FDA ODAC votes 11 to 0 supporting favorable
risk-benefit assessment of CARVYKTI based on results from the Phase
3 CARTITUDE-4 study
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a
global leader in cell therapy, announced today that the U.S. Food
and Drug Administration (FDA) Oncologic Drugs Advisory Committee
(ODAC) recommended CARVYKTI® (ciltacabtagene autoleucel, cilta-cel)
for the treatment of adult patients with relapsed or refractory
multiple myeloma who have received at least one prior line of
therapy including a proteasome inhibitor (PI) and an
immunomodulatory agent (IMiD) and are refractory to lenalidomide.
The positive recommendation follows the committee’s evaluation of
efficacy and safety data from the Phase 3 CARTITUDE-4 study. The
committee voted unanimously in favor of CARVYKTI (11 to 0) finding
the risk-benefit assessment of cilta-cel for the proposed
indication as favorable. A supplemental Biologics License
Application (sBLA) supported by the CARTITUDE-4 study is currently
under review by the FDA with a target Prescription Drug User Fee
Act (PDUFA) date of April 5, 2024.
“The advisory committee’s positive recommendation for CARVYKTI®
brings us one step closer to helping more patients fighting
relapsed and refractory multiple myeloma,” said Ying Huang, Ph.D.,
Chief Executive Officer of Legend Biotech. “We are committed to
improving the lives of patients with multiple myeloma, and we’re
excited by the prospect of bringing our innovative therapy to
patients earlier in the course of their disease.”
The committee reviewed results from the CARTITUDE-4 study
(NCT04181827), the first randomized Phase 3 study evaluating the
efficacy and safety of CARVYKTI® versus pomalidomide, bortezomib
and dexamethasone (PVd) or daratumumab, pomalidomide and
dexamethasone (DPd) in the treatment of patients with relapsed and
lenalidomide-refractory multiple myeloma who have received one to
three prior lines of therapy.1
Outcomes from the Phase 3 CARTITUDE-4 study were first presented
at the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting. These study results also supported the recent European
Medicines Agency (EMA) Committee for Medicinal Products for Human
Use (CHMP) positive opinion for CARVYKTI® in adult patients with
relapsed or refractory multiple myeloma who have received at least
one prior line of therapy including a proteasome inhibitor (PI) and
an immunomodulatory agent (IMiD), have demonstrated disease
progression on the last therapy and are refractory to
lenalidomide.
The ODAC is assembled upon request from the FDA to review and
evaluate safety and efficacy data of human drug products for use in
the treatment of oncologic diseases. The committee provides
non-binding recommendations based on its evaluation; final
decisions on approval of the drug are made by the FDA.
CARVYKTI® INDICATIONS AND USAGE
CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation
antigen (BCMA)-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult patients with
relapsed or refractory multiple myeloma, after four or more prior
lines of therapy, including a proteasome inhibitor, an
immunomodulatory agent, and an anti-CD38 monoclonal antibody.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE
SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT
CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES
Cytokine Release Syndrome (CRS),
including fatal or life-threatening reactions, occurred in patients
following treatment with CARVYKTI®. Do not administer CARVYKTI® to
patients with active infection or inflammatory disorders. Treat
severe or life-threatening CRS with tocilizumab or tocilizumab and
corticosteroids. Immune Effector Cell-Associated
Neurotoxicity Syndrome (ICANS), which may be fatal or
life-threatening, occurred following treatment with CARVYKTI®,
including before CRS onset, concurrently with CRS, after CRS
resolution, or in the absence of CRS. Monitor for neurologic events
after treatment with CARVYKTI®. Provide supportive care and/or
corticosteroids as needed. Parkinsonism and Guillain-Barré
syndrome and their associated complications resulting in fatal or
life-threatening reactions have occurred following treatment with
CARVYKTI®.
Hemophagocytic
Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS),
including fatal and life-threatening reactions, occurred in
patients following treatment with CARVYKTI®. HLH/MAS can occur with
CRS or neurologic toxicities.
Prolonged and/or recurrent cytopenias
with bleeding and infection and requirement for stem cell
transplantation for hematopoietic recovery occurred following
treatment with CARVYKTI®.
Secondary hematological malignancies,
including myelodysplastic syndrome and acute myeloid leukemia, have
occurred following treatment with CARVYKTI®.
CARVYKTI® is available only through a
restricted program under a Risk Evaluation and Mitigation Strategy
(REMS) called the CARVYKTI® REMS Program.
