- Breakthrough Therapy Designation based on updated data from
Phase 2 MagnetisMM-3 study that showed an overall response rate of
61.0% and a manageable safety profile after a median follow-up of
6.8 months
- Data to be presented at the 64th American Society of Hematology
Annual Meeting and Exposition 2022 (ASH 2022)
Pfizer Inc. (NYSE:PFE) today announced its investigational
cancer immunotherapy, elranatamab, received Breakthrough Therapy
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of people with relapsed or refractory multiple
myeloma (RRMM). Elranatamab is a B-cell maturation antigen
(BCMA)-CD3-targeted bispecific antibody (BsAb).
“The FDA’s Breakthrough Designation recognizes the potential of
elranatamab as an innovative medicine for people with multiple
myeloma whose disease has relapsed or is refractory to existing
treatments, which at present leaves very few avenues for staving
off this currently incurable cancer,” said Chris Boshoff, M.D.,
Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer
Global Product Development. “This marks Pfizer’s twelfth FDA
Breakthrough Therapy Designation in Oncology, a testament to our
relentless commitment to developing transformational cancer
medicines in areas of high unmet need. We look forward to working
with the FDA to accelerate the development of this therapy.”
The FDA’s Breakthrough Therapy Designation is intended to
expedite the development and review of a medicine that is intended
to treat a serious or life-threatening disease and preliminary
clinical evidence indicates the drug may demonstrate substantial
improvement over existing therapies.1
BsAbs are a novel form of cancer immunotherapy that bind to and
engage two different targets at once. One arm binds directly to
specific antigens on cancer cells and the other arm binds to
T-cells, bringing both cell types together. Elranatamab is designed
to bind to BCMA, which is highly expressed on the surface of
multiple myeloma (MM) cells, and the CD3 receptor found on the
surface of T-cells, bridging them together and activating the
T-cells to kill the myeloma cells. The binding affinity of
elranatamab for BCMA and CD3 has been engineered to elicit potent
T-cell mediated anti-myeloma activity. Elranatamab is administered
subcutaneously, which offers more convenience over intravenous
administration, and may mitigate the risk of potential adverse
events, such as cytokine release syndrome (CRS).
The Breakthrough Therapy Designation is based on six-month
follow-up data from cohort A (n=123) of MagnetisMM-3, an
open-label, multicenter, single arm, Phase 2 study evaluating the
safety and efficacy of elranatamab monotherapy in patients with
RRMM. Patients received subcutaneous (SC) elranatamab 76 mg weekly
(QW) with a 2-step-up priming dose regimen administered during the
first week. The study showed elranatamab demonstrated a manageable
safety profile, and at a median follow-up of 6.8 months, patients
achieved an overall response rate (ORR) of 61.0%. Among responders,
there was 90.4% probability of maintaining a response ≥6 months.
The most common treatment-emergent adverse event (TEAE) regardless
of causality was CRS (57.9%), with the majority of events reported
being either Grade 1 (43.2%) or Grade 2 (14.2%). Updated data from
MagnetisMM-3 will be presented at the 64th American Society of
Hematology Annual Meeting and Exposition 2022 (ASH 2022), taking
place December 10-13, 2022, in New Orleans.
MagnetisMM-3 is part of the robust MagnetisMM clinical research
program, which has registration-intent trials planned or ongoing
that explore elranatamab both as monotherapy and in combination
with standard or novel therapies, spanning multiple patient
populations from newly diagnosed multiple myeloma (NDMM),
double-class exposed disease and RRMM.
In addition to the Breakthrough Therapy Designation, elranatamab
has 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.
About Multiple Myeloma
MM is a blood cancer that affects plasma cells made in the bone
marrow. Healthy plasma cells make antibodies that help the body
fight infection. According to the latest figures available, there
are over 34,000 new cases of MM diagnosed annually in the U.S. and
176,000 globally.2, 3 Despite treatment advances, MM remains
incurable. The median overall survival is just over five years, and
most patients receive four or more lines of therapy.4
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines
wherever we believe we can make a meaningful difference in the
lives of people living with cancer. Today, we have an
industry-leading portfolio of 24 approved innovative cancer
medicines and biosimilars across more than 30 indications,
including breast, genitourinary, colorectal, blood and lung
cancers, as well as melanoma.
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 November 3, 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 U.S. Food and Drug Administration. Breakthrough Therapy
Designation. Available at:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
Accessed September 23, 2022.
2 American Cancer Society. Multiple Myeloma. Available at:
https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html.
Accessed May 25, 2022.
3 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.
4 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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