SUMMARY

• Johnson & Johnson does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• IMPACT AL is an ongoing, phase 2 study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO (Tec-Dara subcutaneous [SC]) in patients with previously untreated systemic AL amyloidosis.^1,2
• TeclistAMY is an ongoing, phase 2 study evaluating the efficacy and safety of TECVAYLI monotherapy in patients with previously treated systemic AL amyloidosis.¹
• Mico et al (2025)³ evaluated the use of TECVAYLI in 8 patients with relapsed or refractory (RR) amyloidosis.
• Stalker et al (2024)⁴ published a single-center, retrospective case series evaluating patients with heavily pretreated RR systaemic AL amyloidosis who were treated with TECVAYLI.
• Mann et al (2023)⁵ presented a retrospective analysis to evaluate the efficacy of TECVAYLI in 3 identified patients with RR AL amyloidosis and multiple myeloma (MM).
• Chakraborty et al (2023)⁶ evaluated the use of TECVAYLI in 7 patients with AL amyloidosis with or without concurrent relapsed or refractory multiple myeloma (RRMM) who were treated at 2 different medical centers.
• Forgeard et al (2023)⁷ conducted a multinational, retrospective case series analysis in patients with RR AL amyloidosis who received TECVAYLI.
• Other relevant literature has been included in the references section for your review.^8,9

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.

CLINICAL DATA - IMPACT AL

• IMPACT AL (NCT07110844) is an ongoing, phase 2 study evaluating the efficacy of Tec-Dara SC in patients with previously untreated systemic AL amyloidosis.¹ 

Study Design/Methods

• The IMPACT AL trial uses Simon’s optimal 2stage design to evaluate whether Tec-Dara SC achieves a hematologic complete response (hemeCR) rate of 80% at 6 months, compared with a null hypothesis response rate of 55% (derived from Dara-bortezomib, cyclophosphamide, and dexamethasone [VCd] from the ANDROMEDA study).
  • Stage 1: 8 patients will be enrolled, and the study will stop for futility if ≤3 patients achieve a hemeCR.
  • Stage 2: if the futility boundary is not met, an additional 13 patients will be enrolled (total N=21), with overall success defined as at least 15 patients achieving a hemeCR.
• To account for an anticipated dropout rate of 16%, the total planned enrollment is 25 patients, with α=0.10 and 80% power.
• See further details in Figure: IMPACT AL Study Design.

CLINICAL DATA - TeclistAMY

TeclistAMY (EMN40; NCT06649695) is an ongoing, multicenter, open-label, single-arm, phase 2 study evaluating the safety and efficacy of TECVAYLI monotherapy in patients with previously treated AL amyloidosis.¹⁰

Study Design/Methods

• Study design is presented in Figure: TeclistAMY Study Design.
• The follow-up period will be up to 12 months after the last participant enters the follow-up phase. Safety will be reviewed by an independent data monitoring committee after 6 patients complete ≥1 cycle; the trial will continue if no safety signals are identified.

CASE SERIES

Mico et al (2025)³ describes the use of TECVAYLI in 8 patients with RR amyloidosis.

Study Design/Methods

• Hematologic and organ responses along with treatment-related side effects were analyzed.
• The Mayo systems were used to indicate the disease stages.
• Adverse events were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) and cytokine release syndrome (CRS) was graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

Results

• Select patient characteristics are presented in the Table: Patient Characteristics.
• A summary of response across the 8 patients is detailed in Table: Summary of Patients Treated With TECVAYLI for RR Amyloidosis.
• Patients were treated with escalating dose of TECVAYLI.

Efficacy

• The hematologic response rate was 100%: 7 patients achieved complete response (CR); and 1 patient achieved very good partial response (VGPR).
• The cardiac response rate was 29% (CR, n=1; partial response, n=1) and the renal response rate was 20% (n=1).

Safety

• Grade 1 CRS was reported in 2 patients.
• Grade 3 toxicities were reported in 2 patients.
  • One female patient experienced aminotransferase >1000 IU/L a day after the first 0.6 mg/kg dose followed by an unmaintained CR for 7 months.
  • One female patient reported grade 3 thrombocytopenia which resolved after treatment discontinuation.
• There were no relapses or deaths.

Stalker et al (2024)⁴ published a single-center, retrospective case series evaluating patients with heavily pretreated RR AL amyloidosis who were treated with TECVAYLI at the Hospital of the University of Pennsylvania.

Study Design/Methods

• Adult patients with biopsy-proven AL amyloidosis treated with TECVAYLI from December 2022 to February 2024 were included.
• The data cut-off for this analysis was February 29, 2024. 
• All patients received TECVAYLI step-up dosing according to the United States prescribing information while hospitalized. All patients received monthly intravenous immunoglobulin (IVIG) and prophylaxis for Pneumocystis jirovecii pneumonia (PJP) and herpes zoster.
• The revised Mayo Clinic Criteria were used to grade cardiac amyloidosis. The renal staging system was used to grade renal amyloidosis.
• Hematologic and organ response were assessed via consensus guidelines.
• Adverse events were graded based on Common Terminology Criteria for Adverse Events and CRS was graded according to the ASTCT consensus scale.