WARNINGS AND PRECAUTIONS
CYTOKINE RELEASE SYNDROME (CRS) including fatal or
life-threatening reactions, occurred following treatment with
CARVYKTI® in 95% (92/97) of patients receiving ciltacabtagene
autoleucel. Grade 3 or higher CRS (2019 ASTCT grade) occurred in 5%
(5/97) of patients, with Grade 5 CRS reported in 1 patient. The
median time to onset of CRS was 7 days (range: 1-12 days). The most
common manifestations of CRS included pyrexia (100%), hypotension
(43%), increased aspartate aminotransferase (AST) (22%), chills
(15%), increased alanine aminotransferase (ALT) (14%) and sinus
tachycardia (11%). Grade 3 or higher events associated with CRS
included increased AST and ALT, hyperbilirubinemia, hypotension,
pyrexia, hypoxia, respiratory failure, acute kidney injury,
disseminated intravascular coagulation and hemorrhage, HLH/MAS,
angina pectoris, supraventricular and ventricular tachycardia,
malaise, myalgias, increased C-reactive protein, ferritin, blood
alkaline phosphatase and gamma-glutamyl transferase.
Identify CRS based on clinical presentation. Evaluate for and
treat other causes of fever, hypoxia, and hypotension. CRS has been
reported to be associated with findings of HLH/MAS, and the
physiology of the syndromes may overlap. HLH/MAS is a potentially
life-threatening condition. In patients with progressive symptoms
of CRS or refractory CRS despite treatment, evaluate for evidence
of HLH/MAS. One patient with CRS and suspected HLH/MAS developed a
fatal retroperitoneal hemorrhage in the setting of
thrombocytopenia, coagulopathy, and anticoagulation in another
ongoing study of CARVYKTI®.
Sixty-nine of 97 (71%) patients received tocilizumab and/or a
corticosteroid for CRS after infusion of ciltacabtagene autoleucel.
Forty-four (45%) patients received only tocilizumab, of whom 33
(34%) received a single dose and 11 (11%) received more than one
dose; 24 patients (25%) received tocilizumab and a corticosteroid,
and one patient (1%) received only corticosteroids. Ensure that a
minimum of two doses of tocilizumab are available prior to infusion
of CARVYKTI®.
Monitor patients at least daily for 10 days following CARVYKTI®
infusion at a REMS-certified healthcare facility for signs and
symptoms of CRS. Monitor patients for signs or symptoms of CRS for
at least 4 weeks after infusion. At the first sign of CRS,
immediately institute treatment with supportive care, tocilizumab,
or tocilizumab and corticosteroids.
Counsel patients to seek immediate medical attention should
signs or symptoms of CRS occur at any time.
NEUROLOGIC TOXICITIES, which may be severe,
life-threatening, or fatal, occurred following treatment with
CARVYKTI®. Neurologic toxicities included ICANS, neurologic
toxicity with signs and symptoms of parkinsonism, Guillain-Barré
Syndrome, immune mediated myelitis, peripheral neuropathies, and
cranial nerve palsies. Counsel patients on the signs and symptoms
of these neurologic toxicities, and on the delayed nature of onset
of some of these toxicities. Instruct patients to seek immediate
medical attention for further assessment and management if signs or
symptoms of any of these neurologic toxicities occur at any
time.
Overall, one or more subtypes of neurologic toxicity described
below occurred following ciltacabtagene autoleucel in 26% (25/97)
of patients, of which 11% (11/97) of patients experienced Grade 3
or higher events. These subtypes of neurologic toxicities were also
observed in two ongoing studies.
Immune Effector Cell-Associated
Neurotoxicity Syndrome (ICANS): Patients may experience
fatal or life-threatening ICANS following treatment with CARVYKTI®,
including before CRS onset, concurrently with CRS, after CRS
resolution, or in the absence of CRS. ICANS occurred in 23% (22/97)
of patients receiving ciltacabtagene autoleucel including Grade 3
or 4 events in 3% (3/97) and Grade 5 (fatal) events in 2% (2/97).
The median time to onset of ICANS was 8 days (range 1-28 days). All
22 patients with ICANS had CRS. The most frequent (≥5%)
manifestation of ICANS included encephalopathy (23%), aphasia (8%)
and headache (6%).
Monitor patients at least daily for 10 days following CARVYKTI®
infusion at the REMS-certified healthcare facility for signs and
symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor
patients for signs or symptoms of ICANS for at least 4 weeks after
infusion and treat promptly. Neurologic toxicity should be managed
with supportive care and/or corticosteroids as needed.
