SUMMARY

• Janssen does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
• Infections have been reported as an adverse event (AE) in the MonumenTAL-1, MonumenTAL-2, TRIMM-2, and RedirecTT-1 studies.^1-6
• 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).^1,4,7
  • Schinke et al (2025)^8,9 published the infection profile and parameters of humoral immune function from the MonumenTAL-1 study at a median follow-up of 18.8 months for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort, 12.7 months for the 0.8 mg/kg SC every other week (Q2W) cohort, and 14.8 months for the prior T-cell redirection therapy (TCR)-exposed cohort.
  • Rasche et al (2025)⁷ presented the incidence of infections 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.
  • Chari et al (2025)^4,10 published the incidence of infections 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.
  • Schinke et al (2024)¹¹ presented the incidence of infections from a subgroup analysis in Black and White patients at a median follow-up of 26 months for the Black subgroup and 31 months for the White subgroup. The subgroup of patients received TALVEY at the recommended phase 2 doses (RP2Ds) of 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W.
  • Rasche et al (2024)¹² presented the incidence of infections 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 prior TCR-exposed cohort.
  • Chari et al (2024)¹³ published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Infections were reported in the QW, Q2W, and prior TCR-exposed cohort.
  • Rodriguez-Otero et al (2023)¹⁴ presented data on infections and immune function from the MonumenTAL-1 study at a median follow-up of 18.8 months for the 0.4 mg/kg SC QW cohort, 12.7 months for the 0.8 mg/kg SC Q2W cohort, and 14.8 months for the prior TCR-exposed cohort.
  • The prophylactic tocilizumab cohort is evaluating the administration of tocilizumab (8 mg/kg intravenous [IV]) prior to TALVEY to mitigate cytokine release syndrome (CRS) in 27 patients with RRMM.¹⁵
    • Dytfeld et al (2025)¹⁵ presented the incidence of infections from the prophylactic tocilizumab cohort at a median follow-up of 4.4 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).⁵
  • Cohort D is evaluating the efficacy and safety of TALVEY + DARZALEX FASPRO^® (daratumumab and hyaluronidase) + lenalidomide in 34 patients with newly diagnosed multiple myeloma (NDMM).¹⁶
    • Nooka et al (2024)¹⁶ presented the incidence of infections in 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 + pomalidomide in 35 patients with RRMM.¹⁷
    • Searle et al (2024)¹⁷ presented the incidence of infections in the TALVEY + pomalidomide cohort from the MonumenTAL-2 study at a median follow-up of 16.8 months.
• RedirecTT-1 is an ongoing, open-label, phase 1b/2 study evaluating the safety and efficacy of TALVEY and TECVAYLI^® (teclistamab-cqyv) in patients with RRMM, including those with extramedullary disease (EMD).^3,18-20
  • Kumar et al (2025)²⁰ presented the incidence of infections from phase 2 of the RedirecTT-1 study in patients with RRMM and EMD at a median follow-up of 12.6 months.
  • Cohen et al (2025)^3,21 published the incidence of infections from the phase 1 dose-escalation segment of the RedirecTT-1 study at a median follow-up of 20.3 months in the all dose levels (dose levels 1-5) cohort.
• 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.^6,22
  • Bahlis et al (2024)⁶ presented the incidence of infections in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 15.8 months and 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.^23,24 
  • Perrot et al (2025)²³ presented the incidence of infections of 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:
  • Nursing and advance practice practitioner’s considerations for management of infections.²⁵

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.

CLINICAL DATA - Monumental-1 Study

MonumenTAL-1 (MMY1001; NCT03399799, NCT04634552) is a phase 1/2 study of TALVEY in patients with RRMM.^26,27

The study was conducted in 3 parts; the primary objectives are listed below²⁸:

• Part 1 (phase 1; dose escalation): to characterize the safety of TALVEY and determine the RP2Ds and schedule.
• Part 2 (phase 1; dose expansion): to further characterize the safety of TALVEY at the RP2Ds.
• Part 3 (phase 2): to evaluate the efficacy of TALVEY at the RP2Ds.