Results

Baseline Characteristics

• Eight patients were included in this analysis. Baseline characteristics are presented in Table: Baseline Characteristics.

Efficacy

• All patients achieved at least VGPR, with a median time to hematologic VGPR of 13 days (range, 12-18).
• All patients had normalization of free light chain (FLC) and 6 patients (75%) patients achieved undetectable FLC levels.
• Out of the 6 patients with completed immunofixations, all 6 achieved hematologic complete response (hCR). Median time to hCR was 88 days (range, 32-150).  
• The median difference between involved and uninvolved free light chains (dFLC) was 59.6 (range, 3.6–333.4) prior to TECVAYLI initiation and 1.4 (range, 0.0-78.5) on the first laboratory check after completion of TECVAYLI ramp-up.
• A total of 4/5 patients (80%) with cardiac involvement, achieved a cardiac response at a median time of 122 days (range, 54-292). The median N-terminal pro-B-type natriuretic peptide (NT proBNP) of the 5 patients with cardiac involvement was 1098 (range 150–35000) before TECVAYLI initiation and 337 (range, 50–28120) after TECVAYLI on the most recent laboratory check by data cutoff.
• Of the 7 patients with renal involvement, 2 patients had achieved a response prior to TECVAYLI and 3 of the remaining 5 patients (60%) achieved renal response at a median time of 99 days (range, 75-347).  
• The median duration of response was 165 days (range, 11-410) from TECVAYLI start to discontinuation or censored at the last contact at the end of data collection.
• With a median duration of follow-up of 8.5 months (range, 1-14), all patients were still alive and 6 patients (75%) remained on TECVAYLI. A total of 4 patients were continued on TECVAYLI for ≥6 months; all transitioned to less frequent dosing (3 patients to every other week [Q2W] and 1 patient to every 4 weeks [Q4W]).
• With a median duration of follow-up of 13 months (range, 3-14), 5 of the 6 patients with hCR remained in hCR.

Safety

• Six patients developed CRS (grade 1, n=5; grade 2, n=1). The median time to onset of CRS was 4 days (range, 1-7). Tocilizumab was administered to 2 patients and 1 patient received steroids for CRS.
• No patients developed immune effector cell-associated neurotoxicity syndrome (ICANS).
• Two patients developed treatment-emergent neutropenia. One was Grade 3 agranulocytosis that improved with granulocyte colony-stimulating factor (G-CSF) and treatment discontinuation.
• Two cases of grade 2 acute kidney injury were reported. One case lasted 12 days and the other case initially lasted 7 days but worsened and eventually required TECVALYI discontinuation.
• Grade 3 sclerouveitis (n=1) developed 5 days after TECVAYLI initiation, and grade 3 hypertensive urgency (n=1) was reported within the first 5 days of TECVAYLI initiation.
• No patients developed cardiac decompensation while on TECVAYLI.
• Two cases of grade ≥ 3 infections requiring hospitalization were reported (grade 3 colitis [n=1] and grade 3 septic shock in the setting of a hip fracture after a fall [n=1]).
• Two patients discontinued TECVAYLI due to adverse events related to therapy.
  • A hematologic response was maintained in 1 patient 97 days after discontinuation.
  • The other patient had hematologic progression 153 days after discontinuation. Since then, this patient has resumed therapy with TECVAYLI and regained a CR.    

Mann et al (2023)⁵ presented a retrospective analysis to evaluate the efficacy of TECVAYLI in 3 identified patients with RR systemic AL amyloidosis and MM.

Study Design/Methods

• All patients with RR AL amyloidosis and MM, who had received TECVAYLI at two United States (US) academic centers between October 2022 and July 2023 were included.
• Hematologic and organ response were assessed via consensus guidelines.
• Toxicity assessment was based on the NCI CTCAE v5.0.
• CRS and neurotoxicity were graded according to the 2019 ASTCT criteria.
• All patients had TECVAYLI initiation in the hospital and received step-up doses of 0.06 mg/kg, 0.3 mg/kg, and 1.5 mg/kg followed by weekly outpatient doses of 1.5 mg/kg.
• CRS and neurologic toxicities were monitored according to institutional protocols.

Results

Baseline Characteristics

• A total of 3 patients (median age, 67 years [range, 54-70]; male, n=3; AL λ-type, n=2) were identified.
• The median number of prior therapies was 7 (5-10), and all the patients were refractory to bortezomib, lenalidomide and daratumumab.
• Median involved free light chain (iFLC) level was 228 mg/L (45.5-1272) with 10% median bone marrow plasmacytosis.
• One patient had rapidly progressive MM.

