SUMMARY

• Johnson & Johnson does not recommend the use of TECVAYLI in a manner 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.
• MajesTEC-1 is a phase 1/2, multicohort study evaluating the safety and efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).¹
  • Cohort A (triple-class exposed) included 165 patients who were previously treated with a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody (mAb).¹
    • Moreau et al (2022)^1,2 published safety and efficacy results of patients receiving TECVAYLI in the MajesTEC-1 study. At a median follow-up of 14.1 months, 68 deaths were reported overall.
    • Nooka et al (2024)³ published the incidence, timing, and management of infections in patients receiving TECVAYLI in the MajesTEC-1 study. At a median follow-up of 22.8 months, 21 deaths due to infections were reported overall.
    • van de Donk et al (2024)^4,5 conducted a post hoc analysis that evaluated the potential impact of coronavirus disease 2019 (COVID-19) on outcomes in patients receiving the recommended phase 2 dose (RP2D) of TECVAYLI in the MajesTEC-1 study. At a median follow-up of 22.8 months, 18 deaths due to COVID-19 infections were reported; 4deaths from COVID-19 were considered by the investigators to be related to TECVAYLI treatment.
    • Costa et al (2024)⁶ presented a subgroup analysis evaluating the safety and efficacy outcomes in patients with high-risk (HR) features from the MajesTEC-1 study. At a data cutoff of Aug 22, 2023, a total of 94 deaths were reported in the overall RP2D population. Details on deaths in patients with HR features are provided in Table: MajesTEC-1 (Cohort A): Mortality in Patients With HR Features.
  • Cohort C included 40 patients, previously treated with a PI, an immunomodulatory agent, an anti-CD38 mAb and anti-B-cell maturation antigen (BCMA)-targeted therapies.⁷
    • Touzeau et al (2024)⁷ published the safety and efficacy of TECVAYLI in cohort C of the MajesTEC-1 study. At a median follow-up of 28.0 months, 25 deaths were reported.
  • The prophylactic tocilizumab cohort is evaluating the administration of intravenous (IV) tocilizumab (8 mg/kg) prior to TECVAYLI dosing for the reduction of cytokine release syndrome (CRS) in 24 patients.^8,9
    • van de Donk et al (2024)⁸ presented the effects of prophylactic tocilizumab for the reduction of CRS in patients treated with TECVAYLI. At a median follow-up of 8.1 months, 1 death was reported due to an adverse event (AE; pulmonary embolism).
• MajesTEC-2 is an ongoing, phase 1b, multicohort study evaluating the safety and efficacy of TECVAYLI in combination with other anticancer therapies in patients with multiple myeloma (MM).¹⁰
  • Cohort A included 17 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO^® (daratumumab and hyaluronidase) and pomalidomide.¹¹
    • D’Souza et al (2024)¹¹ presented safety and efficacy in cohort A. At a median follow-up of 16.2 months, 1 death due to pseudomonal bacteremia and 3 deaths due to COVID-19-related pneumonia were reported.
  • Cohort C included 28 patients with RRMM who received TECVAYLI and nirogacestat.¹²
    • Offner et al (2023)¹² presented safety and efficacy in cohort C. At a median follow-up of 14.7 months, 5 deaths were reported due to treatment-emergent adverse events (TEAEs).
  • Cohort D included 31 patients with MM who received TECVAYLI in combination with lenalidomide (Tec-Len).¹³
