Treatment Perspectives

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).

M. Yair Levy, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Medical Oncologist/Hematologist

Dallas, TX

Dr M. Yair Levy is a paid consultant of Johnson & Johnson.

M. Yair Levy, MD is a paid consultant of Johnson & Johnson.

“When reviewing the primary and long-term efficacy data from the MonumenTAL-1 clinical trial, I was pleased to see the number of patients that experienced responses at 5th line therapy and all being triple-class exposed as well as some patients having prior T-cell redirection therapy. This is why I prefer to prescribe TALVEY^® to my adult patients with relapsed or refractory multiple myeloma, and I encourage you to review the efficacy data as you evaluate the needs of your patients, as well.

Safety Profile

See the data

Access and Support

Explore the available resources

Dosing Flexibility

Discover the dosing schedule

Mechanism of Action

Learn more about the mechanism of action

When reviewing the primary and long-term efficacy data from the MonumenTAL-1 clinical trial, I was pleased to see the number of patients that experienced responses at 5th line therapy and all being triple-class exposed as well as some patients having prior T-cell redirection therapy. This is why I prefer to prescribe TALVEY^® to my adult patients with relapsed or refractory multiple myeloma, and I encourage you to review the efficacy data as you evaluate the needs of your patients, as well.

M. Yair Levy, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Medical Oncologist/Hematologist

Dallas, TX

Dr M. Yair Levy is a paid consultant for Johnson & Johnson.

MonumenTAL-1 Trial: A Brief Overview

MonumenTAL-1 trial design: The efficacy of TALVEY^® as a single agent was evaluated in 219 patients with relapsed or refractory multiple myeloma in the single-arm, open-label, multicenter, phase 1/2 MonumenTAL-1 trial. The trial included patients who had received ≥3 prior systemic therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Efficacy was based on ORR and DOR as assessed by an IRC using IMWG criteria and reflected patients who had received 4 or more prior lines of therapy.^1-3*

Patients naïve to T-cell redirection therapy^† were randomized to receive TALVEY^® Q2W or QW:

Patients exposed to T-cell redirection therapy^† received TALVEY^® QW:

Key eligibility criteria¹:

Received ≥3 prior systemic therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
ECOG PS of 0-2 included
No T-cell redirection therapy^† within 3 months
No prior Grade 3 or higher CRS related to any T-cell redirection therapy^†
No autologous stem cell transplant within the past 12 weeks
No stroke, seizure, or allogeneic stem cell transplant within the past 6 months
No CNS involvement or clinical signs of meningeal involvement of multiple myeloma, or plasma cell leukemia
No active or documented history of autoimmune disease, with the exception of vitiligo, resolved childhood atopic dermatitis, resolved Graves' Disease that is euthyroid based on clinical and laboratory testing

Primary endpoint: ORR³

Key secondary endpoints: DOR and TTR³

Clinical trial dosing¹

Patients received TALVEY^® Q2W (0.8 mg/kg) or QW (0.4 mg/kg) as a subcutaneous injection until disease progression or unacceptable toxicity, after the step-up dosing schedule.

Inclusion of patients who were naïve and exposed to T-cell redirection therapy^† demonstrated the versatile use of TALVEY^®.¹

Patients with a range of characteristics, including those with high-risk features, were studied in MonumenTAL-1¹

In patients naïve to T-cell redirection therapy,^† 22% had ISS stage III, 29% had high-risk cytogenetics, 22% had extramedullary disease, and 73% were triple-class refractory

Naive to T-Cell Redirection Therapy table

In patients exposed to T-cell redirection therapy,^† 81% had prior CAR-T and 25% had prior bispecific antibody therapy

Exposed to T-Cell Redirection Therapy table

In patients who were triple-class exposed,

TALVEY^® provided powerful efficacy^1,2

Naïve to T-Cell Redirection Therapy^†

73.6% of patients responded to TALVEY^®, with over 30% achieving ≥CR^1,2

Naive to T-Cell Redirection Therapy: Q2W Dosing image

73% of patients responded to TALVEY^® monotherapy, with 35% achieving ≥CR^1,2

Naive to T-Cell Redirection Therapy: QW Dosing image

MonumenTAL-1 Longer-Term Follow-Up Analysis: Naïve to T-Cell Redirection Therapy^†

You are now viewing a subsequent follow-up analysis of the MonumenTAL-1 trial. This information is not included in the current full Prescribing Information. These long-term follow-up data reﬂect the patients naïve to T-cell redirection therapy^† receiving TALVEY^® Q2W; any increase in n-value is due to this longer-term follow-up and additional patients.

