- Patients in MagnetisMM-3 demonstrated a median overall survival
(OS) of 24.6 months, with median progression-free survival (PFS) of
17.2 months
Pfizer Inc. (NYSE: PFE) today announced detailed overall
survival (OS) results from the Phase 2 MagnetisMM-3 study of
ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated
relapsed or refractory multiple myeloma (RRMM). The study
demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in
cohort A (n=123) of the pivotal single arm trial.
These data from MagnetisMM-3 will be presented during a poster
session (#932) at the European Hematology Association (EHA) Hybrid
Congress in Madrid, Spain, from June 13-16. Additional
presentations at EHA 2024 will highlight ELREXFIO data across the
comprehensive MagnetisMM clinical trial program.
“These compelling overall survival data support the clinical
benefit ELREXFIO has already demonstrated and its potential to be a
transformative treatment option for people with multiple myeloma,”
said Roger Dansey, M.D., Chief Development Officer, Oncology,
Pfizer. “The latest results from MagnetisMM-3 reinforce the very
promising efficacy observed with ELREXFIO in a relapsed or
refractory setting, with deep and durable responses and although
definitive conclusions cannot be drawn across studies, the longest
reported median progression-free survival among B-cell maturation
antigen bispecific antibodies.”
After more than two years of follow-up in the MagnetisMM-3
trial, the overall response rate (ORR) for patients on ELREXFIO was
61.0% (37.4% ≥complete response rate (CRR)), with responses
deepening over time, and the median duration of response (DOR) was
not reached. At two years, the estimated DOR rate was 66.9% (95%
CI: 54.4, 76.7) for all responders, and 87.9% (95% CI: 73.1, 94.8)
for patients with CR or better response. Median progression-free
survival (PFS) was 17.2 months (95% CI: 9.8 months-NE). For
patients with CR or better response, the median PFS was not
reached, and at two years, the estimated PFS rate was 90.6% (95%
CI: 76.9, 96.4).
“People with relapsed or refractory multiple myeloma often have
limited therapeutic options as their disease progresses due to
treatment resistance, resulting in increasingly shorter remission
and duration of response,” said MagnetisMM-3 clinical trial
investigator Mohamad Mohty, M.D., Ph.D., Professor of Hematology
and Head of the Hematology and Cellular Therapy Department at the
Saint-Antoine Hospital and Sorbonne University, Paris, France.
“These impactful overall survival data are particularly encouraging
given the very advanced patient population with characteristics
associated with poorer outcomes.”
The safety and tolerability of ELREXFIO in MagnetisMM-3 were
consistent with what have been previously observed. Five patients
(4.1%) experienced secondary primary malignancies (SPMs), all cases
being squamous cell carcinoma of the skin, consistent with SPMs
often observed in patients with multiple myeloma (MM), while no
hematological SPMs were reported. Due to the risk of cytokine
release syndrome (CRS) and immune effector cell-associated
neurotoxicity syndrome (ICANS), patients should be monitored for
signs and symptoms for 48 hours after administration of each of the
two step-up doses within the ELREXFIO dosing schedule and
instructed to remain in proximity of a healthcare facility. In the
EU, precautionary hospitalization is not required. Patients are not
required to stay near a healthcare facility for the 76 mg first
treatment dose.
Based on results of the MagnetisMM-3 trial, ELREXFIO received
accelerated approval in August 2023 from the U.S. Food and Drug
Administration for the treatment of adult patients with RRMM who
have received at least four prior lines of therapy, including a
proteasome inhibitor, an immunomodulatory agent, and an anti-CD38
antibody. Continued approval for this indication is contingent upon
verification of clinical benefit in a confirmatory trial. In
December 2023, the European Commission granted conditional
marketing authorization for ELREXFIO for the treatment of adult
patients with RRMM who have received at least three prior
therapies, including a proteasome inhibitor, an immunomodulatory
agent and an anti-CD38 antibody, and have demonstrated disease
progression on the last therapy. ELREXFIO has also received
approval in Switzerland, Brazil and Canada under Project Orbis, a
framework for the concurrent submission and review of oncology
drugs among international partners to potentially expedite
approvals. Two other countries (Australia and Singapore) are
participating in Project Orbis. The Medicines and Healthcare
products Regulatory Agency (MHRA) granted ELREXFIO authorization
for Great Britain for RRMM.
Pfizer’s comprehensive ongoing MagnetisMM clinical development
program is investigating the use of elranatamab across the entire
spectrum of patients with MM, from RRMM to newly diagnosed MM.
Ongoing registrational-intent trials are comparing elranatamab to
current standards of care both as monotherapy and in combination
with standard or novel therapies. These include MagnetisMM-4
investigating elranatamab treatment with other anti-cancer
therapies, MagnetisMM-5 in the double-class exposed setting,
MagnetisMM-6 in newly diagnosed patients who are ineligible for
stem cell transplant, MagnetisMM-7 in newly diagnosed patients
after transplant, and MagnetisMM-32 in patients with prior
anti-CD38-directed therapy.
