Approved for advanced MAGE-A4+synovial sarcoma
in adults with certain HLA types who have received prior
chemotherapy
TECELRA is the first new treatment option for
people with synovial sarcoma in more than a decade
Adaptimmune to hold webcast at
https://www.gowebcasting.com/13428 on August 2, at 8:00 a.m.
EDT
Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working
to redefine the treatment of solid tumor cancers with cell therapy,
today announced U.S. Food and Drug Administration (FDA) accelerated
approval of TECELRA® (afamitresgene autoleucel) for the treatment
of adults with unresectable or metastatic synovial sarcoma who have
received prior chemotherapy, are HLA-A*02:01P, -A*02:02P,
-A*02:03P, or -A*02:06P positive and whose tumor expresses the
MAGE-A4 antigen as determined by FDA-approved or cleared companion
diagnostic devices. This indication is approved under accelerated
approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial. TECELRA is the first engineered cell therapy for a solid
tumor cancer approved in the U.S., and the first new therapy option
in more than a decade for synovial sarcoma, a rare, soft tissue
cancer that most commonly impacts young adults.
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the full release here:
https://www.businesswire.com/news/home/20240801538240/en/
TECELRA (afamitresgene autoleucel)
logo
Adrian Rawcliffe, Adaptimmune's Chief Executive
Officer:
“The approval of TECELRA is a momentous step in Adaptimmune’s
journey to redefine the way cancer is treated and the culmination
of a decade of groundbreaking R&D. I want to thank the
patients, caregivers, investigators, and clinical teams as well as
everyone at Adaptimmune and our partners who made possible this
watershed moment for cell therapy and for people with synovial
sarcoma. We are committed to advancing our robust clinical pipeline
to serve more patients in need and plan to progress lete-cel, the
next late-stage investigational treatment in our sarcoma franchise,
with a rolling BLA submission to the FDA next year.”
The approval of TECELRA was based on results of the SPEARHEAD-1
(Cohort 1) trial, which included 44 patients. The major efficacy
outcome was overall response rate (ORR) determined by independent
review and supported by duration of response. TECELRA treatment
resulted in an ORR of 43% with a complete response rate of 4.5%.
The median duration of response was 6 months (95% CI: 4.6, not
reached). Among patients who were responsive to the treatment, 39%
had a duration of response of 12 months or longer.*
Data from the pivotal SPEARHEAD-1 trial were previously
published in The Lancet earlier this year.
With this approval, Adaptimmune is positioned to make a
significant impact on the synovial sarcoma community. HCPs can
begin testing patients, Adaptimmune systems are ready to take
TECELRA orders, and an integrated support program,
AdaptimmuneAssist, is available to enable a seamless and
personalized experience through the treatment journey. Adaptimmune
plans to have at least six to ten authorized treatment centers
(ATCs) up and running this year and to onboard approximately 30
treatment centers within the first two years. These ATCs are
recognized leaders in sarcoma research and treatment.
Brandi Felser, Chief Executive Officer, Sarcoma Foundation of
America:
“For decades, therapeutic options for people diagnosed with
synovial sarcoma have been limited. With a current five-year
survival rate as low as 36%, and for those with metastatic disease
at diagnosis, as low as 20%, it is long past time that synovial
sarcoma patients have expanded treatment options. Since one third
of patients are diagnosed under age 30, improved outcomes can have
a tremendous impact. Today, there is a renewed sense of hope for
this patient community.”
Sandra D’Angelo, MD, Sarcoma Medical Oncologist and Cell
Therapist, Memorial Sloan Kettering Cancer Center; SPEARHEAD Trial
Principal Investigator:
“TECELRA (afami-cel), which uses each patient’s own immune cells
to recognize and attack their cancer cells in a one-time infusion
treatment, is significantly different than the current standards of
care for advanced synovial sarcoma. This approval represents a
much-needed new option for people diagnosed with this sarcoma and
an important milestone for the use of cell therapies in solid tumor
cancers.”
