Data from the investigational Phase 1b RedirecTT-1 study demonstrate a safety profile
consistent to TALVEY® and TECVAYLI®
monotherapies
RIO DE
JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) today announced updated results from the
investigational Phase 1b RedirecTT-1
study evaluating the first-ever bispecific antibody combination of
TALVEY® (talquetamab-tgvs), the first and only
FDA-approved bispecific targeting GPRC5D, and TECVAYLI®
(teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific
therapy, showing high response rates and durable responses, with a
consistent safety profile to each monotherapy, in patients with
relapsed or refractory multiple myeloma (RRMM) who were
triple-class exposed, including those with extramedullary disease.
These data were featured in an oral presentation at the 2024
International Myeloma Society Annual Meeting (Abstract # OA –
03).
"As multiple myeloma progresses, it becomes more difficult to
treat, especially in patients with extramedullary disease, which
spreads beyond the bone marrow and typically becomes resistant to
standard therapies," said Yael
Cohen, M.D., Head of Myeloma Unit, Hematology Institute, Tel
Aviv Sourasky Medical Center, Israel, and principal study investigator.*
"These results reflect promising efficacy and a manageable safety
profile for this combination of two first-in-class, innovative
bispecific therapies and provide a potentially promising
off-the-shelf option for patients with advanced multiple
myeloma."
At data cutoff, 44 patients had been treated with the
recommended phase 2 regimen (RP2R) of 0.8 mg/kg of TALVEY® in
combination with 3 mg/kg of TECVAYLI® every other week, the overall
response rate (ORR) was 79.5 percent, with a complete response or
better (CR+) rate of 52.3 percent, an 18-month duration of response
(DOR) of 85.9 percent, and an 18-month progression-free survival
(PFS) rate of 69.8 percent with median follow-up of 18.2
months.1
Results from a subgroup analysis of patients with extramedullary
disease (EMD; ≥1 bone-independent lesion of ≥2 cm), a patient
population often facing limited treatment options, demonstrated
meaningful ORR and DOR for bispecific antibody-based treatment. At
the RP2R (n=18), results showed an ORR of 61.1 percent, with CR+
rate of 33.3 percent, an 18-month DOR of 81.8 percent, and an
18-month PFS rate of 52.9 percent in patients with EMD at median
follow-up 13.6 months.1
The combination of TALVEY® and TECVAYLI®
had a safety profile that was consistent with the known safety
profiles of each agent as monotherapy. Cumulative incidence of
Grade 3/4 infections was slightly higher than that seen with either
agent as monotherapy but plateaued from six months, and
non-hematologic adverse events were generally low grade, including
taste (50 percent) and non-rash skin (56.8 percent) and nail (47.7
percent) AEs, with no discontinuations due to
cytopenias.1
"TALVEY and TECVAYLI have already demonstrated powerful efficacy
as standalone therapies as first-in-class bispecifics in the
clinical and real-world settings," said Jordan Schecter, M.D., Vice President, Disease
Area Leader, Multiple Myeloma, Innovative Medicine at Johnson &
Johnson. "We continue to research this innovative combination, as
this study demonstrates both the efficacy and manageable safety
profile of this combination, particularly in hard-to-treat patients
such as those with EMD, as well as the combinability of TALVEY with
other effective therapies."
Additional data underscoring the combinability of
TALVEY® from the TRIMM-2 study will also be
presented at IMS. First results from the RedirecTT-1 study were
presented at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting.
About RedirecTT
The RedirecTT-1 (NCT04586426) study is
an ongoing Phase 1b dose escalation
study of the combination of the bispecific T-cell redirection
antibodies TALVEY® and TECVAYLI® in patients
(n=208) with relapsed or refractory multiple myeloma. The primary
objective is to identify the recommended Phase 2 regimen(s)
(RP2R[s]) and schedule for the study treatment and to characterize
the safety of the RP2R(s) for the study treatment. In part 1,
patients will receive TALVEY® and TECVAYLI®
with or without daratumumab in 28-day cycles following initial
step-up doses. In part 2, patients will receive treatment doses
(combination of TALVEY® and
TECVAYLI® and daratumumab + TALVEY® +
TECVAYLI® regimens) which will be determined by the
recommended Phase 2 regimen (s) (RP2R[s]) of the study treatment
identified in Part 1. In part 3, patients will receive
TALVEY® + TECVAYLI® combination therapy, at
the RP2R selected from Part 1 and Part 2.