    • Tan et al (2023)¹³ presented safety and efficacy in cohort D. At a median follow-up of 10.8 months, 3 deaths were reported due to AEs.
  • Cohort E included 32 patients with RRMM who received TECVAYLI in combination with DARZALEX FASPRO and lenalidomide (Tec-DR).¹⁴
    • Searle et al (2022)¹⁴ presented safety and efficacy in cohort E. At a median follow-up of 8.4 months, 2 deaths were reported due to AEs.
• MajesTEC-3 is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO (Tec-Dara subcutaneous [SC]) vs investigator’s choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with RRMM after 1-3 prior lines of therapy (LOTs).¹⁵ 
  • Costa et al (2025)¹⁵ published the safety and efficacy results from the MajesTEC-3 study. At a median follow-up of 34.5 months, death occurred in 15.9% of patients in the Tec-Dara SC arm and 33.1% of patients in the DPd/DVd arm.
• MajesTEC-4 is an open-label, randomized, multicenter, phase 3 study assessing the efficacy and safety of Tec-Len and TECVAYLI alone vs lenalidomide alone as maintenance therapy after an autologous stem cell transplant (ASCT) in patients with newly diagnosed multiple myeloma (NDMM).¹⁶
  • Zamagni et al (2024)¹⁶ presented the preliminary efficacy and safety results from the safety run-in (SRI) of cohort 1 (Tec-Len; TECVAYLI weekly [QW] to every 4 weeks [Q4W]) at a median follow-up of 21.1 months, cohort 2 (Tec-Len; TECVAYLI Q4W) at a median follow-up of 9.2 months, and cohort 3 (TECVAYLI [Q4W]) at a median follow-up of 9.2 months.
    • At a median follow-up of 9.2 months, 1 death due to a COVID-19-related TEAE was reported in SRI cohort 2. No deaths were reported in SRI cohorts 1 and 3.
• MajesTEC-5 is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI-based combination regimens in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM).¹⁷
  • Raab et al (2025)¹⁸ presented the updated efficacy and safety results of Tec-DR and TECVAYLI in combination with DARZALEX FASPRO, bortezomib, and lenalidomide (Tec-DVR) from the 3 induction cohorts of the MajesTEC-5 study. At a median follow-up of 7.3 months (range, 3.1-14.5), no deaths were reported due to TEAEs in any of the induction cohorts.
• MajesTEC-7 is a randomized, phase 3, open-label, multicenter study comparing the safety and efficacy of Tec-DR and TALVEY^® in combination with DARZALEX FASPRO and lenalidomide (Tal-DR) vs DARZALEX FASPRO in combination with lenalidomide and dexamethasone (DRd) in patients with NDMM who are ineligible or not intended for transplant as initial therapy.¹⁹
  • Touzeau et al (2024)¹⁹ presented the initial results from the SRI cohort 1 (Tec-DR). At a median follow-up of 13.8 months, 1 patient died from influenza pneumonia in cycle 3.
• TRIMM-2 is an ongoing, phase 1b, multicohort study evaluating the safety and efficacy of DARZALEX FASPRO regimens in combination with bispecific T-cell redirecting antibodies in patients with RRMM.²⁰
  • D’Souza et al (2024)¹¹ presented safety and efficacy results from the TECVAYLI + DARZALEX FASPRO + pomalidomide cohort in 10 patients. At a median follow-up of 38.3 months, deaths due to infection were reported in 2 patients.
  • Rodriguez-Otero et al (2022)²⁰ presented safety and efficacy results from the TECVAYLI and DARZALEX FASPRO cohorts in 65 patients. At a median follow-up of 8.6 months, 4 deaths were reported due to AEs.

