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Developed under the direction and sponsorship of Johnson & Johnson.
Samantha Shenoy 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. Samantha Shenoy is not a study author on the Phase 2 MonumenTAL-1 trial.

In this article, Samantha Shenoy, MSN, NP, of University of California San Francisco, shares her insights on TALVEY®, a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s).

Q: What is TALVEY® and what is your experience treating patients with it?

 is a bispecific T-cell engaging antibody that binds to the CD3 receptor on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells, non-malignant plasma cells and healthy tissue. TALVEY

 is available as a weekly or biweekly subcutaneous injection after an initial step-up phase. The flexible dosing options with TALVEY

 are important, and in our practice, we prefer the biweekly dosing approach so that patients have more time between doses.

I have been treating patients with TALVEY

 as part of the clinical trial and in practice for more than three years. Despite being heavily pretreated and often having poor prognoses, we are seeing some excellent responses in many patients who are living with this rare, incurable cancer.

Q: What type of results are you seeing with TALVEY®?

In our practice, we are seeing positive results in patients that are consistent with what the clinical trial demonstrated. Results from the Phase 2 MonumenTAL-1 study showed powerful efficacy, with an overall response rate (ORR) of more than 70 percent for patients not exposed to prior T-cell redirection therapy (a bispecific antibody or CAR-T cell therapy) who received either the biweekly dose of 0.8 mg/kg or weekly dose of 0.4 mg/kg (n=187). Responses were durable with a median duration of response of 9.5 months for those receiving the weekly dose.

 The median duration of response had not been reached in patients receiving a biweekly dose.

The study also included 32 patients who were exposed to prior T-cell redirection therapy with 72 percent achieving an ORR at the 0.4 mg/kg weekly dose, demonstrating the versatile use and meaningful efficacy of TALVEY

 across these different patient populations.

Q: Why is it important to have these bispecific antibodies available in the later lines of therapy?

Multiple myeloma is a heterogeneous and incurable disease. Patients experience multiple relapses and after each one, have even fewer treatment options available. Multiple myeloma is also highly variable, and clinicians need treatment options that attack the disease in different ways.

The multiple myeloma treatment landscape has changed significantly in recent years, and I’m excited about how therapies, like bispecific antibodies, are making a difference for patients in our practice and changing how we treat this disease.

Initially, the patient can choose between a weekly or biweekly dosing option. Then, they are started on a step-up dosing schedule in the inpatient setting due to the risk of cytokine release syndrome and neurotoxicity including ICANS. Once the full dose is given, our patients receive TALVEY

 either every two weeks or once weekly on an outpatient basis.

Q: How do you work with community providers on the transition of care?

As we start to transition patients to community treatment centers, our goal will be to make the transition of care as seamless as possible, which requires the close collaboration of all parties. It is essential that we educate community oncologists, pharmacists, nurses and staff about the signs and symptoms of the side effects of this treatment (listed below) and mitigation strategies to help support the treatment team in case an adverse reaction occurs. We believe this will give the patient the best opportunity to benefit from the therapy. Communication is key to ensuring the team, the patient and their care partners are on the same page about the medical plan, have adequate support for travel to the new treatment location and are fully prepared in case of adverse events (AEs).

Q: What are some of the adverse events related to this therapy?

 is a bispecific antibody that engages T-cells and there is a boxed warning regarding the risk of cytokine release syndrome and neurotoxicity, including ICANS.

In the clinical trial, GPRC5D-related AEs included dysgeusia (taste alterations), skin and nail toxicities, xerostomia (dry mouth), weight loss and dysphagia (difficulty swallowing). These side effects can be challenging for patients as they can impact their day-to-day lives. We typically see dysgeusia, xerostomia and skin toxicities early in treatment with the other AEs developing later, but all patients are different and should consult with their healthcare provider if they experience any signs or symptoms of a side effect.

Additionally, infection is a general concern with multiple myeloma patients. However, in the MonumenTAL-1 study, 16 percent of patients experienced serious infections with TALVEY®.

 In our practice, we do not start patients on intravenous immunoglobulin (IVIG) prophylactically.

We monitor our patients for signs and symptoms of these AEs and consider withholding or discontinuing TALVEY

 in some instances on the severity of symptoms, but our goal is to always achieve the best response and help our patients get the optimal benefit of the therapy. In our practice, we have developed measures to help patients manage these symptoms and avoid discontinuation.

Q: How do you prepare your patients for treatment and the impact some of the side effects can have on day-to-day life?