TECELRA is contraindicated in adults who are heterozygous or
homozygous for HLA-A*02:05P.
TECELRA can cause serious side effects, including cytokine
release syndrome (CRS), immune effector cell–associated
neurotoxicity syndrome (ICANS), prolonged severe cytopenia,
infections, secondary malignancies, and hypersensitivity reactions.
Most common adverse reactions (incidence ≥20%) were CRS, nausea,
vomiting, fatigue, infections, pyrexia, constipation, dyspnea,
abdominal pain, non-cardiac chest pain, decreased appetite,
tachycardia, back pain, hypotension, diarrhea, edema, low white
blood cells, low red blood cells and low platelets. Please see
Important Safety Information, including Boxed Warning
below.
Biomarker tests for human leukocyte antigens (HLA) type and
melanoma-associated antigen A4 (MAGE-A4) tumor expression are
required prior to treatment with TECELRA. Adaptimmune has partnered
with Agilent Technologies for the development, manufacturing, and
supply of a companion diagnostic for the MAGE-A4 biomarker, MAGE-A4
IHC 1F9 pharmDx, which also received approval today from the U.S.
FDA and is now available. Additionally, the company partnered with
Thermo Fisher Scientific to expand the labeling of Thermo Fisher’s
companion diagnostic product SeCoreTM CDx HLA-A Locus Sequencing
System to include TECELRA and to aid in the identification of
HLA-A*02:01, A*02:02, A*02:03, and A*02:06-positive patients with
synovial sarcoma.
For more information about TECELRA visit
www.adaptimmune.com.
Conference Call Details
The Company will host a live webcast to provide additional
details tomorrow, August 2, 8:00 a.m. EDT. A live webcast of the
conference call and replay can be accessed here:
https://www.gowebcasting.com/13428. Call in information is as
follows: 1-844-763-8274 (TOLL FREE US or Canada) or
+1-647-484-8814 (International).
About Synovial Sarcoma
There are more than 50 different types of soft tissue sarcomas
which are categorized by tumors that appear in fat, muscle, nerves,
fibrous tissues, blood vessels, or deep skin tissues.1 Synovial
sarcoma accounts for approximately 5 to 10% of all soft tissue
sarcomas (there are approximately 13,400 new soft tissue cases in
the U.S. each year).1,2 One third of patients with synovial sarcoma
will be diagnosed under the age of 30.2 The five-year survival rate
for people with metastatic disease is approximately 20% and most
people undergoing standard of care treatment for advanced disease
experience recurrence and go through multiple lines of therapy,
often exhausting all options.1,3
About TECELRA
TECELRA® (afamitresgene autoleucel) is a melanoma-associated
antigen A4 (MAGE-A4)-directed genetically modified autologous T
cell immunotherapy indicated for the treatment of adults with
unresectable or metastatic synovial sarcoma who have received prior
chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P
positive and whose tumor expresses the MAGE-A4 antigen as
determined by FDA-approved or cleared companion diagnostic
devices.
This indication is approved under accelerated approval based on
overall response rate and durability of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION: DO NOT use TECELRA in adults who are
heterozygous or homozygous for HLA-A*02:05P.
BOXED WARNING: Cytokine release syndrome (CRS), which may be
severe or life-threatening, occurred in patients receiving TECELRA.
At the first sign of CRS, immediately evaluate patient for
hospitalization and institute treatment with supportive care.
Ensure that healthcare providers administering TECELRA have
immediate access to medications and resuscitative equipment to
manage CRS.
CRS
- CRS occurred in 75% of patients (2% Grade ≥3) with a median
onset of 2 days (range: 1 to 5 days) and median resolution of 3
days (range: 1 to 14 days). CRS (including Grade 1) was managed
with tocilizumab in 55% of patients who experienced CRS.
