbociclib + endocrine therapy in HR+/HER2- ABC
patients: Interim Results of the PERFORM study Pfeiler et al
EARLY PIPELINE
Oral Presentation, Proffered Paper
(Abstract 607O) Friday, September 13, 4:00 PM-5:30 PM CEST Interim
results of a Phase 1 study of SGN-PDL1V (PF-08046054) in patients
with PDL1-expressing solid tumors Oliva Bernal et al
GASTROINTESTINAL CANCER
Mini Oral Presentation (Abstract 515MO)
Saturday, September 14, 2:45 PM-4:15 PM CEST Encorafenib +
cetuximab (EC) + FOLFIRI for BRAF V600E-mutant metastatic
colorectal cancer (mCRC): updated results from the BREAKWATER
safety lead-in (SLI) Tabernero et al
GENITOURINARY CANCER
Mini Oral Presentation (Abstract 1966MO)
Sunday, September 15, 8:30 AM-10:00 AM CEST EV-302: Exploratory
analysis of nectin-4 expression and response to 1L enfortumab
vedotin (EV) + pembrolizumab (P) in previously untreated locally
advanced or metastatic urothelial cancer (la/mUC) Powles et al
Poster Presentation (Abstract 1968P)
Sunday, September 15, 9:00 AM-5:00 PM CEST Study EV-103 dose
escalation/cohort A (DE/A): 5y follow-up of first-line (1L)
enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin
(cis)-ineligible locally advanced or metastatic urothelial
carcinoma (la/mUC) Rosenberg et al
Poster Presentation (Abstract 2001P)
Sunday, September 15, 9:00 AM-5:00 PM CEST Epidemiology and
treatment patterns of patients with locally advanced or metastatic
urothelial cancer in France: a non-interventional database study
Joly et al
Poster Presentation (Abstract 1638P)
Sunday, September 15, 9:00 AM-5:00 PM CEST Enzalutamide (ENZA) with
or without leuprolide in patients (pts) with high-risk
biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post
hoc analysis by age Shore et al
Poster Presentation (Abstract 1626P)
Sunday, September 15, 9:00 AM-5:00 PM CEST Incidence of hematologic
toxicities in the homologous recombination repair (HRR)-deficient
population of the TALAPRO-2 trial and their potential association
with germline vs somatic origin of HRR gene alterations Azad et
al
Poster Presentation (Abstract 1637P)
Sunday, September 15, 9:00 AM-5:00 PM CEST Efficacy of talazoparib
and enzalutamide in metastatic castration-resistant prostate cancer
(mCRPC) patients previously treated with androgen receptor pathway
inhibitors (ARPI) or docetaxel – post hoc analysis from both
cohorts in TALAPRO-2 study Agarwal et al
Poster Presentation (Abstract 1633P)
Sunday, September 15, 9:00 AM-5:00 PM CEST Phase 3 study of
talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as
first-line (1L) treatment in patients (pts) with metastatic
castration-resistant prostate cancer (mCRPC): TALAPRO-2 (TP-2)
China cohort Zeng et al
Mini Oral Presentation (Abstract 1967MO)
Sunday, September 15, 8:30 AM-10:00 AM CEST Preliminary efficacy
and safety of disitamab vedotin (DV) with pembrolizumab (P) in
treatment (Tx)-naive HER2-expressing, locally advanced or
metastatic urothelial carcinoma (la/mUC): RC48G001 Cohort C Galsky
et al
MELANOMA
Poster Presentation (Abstract 1071TiP)
Saturday, September 14, 9:00 AM-5:00 PM CEST Phase 1 study of the
investigational CD228 x 4-1BB costimulatory antibody Anticalin
bispecific SGN-BB228 (PF-08046049) in advanced melanoma and other
solid tumors Dummer et al
SUPPORTIVE AND PALLIATIVE CARE
Oral Presentation, Proffered Paper
(Abstract LBA82) Saturday, September 14, 2:45 PM-4:25 PM CEST
Efficacy and safety of ponsegromab, a first-in-class, monoclonal
antibody inhibitor of growth differentiation factor-15, in patients
with cancer cachexia: A randomized, placebo-controlled, Phase 2
study Crawford et al
THORACIC CANCER
Mini Oral Presentation (Abstract LBA56)
Saturday, September 14, 10:15 AM-11:45 AM CEST Updated efficacy and
safety from the Phase 2 PHAROS study of encorafenib plus
binimetinib in patients with BRAF V600E-mutant metastatic NSCLC
(mNSCLC) Riely et al
Poster Presentation (Abstract 1398TiP)
Saturday, September 14, 9:00 AM-5:00 PM CEST Be6A Lung-01, a Phase
3 study of sigvotatug vedotin (SV), an investigational
antibody-drug conjugate (ADC) versus docetaxel in patients (pts)
with previously treated non-small cell lung cancer (NSCLC) Peters
et al
Poster Presentation (Abstract 1279P)
Saturday, September 14, 9:00 AM-5:00 PM CEST First-line lorlatinib
vs crizotinib in Asian patients with ALK+ non-small cell lung
cancer (NSCLC): 5-year outcomes from the CROWN study Wu et al
*The PHAROS trial is conducted with support from Pierre
Fabre.
**Pfizer and Astellas have a clinical collaboration agreement
with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in
patients with previously untreated metastatic urothelial
cancer.
Prescribing Information for Pfizer Medicines
Please see full Prescribing Information for PADCEV.
Please see full Prescribing Information for BRAFTOVI and full
Prescribing Information for MEKTOVI.
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 antibody-drug conjugates (ADCs), small
molecules, bispecific antibodies and other immunotherapy 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 that help people with cancer globally
live better and longer lives.
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 health care
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 health care
providers, governments and local communities to support and expand
access to reliable, affordable health care 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 Facebook.com/Pfizer.
DISCLOSURE NOTICE:
The information contained in this release is as of September 11,
2024. The Company 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
Oncology, Pfizer’s Oncology portfolio of marketed and
investigational therapies, including combinations, and an
investigational therapy for a cancer-related condition;
expectations for our product pipeline, in-line products and product
candidates, including their potential benefits, clinical trial
results and other developing data; potential breakthrough, best- or
first-in-class or blockbuster status or expected market entry of
our medicines; and other statements about our business, operations
and financial results that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risk and
uncertainties include, among other things, uncertainties regarding
the commercial success of Pfizer’s oncology portfolio; 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; risks associated with interim
and preliminary 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 drug applications, biologics license applications and/or
emergency use authorization applications may be filed in any
jurisdictions for any potential indication for Pfizer’s product
candidates; whether and when any such applications that may be
pending or filed for any of Pfizer’s 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 any such 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 Pfizer’s products or product candidates,
including development of products or therapies by other companies;
manufacturing capabilities or capacity; uncertainties regarding the
impact of COVID-19 on Pfizer’s 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.
i Cleveland Clinic. Cachexia (Wasting Syndrome). Cachexia
(Wasting Syndrome): Symptoms & Treatment (clevelandclinic.org).
Accessed September 3, 2024. ii Lisa Martin, Michael B. Sawyer,
Cancer Cachexia: Emerging Preclinical Evidence and the Pathway
Forward to Clinical Trials, JNCI: Journal of the National Cancer
Institute, Volume 107, Issue 12, December 2015, djv322,
https://doi.org/10.1093/jnci/djv322
Category: Pipeline
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