Updated data show 100 percent overall response rate with 56
percent of patients achieving complete response or better with
weekly dosing, supporting the combinability of the GPRC5D
bispecific antibody
Safety profile, including infection rates, similar to
TALVEY® and DARZALEX FASPRO®
monotherapies
RIO DE
JANEIRO, Sept. 27, 2024 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) today announced updated
results from the investigational Phase 1b TRIMM-2 study evaluating the combination of
TALVEY® (talquetamab-tgvs) with DARZALEX
FASPRO® (daratumumab and
hyaluronidase-fihj) and pomalidomide in patients with relapsed or
refractory multiple myeloma that demonstrated an overall response
rate (ORR) of 82 percent, further supporting the investigation of
this combination. These data were featured in an oral presentation
at the 2024 International Myeloma Society Annual
Meeting (Abstract #OA – 01).
The results from the Phase 1b
TRIMM-2 study evaluating TALVEY®, the first
bispecific T-cell engager to target GPRC5D, combined with DARZALEX
FASPRO®, the first subcutaneous anti-CD38
monoclonal antibody, and pomalidomide included patients who
received at least three prior lines of therapy, including a
proteasome inhibitor (PI) and immunomodulatory drug (IMiD), or were
double refractory to a PI and IMiD and had not received anti-CD38
therapy in the previous 90 days.1
At data cutoff, 77 patients had received TALVEY® in
doses of 0.4 mg/kg weekly (QW) or 0.8 mg/kg biweekly
(Q2W), with step-up doses, combined with DARZALEX
FASPRO® and pomalidomide. In the QW arm (n=18),
the overall response rate (ORR) was 100 percent, with 56 percent
having a complete response (CR) or better. The Q2W arm (n=59)
achieved 76 percent ORR, with 56 percent achieving CR or better.
The median duration of response (DOR) in the Q2W arm was 26.4
months, and the median progression-free survival (PFS) was 20.3
months. Results showed 52 percent of patients who are anti-CD38
refractory (n=64) achieved CR or better and 70.8 percent of
patients who received prior chimeric antigen receptor T cell
(CAR-T) therapy (n=24) achieved CR or better. Patients who had
received prior bispecific antibodies (n=29) achieved an 82.8
percent ORR.1
"The deep and durable responses shown in these latest results
from TRIMM-2 further support the potential of TALVEY in combination
with DARZALEX FASPRO, which has become a standard of care in
multiple myeloma, and pomalidomide," said Nizar Bahlis, M.D.,
Associate Professor, Arnie Charbonneau Cancer Institute,
University of Calgary and presenting
author.* "With high overall response rates seen across cohorts,
this combination shows potential for significant disease control
and survival in patients who have received multiple lines of prior
therapy, including exposure to prior bispecific antibodies."
The safety profile of this combination reflected the known
profiles of TALVEY®, DARZALEX FASPRO®
and pomalidomide. Despite the incidence of neutropenia (83.3
percent in the QW arm and 79.7 percent in the Q2W arm) being high,
the Grade 3/4 infection rate was generally low (16.7 percent and
37.3 percent, respectively). The majority of on-target, off-tumor
treatment-related adverse events (TRAEs), including oral (100
percent in the QW arm, 84.7 percent in Q2W arm), skin (88.9
percent, 67.8 percent), nail (83.3 percent, 55.9 percent) and
weight decrease (66.7 percent, 49.2 percent) were low-grade (Grade
1/2) and did not lead to discontinuation of therapy. These results
support further investigation of TALVEY® in combination
with DARZALEX FASPRO®, with or without
pomalidomide, in patients who have received earlier lines of
therapy, including a proteasome inhibitor and lenalidomide, which
is currently being investigated in the registrational, Phase 3
MonumenTAL-3 study.1
"We continue to be encouraged by the potential versatility of
TALVEY as a combination partner with other therapies to address
unmet needs for patients with relapsed or refractory multiple
myeloma who have limited treatment options at this advanced stage,"
said Jordan Schecter, M.D., Vice
President, Disease Area Leader, Multiple Myeloma, Innovative
Medicine at Johnson & Johnson. "By simultaneously targeting
GPRC5D and CD38 on myeloma cells with the combination of
TALVEY and DARZALEX FASPRO, we are aiming to attack multiple
myeloma in different ways to help improve outcomes for patients
with this serious illness and limited treatment options."
Additional data underscoring the combinability of
TALVEY® from the RedirecTT-1 study will also be
presented at IMS. Results from the TRIMM-2 study were
previously presented at the 2023 ASCO Annual Meeting.
About TRIMM-2 Study
The TRIMM-2 (NCT04108195) study is an ongoing Phase 2 study of
DARZALEX FASPRO® regimens in
combination with TALVEY® for the treatment of patients
with multiple myeloma. The primary objectives of the TRIMM-2 study
were to identify the Phase 2 dose (RP2D) for each component of the
treatment combination (Part One); characterize the safety of the
treatment combination at the RP2D (Part 2); and assess antitumor
activity, pharmacokinetics and pharmacodynamics for the combination
treatment (Part 3). Patients in the study (N=65) all had multiple
myeloma and had received a minimum three prior lines of therapy or
were double refractory to a proteasome inhibitor (PI) and an
immunomodulatory agent; patients who had been exposed or refractory
to an anti-CD38 therapy more than ninety days prior to the start of
the trial were also included, as well as those refractory to
anti-CD38 therapy.