- In patients who experienced CRS, the most common symptoms
included fever, tachycardia, hypotension, nausea/vomiting, and
headache.
Immune Effector Cell–associated Neurotoxicity Syndrome
(ICANS)
- ICANS has been observed following administration of TECELRA.
One patient (2%) had Grade 1 ICANS with a median onset of 2 days
and resolution of 1 day.
- ICANS symptoms can include mental status changes,
disorientation to time and place, drowsiness, inattention, altered
level of consciousness, seizures, cerebral edema, impairment of
cognitive skills, progressive aphasia, and motor weakness.
- Advise patients to refrain from driving and engaging in
hazardous occupations or activities, such as operating heavy
machinery or potentially dangerous machinery for 4 weeks following
infusion due to the potential for neurologic events, including
dizziness and presyncope.
Monitoring for CRS and ICANS During and Following TECELRA
Infusion
- Ensure that healthcare providers administering TECELRA have
immediate access to medications and resuscitative equipment to
manage CRS and ICANS. Ensure patients are euvolemic prior to
initiating TECELRA.
- During and following TECELRA administration, closely monitor
patients for signs and symptoms of CRS and ICANS. Following
treatment with TECELRA, monitor patients for at least 7 days at the
healthcare facility. Continue to monitor patients for at least 4
weeks following treatment with TECELRA. Counsel patients to seek
medical attention should signs or symptoms of CRS or ICANS
occur.
- At the first sign of CRS or ICANS, immediately evaluate
patients for hospitalization and administer supportive care based
on severity and consider further management per clinical practice
guidelines.
Prolonged Severe Cytopenia
- Anemia, neutropenia, and/or thrombocytopenia can occur for
several weeks following lymphodepleting chemotherapy and TECELRA
infusion. Patients with Grade ≥3 cytopenia not resolved by week 4
included anemia (9%), neutropenia (11%), and thrombocytopenia (5%).
The median time to resolution was 7.3 weeks (range: 6.1 to 8.4
weeks) for anemia, 9.3 weeks (range: 6.4 to 12.3 weeks) for
neutropenia, and 6.3 weeks (range: 6.1 to 6.4 weeks) for
thrombocytopenia.
- Monitor blood counts after TECELRA infusion. Manage cytopenia
with growth factor and blood product transfusion according to
clinical practice guidelines.
Infections
- Infections may occur following lymphodepleting chemotherapy and
TECELRA infusion and occurred in 32% of patients (14% Grade
3).
- Do not administer TECELRA to patients with active infections
and/or inflammatory disorders.
- Monitor patients for signs and symptoms of infection before and
after TECELRA infusion and treat patients appropriately.
- Febrile neutropenia was observed in patients after TECELRA
infusion and may be concurrent with CRS. In the event of febrile
neutropenia, evaluate for infection and manage with broad-spectrum
antibiotics, fluids, and other supportive care, as medically
indicated.
- Viral reactivation has occurred in patients following TECELRA.
Perform screening for Epstein-Barr virus, cytomegalovirus,
hepatitis B virus, hepatitis C virus, and human immunodeficiency
virus (HIV) or any other infectious agents if clinically indicated.
Consider antiviral therapy to prevent viral reactivation per local
guidelines.
Secondary Malignancies
- Patients treated with TECELRA may develop secondary
malignancies or recurrence of their cancer. Monitor for secondary
malignancies.
Hypersensitivity Reactions
- Serious hypersensitivity reactions, including anaphylaxis, may
occur due to dimethyl sulfoxide (DMSO) in TECELRA. Observe patients
for hypersensitivity reactions during infusion.
Potential for HIV Nucleic Acid Test False-Positive
Results
- The lentiviral vector used to make TECELRA has limited, short
spans of genetic material that are identical to HIV. Therefore,
some commercial HIV nucleic acid tests may yield false-positive
results in patients who have received TECELRA.