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 B-cell maturation antigen (BCMA) antibody-drug conjugate [ADC] allowed).^1,29
• TCR naive: 0.8 mg/kg SC Q2W, not previously exposed to TCRs (prior BCMA ADC allowed).^1,29
• TCR exposed: 0.4 mg/kg SC QW or 0.8 mg/kg SC Q2W, have been previously exposed to TCRs.^1,29
  • Among the prior TCR-exposed cohort, patients were divided based on type of TCR (CAR-T, BsAb, or CAR-T and BsAb).
• Prophylactic tocilizumab: 0.8 mg/kg SC Q2W; tocilizumab 8 mg/kg IV prior to the first step-up dose (SUD) of TALVEY to mitigate CRS.¹⁵
• Key eligibility criteria⁴:
  • ≥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.

Schinke et al (2025)^8,9published the infection profile and parameters of humoral immune function from a post hoc analysis of the MonumenTAL-1 study at a median follow-up of 18.8 months for the 0.4 mg/kg SC QW cohort, 12.7 months for the 0.8 mg/kg SC Q2W cohort, and 14.8 months for the prior TCR-exposed cohort.

Safety

• Median duration of TALVEY treatment was 6.9 months for the 0.4 mg/kg SC QW cohort, 8.8 months for the 0.8 mg/kg SC Q2W cohort, and 5.7 months for the prior TCR-exposed cohort.
• Infections were reported concurrently with grade 3/4 neutropenia in 7.7% of patients in the 0.4 mg/kg QW cohort, 2.1% of patients in the 0.8 mg/kg Q2W cohort, and 17.6% of patients in the prior TCR-exposed cohort.
• Febrile neutropenia (grade 3/4) was reported in 2.8% of patients in the 0.4 mg/kg QW cohort, 0.7% of patients in the 0.8 mg/kg Q2W cohort, and 3.9% of patients in the prior TCR-exposed cohort.
• Summary of infections across the cohorts is shown in Table: MonumenTAL-1 Study: Summary of Infections and MonumenTAL-1 Study: Incidence of Infections.
• Any-grade infections were reported in cycles 1-2 (30.2% in the 0.4 mg/kg SC QW cohort; 23.0% in the 0.8 mg/kg SC Q2W cohort; 45.1% in the prior TCR-exposed cohort), with bacterial and fungal infections occurring early. See Table: MonumenTAL-1 Study: Summary of Infections by Treatment Cycle.
• Any-grade infection risk peaked early in treatment, decreased by month 3, and cumulative incidence stabilized at ~8 months (any grade). New-onset grade 3/4 infections peaked within the first 100 days and leveled off at ~4 months. Grade 3/4 infections occurred more frequently in nonresponders than in responders.
• Opportunistic infections across cohorts are shown in Table: MonumenTAL-1 Study: Any-Grade and Grade 3/4 Opportunistic Infections Across Cohorts. No cases of Pneumocystis
• pneumonia were reported.
• Infection prophylaxis and management across cohorts is presented in Table: MonumenTAL-1 Study: Infection Prophylaxis and Management.
• Gastrointestinal infections were reported in 3.5% of patients in the 0.4 mg/kg QW cohort, 2.1% in the 0.8 mg/kg Q2W cohort, and 3.9% in the prior TCR-exposed cohort.
• Viral infections (adenovirus, herpes zoster, and oral herpes) were reported in 2.1% of patients in the 0.4 mg/kg QW cohort, 2.8% in the 0.8 mg/kg Q2W cohort, and 7.8% in the prior TCR-exposed cohort.
• Fungal infections were reported in 11.2% of patients (n=16) in the 0.4 mg/kg QW cohort, 7.1% of patients (n=11) in the 0.8 mg/kg Q2W cohort, and 7.7% of patients (n=6) in the prior TCR-exposed cohort.
• A total of 5 patients (1.5%) died from infections across cohorts.
  • Death due to infections was reported in 2.1% of patients in the 0.4 mg/kg QW cohort and 1.4% of patients in the 0.8 mg/kg Q2W cohort.
  • COVID-19 pneumonia was the reported cause of death in 1 patient each in the 0.4 mg/kg QW and 0.8 mg/kg Q2W cohorts, respectively.