Over 70% of patients responded to TALVEY^® Q2W dosing, with over 40% achieving ≥CR at a median follow-up of >23 months^2,4

Long- Term Data: Naive to T-Cell Redirection Therapy: Q2W Dosing image

73% of patients responded to TALVEY^® QW dosing, with 35% achieving ≥CR at a median follow-up of >29 months^2,4

Long- Term Data: Naive to T-Cell Redirection Therapy: QW Dosing image

Exposed to T-Cell Redirection Therapy^†

In patients who were exposed to T-cell redirection therapy,^†

Durable responses were seen in patients exposed to T-cell redirection therapy^1,2†

Exposed to T-Cell Redirection Therapy bar chart

MonumenTAL-1 Longer-Term Follow-Up Analysis: Exposed to T-Cell Redirection Therapy^†

You are now viewing a subsequent follow-up analysis of the MonumenTAL-1 trial. This information is not included in the current full Prescribing Information. These long-term follow-up data reflect the patients exposed to T-cell redirection therapy^† receiving TALVEY^® QW; any increase in n-value is due to this longer-term follow-up and additional patients.

72% of patients responded to TALVEY^®, with 50% achieving ≥CR^§ at a median follow-up of >20 months^2,4

Long-term data: Exposed to T-Cell Redirection Therapy: QW Dosing image

Efficacy results reflect patients who received ≥4 prior lines of therapy.¹

T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.¹

Baseline cytogenetic data were not available in 11% of patients.

≥CR: sCR+CR.

Reflects the median prior lines of therapy for the entire naïve to T-cell redirection therapy population (Q2W and QW dosing).¹

Deep responses: sCR+CR+VGPR.

ORR: sCR+CR+VGPR+PR.

Due to rounding, calculation may not be exact.

≥VGPR: sCR+CR+VGPR

See more clinical study data

I prescribe TALVEY^® for my adult patients with relapsed or refractory multiple myeloma. When exploring treatment options for appropriate patients, I consider the adverse reactions that are seen in clinical trials in adult patients with relapsed or refractory multiple myeloma.

M. Yair Levy, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Medical Oncologist/Hematologist

Dallas, TX

Dr M. Yair Levy is a paid consultant for Johnson & Johnson.

Safety From the MonumenTAL-1 Trial¹

CRS, including life-threatening or fatal reactions, can occur in patients receiving TALVEY^®1

In the clinical trial, CRS occurred in 76% of patients (N=339) who received TALVEY^® at the recommended dosages

CRS was primarily Grade 1 and 2, with Grade 3 events occurring in 1.5% of patients
Recurrent CRS occurred in 30% of patients

Median time to onset: 27 hours (range: 0.1-167) from the last dose

Median duration: 17 hours (range: 0-622)

CRS Experienced After Each Dose of TALVEY table

Neurologic toxicity, including ICANS, and serious and life-threatening or fatal reactions, can occur with TALVEY^®1

Neurologic toxicity, including ICANS, occurred in 55% of patients at the recommended dosages

Grade 3 and 4 events occurred in 6% of patients
Most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction, including ataxia/cerebellar ataxia (10%)

ICANS was reported in 9% of 265 patients where ICANS was collected and who received TALVEY^® at the recommended dosages

Recurrent ICANS occurred in 3% of patients
ICANS can occur concurrently 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
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

Median time to onset: 2.5 days (range: 1-16) from the last dose

Median duration: 2 days (range: 1-22)

ICANS Experienced After Each Dose of TALVEY table

TALVEY^® is available only through a restricted program called the TECVAYLI^® and TALVEY^® Risk Evaluation and Mitigation Strategy (REMS) Program. Visit TEC-TALREMS.com.

Adverse reactions (≥10%) in patients with relapsed or refractory multiple myeloma who received TALVEY^® in MonumenTAL-1¹

Adverse reactions were graded based on CTCAE version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria.