Parkinsonism: Of the 25 patients in
the CARTITUDE-1 study experiencing any neurotoxicity, six male
patients had neurologic toxicity with several signs and symptoms of
parkinsonism, distinct from immune effector cell-associated
neurotoxicity syndrome (ICANS). Neurologic toxicity with
parkinsonism has been reported in other ongoing trials of
ciltacabtagene autoleucel. Patients had parkinsonian and
non-parkinsonian symptoms that included tremor, bradykinesia,
involuntary movements, stereotypy, loss of spontaneous movements,
masked facies, apathy, flat affect, fatigue, rigidity, psychomotor
retardation, micrographia, dysgraphia, apraxia, lethargy,
confusion, somnolence, loss of consciousness, delayed reflexes,
hyperreflexia, memory loss, difficulty swallowing, bowel
incontinence, falls, stooped posture, shuffling gait, muscle
weakness and wasting, motor dysfunction, motor and sensory loss,
akinetic mutism, and frontal lobe release signs. The median onset
of parkinsonism in the 6 patients in CARTITUDE-1 was 64 days (range
14-914 days) from infusion of ciltacabtagene autoleucel.
Monitor patients for signs and symptoms of parkinsonism that may
be delayed in onset and managed with supportive care measures.
There is limited efficacy information with medications used for the
treatment of Parkinson’s disease, for the improvement or resolution
of parkinsonism symptoms following CARVYKTI® treatment.
Guillain-Barré Syndrome: A fatal
outcome following Guillain-Barré Syndrome (GBS) has occurred in
another ongoing study of ciltacabtagene autoleucel despite
treatment with intravenous immunoglobulin (IVIG). Symptoms reported
include those consistent with Miller-Fisher variant of GBS,
encephalopathy, motor weakness, speech disturbances and
polyradiculoneuritis.
Monitor for GBS. Evaluate patients presenting with peripheral
neuropathy for GBS. Consider treatment of GBS with supportive care
measures and in conjunction with immunoglobulin and plasma
exchange, depending on severity of GBS.
Immune Mediated Myelitis: Grade 3
myelitis has occurred 25 days following treatment in another
ongoing study. Symptoms reported included hypoesthesia of the lower
extremities and the lower abdomen with impaired sphincter control.
Symptoms improved with the use of corticosteroids and intravenous
immune globulin. Myelitis was ongoing at the time of death from
other cause.
Peripheral Neuropathy: Seven
patients in CARTITUDE-1 developed peripheral neuropathy. These
neuropathies presented as sensory, motor, or sensorimotor
neuropathies. Median time of onset of symptoms was 66 days (range
4-914 days), median duration of peripheral neuropathies was 138
days (range 2-692 days) including those with ongoing neuropathy.
Patients who experienced peripheral neuropathy also experienced
cranial nerve palsies or GBS in other ongoing trials of
ciltacabtagene autoleucel. Monitor patients for signs and symptoms
of peripheral neuropathies.
Cranial Nerve Palsies: Three
patients (3.1%) experienced cranial nerve palsies in CARTITUDE-1.
All three patients had 7th cranial nerve palsy; one patient had 5th
cranial nerve palsy as well. Median time to onset was 26 days
(range 21-101 days) following infusion of ciltacabtagene
autoleucel. Occurrence of 3rd and 6th cranial nerve palsy,
bilateral 7th cranial nerve palsy, worsening of cranial nerve palsy
after improvement, and occurrence of peripheral neuropathy in
patients with cranial nerve palsy have also been reported in
ongoing trials of ciltacabtagene autoleucel. Monitor patients for
signs and symptoms of cranial nerve palsies. Consider management
with systemic corticosteroids, depending on the severity and
progression of signs and symptoms.
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE
ACTIVATION SYNDROME (MAS): Fatal HLH occurred in one patient
(1%), 99 days after ciltacabtagene autoleucel. The HLH event was
preceded by prolonged CRS lasting 97 days. The manifestations of
HLH/MAS include hypotension, hypoxia with diffuse alveolar damage,
coagulopathy, cytopenia, and multi-organ dysfunction, including
renal dysfunction.
One patient with Grade 4 HLH/MAS developed fatal intracerebral
and gastrointestinal hemorrhage in the setting of coagulopathy and
thrombocytopenia 12 days after treatment in another ongoing study.
Patients who develop HLH/MAS have an increased risk of severe
bleeding. Monitor hematological parameters in patients with HLH/MAS
and transfuse per institutional guidelines.