About MonumenTAL-3
The MonumenTAL-3 (NCT05455320)
study is an ongoing Phase 3 study of TALVEY® in
combination with DARZALEX FASPRO® with or without
pomalidomide compared to DARZALEX FASPRO®
combined with pomalidomide and dexamethasone in patients with
relapsed of refractory multiple myeloma who have received at least
one prior line of therapy.
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.9 Since FDA approval, 1,500 patients
were treated with TALVEY®. The European Commission (EC)
granted conditional marketing authorization (CMA) of
TALVEY® 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.10
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 DARZALEX FASPRO®
DARZALEX FASPRO® (daratumumab and
hyaluronidase-fihj) received U.S. FDA approval in
May 2020 and is approved for nine
indications in multiple myeloma, four of which are for frontline
treatment in newly diagnosed patients who are transplant eligible
or ineligible.11 It is the only subcutaneous
CD38-directed antibody approved to treat patients with multiple
myeloma. DARZALEX FASPRO® is
co-formulated with recombinant human hyaluronidase PH20 (rHuPH20),
Halozyme's ENHANZE® drug delivery technology.
In August 2012, Janssen
Biotech, Inc. and Genmab A/S entered a worldwide agreement, which
granted Janssen an exclusive license to develop, manufacture and
commercialize daratumumab.
For more information,
visit https://www.darzalexhcp.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®.
DARZALEX FASPRO® INDICATIONS AND
IMPORTANT SAFETY INFORMATION
INDICATIONS
DARZALEX FASPRO® (daratumumab and
hyaluronidase-fihj) is indicated for the treatment of adult
patients with multiple myeloma:
- In combination with bortezomib, lenalidomide, and dexamethasone
for induction and consolidation in newly diagnosed patients who are
eligible for autologous stem cell transplant
- In combination with bortezomib, melphalan, and prednisone in
newly diagnosed patients who are ineligible for autologous stem
cell transplant
- In combination with lenalidomide and dexamethasone in newly
diagnosed patients who are ineligible for autologous stem cell
transplant and in patients with relapsed or refractory multiple
myeloma who have received at least one prior therapy
- In combination with bortezomib, thalidomide, and dexamethasone
in newly diagnosed patients who are eligible for autologous stem
cell transplant
- In combination with pomalidomide and dexamethasone in patients
who have received at least one prior line of therapy including
lenalidomide and a proteasome inhibitor (PI)
- In combination with carfilzomib and dexamethasone in patients
with relapsed or refractory multiple myeloma who have received one
to three prior lines of therapy
- In combination with bortezomib and dexamethasone in patients
who have received at least one prior therapy
- As monotherapy in patients who have received at least three
prior lines of therapy including a PI and an immunomodulatory agent
or who are double refractory to a PI and an immunomodulatory
agent
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DARZALEX FASPRO® is contraindicated in
patients with a history of severe hypersensitivity to daratumumab,
hyaluronidase, or any of the components of the formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity and Other Administration Reactions
Both systemic administration-related reactions, including severe or
life-threatening reactions, and local injection-site reactions can
occur with DARZALEX FASPRO®. Fatal reactions have
been reported with daratumumab-containing products, including
DARZALEX FASPRO®.
Systemic Reactions
In a pooled safety population of 1249 patients with multiple
myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who
received DARZALEX FASPRO® as
monotherapy or in combination, 7% of patients experienced a
systemic administration-related reaction (Grade 2: 3.2%, Grade 3:
0.7%, Grade 4: 0.1%). Systemic administration-related reactions
occurred in 7% of patients with the first injection, 0.2% with the
second injection, and cumulatively 1% with subsequent injections.
The median time to onset was 2.9 hours (range: 5 minutes to 3.5
days). Of the 165 systemic administration-related reactions that
occurred in 93 patients, 144 (87%) occurred on the day of
DARZALEX FASPRO® administration.
Delayed systemic administration-related reactions have occurred in
1% of the patients.
Severe reactions included hypoxia, dyspnea, hypertension,
tachycardia, and ocular adverse reactions, including choroidal
effusion, acute myopia, and acute angle closure glaucoma. Other
signs and symptoms of systemic administration-related reactions may
include respiratory symptoms, such as bronchospasm, nasal
congestion, cough, throat irritation, allergic rhinitis, and
wheezing, as well as anaphylactic reaction, pyrexia, chest pain,
pruritus, chills, vomiting, nausea, hypotension, and blurred
vision.
Pre-medicate patients with histamine-1 receptor antagonist,
acetaminophen, and corticosteroids. Monitor patients for systemic
administration-related reactions, especially following the first
and second injections. For anaphylactic reaction or
life-threatening (Grade 4) administration-related reactions,
immediately and permanently discontinue
DARZALEX FASPRO®. Consider administering
corticosteroids and other medications after the administration of
DARZALEX FASPRO® depending on dosing
regimen and medical history to minimize the risk of delayed
(defined as occurring the day after administration) systemic
administration-related reactions.
