SUMMARY

• Please refer to the local labeling for relevant information on use in renal impairment (RI).
• MajesTEC-1 is a phase 1/2, multicohort study evaluating the efficacy and safety of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).^1,2
  • Per protocol, patients enrolled in the study were required to have adequate renal function during the screening phase described as: serum creatinine ≤1.5 mg/dL or creatinine clearance (CrCl) ≥40 mL/min/1.73 m² or estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73 m² based upon Modified Diet in Renal Disease (MDRD) formula calculation.²
• Charkviani et al (2025)^3,4 published a retrospective, observational cohort study describing the incidence, severity, and associated outcomes of acute kidney injury (AKI) in patients with RRMM treated with TECVAYLI compared to patients treated with B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.
• Dima et al (2025)^5,6 published a multicenter, retrospective study describing the outcomes of TECVAYLI treatment in patients with RRMM and RI.
• Lebreton et al (2024)⁷ published a retrospective analysis describing the safety and efficacy of TECVAYLI in 15 patients with RRMM on dialysis treated in France through an early access program. 
• Additional case series and case reports have been summarized and are included below for your reference.^8-10

product labeling

There were no clinically significant differences in the pharmacokinetics of teclistamab-cqyv based on mild or moderate renal impairment (eGFR by MDRD method: 30 to 89 mL/min). The effects of severe renal impairment (eGFR less than 30 mL/min) on the pharmacokinetics of teclistamab-cqyv are unknown.¹¹

retrospective studIES

Charkviani et al (2025)^3,4 published a retrospective, observational cohort study describing the incidence, severity, and associated outcomes of AKI in patients with RRMM treated with TECVAYLI compared to patients treated with BCMA-directed CAR-T therapy.

Study Design/Methods

• The study included consecutive patients with RRMM who received at least 1 dose of TECVAYLI or received BCMA-directed CAR-T therapy (idecabtagene vicleucel or ciltacabtagene autoleucel) between December 1, 2022, and May 15, 2023. Patients with end-stage kidney disease (ESKD; defined as those who had been on maintenance hemodialysis [HD] for >3 months before starting treatment) at treatment initiation were excluded. Patients were followed until August 1, 2023.
• Primary endpoint: incidence of AKI during follow-up.
• Secondary endpoints: clinical and laboratory characteristics before, during, and after AKI events, including AKI severity and renal recovery; electrolyte levels following treatment initiation; and hematologic response and mortality during follow-up.
• TECVAYLI dosing: step-up doses (SUDs) of TECVAYLI (0.06 mg/kg and 0.3 mg/kg subcutaneously [SC]) were administered 2 to 4 days apart and completed 2 to 4 days prior to the first treatment dose of TECVAYLI 1.5 mg/kg SC. Subsequent treatment doses included TECVAYLI 1.5 mg/kg SC weekly (QW).
• AKI was defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in the serum creatinine levels ≥1.5 times the baseline value following initiation of therapy. The severity of AKI was classified based on the KDIGO staging system.

Results

Treatment Disposition, Baseline Characteristics, and Disease Characteristics

• A total of 64 patients with RRMM were included in this study; 34 patients received TECVAYLI, and 30 patients received CAR-T therapy. Baseline patient characteristics are presented in Table: Select Baseline Demographics and Clinical Characteristics.
• The average follow-up duration was 148 days (standard deviation [SD], 6.4) after treatment initiation.

Incidence of AKI and Associated Outcomes

• A total of 14 AKI events were reported during follow-up. Ten events were reported in the TECVAYLI group (stage 1, n=6; stage 2, n=3; stage 3, n=1) and 4 events were reported in the CAR-T group (stage 1, n=3; stage 2, n=1) groups.
• Hematologic response and incidence of AKI are detailed in Table: Hematologic Response and Incidence of AKI.
• AKI-free survival estimates at 180 days post-treatment were 68% (95% confidence interval [CI], 53-87) in the TECVAYLI group and 90% (95% CI, 79-100) in the CAR-T group.
• In the TECVAYLI group, the incidence of AKI was associated with higher involved free light chains at baseline (hazard ratio [HR] per 10-unit increase, 1.03 [95% CI, 1.01-1.05]; P=0.002).
• In the TECVAYLI group, 8 of the 10 patients with AKI events developed AKI while receiving TECVAYLI QW; 2 patients developed AKI after treatment discontinuation.