PRODUCT LABELING

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

clinical data - MajesTEC-1 STUDY

MajesTEC-1 (NCT03145181; NCT04557098) is evaluating the safety and efficacy of TECVAYLI in patients with RRMM.¹

Study Design/Methods

The main objectives are as follows: part 1 (dose escalation) to determine the RP2D for TECVAYLI; part 2 (dose expansion) to distinguish safety and tolerability at the RP2D; and part 3 (the phase 2 component) to evaluate the efficacy of TECVAYLI at the RP2D.^1,21

• Key eligibility criteria:
  • Cohort A: ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb, no prior BCMA-targeted therapy use.¹
  • Cohort C: ≥3 prior LOTs, a prior PI, an immunomodulatory drug, and an anti-CD38 mAb, enrolled patients who had prior exposure to BCMA-targeted treatment (chimeric antigen receptor [CAR]-T cell and/or antibody drug conjugate [ADC]).⁷
  • Prophylactic tocilizumab cohort: ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.⁹

Cohort A Safety Results

Moreau et al (2022)^1,2 published safety and efficacy results of patients receiving TECVAYLI in the MajesTEC-1 study at a median follow-up of 14.1 months (range, 0.3-24.4).

• A total of 68 deaths (41.2%) were reported:
  • Progressive disease: 41 deaths (24.8%)
  • AEs unrelated to TECVAYLI: 14 deaths (8.5%; COVID-19, n=10 [6.1%]); pneumonia, n=1 [0.6%]; hemoperitoneum, n=1 [0.6%]; pseudomonal pneumonia, n=1 [0.6%]; and hypovolemic shock, n=1 [0.6%])
  • AEs considered by the investigator to be related to TECVAYLI: 5 deaths (3.0%; COVID-19, n=2 [1.2%]; hepatic failure, n=1 [0.6%]; streptococcal pneumonia, n=1 [0.6%]; progressive multifocal leukoencephalopathy, n=1 [0.6%])
  • Other causes: 8 deaths (4.8%; unknown, n=2 [1.2%]; respiratory failure due to pneumonia, n=1 [0.6%]; trauma after fall, n=1 [0.6%]; sepsis/bronchopneumonia/MM, n=1 [0.6%]; COVID-19, n=1 [0.6%]; presumed pneumonia, but not clinically diagnosed as such, n=1 [0.6%]; left pneumonitis complicated by multi-visceral failure, n=1 [0.6%]).
    • Other cause deaths were not considered treatment emergent because these patients died after subsequent myeloma therapy was initiated.

Nooka et al (2024)³ published the incidence, timing, and management of infections in patients receiving TECVAYLI in the MajesTEC-1 study at a median follow-up of 22.8 months (range, 0.3-33.6).

• A total of 21 deaths (12.7%) were reported due to infections: COVID-19 (n=18), bilateral pneumonia (unknown pathogen; n=1), pneumococcal pneumonia (n=1), and progressive multifocal leukoencephalopathy (PML; n=1).
  • One patient (0.6%) who died from PML after 16.1 months had discontinued TECVAYLI treatment 2.5 months earlier due to grade 4 PML.
• Most patients were enrolled before COVID-19 vaccines were available. Once the COVID-19 vaccine was available, 60% of patients (n=99) received at least one dose, including 13/18 patients who died from COVID-19 (12 received all doses after starting TECVAYLI; one received 2 doses prior then a third dose during TECVAYLI treatment).
  • Patients who were unvaccinated tended to die earlier (0.7–5.9 months; between January 2021 and November 2021 [n=6]) than vaccinated patients (4.3-25.9 months; between April 2021 and December 2022 [n=12]).
  • At the time of death, 13/18 patients had partial response or better (≥PR) and 2/18 had stable disease (3 deaths were reported before any post-baseline efficacy assessments).
• Deaths due to respiratory infections were reported in 2 patients (1.2%); 1 after 1.9 months (bilateral pneumonia, pathogen unknown) and 1 after 10.6 months (pneumococcal pneumonia).

van de Donk et al (2024)^4,5 conducted a post hoc analysis that evaluated the potential impact of COVID-19 on outcomes in patients receiving the RP2D of TECVAYLI in the MajesTEC-1 study (data cutoff date January 4, 2023). Of note, MajesTEC-1 recruitment occurred concurrently with the pandemic, starting in March of 2020. COVID-19 vaccines were not approved until late 2020 to early 2021, approximately 9 months into MajesTEC-1 enrollment.

Methods

• Infections were managed per institutional guidelines and/or TECVAYLI interruption; vaccination (including booster doses) was recommended per availability.
• Patients with grade 5 COVID-19 infection were censored at the time of last disease evaluation for analyses of progression-free survival (PFS; n=17) and duration of response (DOR) (n=13) if death occurred without disease progression. All patients who died from COVID-19 (n=18) were censored at the time of death for analysis of overall survival (OS).

