Multiple Myeloma
Understanding
TALVEY
®
(talquetamab-tgvs)
September 2026 Edition
HAVE QUESTIONS? WE CAN HELP The IMF team is here to support you and your loved ones with the most up-to-date information about myeloma Call the IMF at 1.818.487.7455 (and press 1) or visit the web page at mmsm.link/infoline to schedule a time to talk with us about your myeloma experience or if you wish to discuss the contents of this booklet.
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Contents You are not alone
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Have questions? We can help
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IMF publications
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Understanding myeloma vocabulary
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What you will learn from this booklet
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Who can be treated with Talvey
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How Talvey works
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How patients receive Talvey
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Clinical trial experience with Talvey
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Special precautions with Talvey
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Possible common side effects of Talvey
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When to seek medical help
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Patient assistance program
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In closing
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You are not alone
The International Myeloma Foundation (IMF) has a mission: Accelerating the prevention and cure of myeloma and improving the quality of life for patients and families. The IMF gives information and support for people with multiple myeloma (also known as “myeloma”) and their care partners, friends, and family members. We do this on our website, myeloma.org, and through many programs and services like booklets, tip cards, classes, webinars, workshops, support groups, and much more.
Have questions? We can help
Myeloma is a cancer that many people have not heard of at the time of their diagnosis. The IMF can help you learn more about myeloma, understand what resources are available, and help you live well with this disease. The IMF can give you current information so you can work with your doctor to make the best decisions for your health. ¡ For information and support, call the IMF at 1.818.487.7455 (and press 1) or visit mmsm.link/infoline to schedule a time to talk with us. ¡ Want answers and don’t want to wait? Ask Myelo®, your AI assistant at myeloma.org. Myelo will help you find the right information and resources 24/7.
IMF publications
The IMF’s Patient Handbook explains what myeloma is, how doctors test for it, and how it affects the body. The Patient Handbook also introduces you to the many ways to treat myeloma and to manage its symptoms. The Patient Handbook also directs you to many helpful resources. The IMF’s Understanding-series booklets offer more information about different myeloma-specific topics, such as symptoms, treatments, and possible side effects. All IMF publications are free and can be read online, downloaded, or mailed to you. If you would like to read IMF publications digitally, just click on the light blue links in this booklet or go to publications.myeloma.org.
Understanding myeloma vocabulary
Myeloma is a complicated disease, but the language that describes it doesn’t have to be hard to understand. Getting comfortable with the language of myeloma will help you learn more about this disease and have better communication with your healthcare team. Words in bold+blue in this booklet are explained in the IMF’s companion publication, Understanding Myeloma Vocabulary, which is located at glossary.myeloma.org. 4
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What you will learn from this booklet
This booklet discusses Talvey® (also known by its generic drug name, as talquetamab-tgvs, or “tal” for short). You will learn who can be treated with Talvey, how Talvey works, its dose and schedule, and clinical trial experience with Talvey. You will also learn about support programs for patients who are prescribed Talvey, and the possible side effects for you to discuss with your doctor.
Who can be treated with Talvey
In 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Talvey for the treatment of adults with relapsed/refractory multiple myeloma (RRMM), disease that returned after treatment and a period of improvement. Myeloma patients can be treated with Talvey after 4 or more prior lines of therapy. The prior therapies must include the following:
¡ Proteasome inhibitor Velcade® (bortezomib) Kyprolis® (carfilzomib), or Ninlaro® (ixazomib). ¡ Immunomodulatory agent Revlimid® (lenalidomide), Pomalyst® (pomalidomide), or Thalidomide. ¡ Anti-CD38 monoclonal antibody Darzalex® (daratumumab), Darzalex Faspro® (daratumumab + hyaluronidase fihj), Sarclisa® (isatuximab), or Sarclisa ESCENA™ (isatuximab-irfc). Figure 1. Talvey mechanism of action Talvey binds to CD3 on the surface of the T cell
CD3 protein complex
TALVEY® (talquetamab-tgvs) Talvey binds to GPRC5D on the myeloma cell surface GPRC5D tumor-specific surface antigens
T cell myeloma cell
Talvey activates the T cell to release cytotoxic granules that kill the myeloma cell
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How Talvey works
Talvey uses the patient’s immune system to attack their myeloma. Talvey is part of the drug class of bispecific antibodies. A drug class is a group of medications that have a similar chemical structure or a similar way of working. A bispecific antibody has two “arms” that attach to two (“bi”) targeted cells. One arm attaches to GPRC5D (G protein–coupled receptor, class C, group 5, member D) on the surface of myeloma cells. The other arm attaches to CD3 (cluster of differentiation 3) on the surface of the patient’s own immune system T cell (T lymphocyte). Next, Talvey activates the T cells to release toxic granules that kill the myeloma cells. Talvey is the first medication in the drug class of bispecific antibodies approved by the FDA that targets GPRC5D and CD3.
