SUMMARY

• Johnson & Johnson does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
• This response provides relevant data from company-sponsored clinical trials, and the content is limited to the studies included below.
• MonumenTAL-1 is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).¹
  • Rasche et al (2025)² presented the incidence of oral and weight loss AEs from the MonumenTAL-1 study at an extended median follow-up of 38.2 months for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort, 31.2 months for the 0.8 mg/kg SC every other week (Q2W) cohort, and 30.3 months for the prior T-cell redirection therapy (TCR)-exposed (QW and Q2W) cohorts.
  • Chari et al (2025)¹ published the incidence of oral and weight loss AEs from a post hoc analysis of the MonumenTAL-1 study at a median follow-up of 25.6 months for the 0.4 mg/kg SC QW cohort, 19.4 months for the 0.8 mg/kg SC Q2W cohort, and 16.8 months for the prior TCR-exposed cohort.
  • Rasche et al (2024)³ presented the incidence of taste-related AEs and taste disorder AEs from the MonumenTAL-1 study at a median follow-up of 29.8 months for the 0.4 mg/kg SC QW cohort, 23.4 months for the 0.8 mg/kg SC Q2W cohort, and 20.5 months for the prior TCR-exposed cohort.
  • Chari et al (2024)⁴ published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Oral AEs were reported in the QW, Q2W, and TCR cohorts.
  • Chari et al (2023)⁵ presented the incidence of oral toxicities and weight loss AEs in patients from the Prospective Dose Intensity Reduction Cohorts of the MonumenTAL-1 study at a median follow-up of 13.2 months.
• MonumenTAL-2 is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with multiple myeloma (MM).^6-8
  • Cohort D is evaluating the efficacy and safety of TALVEY in combination with DARZALEX FASPRO^® (daratumumab hyaluronidase) and lenalidomide in 34 patients with newly diagnosed multiple myeloma (NDMM).⁸
    • Nooka et al (2024)⁸ presented the incidence of taste-related treatment-emergent adverse events (TEAEs), dry mouth, and weight loss AEs of the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 13.2 months and the TALVEY 0.8 mg/kg every 4 weeks (Q4W)+ DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 5.8 months.
  • Cohort E is evaluating the safety and efficacy of TALVEY in combination with pomalidomide in patients with RRMM.⁶
    • Quach et al (2025)⁶ presented the incidence of oral and decreased weight AEs from the TALVEY + pomalidomide cohort of the MonumenTAL-2 study at a longer median follow-up of 20.7 months.
• RedirecTT-1 is an ongoing, open-label, phase 1b/2 evaluating the safety and efficacy of TALVEY and TECVAYLI^® (teclistamab-cqyv) in patients with RRMM, including those with extramedullary disease (EMD).^9-12
  • Usmani et al (2025)¹⁰ presented the incidence of oral and decreased weight AEs from the RedirecTT-1 phase 2 study in patients with RRMM and EMD at a median follow-up of 16.8 months.
  • Kumar et al (2025)¹¹ published the incidence of oral and decreased weight AEs from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 12.6 months.
  • Mateos et al (2025)¹² presented the incidence of oral and decreased weight AEs from phase 1b of the RedirecTT-1 study across all dose levels (dose levels 1-5) at a median follow up of 38 months, in patients with RRMM, including those with EMD.
  • Cohen et al (2025)⁹ published the incidence of oral AEs from the phase 1 dose-escalation segment of the RedirecTT-1 study at a median follow-up of 20.3 months across all dose levels (dose levels 1-5).
• TRIMM-2 is an ongoing, phase 1b, multicohort open-label study evaluating the efficacy and safety of DARZALEX FASPRO in combination with TECVAYLI or TALVEY with or without pomalidomide in patients with RRMM.^13-15
  • Chari et al (2025)¹⁵ published the incidence of oral AEs and decreased weight AEs in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO cohorts at a median follow-up of 18.6 months (range, 1.2-39.1).
  • Bahlis et al (2024)¹⁴ presented the incidence of oral AEs and decreased weight AEs of the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 15.8 months and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 17.5 months.
• TRIMM-3 is a phase 1b, nonrandomized, open-label study evaluating the dosing, safety, and tolerability of a programmed cell death receptor-1 (PD-1) inhibitor in combination with TALVEY or TECVAYLI in patients with RRMM.^16,17 
  • Perrot et al (2025)¹⁶ presented the incidence of oral and weight loss AEs in the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months.
• Other relevant literature has been identified in addition to the data summarized above.^18-23
  • Health care provider's considerations for management of oral toxicities.^21-23 
  • Retrospective descriptive study reported oral toxicities.¹⁸ 
  • Prospective observational study quantifying the incidence and severity of dysgeusia and xerostomia.¹⁹ 
  • Retrospective descriptive study reported oral toxicities.²⁰ 
  • Patient reported outcomes of oral toxicities.²⁴