Serum Creatinine and eGFR Trends

• The serum creatinine levels appeared to improve in both groups with no significant difference in creatinine levels observed before, during, or after the onset of AKI. Similar results were observed for eGFR levels.

Renal Recovery in Patients With AKI

• In the 10 TECVAYLI patients who experienced AKI during follow-up, 4 patients (40%) had complete renal recovery, 4 patients (40%) had partial recovery, 1 patient (10%) had no recovery, and 1 patient (10%) died shortly after AKI.
• In the 4 CAR-T patients who experienced AKI during follow-up, 2 patients (50%) had complete renal recovery, and 2 patients (50%) had partial recovery.
• Among the 6 patients with renal recovery, the median time to recovery was 26 days (IQR, 23-28).
• No patients in either group required renal replacement therapy during follow-up.

Clinical Characteristics in Patients With AKI

• In the TECVAYLI patients who developed AKI, a possible prerenal cause for the AKI was identified in 4 patients, among whom 3 resolved in <72 hours. Sustained AKI (lasting >72 hours) was noted in 6 patients. A total of 8 patients had progressive disease and did not respond to treatment (4 of these patients had rising free light chains with a concurrent increase in creatinine). Hydration (n=4) and kidney function monitoring (n=4) were the main interventions for AKI.
• In CAR-T patients who developed AKI, 1 patient was associated with each of the following: cytokine release syndrome (CRS), nephrotoxin exposure, hypercalcemia, and volume depletion. Progressive disease was noted in 3 of 4 patients.
• In the 10 TECVAYLI patients who experienced AKI, 5 patients had previously received CAR-T therapy (no patients experienced AKI during their prior CAR-T therapy), 3 patients were classified as high risk due to chromosomal abnormalities, and 2 patients were considered standard risk.
• The free light chain level continued to rise after AKI in the TECVAYLI group.

Mortality in Patients With AKI

• Nine patients died (64%; n=8, TECVAYLI group; n=1, CAR-T group) after a median of 30 days (IQR, 10-39) after their AKI event; 4 patients died (n=2, TECVAYLI group; n=2, CAR-T group) without experiencing an AKI event.

Incidence of CRS in Patients With AKI

• Overall, a total of 30 CRS events were reported after treatment initiation (n=8 [24%], TECVAYLI group; n=22 [73%], CAR-T group).
• None of the patients in the TECVAYLI group who developed AKI had CRS at the time of the event; 1 CAR-T therapy-treated patient had CRS during the AKI event.

Dima et al (2025)^5,6 published a multicenter, retrospective study describing the outcomes of TECVAYLI treatment in patients with RRMM and renal impairment.

Study Design/Methods

• This study included patients with RRMM who received TECVAYLI under a commercial Food and Drug Administration (FDA) label at 13 academic centers participating in the United States (US) Multiple Myeloma (MM) Immunotherapy Consortium. The data cutoff date was April 30, 2024.
• RI was defined as CrCl <40 mL/min at the time of TECVAYLI initiation. Severe RI was defined as CrCl <30 mL/min or as being on dialysis.
• TECVAYLI dosing: SUDs of TECVAYLI (0.06 mg/kg SC and 0.3 mg/kg SC) were administered prior to the first treatment dose of TECVAYLI 1.5 mg/kg SC. Subsequent dosing frequency was at the discretion of the treating physician. For patients on dialysis, TECVAYLI was given after dialysis if it was scheduled on the same day.

Results

Patient Demographics

• A total of 384 consecutive patients were included in this study. At TECVAYLI initiation, 81 patients (21%) had RI, and 45 patients (18%) had severe RI, including 18 patients (5%) who were on dialysis. A documented history of cast nephropathy (either clinically diagnosed or with biopsy) before TECVAYLI initiation was noted in 44% of patients (n=36) with RI.
• Baseline patient characteristics are presented in Table: Select Baseline Demographics and Clinical Characteristics.

Efficacy

• The median follow-up for all cohorts was 9.9 months (95% CI, 9.5-10.6). Efficacy outcomes are detailed in Table: Efficacy Outcomes.