About Multiple Myeloma
Multiple myeloma is a blood cancer affecting a type of white blood
cell called plasma cells found in the bone marrow.2 In
multiple myeloma, these malignant plasma cells proliferate and
replace normal cells in the bone marrow.3 Multiple
myeloma is the second most common blood cancer worldwide and
remains an incurable disease.4 In 2024, it is estimated
that more than 35,000 people will be diagnosed with multiple
myeloma in the U.S. and more than 12,000 will die from the
disease.5 People with multiple myeloma have a 5-year
survival rate of 59.8 percent.6 While some people
diagnosed with multiple myeloma initially have no symptoms, most
patients are diagnosed due to symptoms that can include bone
fracture or pain, low red blood cell counts, tiredness, high
calcium levels, kidney problems or infections.7,8
About TALVEY®
TALVEY® (talquetamab-tgvs)
received approval from the U.S. FDA in August 2023 as a first-in-class GPRC5D-targeting
bispecific antibody for the treatment of adult patients with
relapsed or refractory multiple myeloma who have received at least
four prior lines of therapy, including a proteasome inhibitor, an
immunomodulatory agent, and an anti-CD38 antibody.8
Since FDA approval, 1,500 patients were treated with
TALVEY®. The European Commission (EC) granted
conditional marketing authorization (CMA) of
TALVEY® (talquetamab-tgvs) in August 2023 as monotherapy for the treatment of
adult patients with relapsed and refractory multiple myeloma (RRMM)
who have received at least three prior therapies, including an
immunomodulatory agent, a proteasome inhibitor, and an anti-CD38
antibody and have demonstrated disease progression on the last
therapy.9
TALVEY® is a bispecific T cell engaging
antibody that binds to the CD3 receptor expressed on the surface of
T cells and G protein-coupled receptor class C group 5 member D
(GPRC5D), a novel multiple myeloma target which is highly expressed
on the surface of multiple myeloma cells and non-malignant plasma
cells, as well as some healthy tissues such as epithelial cells of
the skin and tongue.
For more information, visit www.TALVEY.com.
About TECVAYLI®
TECVAYLI® (teclistamab-cqyv) received approval
from the U.S. FDA in October 2022 as
an off-the-shelf (or ready-to-use) antibody that is administered as
a subcutaneous treatment for adult patients with relapsed or
refractory multiple myeloma (RRMM) who have received at least four
prior lines of therapy, including a proteasome inhibitor, an
immunomodulatory agent and an anti-CD38 antibody.2 The
European Commission (EC) granted TECVAYLI® conditional
marketing authorization (CMA) in August
2022 as monotherapy 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 since the last
therapy. In August 2023, the EC
granted the approval of a Type II variation application for
TECVAYLI®, providing the option for a reduced dosing
frequency of 1.5 mg/kg every two weeks in patients who have
achieved a complete response (CR) or better for a minimum of six
months. TECVAYLI® is a first-in-class, bispecific T
cell engager antibody therapy that uses innovative science to
activate the immune system by binding to the CD3 receptor expressed
on the surface of T cells and to the B-cell maturation antigen
(BCMA) expressed on the surface of multiple myeloma cells and some
healthy B-lineage cells. In February
2024, the U.S. FDA approved the supplemental Biologics
License Application (sBLA) for TECVAYLI® for a reduced
dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients
with relapsed or refractory multiple myeloma who have achieved and
maintained a CR or better for a minimum of six months.
For more information, visit www.TECVAYLI.com.
TALVEY® IMPORTANT SAFETY
INFORMATION
INDICATION AND USAGE
TALVEY® (talquetamab-tgvs) is indicated
for the treatment of adult patients with relapsed or refractory
multiple myeloma who have received at least four prior lines of
therapy, including a proteasome inhibitor, an immunomodulatory
agent, and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on
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(s).