PRODUCT LABELING

• TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.
• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.
• TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.

BACKGROUND

• G protein-coupled receptor, class C, group 5, member D (GPRC5D) is a 7-segment transmembrane orphan receptor protein that belongs to the family of G-protein-coupled receptors.²⁵ It is predominantly expressed in cells with a plasma-cell phenotype, with higher expression levels on the surface of malignant plasma cells in patients with MM, thereby making it a potential immunotherapeutic target.^26-28 It is found to be expressed both as a protein and mRNA in the hard keratinized tissues of the tongue (ie, filiform papillae),^29,30 and residential or interstitial plasma cells within the salivary glands and tonsils.²⁹
• Taste disturbances can be categorized into hypogeusia, ageusia, phantogeusia and dysgeusia. Dysgeusia is commonly used as a general term for any type of taste disorder.³¹
• Oral toxicities/taste evaluation can be assessed using the following criteria:
  • National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). Per CTCAE, the maximum possible grade of dysgeusia is 2.³²
  • Subjective total taste acuity (STTA).³³ 

CLINICAL DATA - Monumental-1 Study

MonumenTAL-1 (NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.¹

Study Design/Methods (Phase 2)

Patients were enrolled into 1 of the following 4 cohorts:

• TCR naive: 0.4 mg/kg SC QW, not previously exposed to TCR such as chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibodies (BsAbs; prior BCMA antibody-drug conjugate [ADC] allowed).^34,35
• TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).^34,35
• TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.^34,35
• Key eligibility criteria¹:
  • ≥18 years of age, measurable MM per International Myeloma Working Group (IMWG) criteria.
  • ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.

Rasche et al (2025)² presented the incidence of oral-related and weight loss AEs from the MonumenTAL-1 study at an extended median follow-up of 38.2 months for the 0.4 mg/kg SC QW cohort, 31.2 months for the 0.8 mg/kg SC Q2W cohort, and 30.3 months for the prior TCR-exposed (QW and Q2W) cohorts.

Safety Results

• A summary of oral and weight-loss AEs associated with TALVEY in MonumenTAL-1 is presented in Table: MonumenTAL-1 Study: Summary of Oral and Weight Loss AEs (≥30% in Any Cohort).

Chari et al (2025)^1,36 published the incidence of oral-related and weight loss AEs from the post hoc analysis of phases 1 and 2 of the MonumenTAL-1 study at a median follow-up of 25.6 months (interquartile range [IQR], 8.5-25.9) for the 0.4 mg/kg SC QW cohort, 19.4 months (IQR, 9.2-20.7) for the 0.8 mg/kg SC Q2W cohort, and 16.8 months (IQR, 7.6-18.7) for the prior TCR-exposed cohort.

Safety Results

• A summary of oral and weight-loss AEs associated with TALVEY in MonumenTAL-1 is presented in Tables: MonumenTAL-1 Study: Summary of Oral and Weight Loss AEs in the TCR-Naïve Cohort and MonumenTAL-1 Study: Summary of Oral and Weight Loss AEs in the Prior TCR-Exposed Cohort.
• The median duration and outcomes of oral and weight-loss AEs are shown in Table: MonumenTAL-1 Study: Duration and Outcomes of Oral and Weight-Loss AEs.
• A summary of treatment discontinuation and dose reductions due to oral and weight-loss AEs are presented in Table: MonumenTAL-1 Study: Treatment Discontinuation and Dose Reductions due to Oral and Weight-Loss AEs.
• Weight loss occurred early, but stabilized and increased slightly over time, even in patients with oral AEs.