How patients receive Talvey How Talvey is given
Talvey is given as an injection (“shot”) under the skin. This is called a subcutaneous injection. It is given by a healthcare professional under the skin in your stomach, thigh, or another area of the body.
Dose and schedule
The dose of Talvey is calculated based on the patient’s weight. The two step-up dosing schedules described below are designed to reduce the risk of side effects. Ask your doctor which of the following scheduling options is more appropriate in your particular case. Once every 2 weeks dosing schedule: ¡ Day 1 (also called step-up dose #1) Talvey is given at 0.01 milligram (mg) per kilogram (kg) of body weight. ¡ Day 4 (step-up dose #2) Talvey is given at 0.06 mg/kg. ¡ Day 7 (step-up dose #3) Talvey is given at 0.4 mg/kg. ¡ Day 10 (full dose #1) Talvey is given at 0.8 mg/kg. ¡ Followed by a shot of Talvey given once every 2 weeks at 0.8 mg/kg. Once-weekly dosing schedule: ¡ Day 1 (step-up dose #1) Talvey is given at 0.01 mg/kg. ¡ Day 4 (step-up dose #2) Talvey is given at 0.06 mg/kg. ¡ Day 7 (full dose #1) Talvey is given at 0.4 mg/kg. ¡ Followed by a shot of Talvey given once-weekly at 0.4 mg/kg.
Your doctor will also decide the following
¡ If you should be hospitalized for 2 days (48 hours) after receiving Talvey in order to reduce the risk of side effects. ¡ The total number of treatments with Talvey you will receive.
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¡ T he number of days between your doses of Talvey. ¡ I f you should be prescribed medicines to help reduce your risk of Talvey side effects.
Clinical trial experience with Talvey
A clinical trial is a medical research study with people who volunteer to test scientific approaches to a new treatment or a new combination therapy. Each clinical trial is designed to find better ways to prevent, detect, diagnose, or treat a medical condition, or to answer scientific questions. A clinical trial is launched only after laboratory studies have shown the potential of a treatment or procedure to be more effective and/or less harmful than previous methods. For patients with myeloma, clinical trials can be part of normal care that may provide earlier access to new drugs and therapies that are not yet available outside of a study.
MonumenTAL-1 clinical trial
Talvey received the FDA approval based on the response rate and durability of response data from the MonumenTAL-1 clinical trial of single agent Talvey in patients with RRMM. Nearly 75% of study patients were refractory to 5 drugs prior to being treated with Talvey. The study demonstrated an overall response rate (ORR) of more than 71% with weekly and every-other-week dosing of Talvey.
The MonumenTAL-3 clinical trial
At the annual meeting of the European Hematology Association (EHA), the study selected for the EHA plenary session as one of the top research abstracts was MonumenTAL-3. The study compared the combination of Talvey + Darzalex [Tal-D] and Tal-D + Pomalyst [Tal-DP] vs. Darzalex + Pomalyst + dexamethasone [DPd] in patients with RRMM. Study patients who received either Tal-D or Tal-DP saw benefits in progression-free survival (PFS). These patients included older individuals, patients with high-risk cytogenetics, those who were previously treated with Darzalex, as well as patients with soft tissue plasmacytomas. PFS is the length of time during and after the treatment of myeloma that a patient lives with the disease, but the myeloma does not get worse. In a clinical trial, PFS is one way to measure how well the treatment is working. At 2 years of follow-up, PFS rates for Tal-DP and Tal-D were 81.3% and 77.6%, respectively. Overall survival rates for Tal-DP and Tal-D were 89.2% and 87.9%, respectively.