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY,
including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY
SYNDROME
Cytokine release syndrome (CRS), including life-threatening
or fatal reactions, can occur in patients receiving
TALVEY®. Initiate TALVEY® treatment with
step-up dosing to reduce the risk of CRS. Withhold
TALVEY® until CRS resolves or permanently
discontinue based on severity.
Neurologic toxicity, including immune effector
cell-associated neurotoxicity syndrome (ICANS), and serious and
life-threatening or fatal reactions, can occur with TALVEY®.
Monitor patients for signs and symptoms of neurologic toxicity
including ICANS during treatment. Withhold or discontinue
TALVEY® based on
severity.
Because of the risk of CRS and neurologic toxicity, including
ICANS, TALVEY® is available only
through a restricted program called the TECVAYLI® and
TALVEY® Risk Evaluation and
Mitigation Strategy (REMS).
CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS
Cytokine Release Syndrome (CRS): TALVEY® can cause
cytokine release syndrome, including life-threatening or fatal
reactions. In the clinical trial, CRS occurred in 76% of patients
who received TALVEY® at the recommended dosages, with Grade 1 CRS
occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%.
Recurrent CRS occurred in 30% of patients. CRS occurred in 33%
of patients with step-up dose 3 in the biweekly dosing schedule
(N=153). CRS occurred in 30% of patients with the first 0.4 mg/kg
treatment dose and in 12% of patients treated with the first 0.8
mg/kg treatment dose. The CRS rate for both dosing schedules
combined was less than 3% for each of the remaining doses in Cycle
1 and less than 3% cumulatively from Cycle 2 onward. The median
time to onset of CRS was 27 (range: 0.1 to 167) hours from the last
dose, and the median duration was 17 (range: 0 to 622) hours.
Clinical signs and symptoms of CRS include but are not limited to
pyrexia, hypotension, chills, hypoxia, headache, and tachycardia.
Potentially life-threatening complications of CRS may include
cardiac dysfunction, acute respiratory distress syndrome,
neurologic toxicity, renal and/or hepatic failure, and disseminated
intravascular coagulation (DIC).
Initiate therapy with step-up dosing and administer
pre-treatment medications (corticosteroids, antihistamine, and
antipyretics) prior to each dose of TALVEY® in the
step-up dosing schedule to reduce the risk of CRS. Monitor patients
following administration accordingly. In patients who experience
CRS, pre-treatment medications should be administered prior to the
next TALVEY® dose.
Counsel patients to seek medical attention should signs or
symptoms of CRS occur. At the first sign of CRS, immediately
evaluate patient for hospitalization and institute treatment with
supportive care based on severity, and consider further management
per current practice guidelines. Withhold TALVEY® until
CRS resolves or permanently discontinue based on
severity.
Neurologic Toxicity including ICANS: TALVEY® can cause
serious or life-threatening neurologic toxicity, including immune
effector cell-associated neurotoxicity syndrome (ICANS), including
fatal reactions. In the clinical trial, neurologic toxicity
occurred in 55% of patients who received the recommended dosages,
with Grade 3 or 4 neurologic toxicity occurring in 6% of patients.
The most frequent neurologic toxicities were headache (20%),
encephalopathy (15%), sensory neuropathy (14%), and motor
dysfunction (10%).
ICANS was reported in 9% of 265 patients where ICANS was
collected and who received the recommended dosages. Recurrent ICANS
occurred in 3% of patients. Most patients experienced ICANS
following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3
of the biweekly dosing schedule (1.8%), or the initial treatment
dose of the weekly dosing schedule (2.6%) (N=156) or the biweekly
dosing schedule (3.7%) (N=109). The median time to onset of ICANS
was 2.5 (range: 1 to 16) days after the most recent dose with a
median duration of 2 (range: 1 to 22) days. The onset of ICANS can
be concurrent with CRS, following resolution of CRS, or in the
absence of CRS. Clinical signs and symptoms of ICANS may include
but are not limited to confusional state, depressed level of
consciousness, disorientation, somnolence, lethargy, and
bradyphrenia.