Rasche et al (2024)³ presented the incidence of oral toxicities and weight loss from the MonumenTAL-1 study in patients receiving TALVEY at a median follow-up of 29.8 months for the 0.4 mg/kg SC QW cohort, 23.4 months for the 0.8 mg/kg SC Q2W cohort, and 20.5 months for the prior TCR-exposed cohort.

Safety Results

• Details on GPRC5D-associated oral AEs, including information on dose reductions and discontinuations, are presented in Table: MonumenTAL-1 Study: GPRC5D-Associated Oral AEs.
• Weight loss as assessed by vital signs was reported in 39%, 34%, and 39% of patients in the QW, Q2W, and prior TCR-exposed cohorts, respectively.
  • Weight loss occurred early but later stabilized and improved over time, even in patients with oral toxicities. Details are provided in Figure: MonumenTAL-1 Study: Weight Loss in Patients With Oral Toxicity in the QW and Q2W Cohorts.

Chari et al (2024)⁴ published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Results specific to oral toxicities and weight loss are summarized below.

Safety Results

• A summary of oral AEs associated with TALVEY in MonumenTAL-1 is presented in Table: MonumenTAL-1 Study: Oral AEs Associated With TALVEY.

Dysgeusia

• Dysgeusia as an AE of any grade was reported in 245 (72%) patients.
  • Some events resolved completely or partially, defined as a reduction in severity from grade 2 to grade 1, while others did not resolve.
  • Dysgeusia can begin shortly after TALVEY dosing, sometimes on the first day or within a few days of step-up dosing.
• The median duration of dysgeusia was 235.5 days (range, 1-870).
• Two patients discontinued due to dysgeusia, both in the 0.8 mg/kg Q2W cohort.

Dry Mouth

• Dry mouth as an AE of any grade was reported in 122 (36%) patients; grade 3/4 events were not observed in any patients.
• The median total duration that patients experienced dry mouth across all events was 216 days (range, 4-628).
• No patients discontinued treatment due to dry mouth.

Dysphagia

• Dysphagia as an AE of any grade was reported in 82 (24%) patients, and grade 3/4 events were observed in 3 (1%) patients.
  • Most dysphagia cases were low grade.
  • Three (2.1%) patients, all in the 0.8 mg/kg Q2W cohort, had grade 3 dysphagia.
• The median duration of dysphagia was 165.5 days (range, 20-572).
• No patients discontinued treatment due to dysphagia.

Supportive Measures/Management

• The MonumenTAL-1 protocol specified that oral events should be managed with mouth rinses, such as salt water or liquid corticosteroids, pain medications, and short courses of oral corticosteroids.
• Per investigator experience, dose modification was the most effective management strategy for dysphagia, dysgeusia and dry mouth as per the investigator’s experience. See Table: MonumenTAL-1 Study: Dose Modifications for Oral Events for additional details.
• Concomitant medications were also used to manage dysphagia, dysgeusia and dry mouth in all 3 cohorts. The efficacy of these measures were not formally assessed. See Table: MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Oral AEs for additional details.

Dysgeusia

• Increased TALVEY exposure led to a higher incidence of dysgeusia.
• Nutritional monitoring and appropriate supplementation were implemented.
• High caloric shakes were advised to ensure adequate nutritional intake and prevent weight loss.
• Increased TALVEY exposure led to a higher incidence of dysgeusia.
• Patients experiencing weight loss may need adjustments to weight-based medications, including TALVEY, and other conditions like hypotension and diabetes mellitus should be monitored closely.

Dry mouth

• Increased hydration, intraoral topical agents, and sodium lauryl sulfate (SLS)-free toothpastes were suggested by investigators to manage dry mouth.

Dysphagia

• Tramadol and oxycodone were used for pain, while corticosteroids were used to control inflammation.
• “Magic mouthwash” containing at least 3 of an antihistamine, anesthetic, antacid, antifungal, corticosteroid, or antibiotic was used to manage pain and inflammation.
• Frequent liquids and artificial saliva were administered for dry mouth-induced dysphagia.