Safety Results

• Any-grade and grade 3/4 COVID-19 infection was reported in 29.1% (n=48) and 21.2% (n=35) of patients, respectively, and deaths due to COVID-19 infection were reported in 10.9% (n=18) of patients; 4 deaths from COVID-19 were considered by the investigators to be related to TECVAYLI treatment.
• A total of 7.9% of patients (n=13), including 1/18 patients who died of COVID-19, were vaccinated at least once with a COVID-19 vaccine before TECVAYLI was administered. The patient who died received 2 doses before starting TECVAYLI.
• A total of 60% of patients (n=99), including 13/18 patients who died of COVID19, were vaccinated at least once with a COVID-19 vaccine on study overall (1 dose, n=3; 2 doses, n=4; 3 doses, n=3; 4 doses, n=3 [the patient who was vaccinated pre-TECVAYLI received their 3^rd dose on-study]).
• Patients who never received a COVID-19 vaccination tended to die of COVID-19 earlier during TECVAYLI treatment (range, 0.7-5.9 months) compared to patients who received ≥1 COVID-19 vaccination (range, 2.4-25.9 months). A greater proportion of deaths were reported in 2021 (5/5 vs 5/13 respectively) compared to 2022 (0/5 vs 8/13, respectively).

Costa et al (2024)⁶ presented a subgroup analysis evaluating the safety and efficacy outcomes in patients with HR features from the MajesTEC-1 study.

• At a data cutoff of Aug 22, 2023, a total of 94 deaths (57%) were reported in the overall RP2D population. Details on deaths in patients with HR features are provided in Table: MajesTEC-1 (Cohort A): Mortality in Patients With HR Features.

Cohort C Safety Results

Touzeau et al (2024)⁷ published the safety and efficacy of TECVAYLI in cohort C of the MajesTEC-1 study at a median follow-up of 28.0 months (range, 0.7-31.1).

• A total of 25 deaths (62.5%) were reported. Disease progression was the primary cause of death in 12 patients (30.0%). Two patients (5.0%) died due to events that investigators considered were related to TECVAYLI treatment (COVID-19, n=1; cardiac arrest, n=1). Of the 10 patients with grade 5 TEAEs:
  • A total of 8 patients (20.0%) died due to AEs (COVID-19 [n=4; 10%], and 1 patient each [2.5%] due to cardiac arrest, cardiac failure, coronary artery dissection, and sudden death).
  • The other 2 grade 5 AEs were due to disease progression. The patient who suffered cardiac arrest had pneumonia that began 10 days prior to death.

Prophylactic Tocilizumab Cohort Safety Results

van de Donk et al (2024)⁸ presented the effects of prophylactic tocilizumab for the reduction of CRS in patients treated with TECVAYLI in the prophylactic tocilizumab cohort of the MajesTEC-1 study at a median follow-up of 8.1 months (range, 0.9-13.2).

• One death was reported due to an AE (pulmonary embolism), which was reported 20 days after the last TECVAYLI dose (previously reported at a 2.6-month follow-up).

clinical data - Majestec-2 Study

MajesTEC-2 (NCT04722146) is an ongoing, phase 1b, multicohort, open-label study evaluating the safety and efficacy of TECVAYLI in combination with other anticancer treatments in patients with MM.¹⁰

Study Design/Methods

Key Eligibility Criteria

• Cohort A (TECVAYLI and DARZALEX FASPRO and pomalidomide): received 1 to 3 prior LOTs, including a PI and lenalidomide.¹¹
• Cohort C (TECVAYLI and nirogacestat): disease progression within 12 months of last LOT; ≥3 prior LOTs or double refractory to a PI, and an immunomodulatory drug and triple-class exposed to a PI, an immunomodulatory drug and an anti-CD38 mAb. Patients with prior exposure to BCMA-targeted therapy were permitted.^10,12
• Cohort D (Tec-Len): received ≥2 prior LOTs including a PI, an immunomodulatory drug and an anti-CD38 mAb, no prior BCMA-targeted therapy.¹³
• Cohort E (Tec-DR): received 1-3 prior LOTs including a PI, and an immunomodulatory drug, no prior BCMA-targeted therapy.¹⁴

Cohort A Safety Results

D’Souza et al (2024)¹¹ presented safety and efficacy in cohort A of the MajesTEC-2 study at a median follow-up of 16.2 months (range, 0.5-34.5).