HLH is a life-threatening condition with a high mortality rate
if not recognized and treated early. Treatment of HLH/MAS should be
administered per institutional standards.
CARVYKTI® REMS: Because of the risk of CRS and neurologic
toxicities, CARVYKTI® is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS)
called the CARVYKTI® REMS.
Further information is available at https://www.carvyktirems.com
or 1-844-672-0067.
PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit
prolonged and recurrent cytopenias following lymphodepleting
chemotherapy and CARVYKTI® infusion. One patient underwent
autologous stem cell therapy for hematopoietic reconstitution due
to prolonged thrombocytopenia.
In CARTITUDE-1, 30% (29/97) of patients experienced prolonged
Grade 3 or 4 neutropenia and 41% (40/97) of patients experienced
prolonged Grade 3 or 4 thrombocytopenia that had not resolved by
Day 30 following ciltacabtagene autoleucel infusion.
Recurrent Grade 3 or 4 neutropenia, thrombocytopenia,
lymphopenia, and anemia were seen in 63% (61/97), 19% (18/97), 60%
(58/97), and 37% (36/97) after recovery from initial Grade 3 or 4
cytopenia following infusion. After Day 60 following ciltacabtagene
autoleucel infusion, 31%, 12% and 6% of patients had a recurrence
of Grade 3 or higher lymphopenia, neutropenia, and
thrombocytopenia, respectively, after initial recovery of their
Grade 3 or 4 cytopenia. Eighty-seven percent (84/97) of patients
had one, two, or three or more recurrences of Grade 3 or 4
cytopenias after initial recovery of Grade 3 or 4 cytopenia. Eight
and 12 patients had Grade 3 or 4 neutropenia and thrombocytopenia,
respectively, at the time of death.
Monitor blood counts prior to and after CARVYKTI® infusion.
Manage cytopenias with growth factors and blood product transfusion
support according to local institutional guidelines.
INFECTIONS: CARVYKTI® should not be administered to
patients with active infection or inflammatory disorders. Severe,
life-threatening, or fatal infections occurred in patients after
CARVYKTI® infusion.
Infections (all grades) occurred in 57 (59%) patients. Grade 3
or 4 infections occurred in 21% (20/97) of patients; Grade 3 or 4
infections with an unspecified pathogen occurred in 15%, viral
infections in 7%, bacterial infections in 1%, and fungal infections
in 1% of patients. Overall, 5 patients had Grade 5 infections: lung
abscess (n=1), sepsis (n=3) and pneumonia (n=1).
Grade 5 infections reported in other studies include
bronchopulmonary aspergillosis, pneumocystis jirovecii pneumonia,
and CMV colitis (with HSV-1 hepatitis). Another patient developed
mycotic aneurysm due to cerebral aspergillosis and died of
subarachnoid hemorrhage.
Monitor patients for signs and symptoms of infection before and
after CARVYKTI® infusion and treat patients appropriately.
Administer prophylactic, pre-emptive and/or therapeutic
antimicrobials according to the standard institutional guidelines.
Febrile neutropenia was observed in 10% of patients after
ciltacabtagene autoleucel 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.
In a randomized controlled study of relapsed or refractory
multiple myeloma (CARTITUDE-4), patients treated with
ciltacabtagene autoleucel had an increased rate of fatal COVID-19
infections compared to the standard therapy arm. Counsel patients
on the importance of prevention measures. Follow institutional
guidelines for the vaccination and management of immunocompromised
patients with COVID-19.
Viral Reactivation: Hepatitis B virus (HBV) reactivation, in
some cases resulting in fulminant hepatitis, hepatic failure and
death, can occur in patients with hypogammaglobulinemia. Perform
screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV),
and human immunodeficiency virus (HIV), or any other infectious
agents if clinically indicated in accordance with clinical
guidelines before collection of cells for manufacturing. Consider
antiviral therapy to prevent viral reactivation per local
institutional guidelines/clinical practice.
HYPOGAMMAGLOBULINEMIA was reported as an adverse event in
12% (12/97) of patients; laboratory IgG levels fell below 500 mg/dL
after infusion in 92% (89/97) of patients. Monitor immunoglobulin
levels after treatment with CARVYKTI® and administer IVIG for IgG
<400 mg/dL. Manage per local institutional guidelines, including
infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of
immunization with live viral vaccines during or following CARVYKTI®
treatment has not been studied. Vaccination with live virus
vaccines is not recommended for at least 6 weeks prior to the start
of lymphodepleting chemotherapy, during CARVYKTI® treatment, and
until immune recovery following treatment with CARVYKTI®.