Monitor patients for signs and symptoms of neurologic toxicity
during treatment. At the first sign of neurologic toxicity,
including ICANS, immediately evaluate the patient and provide
supportive care based on severity; withhold or permanently
discontinue TALVEY® based on severity and consider further
management per current practice guidelines. [see Dosage and
Administration (2.5)].
Due to the potential for neurologic toxicity, patients receiving
TALVEY® are at risk of depressed level of consciousness.
Advise patients to refrain from driving or operating heavy or
potentially dangerous machinery during the step-up dosing schedule
and for 48 hours after completion of the step-up dosing schedule,
and in the event of new onset of any neurological symptoms, until
symptoms resolve.
TECVAYLI® and
TALVEY® REMS: TALVEY® is
available only through a restricted program under a REMS, called
the TECVAYLI® and TALVEY® REMS because of the
risks of CRS and neurologic toxicity, including ICANS.
Further information about the TECVAYLI® and
TALVEY® REMS program is available at
www.TEC-TALREMS.com or by telephone at
1-855-810-8064.
Oral Toxicity and Weight Loss: TALVEY® can
cause oral toxicities, including dysgeusia, dry mouth, dysphagia,
and stomatitis. In the clinical trial, 80% of patients had oral
toxicity, with Grade 3 occurring in 2.1% of patients who received
the recommended dosages. The most frequent oral toxicities were
dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia
(18%). The median time to onset of oral toxicity was 15 (range: 1
to 634) days, and the median time to resolution to baseline was 43
(1 to 530) days. Oral toxicity did not resolve to baseline in 65%
of patients.
TALVEY® can cause weight loss. In the clinical trial,
62% of patients experienced weight loss of 5% or greater,
regardless of having an oral toxicity, including 28% of patients
with Grade 2 (10% or greater) weight loss and 2.7% of patients with
Grade 3 (20% or greater) weight loss. The median time to onset of
Grade 2 or higher weight loss was 67 (range: 6 to 407) days, and
the median time to resolution was 50 (range: 1 to 403) days. Weight
loss did not resolve in 57% of patients who reported weight
loss.
Monitor patients for signs and symptoms of oral toxicity.
Counsel patients to seek medical attention should signs or symptoms
of oral toxicity occur and provide supportive care as per current
clinical practice, including consultation with a nutritionist.
Monitor weight regularly during therapy. Evaluate clinically
significant weight loss further. Withhold TALVEY® or
permanently discontinue based on severity.
Infections: TALVEY® can cause infections,
including life-threatening or fatal infections. Serious infections
occurred in 16% of patients, with fatal infections in 1.5% of
patients. Grade 3 or 4 infections occurred in 17% of patients. The
most common serious infections reported were bacterial infection
(8%), which included sepsis and COVID-19 (2.7%).
Monitor patients for signs and symptoms of infection prior to
and during treatment with TALVEY® and treat
appropriately. Administer prophylactic antimicrobials according to
local guidelines. Withhold or consider permanently discontinuing
TALVEY® as recommended, based on
severity.
Cytopenias: TALVEY® can cause cytopenias,
including neutropenia and thrombocytopenia. In the clinical trial,
Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and
Grade 3 or 4 decreased platelets occurred in 22% of patients who
received TALVEY®. The median time to onset for Grade 3
or 4 neutropenia was 22 (range: 1 to 312) days, and the median time
to resolution to Grade 2 or lower was 8 (range: 1 to 79) days. The
median time to onset for Grade 3 or 4 thrombocytopenia was 12
(range: 2 to 183) days, and the median time to resolution to Grade
2 or lower was 10 (range: 1 to 64) days. Monitor complete blood
counts during treatment and withhold TALVEY® as
recommended, based on severity.
Skin Toxicity: TALVEY® can cause serious
skin reactions, including rash, maculo-papular rash, erythema, and
erythematous rash. In the clinical trial, skin reactions occurred
in 62% of patients, with grade 3 skin reactions in 0.3%. The median
time to onset was 25 (range: 1 to 630) days. The median time to
improvement to grade 1 or less was 33 days.
