- Data showed high objective response rate of 61% in RRMM
patients with no prior BCMA-targeted treatment, with 84%
probability of maintaining the response at nine months
- Results showed early and deep responses, and a manageable
safety profile for elranatamab in heavily pretreated patients with
advanced multiple myeloma
Pfizer Inc. (NYSE:PFE) today announced 10.4 month follow-up data
from the pivotal Phase 2 MagnetisMM-3 clinical trial suggesting
elranatamab, a B-cell maturation antigen (BCMA)-CD3-targeted
bispecific antibody (BsAb), is efficacious and has a manageable
safety profile in patients with relapsed or refractory multiple
myeloma (RRMM) in a heavily pretreated population, who have
received at least three classes of prior therapies including a
proteasome inhibitor, an immunomodulatory agent, and an anti-CD38
monoclonal antibody (i.e. triple-class refractory or exposed).
These data are being presented today in an oral session at the 64th
American Society of Hematology (ASH) Annual Meeting and Exposition
2022 (abstract 159).
“Although there are approved treatments for multiple myeloma,
none are currently curative, and patients often find themselves
with dwindling therapeutic options as their disease relapses or
becomes refractory to successive medicines,” said Nizar Bahlis,
M.D., Associate Professor, Arnie Charbonneau Cancer Institute,
University of Calgary, Canada, and lead investigator. “These
longer-term results show early and deep responses with elranatamab
in a heavily pretreated patient population, adding to the growing
body of evidence showing elranatamab has the potential to be a
transformative option in an area of high need.”
Elranatamab is an investigational humanized BsAb that targets
both BCMA-expressing multiple myeloma cells and CD3-expressing
T-cells, bridging them together and activating the T-cells to kill
the myeloma cells. The binding affinities of elranatamab for BCMA
and CD3 have been engineered to elicit potent T-cell-mediated
anti-myeloma activity. Given factors currently limiting the
availability of novel therapies in the triple-class exposed
setting, elranatamab has the potential to reach a broader and
greater number of patients as an off-the-shelf option that is
administered subcutaneously (SC), which offers more convenience
over intravenous administration.
In this analysis, safety and efficacy were analyzed in 123
patients who had received at least one dose of elranatamab (cohort
A – BCMA-naïve) as of the data cut-off on October 14, 2022.
Patients received SC elranatamab 76 mg weekly (QW) on a 28-day
cycle with a step-up priming dose regimen, 12 mg and 32 mg
administered on Day 1 and Day 4, respectively, during Cycle 1. With
a median follow up of 10.4 months, patients who received
elranatamab achieved a high objective response rate of 61%, with
84% probability of maintaining response at nine months. Probability
of progression-free survival and overall survival were 63% and 70%,
respectively, at nine months. The results also suggest elranatamab
has a manageable safety profile and that the two-step-up priming
dose regimen (12/32 mg) mitigated the rate and severity of cytokine
release syndrome (CRS) (58%, all Grade 1/2) and immune effector
cell-associated neurotoxicity syndrome (ICANS, 3%, all Grade 1/2)
in cohort A of MagnetisMM-3 (n=119). The most common hematologic
treatment emergent adverse events (TEAEs) of any grade were –
anemia (48%), neutropenia (48%), thrombocytopenia (30%) and
lymphopenia (26%).
“Discovered and developed at Pfizer, elranatamab is just one
example of our focus on investing in breakthrough science. We're
applying our expertise in hematology developed over a decade to
advance elranatamab as an innovative treatment for multiple
myeloma,” said Chris Boshoff, M.D., Ph.D., Chief Development
Officer, Oncology and Rare Disease, Pfizer Global Product
Development. “We are excited to be sharing our latest research at
ASH, which further supports the efficacy and safety of elranatamab,
and will continue to evaluate its potential benefits through the
MagnetisMM clinical trial program across earlier and broader
populations, including newly diagnosed patients. We are excited by
the potential for elranatamab, if approved, to reach a greater
number of patients globally across the treatment paradigm.”