Humoral Immunity

• At baseline, median CD19⁺ B-cell counts were 5.3 ×10⁶/L in the 0.4 mg/kg SC QW cohort, 10.1 ×10⁶/L in the 0.8 mg/kg SC Q2W cohort, and 22.8 ×10⁶/L in the prior TCR-exposed cohort. CD19⁺ B-cell levels remained consistent through early cycles, with an upward shift noted by cycle 7.
• Hypogammaglobulinemia (immunoglobulin G [IgG] values <400 mg/dL) reported across cohorts is presented in Table: MonumenTAL-1 Study: Summary of Hypogammaglobulinemia.
• From baseline to cycle 3 (3 months), polyclonal IgG levels declined in the combined cohorts. Polyclonal IgG levels in the 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W cohorts remained relatively stable and consistently below the lower limit of normal (7.0 g/L) during this period.
• In the overall population, polyclonal IgG levels began to rise after cycle 3 (month 3) and continued to increase, surpassing baseline levels through cycle 17 (month 17).
• Polyclonal IgA and IgM levels remained stable across all cohorts from baseline through cycle 7, with no decline observed and values stayed below the lower limits of normal (0.7 g/L for IgA and 0.4 g/L for IgM).

MonumenTAL-1 Study: Summary of Infections by Treatment Cycle⁹

MonumenTAL-1 Study: Any-Grade and Grade 3/4 Opportunistic Infections Across Cohorts⁹

MonumenTAL-1 Study: Summary of Hypogammaglobulinemia⁸

Rasche et al (2025)⁷ presented the incidence of infections 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

• Summary of infections across the cohorts is shown in Table: MonumenTAL-1 Study: Summary of Infections.
• The onset of new grade ≥3 infections across combined cohorts is shown in Figure: MonumenTAL-1 Study: New-Onset Grade ≥3 Infections.

Chari et al (2025)^4,10 published the incidence of infections 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

• Details on infections are presented in the Table: MonumenTAL-1 Study: Infections.
• Grade 1/2 upper respiratory tract infections were reported in 17% of patients (n=13) in the prior TCR-exposed cohort.
• The polyclonal immunoglobulin G (IgG) level/titer transiently dropped for the first 2 to 3 months of therapy but gradually increased above the baseline value as patients continued TALVEY therapy. IgG patterns were similar between responders and nonresponders.
• In the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR-exposed cohorts, intravenous immunoglobulin (IVIG; before TALVEY or for posttreatment hypogammaglobulinemia) was administered to 8% (n=12), 9% (n=14), and 19% (n=15) of patients, respectively.
• A total of 5 patients died due to infections (0.4 mg/kg SC QW cohort, n=3; 0.8 mg/kg SC Q2W cohort, n=2). Coronavirus disease 2019 (COVID-19) pneumonia led to death in 2 patients (0.4 mg/kg SC QW, n=1; 0.8 mg/kg SC Q2W cohort, n=1).
• Treatment discontinuation due to infections was reported in 1% of patients (n=2) in the 0.4 mg/kg SC QW cohort and 1% of patient (n=1) in the prior-TCR cohort.
• Dose reduction due to cytomegalovirus (CMV) infection was reported in 1% of patients (n=2) in the 0.8 mg/kg SC QW cohort.

Schinke et al (2024)¹¹ presented the incidence of infections from a subgroup analysis in Black patients who received TALVEY at the RP2Ds of 0.4 mg/kg SC QW and 0.8 mg/kg SC Q2W in phase 1/2 of the MonumenTAL-1 study at a median follow-up was 26 months for the Black subgroup and 31 months for the White subgroup.

Safety Results

• Details on infection-related AEs are summarized in Table: MonumenTAL-1 Study: Summary of Infections in Black vs White Patients.

Rasche et al (2024)¹² presented the incidence of infections 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.