Includes other related terms.

Includes fatal outcome(s): COVID-19 (N=2), dyspnea (N=2), bacterial infection including sepsis (N=1), fungal infection (N=1).

Only Grade 3 adverse reactions occurred.

Per CTCAE v4.03, maximum toxicity grade for dysgeusia is 2 and maximum toxicity grade for dry mouth is 3.

Dysgeusia: ageusia, dysgeusia, hypogeusia and taste disorder.

Stomatitis: cheilitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral mucosal erythema, oral pain, stomatitis, swollen tongue, tongue discomfort, tongue erythema, tongue edema and tongue ulceration.

Oral disorder: oral disorder, oral dysesthesia, oral mucosal exfoliation, oral toxicity and oropharyngeal pain.

Nail disorder: koilonychia, nail bed disorder, nail cuticle fissure, nail discoloration, nail disorder, nail dystrophy, nail hypertrophy, nail pitting, nail ridging, nail toxicity, onychoclasis, onycholysis and onychomadesis.

Skin disorder: palmar-plantar erythrodysesthesia syndrome, palmoplantar keratoderma, skin discoloration, skin exfoliation and skin fissures.

Rash: dermatitis, dermatitis acneiform, dermatitis contact, dermatitis exfoliative, dermatitis exfoliative generalized, erythema, exfoliative rash, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular and stasis dermatitis.

Xerosis: dry eye, dry skin and xerosis.

Bacterial infection including sepsis: bacteremia, bacterial prostatitis, carbuncle, cellulitis, citrobacter infection, clostridium difficile colitis, clostridium difficile infection, cystitis escherichia, cystitis klebsiella, diverticulitis, enterobacter bacteremia, escherichia pyelonephritis, escherichia sepsis, folliculitis, gastroenteritis escherichia coli, helicobacter gastritis, human ehrlichiosis, klebsiella bacteremia, klebsiella sepsis, moraxella infection, otitis media acute, pitted keratolysis, pneumococcal sepsis, pneumonia, pneumonia streptococcal, pseudomonal bacteremia, pyuria, renal abscess, salmonella sepsis, sepsis, septic shock, skin infection, staphylococcal bacteremia, staphylococcal infection, staphylococcal sepsis, streptococcal bacteremia, tooth abscess, tooth infection, urinary tract infection enterococcal, and urinary tract infection pseudomonal.

Fungal infection: body tinea, candida infection, ear infection fungal, esophageal candidiasis, fungal infection, fungal sepsis, fungal skin infection, genital candidiasis, onychomycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, tinea pedis, vulvovaginal candidiasis, and vulvovaginal mycotic infection.

Encephalopathy: agitation, altered state of consciousness, amnesia, aphasia, bradyphrenia, confusional state, delirium, depressed level of consciousness, disorientation, encephalopathy, hallucination, lethargy, memory impairment, mood altered, restlessness, sleep disorder and somnolence.

Sensory neuropathy: dysesthesia, hyperesthesia, hypoesthesia, hypoesthesia oral, immune-mediated neuropathy, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, polyneuropathy, sciatica and vestibular neuronitis.

Motor dysfunction: dysarthria, dysgraphia, dysmetria, dysphonia, gait disturbance, muscle atrophy, muscle spasms, muscular weakness and tremor.

Onset and management guidance for select adverse reactions¹

ORAL TOXICITY

TALVEY^® can cause oral toxicities⁶

80^%

of patients experienced an oral toxicity

Grade 3 occurred in 2.1% of patients who received TALVEY^® at the recommended dosages.

The most frequent oral toxicities were dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia (18%).

65% of patients had oral toxicity that did not resolve to baseline.

Median time to onset in the clinical trial: 15 days (range: 1-634 days)

Median time to resolution in the clinical trial: 43 days (range: 1-530 days)

Patient counseling tips

Coping tips are available to counsel patients on select adverse reactions. The recommendations below from The Leukemia & Lymphoma Society and the American Cancer Society may help patients better cope with select adverse reactions they may be experiencing. This information is not included in the current Prescribing Information and has not been evaluated by the FDA. For more tips, please see lls.org and cancer.org.