Extra-Medullary Disease (EMD)
One of the most challenging forms of myeloma is when the disease grows outside of the bone marrow. This is known as extra-medullary disease (EMD). Historically, myeloma patients with EMD had lower response rates myeloma.org
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to treatment. Patients with EMD tend to have very short periods of remission due to the aggressive nature of EMD. A clinical trial presented at the annual meeting of the American Society of Hematology (ASH) in December 2025 demonstrated remarkable results. The study combined two bispecific antibodies with different targets on the myeloma cell: Talvey, which targets GPRC5D, and Tecvayli® (teclistamabcqyv), which targets B-cell maturation antigen (BCMA). Study patients with EMD had a response rate of 80%, nearly doubling prior therapies and lasting on average more than 12 months. This treatment is not yet approved by FDA.
Finding a clinical trial to match your needs
Myeloma clinical research is very exciting, with many studies enrolling patients. To help you with personalized support for identifying clinical trial options across the U.S., the IMF has partnered with SparkCures. Visit myeloma.org/sparkcures or contact the IMF InfoLine for more information. If you are interested in exploring your potential benefits and risks of clinical trial participation, speak with your myeloma doctor. To learn more about clinical trials in general, read the IMF’s publication Understanding Clinical Trials in Myeloma.
Special precautions with Talvey
All medications come with a risk of side effects. Most side effects are manageable. Some possible side effects require an FDA-mandated Boxed Warning, the strictest caution in the labeling of prescription drugs. You must promptly notify your doctor of any changes in your health, including any new or worsening signs or symptoms that you experience. Even if you think your reaction to treatment is mild – or might be “normal” – be sure to report it to your healthcare team.
Risk Evaluation and Mitigation Strategy (REMS)
REMS programs are required by the FDA for treatments that may have serious safety concerns. REMS programs support the use of treatment and help ensure that the potential benefits outweigh the risks. Talvey is available only through a REMS program. Patients receive a Wallet Card that lists the signs and symptoms of possible complications from Talvey. Carry the Patient Wallet Card with you always and show it to all of your healthcare providers.
Cytokine Release Syndrome (CRS)
Cytokines are proteins that circulate in the bloodstream, usually in response to infection, that can stimulate or inhibit the growth or activity in other cells. 8
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CRS is a potentially fatal, uncontrolled immune reaction in which cytokines become highly elevated and trigger an overwhelming immune system response. A cytokine storm can seriously damage body tissues and organs. CRS occurred in 76% of patients who received Talvey at the recommended dosages in the MonumenTAL-1 study. Mild symptoms were experienced by 57% of study patients. Moderate symptoms were experienced by 17% of study patients. Symptoms requiring treatment were experienced by 1.5% of study patients. At the recommended dosages, recurrent CRS occurred in 30% of study patients. CRS occurred in 33% of patients on the biweekly schedule with step-up dose 3. CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients 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 hours from the last dose, and the median duration was 17 hours.
Immune effector cell-associated neurotoxicity syndrome (ICANS)
ICANS can occur in the days or weeks after the administration of immunotherapy, especially immune effector cell (IEC) and T-cell therapies. Neurotoxicity (also known as neurologic toxicity) occurs when exposure to toxic substances changes the normal activity of the nervous system. In the MonumenTAL-1 study, neurologic toxicity occurred in 55% of patients who received Talvey at 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 who received Talvey at the recommended dosages in phase II of the MonumenTAL-1 study. Recurrent ICANS occurred in 3% of study patients as follows:
¡ Following step-up dose 1 (3%), ¡ Following step-up dose 2 (3%), ¡ Following step-up dose 3 of the biweekly dosing schedule (1.8%), ¡ The initial treatment dose of the weekly dosing schedule (2.6%), or ¡ The biweekly dosing schedule (3.7%). myeloma.org
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The median time to onset of ICANS was 2.5 days after the most recent dose with a median duration of 2 days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.