Adverse Reactions
- Most common adverse reactions (incidence ≥20%) are CRS, nausea,
vomiting, fatigue, infections, pyrexia, constipation, dyspnea,
abdominal pain, non-cardiac chest pain, decreased appetite,
tachycardia, back pain, hypotension, diarrhea, and edema.
- Most common Grade 3 or 4 laboratory abnormalities (incidence
≥20%) were lymphocyte count decreased, neutrophil count decreased,
white cell blood count decreased, red blood cell decreased, and
platelet count decreased.
- Most common serious adverse reactions (≥5%) were CRS and
pleural effusion.
Please see full Prescribing Information,
including Boxed Warning and Medication Guide.
About AdaptimmuneAssist
An integrated support program, AdaptimmuneAssist is now
available to provide access support for patients, their caregivers,
and healthcare providers throughout the TECELRA treatment journey.
AdaptimmuneAssist includes connection with a Treatment Navigator,
travel and financial support programs for eligible patients, and
access to the AdaptimmuneAssist Order Portal (for healthcare
providers only). For more information, physicians and patients may
call 1-855-246-9232.
About Adaptimmune
Adaptimmune is a fully integrated cell therapy company working
to redefine how cancer is treated. With its unique engineered T
cell receptor (TCR) platform, the Company is developing
personalized medicines designed to target and destroy
difficult-to-treat solid tumor cancers and improve the patient’s
cancer treatment experience.
Forward-Looking Statements
This release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995
(PSLRA). Forward-looking statements address our expected future
business, financial performance, financial condition, as well as
the results of operations and often contain words such as
“anticipate” “believe,” “expect,” “may,” “plan,” “potential,”
“will,” and similar expressions, and are based on Adaptimmune’s
current beliefs and expectations. Such statements are based only
upon current expectations of Adaptimmune. Reliance should not be
placed on forward-looking statements because they involve certain
risks and uncertainties. Such risks and uncertainties could cause
our actual results to differ materially from those indicated by
such forward-looking statements, and include, without limitation:
the success, cost and timing of our product development activities
and clinical trials and our ability to successfully advance our TCR
therapeutic candidates through the regulatory and commercialization
processes. For a further description of the risks and uncertainties
that could cause our actual results to differ materially from those
expressed in these forward-looking statements, as well as risks
relating to our business in general, we refer you to our Annual
Report on Form 10-K filed with the Securities and Exchange
Commission for the year ended 31 December, 2023, our Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K, and other
filings with the Securities and Exchange Commission. The
forward-looking statements contained in this press release speak
only as of the date the statements were made and we do not
undertake any obligation to update such forward-looking statements
to reflect subsequent events or circumstances.
Dr. D’Angelo has financial interests related to
Adaptimmune.
1. “What is a Soft Tissue Sarcoma?” American Cancer Society.
https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/soft-tissue-sarcoma.html.
Accessed June 24, 2024. 2. “Soft Tissue Sarcoma.” Cleveland Clinic.
https://my.clevelandclinic.org/health/diseases/21732-soft-tissue-sarcoma.
Accessed June 24, 2024. 3. Jami SA, Mobarak SA, Jiandang S, et al.
Clinical and strategic outcomes of metastatic synovial sarcoma on
limb. Int J Health Sci(Qassim). 2020;14:38–43. *Per Kaplan-Meier
method
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version on businesswire.com: https://www.businesswire.com/news/home/20240801538240/en/
Investor Relations Juli P. Miller, Ph.D. - VP, Corporate
Affairs and Investor Relations T : +1 215 825 9310 M : +1 215 460
8920 Juli.Miller@adaptimmune.com
Media Relations Dana Lynch, Senior Director of Corporate
Communications M: +1 267 990 1217 Dana.Lynch@adaptimmune.com
Adaptimmune Therapeutics (NASDAQ:ADAP)
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Adaptimmune Therapeutics (NASDAQ:ADAP)
過去 株価チャート
から 12 2023 まで 12 2024
