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TECVAYLI - GEM-TECTAL Study
Last Updated: 09/30/2026
SUMMARY
- Johnson & Johnson does not recommend the use of TECVAYLI, DARZALEX FASPRO®
(daratumumab and hyaluronidase) or TALVEY® (talquetamab-tgvs) in a manner that is inconsistent with the approved labeling. - GEM-TECTAL is a phase 2 open-label, nonrandomized, multicenter, pilot study evaluating the efficacy and safety of combination TECVAYLI and DARZALEX FASPRO (Tec-Dara) or combination TALVEY and DARZALEX FASPRO (Tal-Dara) in high-risk patients with newly diagnosed multiple myeloma (NDMM).1
, 2 - Rodríguez-Otero et al (2026)2 presented primary endpoint results from the phase 2 GEM-TECTAL trial evaluating a minimal residual disease (MRD)-guided frontline strategy in high-risk patients with NDMM at a median follow-up of 9.8 months.
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 - GEM-TECTAL STUDY
Study Design/Methods
- Study design is presented in Figure: GEM-TECTAL Study Design.
GEM-TECTAL Study: Tec-Dara Dosing
GEM-TECTAL Study: Tal-Dara Dosing
Abbreviations: CR, complete response; Dara, daratumumab; Dex, dexamethasone; DOR, duration of response; D-VRd, daratumumab, bortezomib, lenalidomide, and dexamethasone; ECOG-PS, Eastern Cooperative Oncology Group Performance Status; EMD, extramedullary disease; ERI, early rescue intervention; FISH, fluorescence in situ hybridization; HRCA, high-risk cytogenetic abnormalities; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; NGF, next-generation flow cytometry; OS, overall survival; PFS, progression-free survival; PMD, paramedullary disease; Q2W, every 2 weeks; Q4W, every 4 weeks; QW, weekly; R-ISS, Revised International Staging System; SUD, step-up dose; Tal, talquetamab; Tal-Dara, talquetamab and daratumumab; Tec, teclistamab; Tec-Dara, teclistamab and daratumumab.
a
b
c
Results
Patient Disposition
- Of 42 eligible patients screened, 30 patients initiated DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) induction and were included in the intent-to-treat (ITT) population.
- Twenty-eight patients completed D-VRd induction (cycle 4) and initiated Tec-Dara intensification. During intensification, 3 patients discontinued treatment due to grade 3 rash (n=1), grade 3 peripheral neuropathy (n=1), or unrelated death due to pulmonary edema (n=1); 25 patients completed 6 cycles of Tec-Dara intensification.
- One patient with MRD-positive disease switched to Tal-Dara early rescue intervention.
- At the data cutoff, 22 patients remained on Tec-Dara maintenance therapy, and 23 patients remained on study.
- All 30 enrolled patients were included in the primary and secondary outcome analyses.
Treatment Disposition, Baseline Characteristics, and Disease Characteristics
- A total of 30 patients were included in the study. Patient characteristics are shown in Table: GEM-TECTAL Study: Patient Characteristics.
- The median follow-up was 9.8 months.
- The data cutoff date was May 7, 2026.
| Characteristic | ITT Cohort (N=30) |
|---|---|
| Median age, years (range) | 70 (48-77) |
| Age ≥70 years, n (%) | 17 (56.7) |
| Male sex, n (%) | 15 (50) |
| ECOG, n (%) | |
| 0-1 | 28 (96.6) |
| 2 | 1 (3.4) |
| Charlson CCI, n (%) | |
| ≤1 | 18 (60) |
| >1 | 3 (10) |
| Not available | 9 (30) |
| ISS, n (%) | |
| 1 | 10 (33.3) |
| 2 | 11 (36.7) |
| 3 | 8 (26.7) |
| R-ISS, n (%) | |
| 1 | 7 (23.3) |
| 2 | 18 (60) |
| 3 | 5 (16.7) |
| EMD/PMD, n (%) | 19 (63.3) |
| Bone plasmacytoma | 18 (60) |
| Extramedullary disease | 1 (3.3) |
| High-risk cytogenetic abnormalitiesa, n (%) | 21 (70) |
| del(17p) | 6 (22.2) |
| del(1p) | 9 (36) |
| amp(1q) | 16 (64) |
| t(4;14) | 7 (25) |
| t(14;16) | 6 (22.2) |
| ≥2 high-risk cytogenetic abnormalities, n (%) | 10 (33.3) |
| Ultra-high-risk diseaseb, n (%) | 21 (70) |
| IMS/IMWG consensus genomic stagingc, n (%) | 19 (63.3) |
| Abbreviations: CCI, Charlson Comorbidity Index; del, deletion; ECOG, Eastern Cooperative Oncology Group; EMD, extramedullary disease; HRCA, high-risk cytogenetic abnormalities; IMWG, International Myeloma Working Group; IMS, International Myeloma Society; ISS, International Staging System; ITT, intent-to-treat; PMD, paramedullary disease; R-ISS, Revised International Staging System; Tec-Dara, TECVAYLI + DARZALEX FASPRO. aHigh-risk cytogenetic abnormalities included del(17p), t(4;14), t(14;16), del(1p), and/or amp(1q). High-risk cytogenetic abnormalities were defined using a cutoff of 20% for deletions and 10% for translocations. bUltra-high-risk disease was defined as R-ISS III, ≥2 HRCA, or HRCA plus EMD/PMD. cTP53 mutations and biallelic 1p deletion were not assessed in this study. | |
Efficacy
- Complete response and MRD negativity outcomes following D-VRd induction and Tec-Dara intensification are summarized in Table: GEM-TECTAL Study: Efficacy Outcomes.