HYPERSENSITIVITY REACTIONS have occurred in 5% (5/97) of
patients following ciltacabtagene autoleucel infusion. Serious
hypersensitivity reactions, including anaphylaxis, may be due to
the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be
carefully monitored for 2 hours after infusion for signs and
symptoms of severe reaction. Treat promptly and manage
appropriately according to the severity of the hypersensitivity
reaction.
SECONDARY MALIGNANCIES: Patients treated with CARVYKTI®
may develop secondary malignancies. Myeloid neoplasms (five cases
of myelodysplastic syndrome, three cases of acute myeloid leukemia
and two cases of myelodysplastic syndrome followed by acute myeloid
leukemia) occurred in 10% (10/97) of patients in CARTITUDE-1 study
following treatment with CARVYKTI®. The median time to onset of
myeloid neoplasms was 485 days (range: 162 to 1040 days) after
treatment with CARVYKTI®. Nine of these 10 patients died following
the development of myeloid neoplasms; four of the 10 cases of
myeloid neoplasm occurred after initiation of subsequent
antimyeloma therapy. Cases of myelodysplastic syndrome and acute
myeloid leukemia have also been reported in the post marketing
setting. Monitor life-long for secondary malignancies. In the event
that a secondary malignancy occurs, contact Janssen Biotech, Inc.,
at 1-800-526-7736 for reporting and to obtain instructions on
collection of patient samples.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the
potential for neurologic events, including altered mental status,
seizures, neurocognitive decline, or neuropathy, patients are at
risk for altered or decreased consciousness or coordination in the
8 weeks following CARVYKTI® infusion. Advise patients to refrain
from driving and engaging in hazardous occupations or activities,
such as operating heavy or potentially dangerous machinery during
this initial period, and in the event of new onset of any
neurologic toxicities.
ADVERSE REACTIONS
The most common non-laboratory adverse reactions (incidence
greater than 20%) are pyrexia, cytokine release syndrome,
hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue,
infections of unspecified pathogen, cough, chills, diarrhea,
nausea, encephalopathy, decreased appetite, upper respiratory tract
infection, headache, tachycardia, dizziness, dyspnea, edema, viral
infections, coagulopathy, constipation, and vomiting. The most
common laboratory adverse reactions (incidence greater than or
equal to 50%) include thrombocytopenia, neutropenia, anemia,
aminotransferase elevation, and hypoalbuminemia.
Please read full Prescribing Information, including Boxed
Warning, for CARVYKTI®.
ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL;
CILTA-CEL)
Ciltacabtagene autoleucel is a BCMA-directed, genetically
modified autologous T-cell immunotherapy, which involves
reprogramming a patient’s own T-cells with a transgene encoding a
chimeric antigen receptor (CAR) that identifies and eliminates
cells that express BCMA. The cilta-cel CAR protein features two
BCMA-targeting single domain antibodies designed to confer high
avidity against human BCMA. Upon binding to BCMA-expressing cells,
the CAR promotes T-cell activation, expansion, and elimination of
target cells.2
In December 2017, Legend Biotech entered into an exclusive
worldwide license and collaboration agreement with Janssen Biotech,
Inc. (Janssen), a Johnson & Johnson company, to develop and
commercialize cilta-cel. In February 2022, cilta-cel was approved
by the U.S. Food and Drug Administration (FDA) under the brand name
CARVYKTI® for the treatment of adults with relapsed or refractory
multiple myeloma. In May 2022, the European Commission (EC) granted
conditional marketing authorization of CARVYKTI® for the treatment
of adults with relapsed and refractory multiple myeloma. In
September 2022, Japan’s Ministry of Health, Labour and Welfare
(MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough
Therapy Designation in the U.S. in December 2019 and in China in
August 2020. In addition, cilta-cel received a PRIority MEdicines
(PRIME) designation from the European Commission in April 2019.
Cilta-cel also received Orphan Drug Designation from the U.S. FDA
in February 2019, from the European Commission in February 2020,
and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in
Japan in June 2020. In March 2022, the European Medicines Agency’s
Committee for Orphan Medicinal Products recommended by consensus
that the orphan designation for cilta-cel be maintained on the
basis of clinical data demonstrating improved and sustained
complete response rates following treatment.