The use of prophylaxis reduces CRS and ICANS
With the use of Talvey, prophylactic medication may be given to prevent or reduce the severity of CRS and ICANS. Research was presented at the ASH annual meeting in December 2024 on the use of tocilizumab (“toci” for short) in patients treated with bispecific antibodies. Toci blocks the interleukin-6 (IL-6) receptor, a cytokine that causes inflammation. A total of 72 study patients, including 16 patients treated with Talvey, received toci with the first step-up-dose of a bispecific antibody. Investigators recorded a low rate of CRS (20%) and ICANS (19%) in the Talvey patients. The rate of recurrence for CRS and ICANS was 0% and 1%.
Infections
The incidence of severe infections was lower when compared to treatments that target BCMA. Preventive measures and management strategies are consistent with non-BCMA-directed therapies for myeloma. In the MonumenTAL-1 study, 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%, including sepsis). Vaccinations are important, especially for immunocompromised individuals and their care partners. Ask your doctor which new or updated vaccines are recommended in your case.
Cytopenias
Cytopenia is a condition in which there is a lower-than-normal number of red blood cells, white blood cells, or platelets. Talvey can cause cytopenias, including neutropenia and thrombocytopenia.
¡ T hrombocytopenia is a low number of platelets in the blood. Platelets help blood to clot. Fewer platelets can lead to easier bruising, bleeding, and slower healing. The “normal” level of platelets varies among laboratories but is approximately 150,000 platelets per micro-liter of circulating blood. Bleeding problems can occur if the count is less than 50,000 platelets. Major bleeding is usually associated with a reduction to less than 10,000 platelets. In the MonumenTAL-1 study, Grade 3 or 4 thrombocytopenia occurred in 22% of patients. ¡N eutropenia is a low level of white blood cells (WBC), and this can lead to infection. Alert your doctor immediately if you have a fever, sore throat, or any other sign of an infection. Your doctor will 10
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determine how to best manage your infection. Treatment depends on the cause of neutropenia and its severity. Mild neutropenia may not need treatment. If treatment is needed, it may include medication to stimulate the growth of neutrophils. In the MonumenTAL-1 study, Grade 3 or 4 neutropenia occurred in 35% of patients.
Hepatotoxicity
Talvey can cause hepatotoxicity (injury to the liver or impairment of liver function). Liver enzyme elevation can occur with or without concurrent CRS. Bilirubin and liver enzymes should be tested at baseline and during treatment. In the MonumenTAL-1 study: ¡ E levated alanine aminotransferase (ALT) blood test results occurred in 33% of patients, with Grade 3 or 4 ALT elevation occurring in 2.7%. ¡ E levated aspartate aminotransferase (AST) occurred in 31% of patients, with Grade 3 or 4 AST elevation occurring in 3.3%. ¡G rade 3 or 4 elevation of total bilirubin occurring in 0.3% of patients.
Embryo-fetal toxicity
Women of reproductive potential and males with female partners of reproductive potential must use effective birth control (contraception) during treatment with Talvey and for at least 3 months after the last dose. Ask your doctor which effective method of birth control you should use. Due to the potential for harm in the breastfed child, lactating women should not breastfeed during treatment with Talvey and for at least 3 months after your last dose.
Possible common side effects of Talvey
Common side effects are those that were experienced by at least 20% of patients in clinical trials.
Oral toxicity
Talvey can cause adverse effects in the mouth and throat. This is due to Talvey targeting the GPRC5D protein, which is also present in healthy tissues, including the tongue and salivary glands. This may cause mouth discomfort, sores, inflammation, redness, and/or the following: ¡D istortion or loss of taste (approx. 71% to 72% of study patients) ¡D ry mouth due to reduced production of saliva (27% to 40% of patients) ¡D ifficulty or pain when swallowing (24% to 25% of patients) In most clinical trial patients, median time to onset of oral side effects was 15–29 days. Median duration of oral side effects was 57–109 days. Resolution of oral side effects was achieved in 31%–73% of patients. Oral side effects were managed with dose reduction in fewer than 9% of myeloma.org
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study patients. If oral side effects continued, their severity was mostly reducedto Grade 1 or 2. In fewer than 2% of study patients, treatment with Talvey was discontinued. Nutritional support: Ask your doctor for a referral to a nutritionist or dietician. Given the possibility of oral side effects described above, you might benefit from nutritional management and supportive measures. Make sure that you are monitored for weight loss.
