Carolina Schinke, MD, University of Arkansas for Medical Sciences, discusses differences in clinical outcomes of black patients with multiple myeloma treated with talquetamab.
Multiple myeloma is a bone marrow-based plasma cell neoplasm characterized by a serum monoclonal protein and skeletal destruction with osteolytic lesions, pathological fractures, bone pain, hypercalcemia, and anemia.
The MonumenTAL-1 clinical trial (NCT03399799/NCT04634552) is a phase 1, first-in-human, open-label, dose escalation study evaluating talquetamab in patients with relapsed or refractory multiple myeloma. Talquetamab is a humanized GPRC5DxCD3 bispecific antibody approved for the treatment of multiple myeloma.
Black individuals have higher incidence and mortality in multiple myeloma but tend to be underrepresented in clinical trials. Preliminary analyses of talquetamab have hinted at differences in safety profile for black patients.
Patients in this study were split into two cohorts: 0.4 mg/kg weekly (QW) and 0.8 mg.kg biweekly (Q2W). In the Q2W cohort, a higher number of black patients had extramedullary disease than white patients. Results in efficacy and adverse events are as follows:
Efficacy:
- Overall Response Rate (ORR):
- Black patients: 100% (QW) and 52.9% (Q2W).
- White patients: 71.9% (QW) and 71.4% (Q2W).
- 12-month Duration of Response:
- Black patients: 50.5% (QW) and 53.3% (Q2W).
- White patients: 42.9% (QW) and 62.9% (Q2W).
- 12-month Progression-Free Survival (PFS):
- Black patients: 61.4% (QW) and 30.0% (Q2W).
- White patients: 32.7% (QW) and 49.9% (Q2W).
Adverse Events (AEs):
- Grade 3/4 Neutropenia:
- Black patients: 41.7% (QW) and 17.6% (Q2W).
- White patients: 28.9% (QW) and 19.8% (Q2W).
- Grade 3/4 Thrombocytopenia:
- Black patients: 8.3% (QW) and 11.8% (Q2W).
- White patients: 21.9% (QW) and 19.8% (Q2W).
- Infections:
- Black patients: 66.7% (QW) and 58.8% (Q2W); grade 3/4 in 16.7% and 23.5%.
- White patients: 60.2% (QW) and 72.2% (Q2W); grade 3/4 in 24.2% and 20.6%.
- Cytokine Release Syndrome (CRS):
- Black patients: 75.0% (QW) and 70.6% (Q2W).
- White patients: 78.9% (QW) and 73.0% (Q2W).
Special AE Observations:
- Taste-related AEs/Dysgeusia:
- Black patients: 83.3% (QW) and 94.1% (Q2W).
- White patients: 71.1% (QW) and 69.0% (Q2W).
- Discontinuations: 1 Black patient and 2 White patients.
- Skin-related AEs:
- Black patients: 91.7% (QW) and 82.4% (Q2W).
- White patients: 54.7% (QW) and 73.8% (Q2W).
- Duration: Longer in Black patients (50/63 days vs. 29/39 days).
- Concomitant medications: Higher use in Black patients (75.0%/58.8% vs. 33.6%/39.7%).
- Cycle Delays/Dose Modifications Due to AEs:
- Black patients: 83.3% (QW) and 41.2% (Q2W).
- White patients: 69.5% (QW) and 59.5% (Q2W).
While the clinical profile between black patients and white patients was generally consistent except for a few areas, results show the importance of evaluating demographic differences in patients in clinical trials.
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To learn more about multiple myeloma and other rare blood cancers, visit https://checkrare.com/diseases/hematologic-disorders/