Many of the patients that I see are beyond the early stages of diagnosis, but still every treatment change can be emotionally overwhelming, especially when they are preparing for potential side effects, like taste alterations, that may impact their daily life. In our healthcare team, we prioritize spending time with patients before they start treatment to educate them and their care partners on the risks and talk to them about expectations and the resources available. I find early, open communication to be key here.

For example, over the past few years, with the support of my nutrition and dermatology colleagues and learning from my patients’ lived experiences, I developed a handout that details management strategies, and I give it to all my patients before they start on TALVEY

I also reiterate to my patients that these side effects may resolve over time in some patients, and we have seen meaningful efficacy with this treatment. We continue to discuss how TALVEY

 works for them and how, together, we can potentially manage side effects to stay on this therapy as long as it’s effectively treating the cancer.

Q: Can you expand on what is included in the handout you share with patients and care partners?

The handout includes general lifestyle recommendations and management strategies for my patients on TALVEY

, including tips for alterations when my patients are experiencing taste alterations and recommendations for products to alleviate dry skin and nail toxicities. For example:

A baking soda or salt rinse before and/or after eating can help with taste alterations

Sugarless gum or hard candies, particularly citrus flavored, can help stimulate saliva for patients experiencing dry mouth

Wearing cotton gloves/socks overnight over a moisturizer helps to maximize absorption and can improve dry skin

Keeping nails short, using a nail hardener and cuticle oil can improve nail toxicities

As I mentioned, connecting with nutritionists and dermatologists was very helpful for me in educating on these measures. I encourage providers to review this as they prepare their patients for treatment. Of note, this handout is based on my personal experience treating patients and all patients are different and should consult with their own healthcare provider for recommendations.

Q: Do you have advice for healthcare professionals who are new to treating patients with TALVEY®?

First, educate your patients on the efficacy and safety data for this treatment. Patients who have already experienced four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and are at this stage in their journey might be hesitant to try a different type of treatment, but we are seeing positive outcomes. In my experience, this is what motivates patients the most and emotionally prepares them for treatment.

In terms of AE management, educating yourself and your patients on a multidisciplinary approach to AE mitigation strategies is key before starting treatment. This therapy has a different mechanism of action, and we are still learning how to best manage patients. Different institutions have different approaches to managing side effects, so I always try to share my experience and approach with my colleagues. When we empower ourselves, along with our patients and their care partners with knowledge of what to expect and tools to help manage some of the side effects, we can better prepare and plan together for if they happen.

To learn more about relapsed or refractory multiple myeloma, visit: 

oncnursingnews.com/clinical/multiple-myeloma

_____________________________________________________________________________

BOXED 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

 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 and treat promptly. Withhold or permanently 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).

 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%. Most events occurred following step-up dose 1 (29%) or step-up dose 2 (44%) at the recommended dosages. 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

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

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 and treat promptly. 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.

 is available only through a restricted program under a REMS, called the TECVAYLI

 REMS because of the risks of CRS and neurologic toxicity, including ICANS.

 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.

 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.

 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 permanent discontinuation of TALVEY® as recommended, based on severity.

 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.

 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

 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)].

 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

 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.

TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

ClinicalTrials.gov Identifier NCT03399799. Accessed April 22, 2024. 

https://clinicaltrials.gov/ct2/show/NCT03399799

ClinicalTrials.gov Identifier NCT04634552. Accessed April 22, 2024. 

https://clinicaltrials.gov/ct2/show/NCT04634552

Evolving Care Strategies in Multiple Myeloma: A Clinician’s Expert Advice on TALVEY® (talquetamab-tgvs)

Glofitamab-gxbm is a CD20×CD3 T-cell engaging bispecific antibody approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (LBCL) not otherwise specified or LBCL arising from follicular lymphoma after 2 or more lines of systemic therapy. Glofitamab-gxbm received accelerated approval on June 15, 2023, based on response rate and durability of response in the phase 1/2 NP30179 study (NCT03075696). Continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial.

Accelerated approval was based on the positive results from the phase 1/2 NP30179 study where glofitamab-gxbm was given as a fixed course to 132 patients. Fifty-six percent of patients treated with glofitamab-gxbm achieved a response, with a median duration of response of 18.4 months. Of those who achieved a response, 68.5% continued to respond at 9 months; 43% of those treated with glofitamab-gxbm achieved a complete response (remission).

Tim Cortese

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