ABOUT CARTITUDE-4
CARTITUDE-4 (NCT04181827) is an ongoing, international,
randomized, open-label Phase 3 study evaluating the efficacy and
safety of cilta-cel versus pomalidomide, bortezomib and
dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone
(DPd) in adult patients with relapsed and lenalidomide-refractory
multiple myeloma who received one to three prior lines of therapy,
including a PI and an IMiD. The primary endpoint of the study was
progression-free survival.3
ABOUT MULTIPLE MYELOMA
Multiple myeloma is an incurable blood cancer that starts in the
bone marrow and is characterized by an excessive proliferation of
plasma cells.4 In 2024, it is estimated that more than 35,000
people will be diagnosed with multiple myeloma, and more than
12,000 people will die from the disease in the U.S.5 While some
patients with multiple myeloma initially have no symptoms, most
patients are diagnosed due to symptoms that can include bone
problems, low blood counts, calcium elevation, kidney problems or
infections.6
ABOUT LEGEND BIOTECH
Legend Biotech is a global biotechnology company dedicated to
treating, and one day curing, life-threatening diseases.
Headquartered in Somerset, New Jersey, we are developing advanced
cell therapies across a diverse array of technology platforms,
including autologous and allogeneic chimeric antigen receptor
T-cell, gamma-delta T cell (gd T) and natural killer (NK)
cell-based immunotherapy. From our three R&D sites around the
world, we apply these innovative technologies to pursue the
discovery of cutting-edge therapeutics for patients worldwide.
Learn more at www.legendbiotech.com and follow us on X (formerly
Twitter) and LinkedIn.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, constitute “forward-looking
statements” within the meaning of The Private Securities Litigation
Reform Act of 1995. These statements include, but are not limited
to, statements relating to Legend Biotech’s strategies and
objectives; statements relating to CARVYKTI®, including Legend
Biotech’s expectations for CARVYKTI®; statements relating to the
potential approval of CARVYKTI® for the treatment of adult patients
with relapsed or refractory multiple myeloma who have received at
least one prior line of therapy including a proteasome inhibitor
and an immunomodulatory agent and are refractory to lenalidomide;
statements about submissions for CARVYKTI®, and the progress of
such submissions with the U.S. Food and Drug Administration (FDA)
and other regulatory authorities; and the potential benefits of
Legend Biotech’s product candidates. The words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors. Legend Biotech’s expectations could be affected by, among
other things, uncertainties involved in the development of new
pharmaceutical products; unexpected clinical trial results,
including as a result of additional analysis of existing clinical
data or unexpected new clinical data; unexpected regulatory actions
or delays, including requests for additional safety and/or efficacy
data or analysis of data, or government regulation generally;
unexpected delays as a result of actions undertaken, or failures to
act, by our third party partners; uncertainties arising from
challenges to Legend Biotech’s patent or other proprietary
intellectual property protection, including the uncertainties
involved in the U.S. litigation process; government, industry, and
general product pricing and other political pressures; as well as
the other factors discussed in the “Risk Factors” section of Legend
Biotech’s Annual Report on Form 20-F filed with the Securities and
Exchange Commission on March 30, 2023. Should one or more of these
risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those described in this press release as anticipated,
believed, estimated or expected. Any forward-looking statements
contained in this press release speak only as of the date of this
press release. Legend Biotech specifically disclaims any obligation
to update any forward-looking statement, whether as a result of new
information, future events or otherwise.
REFERENCES
____________________ 1 ClinicalTrials.gov. A Study Comparing
JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation
Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone
(PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in
Participants With Relapsed and Lenalidomide-Refractory Multiple
Myeloma (CARTITUDE-4). Available at:
https://clinicaltrials.gov/study/NCT04181827. Accessed Nov 2023. 2
CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech,
Inc. 3 ClinicalTrials.gov. A Study Comparing JNJ-68284528, a CAR-T
Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab,
Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed
and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4).
Available at: https://clinicaltrials.gov/study/NCT04181827.
Accessed Nov 2023. 4 American Society of Clinical Oncology.
Multiple myeloma: introduction. Available at:
https://www.cancer.net/cancer-types/multiple-myeloma/introduction.
Accessed March 2023. 5 American Cancer Society. “Key Statistics
About Multiple Myeloma.” Available at:
https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women.
Accessed February 2024. 6 American Cancer Society. Multiple
myeloma: early detection, diagnosis, and staging. Available at:
https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf.
Accessed March 2023.
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INVESTOR CONTACT: Jessie Yeung Tel: (732) 956-8271
jessie.yeung@legendbiotech.com
PRESS CONTACT: Alexandra Ventura Tel: (732) 850-5598
media@legendbiotech.com
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