Comparative Efficacy of Teclistamab Versus Physician's Choice of Therapy in the Long-term Follow-up of APOLLO,POLLUX, CASTOR,and EQUULEUS Clinical Trials in Patients With Triple-class Exposed Relapsed or Refractory Multiple Myeloma |
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| Affiliation: | 1. University Hospital of Salamanca/IBSAL/CIC, Salamanca, Spain;2. Mount Sinai School of Medicine, New York, NY;3. Memorial Sloan Kettering Cancer Center, New York, NY;4. University Hospital Heidelberg, Heidelberg, Germany;5. University Medical Center Hamburg-Eppendorf, Hamburg, Germany;6. Janssen Research & Development, Titusville, NJ;7. Janssen Pharmaceutica NV, Beerse, Belgium;8. Janssen Research & Development, Spring House, PA;9. Janssen Research & Development, Raritan, NJ;10. Janssen Global Services, Raritan, NJ;11. Janssen Research & Development, Bridgewater, NJ;12. University Hospital Hôtel-Dieu, Nantes, France;1. Department of Hematology/ OncologyMember, Plasma Cell Disorders Program Levine Cancer Institute, Atrium Health/Wake Forest Baptist, Charlotte, NC;2. Hematologic Malignancies and Cellular Therapeutics University of Kansas Medical Center, Kansas City, KS;1. Department of Clinical Haematology and Stem Cell Transplantation, Dayanand Medical College and Hospital, Ludhiana, India;2. Department of Medical Oncology, Dayanand Medical College and Hospital, Ludhiana, India;3. Neuberg Supratech Reference Laboratories, Ahmedabad, India;4. Department of Hematopathology, All India Institute of Medical Sciences, New Delhi, India;5. Department of Molecular Genetics, Dayanand Medical College and Hospital, Ludhiana, India;6. Department of Pathology, Dayanand Medical College and Hospital, Ludhiana, India;1. Department of Medicine, University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma, OK;2. Stephenson Cancer Center Biostatistics Research and Design Core, Oklahoma, OK;1. Department of Hematology, Ankara University Faculty of Medicine, Ankara, Turkey;2. Department of Clinical Microbiology, Istinye University Faculty of Medicine, Istanbul, Turkey;3. Department of Hematology, Immunogenetics Laboratory, Ankara University Faculty of Medicine, Ankara, Turkey;4. Department of Biostatistics, Hacettepe University Faculty of Medicine, Ankara, Turkey;1. Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, FL;2. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN;3. Department of Pathology, Mayo Clinic, Jacksonville, FL;4. Division of Hematology, Mayo Clinic, Rochester, MN;5. Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL;6. Division of Epidemiology, Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN |
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| Abstract: | BackgroundThe efficacy and safety of teclistamab in patients with RRMM who received ≥3 prior lines of therapy and were triple-class exposed (TCE) are being evaluated in the single-arm, multicohort, phase I/II MajesTEC-1 trial (NCT04557098). We evaluated the comparative effectiveness of teclistamab versus physician's choice (PC) of therapy in TCE RRMM patients.MethodsIndividual patient-level data from MajesTEC-1 patients who received teclistamab (1.5 mg/kg weekly; clinical cutoff March 16, 2022) were included. An external control arm was created from patients in long-term follow-up of 4 clinical trials of daratumumab who were treated with PC therapy after discontinuation of trial treatments. In the primary analysis, inverse probability of treatment weighting was used to adjust for imbalances in 9 baseline covariates. A fully adjusted model included 5 additional prognostic factors. Outcomes included overall response rate (ORR), very good partial response or better (≥VGPR) rate, overall survival (OS), progression-free survival (PFS), and time to next treatment (TTNT).ResultsAfter adjustment, baseline characteristics were balanced between cohorts. In the primary analysis, outcomes were significantly improved with teclistamab versus PC: ORR (OR [95% CI] 4.81 [3.04-7.72]; P < .0001); ≥VGPR rate (OR, 12.07 [6.91-22.11]; P < .0001); OS (HR, 0.54 [0.40-0.73]; P < .0001); PFS (HR, 0.59 [0.46-0.78]; P = .0001); and TTNT (HR, 0.32 [0.24-0.42]; P < .0001). Results of the fully adjusted model were consistent with the primary analysis.ConclusionTeclistamab showed significantly improved effectiveness versus PC on all outcomes, highlighting its clinical benefit in patients with TCE RRMM and limited treatment options. |
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