Safety

• Safety outcomes and adverse event (AE) management are detailed in Table: Summary and Management of AEs.
• No delayed neurotoxicity or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome was seen in patients with RI.
• In patients with severe RI, any-grade CRS and any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) were reported in 60% and 18% of patients, respectively; grade ≥3 CRS and ICANS were reported in 2% and 4% of patients, respectively.
• Details on patients on dialysis are presented in Table: Safety Outcomes for Patients With End-Stage Renal Disease on Dialysis.
• At data cutoff, 137 patients who received TECVAYLI had died. See Table: Cause of Death for additional details.
• Outcomes for patients with RI by day 30 were as follows:
  • Among the 18 dialysis patients, 2 patients progressed, 2 patients died from myeloma progression and 14 patients remained alive and on dialysis.
  • Among the remaining 63 patients, 14 patients (22%) had progressed or died, 23 patients (37%) had an improvement in their CrCl (10 patients [16%] improved to CrCl ≥40 mL/min; 13 patients [21%] improved to CrCl 30-39 mL/min) and 25 patients (40%) had worsening of their CrCl. CrCl was unavailable for 1 patient.
• Among patients without RI at baseline, 73 patients (24%) progressed or died by day 30, 215 patients (71%) remained in the same range of CrCl ≥40 mL/min and 8 patients (2.6%) had worsening of their CrCl to <40 mL/min by day 30. CrCl was unavailable for 7 patients (2.3%).

Lebreton et al (2024)⁷ published a retrospective analysis describing the safety and efficacy of TECVAYLI in 15 patients with RRMM on dialysis treated in France through an early access program.

Study Design/Methods

• Patients with RRMM and end-stage renal failure treated with TECVAYLI were included in the study, which was submitted to the French Health Data Hub.
• TECVAYLI was administered SC QW at a dose of 1.5 mg/kg, following SUDs of 0.06 mg/kg and 0.3 mg/kg.
• Premedication (including dexamethasone) was administered prior to TECVAYLI per European Medicines Agency (EMA) approved prescribing information.
• TECVAYLI was usually injected after dialysis, but schedules varied based on the dialysis schedule of each patient.

Results

Patient Demographics

• Data was collected from 15 patients treated with TECVAYLI in French hospitals between November 2022 and October 2023. All patients were ineligible for open clinical trials.
• The median follow-up was 166 days (range, 10-315), the median age of 68 years (range, 58-83), and the median time since diagnosis of 6 years (range, 2-9). Patients received a median of 4 prior lines of therapy (range, 3-6).
• Most patients had myeloma-related end-stage renal failure.
• Seven of 10 evaluable patients were considered as high-risk based on cytogenetics.

Dosing and Time to Dialysis

• TECVAYLI SUD 2 was administered after a median of 3 days (range, 2-7) and the first treatment dose was administered after a median of 7 days (range, 4-14).
• TECVAYLI was administered just after dialysis in 9 patients and on non-dialysis days in 3 patients.
• All patients received HD, except for 1 patient who received peritoneal dialysis.
• Dialysis was discontinued in 1 patient due to improved renal function.
• TECVAYLI dosing was reduced to once every 2 weeks (Q2W) for 5 patients, once every 3 weeks for 1 patient and once every 4 weeks (Q4W) for 1 patient.

Safety

CRS and ICANS

• CRS of grade 1/2 occurring in 11 patients (all during the step-up dosing schedule) was treated with tocilizumab (4 patients) and dexamethasone (1 patient). Grade 3/4 CRS was not reported.
• Grade 2 ICANS occurred concurrently with grade 2 CRS in 1 patient, both of which were resolved following treatment with 2 doses of dexamethasone.

Infections

• Grade ≥2 infections were reported in 9 patients (grade 2, n=2; grade 3, n=4; grade 4, n=1; grade 5, n=2); bacteremia was reported in 7 patients (2 of which were fatal) and viral infection was reported in 2 patients.
• Prophylaxis for infections included sulfamethoxazole-trimethoprim and valaciclovir in 12 patients and oracillin in 6 patients.
• Primary prophylaxis with SC or intravenous (IV) polyvalent immunoglobulin G (IgG) was administered to 8 patients.
• Grade 3 coronavirus disease 2019 (COVID-19) was reported in 1 patient.