Additional Pfizer elranatamab presentations at ASH include:
- Elranatamab, a BCMA Targeted T-Cell Engaging Bispecific
Antibody, Induces Durable Clinical and Molecular Responses for
Patients with RRMM (abstract 158, oral)
- MagnetisMM-1 Phase 1/2 first in human MagnetisMM-1 study
(NCT03269136)
- Safety and preliminary efficacy results from Part 1 (safety
lead-in cohort) of MagnetisMM-5, a Phase 3 study of elranatamab +
daratumumab in patients with RRMM (NCT05020236) (poster 1921)
- MagnetisMM-4: An Open Label, Phase 1b/2 Umbrella Study of
Elranatamab in Combination with Other Anti-cancer Treatments for
Patients with Multiple Myeloma (poster 4567)
- Phase 1b/2 MagnetisMM-4 (NCT05090566) ongoing clinical
trial
- Dose Optimization to Mitigate the Risk of CRS with Elranatamab
in Multiple Myeloma (poster 3192)
- Dose-optimization analysis from across MagnetisMM-1
(NCT03269136), MagnetisMM-2 (NCT04798586), MagnetisMM-3
(NCT04649359) and MagnetisMM-9 (NCT05014412)
- A Systematic Meta-analysis of Cytokine Release Syndrome
Incidence in B-Cell Maturation Antigen-Targeting Chimeric Antigen
Receptor T-Cell Therapy and Bispecific Antibodies for Patients with
Relapsed and/or Refractory Multiple Myeloma (poster 4509)
- Meta-analysis of CRS among patients treated with BCMA-targeting
CAR-Ts and BsAbs across 53 studies
MagnetisMM-3 (NCT04649359) is an ongoing open-label,
multicenter, non-randomized study designed to evaluate the safety
and efficacy of elranatamab as monotherapy in patients with RRMM.
Additional data continue to be collected and will be shared as they
mature. Prior to enrollment, participants had received a median of
five lines of treatment. The participants included in this study
represent a difficult-to-treat multiple myeloma patient population;
almost all (97%) of the 123 patients included in this analysis were
triple-class refractory and nearly half (42%) were penta-drug
refractory*. The trial is part of the robust MagnetisMM multiple
indication clinical research program that expands to additional
patient populations over time, with ongoing registration-intent
trials that explore elranatamab both as monotherapy and in
combination with standard or novel therapies, spanning multiple
patient populations from newly diagnosed multiple myeloma,
double-class exposed disease and RRMM.
In November 2022, Pfizer announced elranatamab received
Breakthrough Therapy Designation from the Food and Drug
Administration (FDA) for the treatment of RRMM. Elranatamab has
also been granted Orphan Drug Designation by the FDA and the
European Medicines Agency (EMA) for the treatment of MM. The FDA
and EMA have granted elranatamab Fast Track Designation and the
PRIME scheme, respectively, for the treatment of patients with
RRMM. The UK Medicines and Healthcare Products Regulatory Agency
(MHRA) has also granted elranatamab Innovative Medicine Designation
and the Innovation Passport for the treatment of MM.
* Penta-drug refers to at least 2 proteosome inhibitors, 2
immunomodulatory drugs, and 1 anti-CD38 antibody.
About Multiple Myeloma
Multiple myeloma is a blood cancer that affects plasma cells
made in the bone marrow. Healthy plasma cells make antibodies that
help the body fight infection. There are over 34,000 new cases of
multiple myeloma diagnosed annually in the U.S. and 176,000
globally.1,2 Despite treatment advances, there is currently no
cure. The median overall survival is just over five years, and most
patients receive four or more lines of therapy.3
About Pfizer in Hematology
At Pfizer, we have an industry-leading portfolio of 24 approved
innovative cancer medicines and biosimilars, including seven
therapies to treat hematologic malignancies. We have taken bold new
approaches over the past decade to translate scientific research
into transformative medicines for people living with blood cancer.
For the millions living with blood cancer today and for those
diagnosed tomorrow, we work tirelessly to deliver on our mission:
Breakthroughs that change patients’ 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
more than 170 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
Twitter 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 December 10, 2022. 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
elranatamab, an investigational B-cell maturation antigen
(BCMA)-CD3-targeted bispecific antibody, 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 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 data, including the risk that additional
data from MagnetisMM-3 could differ from the data discussed in this
release; 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 drug
applications for any potential indications for elranatamab may be
filed in any jurisdictions; whether and when regulatory authorities
in any jurisdictions may approve any such applications, 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
elranatamab 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 elranatamab; 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, 2021 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 American Cancer Society.
Multiple Myeloma. Available at:
https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html.
Accessed May 25, 2022. 2 World Health Organization. Globocan 2020:
Multiple Myeloma. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf.
Accessed May 25, 2022. 3 Mikhael, J, Ismaila N, Cheung M, et al.
Treatment of multiple myeloma: ASCO and CCO joint clinical practice
guideline. J Clin Oncol. 37:1228-1263.
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