• One death due to pseudomonal bacteremia and 3 deaths due to COVID-19-related pneumonia were reported.

Cohort C Safety Results

Offner et al (2023)¹² presented safety and efficacy in cohort C of the MajesTEC-2 study at a median follow-up of 14.7 months (range, 0.5-22.9).

• Five deaths due to TEAEs were reported: sepsis, septic shock, COVID-19, cardiac arrest, and Pneumocystis jirovecii pneumonia.

Cohort D Safety Results

Tan et al (2023)¹³ presented safety and efficacy in cohort D of the MajesTEC-2 study at a median follow-up of 10.8 months (range, 1.1-16.8).

• Three AE-related deaths (9.7%) were reported (sepsis [n=1], COVID-19 [n=1], and acute renal failure associated with progressive disease [n=1]).

Cohort E Safety Results

Searle et al (2022)¹⁴ presented safety and efficacy in cohort E of the MajesTEC-2 study at a median follow-up of 8.4 months (range, 1.1-12.9).

• Two deaths were reported due to AEs: COVID-19 (n=1, 77 days after last dose) and multi-organ failure related to sepsis (n=1).

clinical data - majestec-3 study

MajesTEC-3 (NCT05083169) is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO vs DPd or DVd (investigator’s choice) in patients with RRMM after 1-3 prior LOTs.¹⁵

Study Design/Methods

• Key eligibility criteria: RRMM, 1-3 prior LOTs, including a PI and lenalidomide, patients with only 1 prior LOT must have been lenalidomide-refractory per International Myeloma Working Group (IMWG) criteria, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.¹⁵

Safety Results

Costa et al (2025)^15,22 published the efficacy and safety results from the MajesTEC-3 study at a median follow-up of 34.5 months (range, 0.03 to 45.3).

• Deaths were reported in 15.9% of patients (45/283) in the Tec-Dara SC arm and 33.1% (96/290) in the DPd/DVd arm, mainly due to adverse events (AEs; Tec-Dara SC, 7.1% [n=20]; DPd/DVd, 5.9% [n=17]) and progressive disease (PD; Tec-Dara SC, 4.6% [n=13]; DPd/DVd, 20.3% [n=59]).
• Among these deaths, the investigator assessed the event as related to trial treatment in 4.2% of patients (n=12) in the Tec-Dara SC arm and 1.7% of patients (n=5) in the DPd/DVd arm.
• A total of 3.5% (n=10) in the Tec-Dara SC arm and 5.2% of patients (n=15) in the DPd/DVd arm died within 30 days of last study treatment dose, mainly due to AEs (Tec-Dara SC, 2.8% [n=8]; DPd/DVd, 4.1% [n=12]) and PD (Tec-Dara SC, 0.7% [n=2]; DPd/DVd, 0.7 % [n=2]).
• A total of 2.1% (n=6) in the Tec-Dara SC arm and 1.4% of patients (n=4) in the DPd/DVd arm died within 60 days of first study treatment dose, due to AEs (Tec-Dara SC, 1.4% [n=4]; DPd/DVd, 1% [n=3]) and PD (Tec-Dara SC, 0.7% [n=2]; DPd/DVd, 0.3% [n=1]).

CLINICAL DATA - MajesTEC-4 study

MajesTEC-4 (NCT05243797) is an open-label, randomized, multicenter, phase 3 study evaluating the safety and efficacy of Tec-Len and TECVAYLI alone vs lenalidomide alone as maintenance therapy in patients with NDMM.¹⁶

Study Design/Methods

SRI Cohorts

• A SRI period consisting of 3 cohorts was used to establish safety prior to enrolling the randomized phase of the study.¹⁶
• Maintenance regimen (2-year fixed duration): patients who achieved a complete remission (CR) on Tec-Len after 1 year discontinued TECVAYLI and continued on lenalidomide for an additional year.¹⁶
• Key eligibility criteria: NDMM, received 4-6 cycles of 3- or 4-drug induction therapy (PI ± immunomodulatory drug ± anti-CD38 antibody), and ASCT (single or tandem ASCT permitted) and/or consolidation with ≥PR.¹⁶

Safety Results

Zamagni et al (2024)¹⁶ presented the preliminary efficacy and safety results from SRI cohort 1 (Tec-Len; TECVAYLI QW to Q4W) at a median follow-up of 21.1 months (range, 14.8-23.8), SRI cohort 2 (Tec-Len; TECVAYLI Q4W) at a median follow-up of 9.2 months (range, 1.2-12.2), and SRI cohort 3 (TECVAYLI Q4W) at a median follow-up of 9.2 months (range, 3.7-11.5).