Stomatitis

• Patients with stomatitis-related dry mouth should be encouraged to use SLS-free toothpaste and corticosteroid mouthwash.

Chari et al (2023)⁵ presented the incidence of oral toxicities and weight loss AEs of patients in MonumenTAL-1 who switched to reduced or less frequent dosing with TALVEY at a median follow-up of 13.2 months.

Study Design/Methods

• Patients were divided into Responsive Dose Intensity Reduction Cohorts and Prospective Dose Intensity Reduction Cohorts.
  • Prospective Dose Intensity Reduction Cohorts (n=19):
    • TALVEY 0.8 mg/kg Q2W was reduced to 0.4 mg/kg Q2W in 9 patients who had at least partial response (≥PR).
    • TALVEY 0.8 mg/kg Q2W was reduced to 0.8 mg/kg once Q4W in 10 patients who had ≥PR.

Safety Results

• At the data cutoff of October 2, 2023, prospective cohorts showed a trend toward improved resolution of oral toxicities after switch. The same trend was not seen with weight loss. Resolution of oral toxicity and weight loss after switching to less frequent or lower intensity dosing of TALVEY are presented in Figure: MonumenTAL-1 Study: Prospective Cohorts With Change in Oral Toxicity and Weight Loss After Switch vs Matched Cohort Without Dose Reduction.

CLINICAL DATA - Monumental-2 study

MonumenTAL-2 (NCT05050097) is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with MM.^6-8

Study Design/Methods

• Key eligibility criteria:
  • Cohort D: measurable MM, NDMM, ECOG PS of 0-1, and transplant ineligible or not intended for transplant.⁸
  • Cohort E: measurable MM, ≥2 prior LOTs, including a PI and an immunomodulatory drug, ECOG PS of 0-1, prior pomalidomide and prior TCR (CAR-T and BsAb) permitted, and no prior GPRC5D-targeted therapy.⁶ 

Cohort D

Nooka et al (2024)⁸ presented the incidence of oral toxicities and weight loss AEs of the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 13.2 months (range, 10.0-14.6) and the TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohort at a median follow-up of 5.8 months (range, 1.7 [denotes patients who died]-12.0).

Safety Results

• Oral toxicities and weight loss related TEAEs are summarized in Table: MonumenTAL-2 Study (Cohort D): Summary of Oral Toxicities and Weight Loss TEAEs.
• No treatment discontinuations were reported due to oral toxicities or weight loss TEAEs.

Cohort E

Quach et al (2025)⁶ presented the incidence of oral toxicities and decreased weight AEs from the TALVEY + pomalidomide cohort of the MonumenTAL-2 study at a median follow-up of 20.7 months (range, 1.2-38.7).

Safety Results

• Oral toxicity and decreased weight reported at a data cutoff date of March 2025 are summarized in Table: MonumenTAL-2 (Cohort E) Study: Summary of Oral Toxicity and Decreased Weight.

CLINICAL DATA - redirectt-1 STUDY - tAlvey + tecvayli COHORT

RedirecTT-1 (NCT04586426) is an ongoing, open-label, phase 1b/2 study evaluating the safety and effectiveness of the combination of TALVEY and TECVAYLI in patients with RRMM, including those with EMD.^9-12

Study Design/Methods

• Key eligibility criteria: relapsed or refractory or intolerant to established therapies including the last LOT; prior exposure to a PI, an immunomodulatory drug, and an anti-CD38 mAb.⁹

Usmani et al (2025)¹⁰ presented the incidence of oral and decreased weight AEs from the RedirecTT-1 phase 2 study in patients with RRMM and EMD at a median follow-up of 16.8 months.

Safety Results

• Oral and decreased weight AEs are summarized in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Oral and Decreased Weight AEs.
• Oral and decreased weight AEs after switching to Q4W dosing are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Oral and Weight Decrease AEs Following Adjustment to Q4W dosing.
• Discontinuation of both TALVEY and TECVAYLI due to dry mouth, dysphagia and decreased weight was reported in 1 patient, which was resolved.
• Discontinuation of TALVEY due to dysgeusia and dysphagia was reported in 1 patient, which was resolved.

• RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Oral and Weight Decrease AEs Following Adjustment to Q4W Dosing¹⁰

Kumar et al (2025)^11,37 published the incidence of oral and decreased weight AEs from phase 2 of the RedirecTT-1 study at a median follow-up of 12.6 months (range, 0.5-19.5) in patients with RRMM and EMD.

Safety Results

• At the data cutoff date of March 18, 2025, oral and weight decreased AEs were reported in patients with RRMM and EMD.
• AEs were reported up to 30 days after the patient received the last dose of study treatment or until the start of subsequent antimyeloma therapy, whichever occurred first.
• Oral-related AEs included ageusia, cheilitis, dry mouth, dysgeusia (maximum severity is grade 2 according to CTCAE), dysphagia, glossitis, glossodynia, hypogeusia, mouth ulceration, oral discomfort, oral mucosal erythema, oral pain, stomatitis, swollen tongue, taste disorder, tongue discomfort, tongue edema, tongue erythema, and tongue ulceration.
  • Dysgeusia was reported in 70% of patients (n=63), dry mouth in 44% of patients (n=40), and dysphagia in 29% of patients (n=26). All events were low grade except for grade 3 dysphagia in 2 patients (2%); one resolved after 11 days, and one remained unresolved at data cutoff.
• Across all dose levels, any-grade oral AEs were reported in 86.7% of patients (n=78); grade 3/4 oral AEs were reported in 4.4% of patients (n=4).
• Across all dose levels, any-grade decreased weight AEs in 53% of patients (n=48); grade 3/4 weight decrease AEs were reported in 11% of patients (n=10).
• Dose modification due to oral AEs was reported in 10.0% of patients (n=9).
• Median time to onset was 2 days (range, 1-30) relative to the most recent dose where day 1 is the day the most recent dose was received, based on 167 oral AEs.
• Median duration was 115.5 days (range, 1-446) among events with both start and end dates available, based on 72 oral AEs.
• Supportive measures were received by 37.8% of patients (n=34), and patients could have received ≥1 supportive therapy.
• Discontinuation of TALVEY + TECVAYLI due to grade 2 dry mouth, grade 2 dysphagia, and grade 3 decreased weight AEs was reported in 1 patient.
• Discontinuation of TALVEY due to grade 2 dysgeusia and grade 2 dysphagia was reported in 1 patient.

Mateos et al (2025)¹² presented the incidence of oral and decreased weight AEs from phase 1b of the RedirecTT-1 study across all dose levels (dose levels 1-5) at a median follow up of 38 months, in patients with RRMM, including those with EMD.

Safety Results

• AEs related to oral toxicities and decreased weight are summarized in Table: RedirecTT-1 Study: Oral and Decreased Weight AEs.
• Treatment discontinuation is presented in Table: RedirecTT-1 Study: Treatment Discontinuation Due to Oral AEs.

Cohen et al (2025)^9,38 published the incidence of oral AEs from the phase 1 dose-escalation segment of the RedirecTT-1 study at a median follow-up of 20.3 months (range, 0.5-37.1) across all dose levels (dose levels 1-5) and 18.2 months in the recommended phase 2 regimen (RP2R; dose level 5) cohorts.

Safety Results

• At the data cutoff date of March 15, 2024, oral-related adverse events (AEs) were reported for all dose levels (N=94) and for the RP2R cohort (n=44).

Oral-Related AEs

• AEs were graded per CTCAE v5.0 and reported up to 30 days after the last dose of study treatment.
• Oral-related AEs included taste changes (ageusia, dysgeusia, hypogeusia, and taste disorder per CTCAE), dry mouth, and weight decrease. The maximum grade for taste changes was grade 2 per CTCAE.
• Across all dose levels, any-grade taste-change AEs were reported in 64.9% of patients (n=61), dry mouth in 42.6% of patients (n=40), and weight decrease AEs in 34% of patients (n=32).
• In the RP2R cohort, any-grade taste-change AEs were reported in 50% of patients (n=22) and dry mouth in 40.9% of patients (n=18); no weight decrease AEs were reported in this cohort.
• Across the all dose levels and the RP2R cohort, grade 3/4 AEs were not applicable to taste changes per CTCAE, and no grade 3/4 dry mouth AEs were reported. Grade 3/4 weight decrease AEs were reported in 5% of patients (n=5) across the all dose levels and in 0% of patients in the RP2R cohort.