Efficacy

• At a median follow-up of 49 days (range, 44-58), 2 patients achieved hematologic response within 3 weeks of treatment initiation. Both responses were deep with iFLC <10 mg/L and were ongoing at the last follow-up. Summary of efficacy response has been given in Table: Summary of Efficacy Response.
• One patient with rapid renal progression prior to TECVAYLI had a renal response by day 42.

Safety

• Summary of safety and toxicity response is shown in Table: Summary of Safety and Toxicity Response.
• All patients received routine prophylaxis against Varicella zoster virus and PJP, as well as prophylactic IVIG.
• One patient with heavily pre-treated, high-risk MM had an aggressive clinical relapse with widespread osseous involvement within 6 months of an autologous stem cell transplant (ASCT) and experienced progressive disease as best response to TECVAYLI, requiring discontinuation after 29 days in favor of cytotoxic chemotherapy.

Chakraborty et al (2023)⁶ describes the use of TECVAYLI in 7 patients with AL amyloidosis with or without concurrent RRMM, who were treated at 2 different medical centers.

Study Design/Methods

• Patients who were treated with TECVAYLI since approval on October 25, 2022, were included.

Results

• A summary of baseline characteristics, efficacy, and safety results across the 7 patients is detailed in Table: Summary of Patients Treated With TECVAYLI for AL Amyloidosis.

Baseline Characteristics (N=7)

• Six patients had AL amyloidosis with concurrent RRMM; one patient had AL alone.
• The median dFLC was 20.5 mg/dL (range, 5.28-476.7).
• Baseline median NT proBNP was 3307 pg/mL (range, 214-19557).
• Median estimated glomerular filtration rate (eGFR) was 50 mL/min (range, 5-91), one patient was on peritoneal dialysis.
• All patients had prior exposure to anti-CD38 monoclonal antibody. Four patients had prior exposure to B-cell maturation antigen (BCMA) targeted therapy. At the time of TECVAYLI initiation, 5 patients had disease refractory to the prior line of therapy (LOT).
• Five patients had cardiac involvement, 5 had renal involvement, and 5 had two or more organs involved.

Efficacy

• The median duration of follow-up for 6 of the 7 surviving patients was 3.2 months (range, 1.4-9.0).
• All 7 patients achieved hematologic VGPR or better.
• Median time to VGPR from TECVAYLI initiation was 0.6 months (range, 0.3-1.9).
• None of the patients had a hematologic relapse or progression at latest follow-up.

Safety

• Grade 1 CRS occurred in 4 patients. No patients developed ICANS.
• Grade 3 urinary tract infection and grade 4 septic shock secondary to gram-negative bacilli were reported in 2 patients (one each). There were no infection-related deaths.
• One patient developed cytopenia (grade 3 neutropenia and grade 3 thrombocytopenia).
• One patient died 40 days after last TECVAYLI dose due to progressive cardiac deterioration and failure to thrive.

Forgeard et al (2023)⁷ conducted a multinational, retrospective case series analysis in patients with RR AL amyloidosis who received TECVAYLI.

Study Design/Methods

• The study population included 17 patients from 10 university hospitals across Europe who were treated with TECVAYLI between July 2022 and August 2023.
• TECVAYLI was administered subcutaneously as follows: 0.06 mg/kg at day 1, 0.3 mg/kg at day 4, 1.5 mg/kg at day 8, and then 1.5 mg/kg weekly unless otherwise specified.
• Dexamethasone was administered based on local practice.
• VGPR was defined as <40 mg/L dFLC, and partial response as dFLC decrease >50%.

Results

• Of the 17 patients, cardiac involvement was present in 16 (94%) and kidney involvement in 10 (59%).
• Additional patient characteristics at baseline are summarized in Table: Baseline Characteristics.

Efficacy

• At a median duration of follow-up of 3 months, patients had received a median of 3 cycles (range, 0.25-10) of TECVAYLI.
• Responses: A total of 15 patients (88%) achieved ≥VGPR, of whom 7 (41%) patients had achieved CR and 13 patients (76%) had a reduction of involved FLC of <10 mg/L.
  • One patient did not respond, and 1 was not evaluable due to early death.
• Median dFLC at the time of evaluation was 0 mg/L (range, 0-1370).
• The median time to best hematological response was 28 days (range, 14-112).
• Organ response: Five patients (29%) achieved an organ response (cardiac, n=4; cardiac=1; kidney, n=1), and 1 patient died of organ progression (initially Mayo IIIB).

Safety

• CRS/ICANS: A total of 9 patients (53%) had grade 1 CRS after TECVAYLI administration, and 2 patients received tocilizumab. One patient also had concomitant grade 3 ICANS (had a past history of unlabeled auto-inflammatory syndrome).
• Infections: Serious bacterial infections (grade 3-5) were reported in 5 patients (29%), of whom 1 died. Viral infections occurred in 5 patients (29%; grade 3, n=1).
• Twelve patients (71%) received IVIG during the reporting period.
• Two patients discontinued TECVAYLI due to adverse events (grade 3 ICANS and grade 5 infection).

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 18 February 2026.