About MagnetisMM-3
MagnetisMM-3 is an open-label, multicenter, non-randomized Phase
2 study of ELREXFIO monotherapy in participants with multiple
myeloma who are refractory to at least one proteasome inhibitor,
one immunomodulatory drug, and one anti-cluster of differentiation
38 antibody. The study enrolled two cohorts of participants: one
with and one without prior treatment with a B-cell maturation
antigen-directed antibody-drug conjugate or chimeric antigen
receptor T-cell therapy. Participants received subcutaneous
ELREXFIO as two step-up priming doses followed by a weekly 76 mg
injection. The primary endpoint is objective response rate as
assessed by Blinded Independent Central Review (BICR). Key
secondary endpoints include duration of response, progression-free
survival, minimal residual disease negativity rate, overall
survival, and safety. For more information about the trial, visit
www.clinicaltrials.gov (NCT04649359).
About Multiple Myeloma
Multiple myeloma (MM) is an aggressive and currently incurable
blood cancer that affects plasma cells made in the bone marrow.
Healthy plasma cells make antibodies that help the body fight
infection.1 MM is the second most common type of blood cancer, with
over 50,000 new cases diagnosed annually in Europe and over 187,000
new cases diagnosed globally each year.2,3 About 40% of those
diagnosed with MM won’t survive beyond five years,4 and most will
receive 4 or more lines of therapy due to relapse.5 While disease
trajectory varies for each person, relapses are nearly inevitable.6
The goal of therapy for people with relapsing or refractory MM is
to achieve disease control with acceptable toxicity and improved
quality of life.7
About ELREXFIO (elranatamab-bcmm)
ELREXFIO is a subcutaneously delivered B-cell maturation antigen
(BCMA)-cluster of differentiation (CD)3-directed bispecific
antibody immunotherapy that binds to BCMA on myeloma cells and CD3
on T cells, activating the T cells to kill myeloma cells.
U.S. INDICATION
ELREXFIO may cause side effects that are serious,
life-threatening, or can lead to death, including cytokine release
syndrome (CRS) and neurologic problems. CRS is common during
treatment with ELREXFIO.
Tell your healthcare provider or get medical help right away
if you develop any signs or symptoms of CRS or neurologic problems,
including:
- fever of 100.4°F (38°C) or higher
- trouble breathing
- chills
- dizziness or light-headedness
- fast heartbeat
- headache
- increased liver enzymes in your blood
- agitation, trouble staying awake, confusion or disorientation,
or seeing or hearing things that are not real (hallucinations)
- trouble speaking, thinking, remembering things, paying
attention, or understanding things
- problems walking, muscle weakness, shaking (tremors), loss of
balance, or muscle spasms
- numbness and tingling (feeling like “pins and needles”)
- burning, throbbing, or stabbing pain
- changes in your handwriting
Due to the risk of CRS, you will receive ELREXFIO on a
“step-up” dosing schedule and should be hospitalized for 48 hours
after the first “step-up” dose and for 24 hours after the second
“step-up” dose of ELREXFIO.
- For your first dose, you will receive a smaller “step-up” dose
of ELREXFIO on day 1
- For your second dose, you will receive a larger “step-up” dose
of ELREXFIO, which is usually given on day 4 of treatment
- For your third dose, you will receive the first “treatment”
dose of ELREXFIO, which is usually given on day 8
If your dose of ELREXFIO is delayed for any reason, you may need
to repeat step-up dosing. Before each dose of ELREXFIO you receive
during the step-up dosing schedule, you will receive medicines to
help reduce your risk of CRS. Your healthcare provider will decide
if you need to receive medicines to help reduce your risk of CRS
with future doses.
ELREXFIO is available only through the ELREXFIO Risk
Evaluation and Mitigation Strategy (REMS) Program due to the risk
of CRS and neurologic problems. You will receive an ELREXFIO
Patient Wallet Card from your healthcare provider. Carry the
ELREXFIO Patient Wallet Card with you at all times and show it to
all of your healthcare providers. The ELREXFIO Patient Wallet
Card lists signs and symptoms of CRS and neurologic problems.
Get medical help right away if you develop any of the signs and
symptoms listed on the ELREXFIO Patient Wallet Card. You may
need to be treated in a hospital.
Before taking ELREXFIO, tell your healthcare provider about
all of your medical conditions, including if you:
- have an infection
- are pregnant or plan to become pregnant. ELREXFIO may harm your
unborn baby. Females who are able to become pregnant should
do a pregnancy test before starting treatment with ELREXFIO and
should use effective birth control during treatment and for four
months after your last dose of ELREXFIO. Tell your healthcare
provider right away if you become pregnant or think that you may be
pregnant during treatment with ELREXFIO
- are breastfeeding or plan to breastfeed. It is not known if
ELREXFIO passes into your breast milk. Do not breastfeed during
treatment and for four months after your last dose of ELREXFIO
Tell your healthcare provider about all of the medications
you take, including prescription and over-the-counter
medications, vitamins, and herbal supplements.