Taste-Change AEs Across All Dose Levels

• Dose modifications were reported in 5.3% of patients (n=5), and dose discontinuations were reported in 1% of patients (n=1) due to taste-change AEs.
• The median time to onset from the last dose of study treatment was 2 days (range, 1-85), and the median duration was 161.5 days (range, 14-482).
• A total of 64.9% of patients (n=61) received supportive measures for the management of taste-change AEs.

CLINICAL DATA - TRIMM-2 STUDY

TRIMM-2 (NCT04108195) is an ongoing, phase 1b, 2-part, multicohort, open-label study evaluating DARZALEX FASPRO regimens in combination with bispecific TCR antibodies with or without pomalidomide in patients with RRMM.^13-15

Study Design/Methods

• Key eligibility criteria¹⁵:
  • Double refractory to a PI and an immunomodulatory drug or received ≥3 prior LOTs (including a PI and an immunomodulatory drug).
  • Treatment with an anti-CD38 mAb (>90 days prior allowed) including anti-CD38 refractory patients.
  • Prior BsAb and CAR-T were allowed.

Chari et al (2025)^15,39 published the incidence of oral AEs and decreased weight AEs in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO cohorts at a median follow-up of 18.6 months (range, 1.2-39.1).

Safety Results

• Any grade oral events were reported in 89% of patients (n=58), including one grade 3/4 stomatitis event. See Table: TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Oral AEs.
• Dysgeusia (maximum grade 2 per CTCAE v5.0) was reported in 77% of patients (n=50), dry mouth in 57% of patients (n=37), and dysphagia in 25% of patients (n=16), all low grade.
• One patient in the 0.8 mg/kg SC Q2W cohort experienced dose-limiting toxicity due to grade 3 stomatitis/oral mucositis.
• Any-grade weight decrease was reported in 37% of patients (n=24), and grade 3/4 weight decrease was reported in 3% of patients (n=2).
• Dose skip of TALVEY due to weight decrease was reported in 5% of patients (n=3), and dose skip due to oral AEs was reported in 8% of patients (n=5).
• Dose reduction due to oral AEs were reported in 12% of patients (n=8).
• Dose reduction due weight decrease was reported in 9% of patients (n=6).

Bahlis et al (2024)¹⁴ presented the incidence of oral toxicities and weight loss AEs in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + pomalidomide cohorts at a median follow-up of 15.8 months (range, 3.2-37.9) and 17.5 months (range, 0.2-37.7), respectively.

Safety Results

• AEs related to oral toxicities and weight loss are summarized in the Table: TRIMM-2 Study (TALVEY + DARZALEX FASPRO + Pomalidomide Cohort): Oral-Related and Weight Loss AEs.
• No treatment discontinuations were reported due to taste AEs.

CLINICAL DATA - TRIMM-3 Study - TALVEY + CETRELIMAB COHORT

TRIMM-3 (NCT05338775) is a phase 1b, nonrandomized, open-label study evaluating the dosing, safety, and tolerability of TALVEY in combination with cetrelimab in patients with RRMM.^16,17

Study Design/Methods

• Key eligibility criteria¹⁶:
  • MM per IMWG criteria
  • RRMM who may not be eligible for or expected to benefit from available therapies
  • ECOG PS 0 or 1

Perrot et al (2025)¹⁶ presented the incidence of oral toxicities and weight loss AEs in the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months (range, 1.5-32.3).

Safety Results

• AEs related to oral toxicities and weight loss are summarized in Table: TRIMM-3 Study: Oral-Related and Weight Loss AEs (≥25% Overall).

literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 03 February 2026.