Safety Results

• At a longer follow-up, no increase in grade 3/4 infections was observed. Incidence of infections in Q2W cohort is detailed in Figure: New-Onset Grade ≥3 Infections Over Time in the Q2W Cohort.
• IVIG was required in 16%, 14%, and 24% of patients in the QW, Q2W, and prior TCR cohorts, respectively.

Chari et al (2024)¹³ published the clinical management of AEs in patients with RRMM treated with TALVEY in the MonumenTAL-1 study. Results specific to infections are summarized below.

Safety Results

• A summary of infections associated with TALVEY in MonumenTAL-1 is presented in Table: MonumenTAL-1 Study: Infections Associated With TALVEY.
• The most frequently reported any-grade infections were Coronavirus Disease 2019 (COVID-19), upper respiratory tract infections, nasopharyngitis, urinary tract infections, bronchitis, and pneumonia.
  • The most common grade 3/4 infections (requiring invasive or urgent intervention per Common Terminology Criteria for Adverse Events [CTCAE] classification) were pneumonia, urinary tract infections, COVID-19, sepsis, and cellulitis.
  • Most high-grade infections occurred during the first 100 days of treatment.
• No cases of pneumocystis pneumonia were reported.
• Treatment discontinuation due to infections was reported in 2 patients in the 0.4 mg/kg SC QW cohort and 1 patient in the prior TCR-exposed cohort.
• A total of 5 (1.5%) patients died from infections (COVID-19 pneumonia, n=2; 1 patient each due to septic shock, fungal sepsis, and infection).

Supportive Measures/Management

• In MonumenTAL-1, medications given most commonly for infections were antibiotics, with some use of antifungals, anticholinergics, and glucocorticoids. See Table: MonumenTAL-1 Study: Most Common Supportive Measures and Concomitant Treatments for Infections.
• Infection prophylaxis was used in patients receiving TALVEY.
  • Acyclovir was the most common prophylactic medication used in the MonumenTAL-1 study for infections and given to 52.4%, 71.7%, and 74.5% of patients in the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR cohorts, respectively.
  • Valaciclovir was the second most common form of prophylaxis and given to 37.1%, 11.0%, and 17.6% of patients in the 0.4 mg/kg QW, 0.8 mg/kg Q2W, and prior TCR cohorts, respectively.
  • Antibacterial prophylaxis may be beneficial in patients with an elevated risk of developing infections. Antifungal prophylaxis should be considered if patients have undergone treatment with high-dose or prolonged use of corticosteroids.
  • Filgrastim should be considered to manage neutropenia.
• New infections often occurred in early treatment cycles, suggesting the need for more aggressive infection prevention until cytopenia recovers.
• Vaccinations are still expected to be effective as patients treated with TALVEY showed preservation of humoral immune function and no decreases in B cells or polyclonal IgG levels.
  • Vaccines should be given before starting treatment, though this may not always be possible, such as for annual influenza and COVID-19 vaccinations.
• Testing for cytomegalovirus and Epstein-Barr virus is recommended for patients with unexplained fever or unexplained symptoms, such as weight loss, extreme fatigue, and diarrhea.
• Monitoring for hypogammaglobulinemia and administration of IVIG are crucial for preventing and managing infections during novel antibody treatment, including TALVEY.
  • IVIG use should be considered for patients with hypogammaglobulinemia and recurrent infections. Based on investigator experience, it can also be administered on the same day as TALVEY after the CRS risk period has elapsed.
• During SUD and early treatment cycles, fever should be evaluated to distinguish between CRS and infection, as symptoms may overlap.
• Temporarily interrupting dosing to allow infections to resolve before resuming TALVEY is also a key part of infection management.

Prophylactic Tocilizumab Cohort Safety Results

Dytfeld et al (2025)¹⁵ presented the incidence of infections in the prophylactic tocilizumab cohort at a median follow-up of 4.4 months (range, 0.5-18.4).

Safety Results

• Any-grade infections were reported in 55.6% of patients (n=15) and grade 3/4 infections were reported in 18.5% of patients (n=5).