Tips for patients with oral side effects^1,14

These oral side effects may include dysgeusia (change in sense of taste), dry mouth, dysphagia (difficulty swallowing), and sores in the mouth.

Practice good dental hygiene
Keep mouth moist with hard candy, drinking water, or other saliva substitutes
Avoid smoking

WEIGHT LOSS

TALVEY^® can cause weight loss¹

62^%

of patients experienced weight loss*

29% of patients experienced Grade 2 (>10%) weight loss and 2.7% of patients experienced Grade 3 (>20%) weight loss.

57% of patients continued to experience weight loss.

Median time to onset of Grade 2 or higher in the clinical trial: 67 days (~2.2 months; range: 6-407 days)^1,2

Median time to resolution in the clinical trial: 50 days (~1.6 months; range: 1-403 days)^1,2

Patient counseling tips

Tips for patients with weight loss^1,15,16

During treatment, monitor weight. A consultation with a nutritionist may be considered for supportive care.

Maintain a food journal
Maintain a nutritious diet
Engage in physical activity

SKIN TOXICITY

TALVEY^® can cause serious skin reactions

62^%

of patients experienced skin reactions

Skin reactions included rash, maculo-papular rash, erythema, and erythematous rash.

Grade 3 skin reactions occurred in 0.3% of patients.

Median time to onset in the clinical trial data: 25 days (range: 1-630 days)

Median time to improvement in the clinical trial: 33 days^†

Patient counseling tips

Tips for patients with skin changes^1,14

Skin changes may include skin problems, itchy or red skin or raised rash, abnormally dry skin that may affect the mouth and eyes, thickening of the skin and/or redness, swelling, and blistering on the palms of hands and soles of feet, skin discoloration, peeling, dried and cracked skin, rash with acne-like bumps or blisters, or itchy skin.

Take warm (not hot) baths or showers
Pat skin dry
Use lotions or moisturizing creams with no fragrance
Wash skin with mild soap and cleansers
Avoid direct sunlight and apply sunscreen

Tips for patients with nail changes^1,14

Nail changes may include a change in the appearance of the nail (including koilonychia, nail discoloration, and nail pitting or ridging), nail cuticle fissure, nail toxicity, or nail loss. These are not all the changes that may occur.

Wear gloves when cleaning or gardening
Avoid biting and picking on nails and cuticles
Wear comfortable shoes with extra room around the toes
Keep fingernails and toenails neatly trimmed
Counsel patients to consult with a healthcare provider before getting a manicure

*62% of patients experienced weight loss, regardless of having an oral toxicity.

^†The median time to improvement to Grade 1 or less was 33 days.

Explore additional safety data

“I prescribe TALVEY^® for my adult patients with relapsed or refractory multiple myeloma. When exploring treatment options for appropriate patients...”

“I prescribe TALVEY^® for my adult patients with relapsed or refractory multiple myeloma. When exploring treatment options for...”

M. Yair Levy, MD

Medical Oncologist/Hematologist

M. Yair Levy, MD

Medical Oncologist/Hematologist

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, TX

Once I’ve made the decision to prescribe TALVEY^®, I found that J&J withMe helps my office by providing access and affordability support to help patients throughout their treatment journey on TALVEY^®. I like that my Field Reimbursement Manager from Johnson & Johnson provides dedicated in-office support. My patients get easily connected to TALVEY withMe for cost support and free, personalized 1-on-1 Care Navigator support.

M. Yair Levy, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Medical Oncologist/Hematologist

Dallas, TX

Dr M. Yair Levy is a paid consultant for Johnson & Johnson.

Access and Affordability Resources Plus Personalized Support for Your Patients

At Johnson & Johnson, we are committed to helping people in their fight against cancer. Our J&J withMe program is here at every step to provide personalized support to help patients start and stay on their J&J medicines.

J&J withMe is your single source for access, affordability, and treatment support programs from Johnson & Johnson. Your patients will be connected to TALVEY withMe.

Access Support—to help navigate payer processes.

Affordability Resources—to help your patients discover ways to afford their TALVEY^® medicine.

Dedicated, free 1-on-1 Care Navigator Support for Your Patients—offered through TALVEY withMe to support the nonclinical needs that may arise while on TALVEY^®.

