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Relapsed and refractory multiple myeloma can be difficult to manage, especially as patients progress through multiple lines of therapy and treatment options may become more limited.1 Since the disease can behave differently from person to person, it’s important for patients and their care partners to understand their options and what to expect during the treatment journey.2
CURE sat down with Marlee Bogema, MSN, FNP-C, from The Cancer and Hematology Centers, who shared her perspectives on a treatment option for adults living with relapsed and refractory multiple myeloma and what patients and their care partners should know as they navigate their options.
This article is sponsored by Johnson & Johnson. Marlee Bogema, MSN, FNP-C, is a paid consultant for Johnson & Johnson and must present information in accordance with U.S. Food & Drug Administration (FDA) requirements applicable to Johnson & Johnson.
CURE: For people living with multiple myeloma, what is most important for them to know about the disease and their treatment options today?
Marlee Bogema, MSN, FNP-C: The way we approach and treat multiple myeloma has changed drastically in the past ten years. When I first started getting to know this complex disease, there were only a few treatments to choose from.3 Now, we have more options than ever before – and we’re seeing many patients live longer beyond their diagnosis than in the past.3 However, every patient’s experience is different, so it’s important that they work closely with their care team to find the treatment approach that is right for them.
We also have more advanced diagnostics and testing capabilities that help us better understand how well treatments are working.4 That means we can tailor care more precisely. For example, we can better target treatment based on a patient’s cytogenetics – which tells us about specific changes in their cancer cells – and minimal residual disease (MRD) testing, which refers to the small number of cancer cells that remain in the body during and after cancer treatment.5,6
One treatment option that has entered the arena and which can play an important part in a patient’s care plan is TALVEY® (talquetamab-tgvs), which is approved 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 to treat their multiple myeloma.7 This indication is approved under accelerated approval based on response rate and durability of response.7 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).7
TALVEY® was studied in 219 patients in the Phase 1/2 MonumenTAL-1 trial.7 Results showed that 73% and 73.6% of patients receiving TALVEY® weekly and biweekly, respectively, responded to treatment.7
TALVEY® is available as an every-two-week or once-weekly subcutaneous injection after an initial step-up dosing phase.7 Once the patient and their care team have chosen a treatment plan, they begin a step-up dosing schedule where the patient receives the first two or three doses of TALVEY® at a smaller dose and increases up to the full treatment dose.7 Patients should be hospitalized for at least 48 hours after administration of all doses within the step-up dosing schedule, which allows them to be monitored for any potential serious or life-threatening side effects, including cytokine release syndrome (CRS) and neurologic problems like immune effector cell-associated neurotoxicity syndrome (ICANS).7
CURE: How would you describe TALVEY® to a patient or care partner who’s hearing about it for the first time? What are the key points you emphasize for patients?
Bogema: I usually start by telling patients, “I’m going to give you a medication that I like to think of as alphabet soup.” Then I explain that TALVEY® targets something called “GPRC5D” – a protein found on multiple myeloma cells, as well as some healthy cells in the body.8 This is a target that their myeloma hasn’t seen before, which means we’re going after it in a different way than previous treatments. In fact, TALVEY® is the first-in-class FDA-approved GPRC5D targeting agent.8,9
TALVEY® is what’s known as a bispecific antibody. That means it binds to two proteins at once – GPRC5D on the multiple myeloma cells and “CD3” on the T-cells, which are part of the immune system. This dual targeting may help activate the body’s immune system to recognize and attack the multiple myeloma cells.8
Bispecifics are an exciting class of medications in oncology care; however, there are certain side effects we closely watch for when we activate the immune system, such as CRS and neurologic problems like ICANS (which can occur during the step-up dosing phase), as well as taste, skin, and nail changes. I like to set expectations around safety right away when discussing treatment with bispecific antibodies – we make sure patients and their care partners know what side effects to look out for so we can work together to manage them.
CURE: Who might be a good candidate for TALVEY®, and when in the multiple myeloma treatment journey is it typically considered?
Bogema: TALVEY® is FDA-approved for adults living with relapsed or refractory multiple myeloma who have already received at least four different kinds of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.7 At this point in treatment, options may become more limited, and TALVEY® may be able to help by targeting the disease in a new way.10 I also tend to reach for TALVEY® in patients who have relapsed from B-cell maturation antigen (BCMA)-targeted therapies.
CURE: What side effects do you commonly see with TALVEY®, and why is it important for patients and their loved ones to know what they may expect? How can they work with their treatment team to manage any side effects they experience?
Bogema: I spend time talking with patients and their care partners about some of the more common side effects that can affect daily life – particularly taste, skin, and nail issues.8 Many patients notice that sweet foods and meats taste different, which can lead to reduced appetite and weight loss.11 We monitor weight fluctuations very closely and involve dietitians, if needed, to ensure patients are maintaining proper nutrition. Nail and skin changes – like peeling or discoloration – can be visible and emotionally difficult, so I do my best to prepare patients ahead of time.
These side effects can be common while undergoing treatment with TALVEY®, and we have strategies to help manage them – but only if we know about them early.7 These strategies include certain lotions and mouth rinses that can help protect and lubricate the affected areas. We may also give the patient a break in therapy, but I usually hold this as a last resort.
I always ask patients and their care partners to track how they are feeling and to contact us as they notice a change, even if it feels small. The earlier the care team is alerted to potential side effects, the better chance we may have of handling them. We can adjust care, offer support, and make the experience more manageable when we work together from the start.