Do not drive, operate heavy or potentially dangerous
machinery, or do other dangerous activities during treatment with
ELREXFIO:
- for 48 hours after completing each of the 2 doses of ELREXFIO
that are part of the “step-up dosing schedule” and your first full
treatment dose, and
- at any time during treatment with ELREXFIO if you develop any
new neurologic symptoms, such as dizziness, confusion, shaking
(tremors), sleepiness, or any other symptom that impairs
consciousness, until the symptoms go away
Infections: Upper respiratory tract infection and
pneumonia are common during treatment with ELREXFIO. ELREXFIO can
cause bacterial and viral infections that are severe,
life-threatening, or that may lead to death.
- Your healthcare provider may prescribe medications for you to
help prevent infections and treat you as needed if you develop an
infection during treatment with ELREXFIO
- Tell your healthcare provider right away if you develop any
signs or symptoms of an infection during treatment with ELREXFIO,
including: fever of 100.4°F (38°C) or higher, chills, cough,
shortness of breath, chest pain, sore throat, pain during
urination, or feeling weak or generally unwell
- People with active infections should not start ELREXFIO
Decreased white blood cell counts: Decreased white blood
cell counts are common during treatment with ELREXFIO and can also
be severe. A fever can occur with low white blood cell counts and
may be a sign that you have an infection. Your healthcare provider
will treat you as needed.
Liver problems: ELREXFIO can cause increased liver
enzymes and bilirubin in your blood. These increases can happen
with or without you also having CRS. Tell your healthcare provider
if you develop any of the following signs or symptoms of a liver
problem, including:
- tiredness
- loss of appetite
- pain in your right upper stomach-area
- dark urine
- yellowing of your skin or the white part of your eyes
The most common side effects of ELREXFIO include:
- tiredness
- injection site reaction, such as redness, itching, pain,
bruising, rash, swelling, and tenderness
- diarrhea
- muscle and bone pain
- decreased appetite
The most common severe abnormal lab test results with ELREXFIO
include decreased white blood cells, red blood cells, and
platelets.
Your healthcare provider may temporarily or permanently stop
ELREXFIO if you have any of the side effects listed and they are
severe. These are not all of the possible side effects of
ELREXFIO.
Call your healthcare provider for medical advice about side
effects. You may report side effects to the U.S. Food and Drug
Administration (FDA) at 1-800-FDA-1088.
What is ELREXFIO?
ELREXFIO is a prescription medication used to treat adults with
multiple myeloma who:
- have already received at least 4 treatment regimens, including
a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38
monoclonal antibody, to treat their multiple myeloma,
and
- their cancer has come back or did not respond to prior
treatment
ELREXFIO was approved based on patient responses and durability
of response. There are ongoing studies to confirm its clinical
benefit. It is not known if ELREXFIO is safe and effective in
children.
Please read full Prescribing Information,
including BOXED WARNING, for ELREXFIO.
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: 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 June 14,
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
Oncology and ELREXFIO (elranatamab-bcmm), a B-cell maturation
antigen (BCMA) CD3-directed bispecific antibody, including its
potential benefits and the MagnetisMM clinical program, 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 ELREXFIO;
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 drug applications for any potential indications
for ELREXFIO may be filed in any particular 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 ELREXFIO 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 ELREXFIO; 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.
References
1 Multiple Myeloma Research Foundation (MMRF). What is Multiple
Myeloma? Available from: https://themmrf.org/multiple-myeloma/
[Last accessed: April 2024]. 2 Myeloma Patients Europe. Myeloma A
Patients Guide; Updated May 2022. Available from:
https://www.mpeurope.org/wp-content/uploads/2023/01/Myeloma-Patients-Guide.pdf
[Last accessed: April 2024]. 3 World Health Organization. Globocan
2020: Multiple Myeloma. Available from:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf
[Last accessed: April 2024]. 4 National Cancer Institute.
Surveillance, Epidemiology, and End Results Program. Cancer Stat
Facts: Myeloma. Available from:
https://seer.cancer.gov/statfacts/html/mulmy.html [Last accessed:
April 2024]. 5 Mikhael, J, Ismaila N, Cheung M, et al. Treatment of
multiple myeloma: ASCO and CCO joint clinical practice guideline. J
Clin Oncol. 2019;37(14):1228–1263. 6 Dimopoulos MA, Richardson P,
Lonial S. Treatment options for patients with heavily pretreated
relapsed and refractory multiple myeloma. Clin Lymphoma Myeloma
Leuk. 2022;22(7):460–473. doi:10.1016/j.clml.2022.01.011 7
Bazarbachi AH, Al Hamed R, Malard F, et al. Relapsed refractory
multiple myeloma: a comprehensive overview. Leukemia.
2019;33(10):2343–2357.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240612153378/en/
Media Contact: +44 (0) 1737-332-335 EUPress@pfizer.com Investor
Contact: +1 (212) 733-4848 IR@Pfizer.com
Pfizer (NYSE:PFE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Sep 2023 to Sep 2024