• One death due to a COVID-19-related TEAE was reported in SRI cohort 2.
• No deaths were reported in SRI cohorts 1 and 3.

CLINICAL DATA - MajesTEC-5 study

MajesTEC-5 (GMMG-HD10; DSMM-XX) is an open-label, nonrandomized, phase 2 study assessing the safety and efficacy of TECVAYLI-based combination regimens in patients with TE-NDMM.¹⁷

Study Design/Methods

• Key eligibility criteria: patients with NDMM per IMWG criteria and measurable disease; highdose therapy (HDT) and ASCT intended (except arms D and G). Arm C/C2 only: received 4-6 cycles of 28‑day PI‑ and/or immunomodulatory‑based induction ± anti‑CD38 mAb and a single/tandem ASCT, 1 prior LOT, at least a PR per IMWG 2016 criteria, and HDT/ASCT within 12 months of induction start and within 6 months of last ASCT (7 months with consolidation).¹⁷

Safety Results

Raab et al (2025)¹⁸ presented the updated efficacy and safety results of the 3 TECVAYLI induction cohorts of the MajesTEC-5 study at a median follow-up of 7.3 months (range, 3.1-14.5).

• No deaths were reported due to TEAEs in any of the induction cohorts.

CLINICAL DATA - MAJESTEC-7 STUDY - TECVAYLI + TALVEY COHORT

MajesTEC-7 (NCT05552222) is a randomized, phase 3, open-label, multicenter study comparing the safety and efficacy of Tec-DR and Tal-DR vs DRd in patients with NDMM who are ineligible or not intended for transplant as initial therapy.¹⁹

Study Design/Methods

SRI Cohort 1 (Tec-DR)

• A SRI period was used to establish safety prior to enrolling the randomized phase of the study.¹⁹
• Key eligibility criteria: NDMM either ineligible or not intended for ASCT.¹⁹

Safety Results

Touzeau et al (2024)¹⁹ presented the initial results from the SRI of 26 patients in cohort 1 (Tec-DR) of the MajesTEC-7 study at a median follow-up of 13.8 months (range, 2.0-15.4).

• One patient died from influenza pneumonia in cycle 3.

clinical data - TRIMM-2 STUDY

TRIMM-2 (NCT04108195) is an ongoing, phase 1b, 2-part, multicohort, open-label study evaluating the safety and efficacy of DARZALEX FASPRO regimens in combination with bispecific T-cell redirection anti bodies in patients with RRMM.²⁰

Study Design/Methods

• Key eligibility criteria: received ≥3 prior LOTs (including a PI and an immunomodulatory drug) or double refractory to a PI and an immunomodulatory drug; anti-CD38 mAb >90 days prior, and prior bispecific antibodies (BsAb) and CAR-T therapy were allowed²⁰

Safety Results

D'Souza et al (2024)¹¹ presented the safety and efficacy results from the TECVAYLI + DARZALEX FASPRO + pomalidomide cohort at a median follow-up of 38.3 months (range, 1.2-39.6).

• Deaths due to infection were reported in 2 patients; 1 due to pneumonia and 1 due to COVID-19 pneumonia.

Rodriguez-Otero et al (2022)²⁰ presented safety and efficacy results from the TECVAYLI and DARZALEX FASPRO cohorts in the TRIMM-2 study at a median follow-up of 8.6 months (range, 0.3-19.6).

• Four deaths were reported due to AEs (bacterial pneumonia, sepsis, hepatic failure and COVID-19). The deaths were considered unrelated to treatment with TECVAYLI or DARZALEX FASPRO.

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 05 February 2026.