Ocular adverse reactions, including acute myopia and narrowing
of the anterior chamber angle due to ciliochoroidal effusions with
potential for increased intraocular pressure or glaucoma, have
occurred with daratumumab-containing products. If ocular symptoms
occur, interrupt DARZALEX FASPRO® and
seek immediate ophthalmologic evaluation prior to restarting
DARZALEX FASPRO®.
Local Reactions
In this pooled safety population, injection-site reactions occurred
in 7% of patients, including Grade 2 reactions in 0.8%. The most
frequent (>1%) injection-site reaction was injection-site
erythema. These local reactions occurred a median of 5 minutes
(range: 0 minutes to 6.5 days) after starting administration of
DARZALEX FASPRO®. Monitor for local
reactions and consider symptomatic management.
Neutropenia
Daratumumab may increase neutropenia induced by background therapy.
Monitor complete blood cell counts periodically during treatment
according to manufacturer's prescribing information for background
therapies. Monitor patients with neutropenia for signs of
infection. Consider withholding
DARZALEX FASPRO® until recovery of
neutrophils. In lower body weight patients receiving
DARZALEX FASPRO®, higher rates of Grade 3-4
neutropenia were observed.
Thrombocytopenia
Daratumumab may increase thrombocytopenia induced by background
therapy. Monitor complete blood cell counts periodically during
treatment according to manufacturer's prescribing information for
background therapies. Consider withholding
DARZALEX FASPRO® until recovery of
platelets.
Embryo-Fetal Toxicity
Based on the mechanism of action,
DARZALEX FASPRO® can cause fetal harm
when administered to a pregnant woman.
DARZALEX FASPRO® may cause depletion of
fetal immune cells and decreased bone density. Advise pregnant
women of the potential risk to a fetus. Advise females with
reproductive potential to use effective contraception during
treatment with DARZALEX FASPRO® and for
3 months after the last dose.
The combination of
DARZALEX FASPRO® with lenalidomide,
thalidomide, or pomalidomide is contraindicated in pregnant women
because lenalidomide, thalidomide, and pomalidomide may cause birth
defects and death of the unborn child. Refer to the lenalidomide,
thalidomide, or pomalidomide prescribing information on use during
pregnancy.
Interference With Serological Testing
Daratumumab binds to CD38 on red blood cells (RBCs) and results in
a positive indirect antiglobulin test (indirect Coombs test).
Daratumumab-mediated positive indirect antiglobulin test may
persist for up to 6 months after the last daratumumab
administration. Daratumumab bound to RBCs masks detection of
antibodies to minor antigens in the patient's serum. The
determination of a patient's ABO and Rh blood type are not
impacted.
Notify blood transfusion centers of this interference with
serological testing and inform blood banks that a patient has
received DARZALEX FASPRO®. Type and screen
patients prior to starting
DARZALEX FASPRO®.
Interference With Determination of Complete Response
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal
antibody that can be detected on both the serum protein
electrophoresis (SPE) and immunofixation (IFE) assays used for the
clinical monitoring of endogenous M-protein. This interference can
impact the determination of complete response and of disease
progression in some DARZALEX FASPRO®-treated
patients with IgG kappa myeloma protein.
ADVERSE REACTIONS
In multiple myeloma, the most common adverse reaction (≥20%)
with DARZALEX FASPRO® monotherapy is
upper respiratory tract infection. The most common adverse
reactions with combination therapy (≥20% for any combination)
include fatigue, nausea, diarrhea, dyspnea, insomnia, headache,
pyrexia, cough, muscle spasms, back pain, vomiting, hypertension,
upper respiratory tract infection, peripheral neuropathy,
peripheral sensory neuropathy, constipation, pneumonia, edema,
peripheral edema, musculoskeletal pain, and rash.
The most common hematology laboratory abnormalities (≥40%) with
DARZALEX FASPRO® are decreased
leukocytes, decreased lymphocytes, decreased neutrophils, decreased
platelets, and decreased hemoglobin.
Please click here to read full
Prescribing Information for
DARZALEX FASPRO®.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and
cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in
Innovative Medicine and MedTech, we are uniquely positioned to
innovate across the full spectrum of healthcare solutions today to
deliver the breakthroughs of tomorrow, and profoundly impact health
for humanity. Learn more at https://www.jnj.com/ or at
www.janssen.com/johnson-johnson-innovative-medicine. Follow us at
@JanssenUS and @JNJInnovMed. Janssen Research & Development,
LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC
are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of TALVEY® or DARZALEX
FASPRO®. 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., Janssen Global Services,
LLC 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., Janssen Global Services, LLC nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or
developments.
* Nizar Bahlis, M.D., Associate Professor, Arnie Charbonneau
Cancer Institute, University of
Calgary, has provided consulting, advisory, and speaking
services to Johnson & Johnson; he has not been paid for any
media work.
1 Bahlis, N., et al. Talquetamab + daratumumab +
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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
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4 Multiple Myeloma. City of Hope, 2022. Multiple
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