Efficacy

• Median time to best response was 40 days (range, 6-124).
• A total of 14 patients achieved a response. Of these, 2 patients experienced stringent complete response (sCR), 2 patients experienced complete response (CR), 7 patients had very good partial response (VGPR) and 2 patients had partial response (PR).
• One patient with progressive disease had extramedullary disease and died from sepsis.
• One patient was not evaluable for response.
• Median PFS was not reached.

CASE SERIES and case reports

Mohan et al (2025)¹⁰ reported a case of a 68-year old male who developed acute interstitial nephritis (AIN) after starting TECVAYLI for RRMM. The patient was stable on immune checkpoint inhibitor (ICI) therapy for squamous cell carcinoma (SCC) for 3 years.

Khouderchah et al (2024)⁸ published a case series that described the clinical course and outcomes in 4 patients with RRMM who were treated with TECVAYLI. These 4 patients had end-stage renal disease (ESRD) and were on HD at the time of TECVAYLI initiation.

Patient 1

• A 65 year old female diagnosed with kappa free light chain (FLC) MM with high risk-cytogenetics developed progressive myeloma-related renal impairment and was started on HD. After treatment with 11 prior lines of therapy (LOTs), the patient was started on TECVAYLI.
• The patient was hospitalized and received 2 SUDs of SC TECVAYLI on days 1 and 4 (0.06 mg/kg and 0.3 mg/kg, respectively), followed by the first full dose on day 7 (1.5 mg/kg).
• HD was continued irrespective of TECVAYLI administration. The patient had an incomplete HD run on day 1, and then underwent 3-hour HD runs on days 2, 5, and 7, including a HD session just prior to TECVAYLI administration on day 7. An additional HD session occurred on day 9.
• The patient had no evidence of CRS and ICANS; she was discharged 48 hours after the first full dose of TECVAYLI.
• The patient was continued on QW TECVAYLI. Prior to the start of cycle 3, she exhibited progressive disease (per International Myeloma Working Group [IMWG] response criteria) and enlargement of a known plasmacytoma on the forehead (as seen on imaging). TECVAYLI was discontinued.

Patient 2

• A 68 year old male diagnosed with IgA kappa light chain MM with high-risk cytogenetics had ESRD from MM requiring chronic HD and chronic anemia requiring QW red blood cell (RBC) transfusions. After treatment with 6 prior LOT, the patient was started on TECVAYLI.
• The patient was hospitalized and received 2 SUDs of SC TECVAYLI on days 1 and 3 (0.06 mg/kg and 0.3 mg/kg, respectively), followed by the first full dose on day 5 (1.5 mg/kg SC). He received HD and 2 units of packed RBCs prior to SUD 1 with subsequent HD on days 7, 11, 13, and 15. Ultrafiltration was only performed on days 8 and 9.
• The patient had no clinical evidence of CRS or ICANS.
• The patient had orthopnea and shortness of breath with exertion before initiating TECVAYLI therapy. On day 6, he developed worsening orthopnea and was found to have newly diagnosed dilated cardiomyopathy, with a left ventricular ejection fraction of 28 (previously 69 in 2017) and pulmonary hypertension.
• Over the course of several days, he received ongoing transfusion support for low hemoglobin. Based on fluid status and blood pressure, HD was modified. Symptoms of cardiomyopathy and pulmonary hypertension were thought to be unrelated to TECVAYLI. He was administered the second full-treatment dose of TECVAYLI on day 13.
• Continuous renal replacement therapy was initiated in the intensive care unit due to cardiac issues prohibiting HD.
• After receiving 2 weeks of full-treatment dose TECVAYLI, the patient achieved PR (per IMWG response criteria), despite his declining clinical status. No further TECVAYLI was given. The patient transitioned to comfort care and passed away shortly after.