Visit JnJwithME.com/hcp/ to learn more

Click here

The patient support and resources provided by J&J withMe are not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, provide case management services, or serve as a reason to prescribe a J&J medicine.

“Once I’ve made the decision to prescribe TALVEY^®, I found that J&J withMe helps...”

“Once I’ve made the decision to prescribe TALVEY^®, I found that J&J withMe helps my office by providing access and affordability...”

M. Yair Levy, MD

Medical Oncologist/Hematologist

I prefer TALVEY^® for my adult patients with relapsed or refractory multiple myeloma because it offers flexibility from the start, with weekly or biweekly dosing available. TALVEY^® is administered via subcutaneous injection following a step-up dosing schedule. I recommend you review the pre-treatment medication information as you consider TALVEY^® for your adult patients.

M. Yair Levy, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Medical Oncologist/Hematologist

Dallas, TX

Dr M. Yair Levy is a paid consultant for Johnson & Johnson.

TALVEY^®: Dosing and Administration Considerations

Flexibility from the start: Q2W and QW dosing available with personalized weight-based dosing.¹ Please refer to Tables 9-12 in the full Prescribing Information to determine the total dose, injection volume, and number of vials required.

TALVEY^® is administered via subcutaneous injection by a healthcare provider Q2W or QW following the step-up dosing schedule

Step-up doses may be administered between 2 to 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions. The full step-up dosing schedule can be completed in 7 days for Q2W and 5 days for QW.

Step-up dosing schedule:

Following step-up dosing, ongoing biweekly dosing begins. Maintain a minimum of 12 days between Q2W doses

Following step-up dosing, ongoing weekly dosing begins. Maintain a minimum of 6 days between QW doses

TALVEY^® is given until disease progression or unacceptable toxicity.

Based on actual body weight.

Administer pretreatment medications prior to each dose of TALVEY^® in the step-up dosing schedule as recommended to reduce the risk of CRS [see Dosage and Administration (2.2, 2.3) in the full Prescribing Information].

Initiate TALVEY^® treatment with step-up dosing to reduce the risk of CRS [see Dosage and Administration (2.2) in the full Prescribing Information].

TALVEY^® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS [see Warnings and Precautions (5.1, 5.2) in the full Prescribing Information].

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TALVEY^® step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1, 5.2) in the full Prescribing Information].

Learn more about flexible dosing

“I prefer TALVEY^® for my adult patients with relapsed or refractory multiple...”

“I prefer TALVEY^® for my adult patients with relapsed or refractory multiple myeloma because it offers flexibility from the start...”

M. Yair Levy, MD

Medical Oncologist/Hematologist

I consider clinical efficacy and safety as well as the mechanism of action to be an important factor when evaluating treatment options for my adult patients with relapsed or refractory multiple myeloma. I choose to prescribe TALVEY^® because of its clinical profile and because it uses a different antigen as a bispecific antibody.

M. Yair Levy, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Medical Oncologist/Hematologist

Dallas, TX

Dr M. Yair Levy is a paid consultant for Johnson & Johnson.

TALVEY^®: Mechanism of Action

TALVEY^® is the first FDA-approved bispecific antibody developed to target GPRC5D^1,5

TALVEY^® induces the lysis of multiple myeloma cells by activating the immune system via GPRC5D x CD3¹

In research that examined GPRC5D mRNA expression in malignant cells, GPRC5D mRNA was found to be substantially expressed in multiple myeloma cell lines⁶
This finding led to the commitment of Janssen Biotech, Inc., to pursue the development of a GPRC5D-targeting therapy for multiple myeloma⁷

Different targets may help address treatment resistance and avoid re-exposure to previous targets^6,8,9

What is currently known about GPRC5D expression?

GPRC5D is expressed on the surface of multiple myeloma cells and non-malignant plasma cells^1,9-13
- Also expressed on healthy tissues such as epithelial cells in keratinized tissues of the skin and tongue
Expressed in a broad range of patients with multiple myeloma⁹
- For example, GPRC5D expression has been detected in patients that varied according to disease staging, cytogenetic abnormalities, gender, and age
Expression is independent of other targets, including BCMA⁶

Discover how TALVEY^® works

“I consider clinical efficacy and safety as well as the mechanism of action to be an important factor when evaluating treatment options for my adult patients...”