Skin-related toxicities
The following Grade 1 or 2 rash and non-rash skin-related side effects were experienced by 30%–73% clinical trial participants:
¡D ryness, ¡ I tchiness, ¡ E xfoliation, peeling, or flaking, ¡H and-foot syndrome (palmar-plantar erythrodysesthesia). For most patients experiencing skin-related toxicity, median time to onset was 20 to 30 days. Median duration was 26 to 39 days for most patients. Resolution was seen in 57%–88% of skin-related events. Most skin-related side effects can be managed with:
¡H eavy moisturizers and hydration. ¡ T opical steroids (to control inflammation, irritation, and redness). ¡O ral steroids (if skin-related toxicity is more severe).
Nail-related toxicities
The incidence of nail-related side effects in study patients was 54%–55% and was mostly Grade 1 or 2. This included:
¡O nycholysis (when the nail separates from the nail bed), ¡O nychomadesis (painless nail shedding), ¡O nychoclasis (the breaking or splitting of nails), ¡D ystrophy (abnormal change in the shape, color, texture, or growth) of fingernails and/or toenails. For most patients, median time to onset was 68 to 69 days, and median duration was 74 to 89 days. Resolution was seen in 26%–33% of events. Dose modification was needed in fewer than 1% of patients. There was no treatment discontinuation due to nail-related side effects. Comfortable shoes, soft socks, good hygiene, keeping nails trimmed, and using moisturizers and/or topical corticosteroids may be helpful. 12
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When to seek medical help
Immediately alert your doctor or seek medical help if you develop any of the symptoms listed above or any other potential side effects of Talvey:
¡ F ever (100.4°F or higher), ¡ F eeling anxious, ¡D izziness or lightheadedness, ¡H eadache, ¡C hills, ¡ F ast heartbeat, ¡D ifficulty breathing, ¡ F eeling very sleepy with low energy, ¡ F eeling confused or disoriented, ¡B eing less alert or aware,
¡ Slow or difficulty thinking, ¡ Seizures, ¡ Trouble speaking or writing, ¡ Muscle weakness, ¡ Shaking (tremors), ¡ Memory loss, ¡ Numbness and tingling (feeling “pins and needles”), ¡ Burning, throbbing, or stabbing pain.
Patient assistance program
If you are prescribed Talvey, you can sign up for the “TALVEY withMe: Personalized 1-on-1 Support.” Visit talvey.com or call 1.833.565.9631 Monday through Friday, 8 a.m. – 8 p.m. (ET) to connect one-on-one with a Care Navigator to explore cost, education, and resources at no cost to you. Your Care Navigator can help guide you to support solutions throughout your treatment journey with Talvey.
In closing
This booklet is not meant to replace the advice of your doctors and nurses who are best able to answer questions about your specific healthcare management plan. The IMF provides educational information that will guide you in your conversations with your healthcare team. To help ensure a good quality of life through effective treatment, you must have an active role in your own medical care. Please visit myeloma.org and join the IMF Myeloma Knowledge Platform at myprofile.myeloma.org. Click on the links included in this booklet for quick access to a variety of resources. Sign up at subscribe.myeloma.org for our quarterly journal Myeloma Today and weekly e-newsletter Myeloma Minute, as well as alerts about IMF news, events, and actions.
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Founded in 1990, the International Myeloma Foundation (IMF) is the world’s leading organization dedicated to multiple myeloma. The IMF is steadfast in its mission: Accelerating the prevention and cure of myeloma and improving the quality of life for patients and families. The IMF serves people impacted by myeloma at every stage of the disease by combining world-class research, trusted education, global advocacy, and direct support. A cornerstone of this work is the International Myeloma Working Group® (IMWG) – a network of more than 300 internationally renowned researchers and clinicians who establish the guidelines that shape how myeloma is diagnosed, treated, and managed across the globe. Through its global network of support groups, educational programs, its 24/7 generative-AI myeloma assistant Myelo®, and its advocacy for greater healthcare access, the IMF helps people living with myeloma and their care partners navigate diagnosis, treatment, and survivorship. At the same time, the IMF ensures scientific advances translate into better care and outcomes. Learn more at
myeloma.org
Follow the International Myeloma Foundation on: /myeloma
@imfmyeloma
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