CLINICAL DATA - Monumental-2 study

MonumenTAL-2 (MMY1004; NCT05050097) is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with MM.^5,16,17,30

Study Design/Methods

• Key eligibility criteria:
  • Cohort D: measurable MM, NDMM, ECOG PS of 0-1, and transplant ineligible or not intended for transplant.^16,30
  • 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.^17,30

Cohort D

Nooka et al (2024)¹⁶ presented the incidence of infections in 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

• Details on infections are summarized in Table: MonumenTAL-2 Study (Cohort D): Summary of Infections.
• Hypogammaglobulinemia was reported in 63% and 54% of patients in the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide and TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohorts, respectively; 50% and 19% of these patients received ≥1 IVIG during treatment, respectively.
• The most commonly reported infections were COVID-19, rhinovirus, and other upper respiratory tract infections.

Cohort E

Searle et al (2024)¹⁷ presented the incidence of infections in the TALVEY + pomalidomide cohort from the MonumenTAL-2 study at a median follow-up of 16.8 months (range, 1.2-25.1).

Safety Results

• TEAEs in ≥25% of patients were reported at a data cutoff date of April 22, 2024.
• The most common infections (mostly grade 1/2) were pneumonia, upper respiratory tract infections, and COVID-19.
  • First-onset infections generally occurred in the first few cycles of treatment.
• Any-grade infections were reported in 80% (n=28) of patients and grade 3/4 infection in 22.9% (n=8) of patients.

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

RedirecTT-1 (MMY1003; 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.^3,18-20,31

Study Design/Methods

• Key inclusion 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.¹⁹

Kumar et al (2025)²⁰ presented the incidence of infections 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

• Details on infections are presented in Table: RedirecTT-1 Study (EMD TALVEY + TECVAYLI Cohort): Infections (≥10% Overall).
• Grade 3/4 infections were primarily observed during early treatment cycles.
• Deaths due to infections were reported in 5.6% of patients, with coronavirus disease 2019 (COVID-19) pneumonia, Klebsiella sepsis, pneumonia, Klebsiella pneumonia, and pseudomonal sepsis reported in 1 patient each.
• Antiviral prophylaxis was administered to 96.7% of patients.
• Treatment-emergent hypogammaglobulinemia or post-treatment immunoglobulin G (IgG) levels below 400 mg/dL were reported in 70% of patients.
• A total of 86.7% of patients received ≥1 dose of IVIG.
• Discontinuation due to pseudomonal pneumonia and pseudomonal sepsis was reported in 1 patient.

Cohen et al (2025)^3,21 published the incidence of infections from the phase 1 dose-escalation segment of the RedirecTT-1 study reported in the all-dose-level cohort at a median follow-up of 20.3 months (range, 0.5-37.1) and in the RP2R cohort at 18.2 months.

Safety Results

Infections

• At a data cutoff of March 15, 2024, infections were reported. See Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Infections (≥5% Overall) for additional details.^3,19,21
• Across all dose levels, the incidence of first onset of grade ≥3 infections was higher in the first 6 months of study treatment and then plateaued. The timing of the first onset of grade ≥3 infections is shown in Table: RedirecTT-1 Study (TALVEY + TECVAYLI Cohort): Timing of First Onset of Grade ≥3 Infections in Patients Across All Dose Levels.^3,21
• Infection prophylaxis was administered as per institutional guidelines. A total of 82% of patients (n=77) across all dose levels received antiviral prophylaxis, and 49% of the patients (n=46) received prophylaxis against Pneumocystis jirovecii pneumonia.^3,21
• In total, 63% of patients (n=59) received a COVID-19 vaccine.³
• Immunoglobulin replacement therapy (0.4 g/kg every 3-6 weeks) was recommended to maintain serum immunoglobulin G (IgG) levels above 400 mg/dL, regardless of current or past infections, with monitoring recommended at least every 3 months after reaching steady state.²¹
• Immunoglobulin replacement was provided per institutional guidelines for managing serious, recurrent, or chronic infections.²¹
• Deaths due to infections were reported in 11.7% of patients (n=11) in the all dose levels cohort and 6.8% of patients (n=3) in the RP2R cohort.^3,21