“I consider clinical efficacy and safety as well as the mechanism of action to be an important factor when...”

M. Yair Levy, MD

Medical Oncologist/Hematologist

MonumenTAL-1 Trial: A Brief Overview

Clinical trial dosing1

Patients with a range of characteristics, including those with high-risk features, were studied in MonumenTAL-11

TALVEY® provided powerful efficacy1,2

Naïve to T-Cell Redirection Therapy†

MonumenTAL-1 Longer-Term Follow-Up Analysis: Naïve to T-Cell Redirection Therapy†

Exposed to T-Cell Redirection Therapy†

Durable responses were seen in patients exposed to T-cell redirection therapy1,2†

MonumenTAL-1 Longer-Term Follow-Up Analysis: Exposed to T-Cell Redirection Therapy†

72% of patients responded to TALVEY®, with 50% achieving ≥CR§ at a median follow-up of >20 months2,4

I prescribe TALVEY® for my adult patients with relapsed or refractory multiple myeloma. When exploring treatment options for appropriate patients, I consider the adverse reactions that are seen in clinical trials in adult patients with relapsed or refractory multiple myeloma.

Safety From the MonumenTAL-1 Trial1

CRS, including life-threatening or fatal reactions, can occur in patients receiving TALVEY®1

Neurologic toxicity, including ICANS, and serious and life-threatening or fatal reactions, can occur with TALVEY®1

Adverse reactions (≥10%) in patients with relapsed or refractory multiple myeloma who received TALVEY® in MonumenTAL-11

Onset and management guidance for select adverse reactions1

Access and Affordability Resources Plus Personalized Support for Your Patients

J&J withMe is your single source for access, affordability, and treatment support programs from Johnson & Johnson. Your patients will be connected to TALVEY withMe.

Visit JnJwithME.com/hcp/ to learn more

TALVEY®: Dosing and Administration Considerations

Step-up dosing schedule:

TALVEY®: Mechanism of Action

TALVEY® is the first FDA-approved bispecific antibody developed to target GPRC5D1,5

TALVEY® induces the lysis of multiple myeloma cells by activating the immune system via GPRC5D x CD31

Different targets may help address treatment resistance and avoid re-exposure to previous targets6,8,9

What is currently known about GPRC5D expression?

INDICATION AND USAGE

IMPORTANT SAFETY INFORMATION

Clinical trial dosing¹

Patients with a range of characteristics, including those with high-risk features, were studied in MonumenTAL-1¹

TALVEY^® provided powerful efficacy^1,2

Naïve to T-Cell Redirection Therapy^†

MonumenTAL-1 Longer-Term Follow-Up Analysis: Naïve to T-Cell Redirection Therapy^†

Exposed to T-Cell Redirection Therapy^†

Durable responses were seen in patients exposed to T-cell redirection therapy^1,2†

MonumenTAL-1 Longer-Term Follow-Up Analysis: Exposed to T-Cell Redirection Therapy^†

72% of patients responded to TALVEY^®, with 50% achieving ≥CR^§ at a median follow-up of >20 months^2,4

I prescribe TALVEY^® for my adult patients with relapsed or refractory multiple myeloma. When exploring treatment options for appropriate patients, I consider the adverse reactions that are seen in clinical trials in adult patients with relapsed or refractory multiple myeloma.

Safety From the MonumenTAL-1 Trial¹

CRS, including life-threatening or fatal reactions, can occur in patients receiving TALVEY^®1

Neurologic toxicity, including ICANS, and serious and life-threatening or fatal reactions, can occur with TALVEY^®1

Adverse reactions (≥10%) in patients with relapsed or refractory multiple myeloma who received TALVEY^® in MonumenTAL-1¹

Onset and management guidance for select adverse reactions¹

TALVEY^®: Dosing and Administration Considerations

TALVEY^®: Mechanism of Action

TALVEY^® is the first FDA-approved bispecific antibody developed to target GPRC5D^1,5

TALVEY^® induces the lysis of multiple myeloma cells by activating the immune system via GPRC5D x CD3¹

Different targets may help address treatment resistance and avoid re-exposure to previous targets^6,8,9