Monitor for skin toxicity, including rash progression. Consider
early intervention and treatment to manage skin toxicity.
Withhold TALVEY® as recommended based on
severity.
Hepatotoxicity: TALVEY® can cause
hepatotoxicity. Elevated ALT occurred in 33% of patients, with
grade 3 or 4 ALT elevation occurring in 2.7%; elevated AST occurred
in 31% of patients, with grade 3 or 4 AST elevation occurring in
3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3%
of patients. Liver enzyme elevation can occur with or without
concurrent CRS.
Monitor liver enzymes and bilirubin at baseline and during
treatment as clinically indicated. Withhold TALVEY® or
consider permanent discontinuation of TALVEY®, based on
severity [see Dosage and Administration (2.5)].
Embryo-Fetal Toxicity: Based on its mechanism of action,
TALVEY® may cause fetal harm when administered to a
pregnant woman. Advise pregnant women of the potential risk to the
fetus. Advise females of reproductive potential to use effective
contraception during treatment with TALVEY® and for 3
months after the last dose.
Adverse Reactions: The most common adverse reactions
(≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal
pain, skin disorder, rash, fatigue, weight decreased, dry mouth,
xerosis, dysphagia, upper respiratory tract infection, diarrhea,
hypotension, and headache.
The most common Grade 3 or 4 laboratory
abnormalities (≥30%) are lymphocyte count decreased, neutrophil
count decreased, white blood cell decreased, and hemoglobin
decreased.
Please read full Prescribing
Information, including Boxed Warning, for
TALVEY®.
TECVAYLI® IMPORTANT SAFETY
INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY
including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY
SYNDROME
Cytokine release syndrome (CRS), including life-threatening
or fatal reactions, can occur in patients receiving
TECVAYLI®. Initiate treatment with TECVAYLI®
step-up dosing schedule to reduce risk of CRS. Withhold
TECVAYLI® until CRS resolves or permanently discontinue
based on severity.
Neurologic toxicity, including Immune Effector
Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and
life-threatening reactions, can occur in patients receiving
TECVAYLI®. Monitor patients for signs or symptoms of
neurologic toxicity, including ICANS, during treatment. Withhold
TECVAYLI® until neurologic toxicity resolves or
permanently discontinue based on severity.
TECVAYLI® is available only through a restricted
program called the TECVAYLI® and TALVEY™ Risk Evaluation
and Mitigation Strategy (REMS).
INDICATION AND USAGE
TECVAYLI® (teclistamab-cqyv) is a bispecific B-cell
maturation antigen (BCMA)-directed CD3 T-cell engager indicated for
the treatment of adult patients with relapsed or refractory
multiple myeloma who have received at least four prior lines of
therapy, including a proteasome inhibitor, an immunomodulatory
agent and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on
response rate. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trial(s).
WARNINGS AND PRECAUTIONS
Cytokine Release Syndrome -
TECVAYLI® can cause cytokine release syndrome (CRS),
including life-threatening or fatal reactions. In the clinical
trial, CRS occurred in 72% of patients who received
TECVAYLI® at the recommended dose, with Grade 1 CRS
occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%.
Recurrent CRS occurred in 33% of patients. Most patients
experienced CRS following step-up dose 1 (42%), step-up dose 2
(35%), or the initial treatment dose (24%). Less than 3% of
patients developed first occurrence of CRS following subsequent
doses of TECVAYLI®. The median time to onset of CRS was
2 (range: 1 to 6) days after the most recent dose with a median
duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of
CRS included, but were not limited to, fever, hypoxia, chills,
hypotension, sinus tachycardia, headache, and elevated liver
enzymes (aspartate aminotransferase and alanine aminotransferase
elevation).
Initiate therapy according to TECVAYLI® step-up
dosing schedule to reduce risk of CRS. Administer pretreatment
medications to reduce risk of CRS and monitor patients following
administration of TECVAYLI® accordingly. At the first
sign of CRS, immediately evaluate patient for hospitalization.