CURE: What advice would you give to patients considering TALVEY® or discussing it with their care team?
Bogema: When considering any new multiple myeloma medication, I encourage patients to think about two main things: their treatment goals, like disease control, along with the side effects.
When being treated with TALVEY®, most people can expect durable responses.7 The MonumenTAL-1 trial showed that the median duration of response (DOR) for the weekly cohort was 9.5 months, while the median DOR was not estimable for the biweekly cohort, and 85% of patients who responded maintained a response for at least 9 months.7 Most patients can also expect changes with their taste, skin, and nails, given that 70%, 41%, and 50% of participants experienced some form of these adverse events, respectively, in the MonumenTAL-1 study.7
These side effects are common and manageable, especially when working with a nutritionist or dermatologist, but they still impact day-to-day life.8 For example, if someone really values food and cooking, it helps to know ahead of time that they may experience changes in taste and that they may want to experiment with different recipes. Having realistic expectations makes a big difference.
Patients should also consider their dose preference. TALVEY® offers flexible dosing – either weekly or every two weeks after the step-up phase.7 Some patients prefer fewer visits, while others feel more comfortable being monitored more frequently. It depends on what feels right for them and where they are on their treatment journey. Because TALVEY® involves step-up dosing and carries risks like CRS and ICANS, it’s important that both the patient and their care partners feel ready and supported through that part of treatment.7
In my role, I’ve guided patients receiving bispecific antibodies in step-up dosing across a range of care settings, as I believe it’s important for patients to have access to these advanced therapies in their local care settings. This belief led me to establish protocols to appropriately support patients having access to critical therapy in my own local community.
Ultimately, patients should work with their doctor and ask questions to understand all the treatment options available to them so they can make an informed choice that reflects their individual needs and goals.
CURE: Do you have any advice for care partners, specifically with loved ones, who are considering starting treatment with a bispecific antibody?
Bogema: In my experience, multiple myeloma care partners are often concerned about their loved ones’ weight and diet while they’re undergoing treatment. Food is something tangible they can control and contribute to, and weight is a metric they can easily monitor. But when patients experience taste changes or appetite loss due to their medications, it can create frustration on both sides. Sometimes that means working toward a specific calorie or protein intake target together or exploring different ways to think about nutrition.
These moments can be emotionally difficult. That’s why I try to work with both the patient and their care partners to set realistic goals and reframe expectations. I also help the patient and care partner understand the impact of treatment on disease control, monitoring lab values, and checking how they are feeling. This open dialogue gives me the partnership to help support them in trying to balance efficacy and quality of life goals.
My biggest piece of advice for care partners is this: lean into your care team and your community – other families could be going through a similar experience, and connecting with them can be a powerful source of comfort and strength. Changes and side effects are expected, and we’re here to support you. This is a shared effort, and we’ll work through it – together.
CURE: What gives you hope when you think about the future of multiple myeloma treatment?
Bogema: What gives me hope is how far we’ve already come in treating multiple myeloma – and how much potential there is for continued progress. I think about the available options we’ve seen developed over the last five years and am excited about what the next five could bring.
New therapies are being developed across different treatment classes, including additional bispecific antibodies and even “trispecific antibodies,” which are designed to engage the immune system in more complex ways.12 As our understanding of the disease deepens, treatments are becoming more personalized and more targeted.
With continued research and innovation, I believe the multiple myeloma treatment landscape will continue to evolve, giving patients access to more options that meet their individual needs at different points in their multiple myeloma journey.
Please review the Important Safety Information and see the full Prescribing Information including the Boxed Warning below. You can talk to your doctor if you have any questions or for more information, visit www.Talvey.com.
INDICATION
What is TALVEY® (talquetamab-tgvs)?
TALVEY® is a prescription medicine to treat adults with multiple myeloma who:
TALVEY® is approved based on patient response. Data are not yet available to show if TALVEY® improves survival or symptoms.
It is not known if TALVEY® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TALVEY®?
TALVEY® may cause side effects that are serious, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and neurologic problems.
Call your healthcare provider or get medical help right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment with TALVEY®:
Cytokine Release Syndrome (CRS). CRS is common during treatment with TALVEY® and can also be serious, life-threatening, or lead to death. Signs and symptoms of CRS may include:
Neurologic problems. Symptoms of neurologic problems with TALVEY® may include:
TALVEY® is available only through the TECVAYLI® and TALVEY® Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.
You will receive a Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.
Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital.
See “What are the possible side effects of TALVEY®?” for more information about side effects.
Before you receive TALVEY®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive TALVEY®?
What should I avoid while receiving TALVEY®?
Do not drive, operate heavy machinery, or do other dangerous activities during and for 48 hours after your TALVEY® “step-up dose” is completed or at any time during treatment with TALVEY®, if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms of neurologic problems until your symptoms go away.
See “What is the most important information I should know about TALVEY®?” for more information about signs and symptoms of CRS and neurologic problems.
What are the possible side effects of TALVEY®?
TALVEY® may cause serious side effects, including:
Your healthcare provider will monitor you for these symptoms and will monitor your weight during treatment with TALVEY®. Tell your healthcare provider if you lose weight during treatment with TALVEY®.
The most common side effects of TALVEY® include:
The most common severe abnormal lab test results with TALVEY® include decreased white blood cells and red blood cells. These are not all the possible side effects of TALVEY®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read full Prescribing Information, including Boxed Warning, for TALVEY®.
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