Hypogammaglobulinemia

• At baseline, 56% of patients across all dose levels (n=53) had non-IgG myeloma.³
  • Of these patients, 70% of patients (n=37) had hypogammaglobulinemia (defined as IgG <400 mg/dL) at baseline and 57% of patients (n=30) had post-treatment hypogammaglobulinemia.³
• The assessments excluded patients with IgG myeloma and those who received IVIG replacement.³
• A total of 57% of patients (n=30) with non-IgG myeloma received IVIG.³
• A patient experienced grade 2 John Cunningham (JC) virus infection on day 163, PD on day 170 (when the patient discontinued TALVEY and TECVAYLI), and died on day 217 from grade 5 JC virus infection.²¹
  • This patient’s baseline IgG value was 248 g/dL; the patient had hypogammaglobulinemia with no IVIG administered and experienced intermittent neutropenia prior to the AE.²¹

CLINICAL DATA - TRIMM-2 STUDY

TRIMM-2 (MMY1002) 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.^6,22,32

Study Design/Methods

• Key eligibility criteria²²:
  • 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.

Bahlis et al (2024)⁶ presented the incidence of infections in the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 15.8 months (range, 3.2-37.9) and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 17.5 months (range, 0.2-37.7).

Safety Results

• Among patients with grade 3/4 infections, 84.0% had onset within the first 6 months.
• IgG <400 mg/dL was reported in 33.8% of patients at baseline and 72.7% of patients after treatment; 53.2% of these patients received ≥1 dose of IVIG.
• The incidences of grade 3/4 and any-grade infections are presented in Table: TRIMM-2 Study (TALVEY + DARZALEX FASPRO + Pomalidomide Cohort): Infections (≥10% Overall).

Dholaria et al (2023)²² presented the incidence of infections in the TRIMM-2 study for the TALVEY 0.4 mg/kg QW + DARZALEX FASPRO 1800 mg Q4W cohort at a median follow-up of 16.8 months (range, 1.9-31.0) and the TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO 1800 mg Q4W cohort at a median follow-up of 15.0 months (range, 1.0-23.3).

Safety Results

• Among patients that reported grade ≥3 infections, 75% experienced onset within the first 6 months.
• The incidences of grade 3/4 and any-grade infections in patients receiving TALVEY 0.4 mg/kg QW SC + DARZALEX FASPRO and TALVEY 0.8 mg/kg Q2W + DARZALEX FASPRO are presented in Table: TRIMM-2 Study (TALVEY + DARZALEX FASPRO Cohort): Infections (≥5%).

Infection Description in Both Cohorts

• Antibacterial, antifungal, or antiviral prophylaxis was given to 95.4% of patients.
• Opportunistic infections occurred in 10.8% of patients.
• Cytomegalovirus reactivation occurred in 3.1% of patients.
• One patient died of treatment-related pneumonia (TALVEY 0.8 mg/kg SC Q2W + DARZALEX FASPRO).
• IgG levels of <500 mg/dL were reported in 35.4% of patients at baseline and increased to 86.2% postbaseline, of whom 33.8% got IVIG.

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

TRIMM-3 (MMY1005; 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.^23,24

Study Design/Methods

• Key eligibility criteria²³:
  • MM per IMWG criteria
  • RRMM who may not be eligible for or expected to benefit from available therapies
  • ECOG PS 0 or 1
• Primary endpoint²³: safety

Perrot et al (2025)²³ presented the incidence of infections in the TALVEY + cetrelimab cohort at a median follow-up of 11.5 months (range, 1.5-32.3).

Safety Results

• A summary of infections is presented in Table: TRIMM-3 Study: Summary of Infections (≥10% Overall).
• One death was reported due to pneumonia.
• Hypogammaglobulinemia (or IgG <400 mg/dL) occurred in 56.8% of patients; 34.1% of these patients received ≥1 dose of IVIG.

literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) topic was conducted on 01 October 2025.