Administer supportive care based on severity and consider further
management per current practice guidelines. Withhold or permanently
discontinue TECVAYLI® based on severity.
TECVAYLI® is available only through a restricted
program under a REMS.
Neurologic Toxicity including ICANS -
TECVAYLI® can cause serious or life-threatening
neurologic toxicity, including Immune Effector Cell-Associated
Neurotoxicity Syndrome (ICANS).
In the clinical trial, neurologic toxicity occurred in 57% of
patients who received TECVAYLI® at the recommended dose,
with Grade 3 or 4 neurologic toxicity occurring in 2.4% of
patients. The most frequent neurologic toxicities were headache
(25%), motor dysfunction (16%), sensory neuropathy (15%), and
encephalopathy (13%). With longer follow-up, Grade 4 seizure and
fatal Guillain-Barré syndrome (one patient each) occurred in
patients who received TECVAYLI®.
In the clinical trial, ICANS was reported in 6% of patients who
received TECVAYLI® at the recommended dose. Recurrent
ICANS occurred in 1.8% of patients. Most patients experienced ICANS
following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the
initial treatment dose (1.8%). Less than 3% of patients developed
first occurrence of ICANS following subsequent doses of
TECVAYLI®. The median time to onset of ICANS was 4
(range: 2 to 8) days after the most recent dose with a median
duration of 3 (range: 1 to 20) days. The most frequent clinical
manifestations of ICANS reported were confusional state and
dysgraphia. The onset of ICANS can be concurrent with CRS,
following resolution of CRS, or in the absence of CRS.
Monitor patients for signs and symptoms of neurologic toxicity
during treatment. At the first sign of neurologic toxicity,
including ICANS, immediately evaluate patient and provide
supportive therapy based on severity. Withhold or permanently
discontinue TECVAYLI® based on severity per
recommendations and consider further management per current
practice guidelines.
Due to the potential for neurologic toxicity, patients are at
risk of depressed level of consciousness. Advise patients to
refrain from driving or operating heavy or potentially dangerous
machinery during and for 48 hours after completion of
TECVAYLI® step-up dosing schedule and in the event of
new onset of any neurologic toxicity symptoms until neurologic
toxicity resolves.
TECVAYLI® is available only through a restricted
program under a REMS.
TECVAYLI® and TALVEY™ REMS -
TECVAYLI® is available only through a restricted program
under a REMS called the TECVAYLI® and TALVEY™ REMS
because of the risks of CRS and neurologic toxicity, including
ICANS.
Hepatotoxicity - TECVAYLI® can cause
hepatotoxicity, including fatalities. In patients who received
TECVAYLI® at the recommended dose in the clinical trial,
there was one fatal case of hepatic failure. Elevated aspartate
aminotransferase (AST) occurred in 34% of patients, with Grade 3 or
4 elevations in 1.2%. Elevated alanine aminotransferase (ALT)
occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%.
Elevated total bilirubin occurred in 6% of patients with Grade 3 or
4 elevations in 0.6%. Liver enzyme elevation can occur with or
without concurrent CRS.
Monitor liver enzymes and bilirubin at baseline and during
treatment as clinically indicated. Withhold TECVAYLI® or
consider permanent discontinuation of TECVAYLI® based on
severity.
Infections - TECVAYLI® can cause severe,
life-threatening, or fatal infections. In patients who received
TECVAYLI® at the recommended dose in the clinical trial,
serious infections, including opportunistic infections, occurred in
30% of patients, with Grade 3 or 4 infections in 35%, and fatal
infections in 4.2%. Monitor patients for signs and symptoms of
infection prior to and during treatment with TECVAYLI®
and treat appropriately. Administer prophylactic antimicrobials
according to guidelines. Withhold TECVAYLI® or consider
permanent discontinuation of TECVAYLI® based on
severity.
Monitor immunoglobulin levels during treatment with
TECVAYLI® and treat according to guidelines, including
infection precautions and antibiotic or antiviral prophylaxis.
