SUMMARY  

• Janssen does not recommend any practices, procedures or usage that deviate from the approved labeling.
• Janssen 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 or combination TALVEY and DARZALEX FASPRO in high-risk patients with newly diagnosed multiple myeloma (NDMM). Enrollment is currently ongoing for this study and results have not been published at this time.¹

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

GEM-TECTAL (clinicaltrials.gov identifier NCT05849610) is a phase 2 open-label, nonrandomized, multicenter, pilot study evaluating the efficacy and safety of combination TECVAYLI and DARZALEX FASPRO or combination TALVEY and DARZALEX FASPRO in high-risk patients with NDMM.¹

Study Design/Methods

• Key inclusion criteria: NDMM as per the International Myeloma Working Group (IMWG) criteria, eligible for transplant and ≤70 years, or fit and ineligible for transplant status with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, have ≥1 of the following high-risk multiple myeloma features: adverse cytogenic abnormalities (del[17p], t[4;14], t[14;16], or 1q amplifications detected by fluorescence in situ hybridization), Revised International Staging System (R-ISS) stage III, presence of extramedullary disease (defined as the presence of paramedullary lesions or extramedullary plasmacytoma, undergone single or tandem autologous stem cell transplant.^1,2
• The targeted enrollment is approximately 30 patients.¹
• Primary endpoint: minimal residual disease (MRD)-complete response (CR) rate after TECVAYLI + DARZALEX FASPRO intensification measured by ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG) positron emission tomography (PET) with computed tomography (CT) and next generation flow (NGF) with a sensitivity of 10^-6.¹
• Key secondary endpoints: incidence of patients testing MRD-positive who convert to MRD-negative after 6 cycles of TALVEY + DARZALEX FASPRO early rescue intervention, incidence of patients with sustained MRD negativity at 12, 18, and 24 months, time to next treatment, duration of response, progression-free survival, event-free survival, overall survival, safety.¹
• Exploratory endpoints: immune profiling, genetic characterization.¹
• Dosing: Patients will undergo an induction therapy consisting of DARZALEX FASPRO, bortezomib, lenalidomide, and dexamethasone (D-VRd) followed by response evaluation, including stem cell collection and MRD assessment, before undergoing a 6-cycle intensification phase of TECVAYLI and DARZALEX FASPRO.¹
  • Patients testing MRD-negative: TECVAYLI + DARZALEX FASPRO maintenance therapy for 2 years.¹
    • Patients converting to MRD-positive or relapse from CR will be treated as MRD-positive.¹
  • Patients testing MRD-positive will receive: TALVEY + DARZALEX FASPRO for 6 cycles before reassessment.¹
    • Patients testing MRD-negative after reassessment: TALVEY + DARZALEX FASPRO therapy for 2 years.¹
    • Patients testing MRD-positive after reassessment: Salvage Therapy.¹

Results

• Enrollment is ongoing for this study, and results have not been published at this time.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 26 August 2024.