Patient 3

• A 65 year old male diagnosed with IgG lambda MM with high-risk cytogenetics had a history of atrial fibrillation and ESRD which required HD at the time of MM diagnosis. After treatment with 8 prior LOT, the patient was started on TECVAYLI.
• The patient was hospitalized and received SC TECVAYLI SUD 1 (0.06 mg/kg SC) and SUD 2 (0.3 mg/kg SC) administered on days 1 and 3, respectively; HD was completed the day after each dose.
• The first full-treatment dose (1.5 mg/kg SC) was completed on day 5; followed by HD the next day. No clinical CRS or ICANS occurred.
• Throughout hospitalization, the patient underwent approximately 3-hour HD sessions 3 times per week. An additional HD session was given due to contrast administration.
• The patient had a prolonged hospitalization due to atrial fibrillation, new malignant pleural effusion and the development of dysphagia which was likely due to cranial nerve involvement from plasmacytoma.
• On day 12, the patient became acutely confused, and the immune effector cell-associated encephalopathy (ICE) score decreased to 5; a neurology consult deemed this to be related to metabolic abnormalities, and TECVAYLI doses were withheld.
• Despite interventions to correct the metabolic abnormalities, the patient’s neurologic status still declined. On day 14, the ICE score decreased to 1, and dexamethasone 10 mg IV every 6 hours was started for potential grade 3 ICANS.
• An increase in C-reactive protein (CRP) was noted (baseline of 1.33 mg/dL increased to 3.78 mg/dL).
• Dexamethasone was increased to every 4 hours; anakinra 100 mg SC was administered for refractory ICANS after the patient’s neurologic status did not improve.
• The family chose to withdraw care and the patient was discharged to hospice after imaging showed persistent disease and minimal improvement in mental status was observed.

Patient 4

• A 61 year old female diagnosed with standard-risk IgG kappa MM developed renal failure secondary to disease and was started on HD. After treatment with 7 prior LOT, the patient was started on TECVAYLI.
• The patient was hospitalized and received SC TECVAYLI SUD 1 (0.06 mg/kg SC) and SUD 2 (0.3 mg/kg SC) administered on days 1 and 3, respectively, with HD performed prior to each dose.
• On day 4, the patient developed grade 1 CRS with a fever of 38°C. On day 6, ferritin levels increased to a peak of 836 ng/mL (from 745 ng/mL at baseline). CRP levels increased to a peak of 11.03 mg/dL (from 0.33 mg/dL at baseline).
• The patient was treated with acetaminophen for fever and was started on broad-spectrum antibiotics. By day 5, the fever resolved and infectious work-up was negative.
• The patient received the first full-treatment dose of SC TECVAYLI (1.5 mg/kg) after HD.
• No additional CRS or ICANS events occurred, and the patient was discharged for outpatient follow-up on day 7.
• The patient had a significant decrease in the kappa FLC (161.98 mg/dL at baseline to 2.63 mg/dL) prior to the second full-treatment dose. She was continued on QW TECVAYLI; prior to the third full-treatment dose, the patient achieved sCR (per IMWG response criteria).
• The patient completed cycle 2 before being transitioned to dosing of Q2W per provider preference. She completed 3 cycles of TECVAYLI and was lost to follow-up.

Joiner et al (2023)⁹ published a case series which reported initial observations in 7 patients with MM and severely impaired renal function treated with TECVAYLI. This series included 4 patients with ESRD on HD therapy at the time of TECVAYLI initiation.The other 3 patients had an eGFR of 16 mL/min, 22 mL/min, and 27 mL/min, respectively.

• Risk factors of the 7 patients included: Eastern Cooperative Oncology Group performance status (ECOG PS) 2-3, cytogenetic abnormalities, extramedullary plasmacytoma, and triple-class and penta-class refractory status.The median follow-up of these observations was 2 months (range, 1-7).
• The FDA approved TECVAYLI prescribing information dosing schedule was followed for dosing cycles 1 and 2. At dosing cycle 3 the frequency was modified to Q2W for 8 doses followed by Q4W starting cycle 7 onward.
  • Infection prophylaxis (starting at onset of TECVAYLI) and monthly IV Ig (starting on the second month) was administered.
• A total of 6 patients experienced CRS (maximum CRS grade 1, n=4; grade 2, n=1; grade 3, n=1). No events of ICANS or infections have been reported at this time.
• Renal improvement was noted in 1 patient with acute renal impairment related to myeloma progression (eGFR from 27 mL/min to 56 mL/min after cycle 1).Stable renal function was maintained in 1 patient.Worsening renal function along with disease progression was observed in 1 patient.
• A total of 5 patients experienced evidence of VGPR and remain on TECVAYLI treatment to date.Two patients with extramedullary plasmacytoma experienced disease progression and discontinued TECVAYLI treatment prior to cycle 2.

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 29 April 2025.