Neutropenia - TECVAYLI® can cause
neutropenia and febrile neutropenia. In patients who received
TECVAYLI® at the recommended dose in the clinical trial,
decreased neutrophils occurred in 84% of patients, with Grade 3 or
4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3%
of patients.
Monitor complete blood cell counts at baseline and periodically
during treatment and provide supportive care per local
institutional guidelines. Monitor patients with neutropenia for
signs of infection. Withhold TECVAYLI® based on
severity.
Hypersensitivity and Other Administration Reactions -
TECVAYLI® can cause both systemic administration-related
and local injection-site reactions. Systemic Reactions - In
patients who received TECVAYLI® at the recommended dose
in the clinical trial, 1.2% of patients experienced
systemic-administration reactions, which included Grade 1 recurrent
pyrexia and Grade 1 swollen tongue. Local Reactions - In patients
who received TECVAYLI® at the recommended dose in the
clinical trial, injection-site reactions occurred in 35% of
patients, with Grade 1 injection-site reactions in 30% and Grade 2
in 4.8%. Withhold TECVAYLI® or consider permanent
discontinuation of TECVAYLI® based on severity.
Embryo-Fetal Toxicity - Based on its mechanism of
action, TECVAYLI® may cause fetal harm when administered
to a pregnant woman. Advise pregnant women of the potential risk to
the fetus. Advise females of reproductive potential to use
effective contraception during treatment with TECVAYLI®
and for 5 months after the last dose.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) were pyrexia, CRS,
musculoskeletal pain, injection site reaction, fatigue, upper
respiratory tract infection, nausea, headache, pneumonia, and
diarrhea. The most common Grade 3 to 4 laboratory abnormalities
(≥20%) were decreased lymphocytes, decreased neutrophils, decreased
white blood cells, decreased hemoglobin, and decreased
platelets.
Please read full Prescribing Information,
including Boxed WARNING, for TECVAYLI®.
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This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development. The reader is cautioned not to rely
on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of Janssen Research & Development,
LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online at
www.sec.gov, www.jnj.com or on request
from Johnson & Johnson. None of Janssen Research &
Development, LLC, Janssen Biotech, Inc., nor Johnson & Johnson
undertake to update any forward-looking statement as a result of
new information or future events or developments.
Source: Johnson & Johnson
* Dr. Yael Cohen, Head of Myeloma
Unit, Hematology Institute, Tel Aviv Sourasky Medical Center, has
provided consulting, advisory, and speaking services
to Johnson & Johnson; she has not been paid for any media
work.
1 Cohen, Y., et al. Talquetamab + teclistamab in
patients with relapsed/refractory multiple myeloma: Updated phase
1b results from RedirecTT-1 with
>1 year of follow-up. IMS 2024. September
27, 2024.
2 Rajkumar SV. Multiple Myeloma: 2020 Update on
Diagnosis, Risk-Stratification and Management. Am J
Hematol. 2020;95(5):548-5672020;95(5):548-567.
http://www.ncbi.nlm.nih.gov/pubmed/32212178
3 National Cancer Institute. Plasma Cell Neoplasms.
Accessed January 17, 2024. Available
at:
https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq
4 Multiple Myeloma. City of Hope, 2022. Multiple
Myeloma: Causes, Symptoms & Treatments. Accessed May 2024.
https://www.cancercenter.com/cancer-types/multiple-myeloma
5 American Cancer Society. Myeloma Cancer Statistics.
Accessed May 2024. Available at:
https://cancerstatisticscenter.cancer.org/types/myeloma
6 SEER*Explorer: An interactive website for SEER
cancer statistics [Internet]. Surveillance Research Program,
National Cancer Institute. Accessed: June
2024. https://seer.cancer.gov/explorer/
7 American Cancer Society. What is Multiple Myeloma?
Accessed May 2024. Available at:
https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
8 American Cancer Society. Multiple Myeloma Early
Detection, Diagnosis, and Staging. Accessed May 2024. Available at:
https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html
9 TALVEY® U.S. Prescribing Information, August 2023.
10 European Medicines Agency. TALVEY Summary of
Product Characteristics. August
2023.
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