| Outcome | ITT Cohort (N=30) | |
|---|---|---|
| After D-VRd Induction | After Tec-Dara Intensification | |
| ORRa | 23 (76.7) | - |
| sCR | 4 (13.3) | 19 (63.3) |
| CR | 2 (6.7) | 6 (20) |
| VGPR | 9 (30) | 3 (10) |
| PR | 8 (26.7) | - |
| SD | 5 (16.7) | - |
| PD | 1 (3.3) | - |
| ≥CR | 6 (20) | 25 (83.3) |
| ≥VGPR | 15 (50) | 30 (100) |
| MRD-negative CR (10- | 4 (13.3)c | 22 (73.3) |
| MRD negativity in patients with ≥VGPR, n (%) | 7 (23.3)c | 24 (80) |
| MRD negativity among patients achieving CRd | - | 22 (88) |
| Abbreviations: CR, complete response; D-VRd, daratumumab, bortezomib, lenalidomide, and dexamethasone; IMWG, International Myeloma Working Group; ITT, intent-to-treat; MRD, minimal residual disease; ORR, overall response rate; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease; Tec-Dara, TECVAYLI + DARZALEX FASPRO; VGPR, very good partial response. Note: Median follow-up was 9.8 months. Data cutoff date was May 7, 2026. aResponse evaluation was performed following IMWG 2016 response criteria. bMRD was assessed by next-generation flow cytometry using EuroFlow standards. Sensitivity level was 10-6 cMRD at cycle 4 of induction. dEvaluated in 25 patients. | ||
Safety
- Summary of treatment-emergent adverse events (TEAEs) is shown in Table: GEM-TECTAL Study: Summary of TEAEs During Tec-Dara Intensification.
| TEAE, n (%) | ITT Cohort (N=28) | ||
|---|---|---|---|
| Any Grade | Grade 1-2 | Grade 3-4 | |
| Any TEAE | 27 (96.4) | - | - |
| Infections | 22 (78.6) | 18 (64.3) | 4 (14.3) |
| Neutropenia | 13 (46.4) | 2 (7.1) | 11 (39.3) |
| CRS | 7 (25) | 7 (25) | - |
| Diarrhea | 7 (25) | 7 (25) | - |
| ICANS | 1 (3.6) | 1 (3.6) | - |
| Abbreviations: CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; ITT, intent-to-treat; Tec-Dara, TECVAYLI + DARZALEX FASPRO; TEAE, treatment-emergent adverse event. Note: Median follow-up was 9.8 months. Data cutoff date was May 7, 2026. | |||
Infections
- Infection details are shown in Table: GEM-TECTAL Study: Infections During Tec-Dara Intensification.
- Immunoglobulin replacement therapy was administered to 75% of patients (21/28) who experienced infections.
- No TECVAYLI discontinuations due to infections were reported.
- No infection-related deaths occurred during Tec-Dara intensification.
| Infection, n (%) | ITT Cohort (N=28) | ||
|---|---|---|---|
| Any Grade | Grade 1-2 | Grade 3-4 | |
| Any infection | 22 (78.6) | 18 (64.3) | 4 (14.3) |
| Upper respiratory tract infection | 15 (53.6) | 13 (46.4) | 2 (7.1) |
| Lower respiratory tract infectiona | 3 (10.7) | 0 | 3 (10.7) |
| COVID-19 | 2 (7.14) | 2 (7.14) | 0 |
| CMV infection | 1 (3.6) | 0 | 1 (3.6) |
| CMV reactivation | 1 (3.6) | 1 (3.6) | 0 |
| Other infectionsb | 4 (14.3) | 4 (14.3) | 0 |
| Abbreviations: CMV, cytomegalovirus; COVID-19, coronavirus disease 2019; ITT, intent-to-treat; Tec-Dara, TECVAYLI + DARZALEX FASPRO. Note: Median follow-up was 9.8 months. Data cutoff date was May 7, 2026. aIncludes grade 3 rhinovirus infection, lower respiratory viral infection. bOther infections included conjunctivitis, rhinitis, urinary tract infection, and varicella; all events were grade 2. Percentages are based on the 28 patients who received Tec-Dara intensification. | |||
Cytokine Release Syndrome
- Cytokine release syndrome (CRS) was reported in 7 patients (25%), with a total of 9 CRS events; all events were grade 1.
- The median duration of CRS was 1 day.
- Tocilizumab was administered to 1 patient for CRS management.
Treatment Discontinuations
- TEAEs led to TECVAYLI discontinuation in 2 patients (7.1%; grade 3 rash considered related to TECVAYLI, n=1; grade 3 sensory/motor neuropathy considered related to TECVAYLI, n=1).
Deaths
- During D-VRd induction, 2 deaths were reported (pulmonary edema, n=1; coronavirus disease 2019 [COVID-19] pneumonia, n=1).
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 28 September 2026.
References
| 1 | Rodríguez-Otero P, Mateos MV, Palacios JJL, et al. Early Treatment With Bispecific T-cell Redirectors (Teclistamab or Talquetamab) + Daratumumab in Newly Diagnosed High-risk Multiple Myeloma: An Open-label, Phase 2, Pilot Study (GEM-TECTAL). Poster presented at: International Myeloma Society; September 27-30, 2023; Athens, Greece. |
| 2 |
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