Final Results of a Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple
Barry Paul1, Jiri Minarik2, Francesca Cottini3
1Atrium Health Levine Cancer Institute Wake Forest University School of Medicine Charlotte North Carolina USA.
Introduction:
Patients with pretreated relapsed/refractory multiple myeloma (RRMM) have a poor prognosis and limited treatment options, underscoring the need for safe treatments with durable efficacy.
Methods:
This Phase 2 study evaluated magrolimab (Magro) plus daratumumab (Dara) or pomalidomide/dexamethasone (Pd) or carfilzomib/dexamethasone (Kd) in RRMM. The primary efficacy endpoint was objective response rate (ORR).
Results:
ORR was 14.3% (Magro+Dara; n = 14), 20.0% (Magro+Pd; n = 10) and 36.4% (Magro+Kd; n = 11). There were two dose-limiting toxicities: febrile neutropenia (Magro+Dara) and infusion-related reaction (Magro+Pd). Grade ≥ 3 Magro-related adverse event (AE) rates were 64.3% (Magro+Dara), 60.0% (Magro+Pd) and 63.6% (Magro+Kd). Two deaths were AE-related; neither was Magro related.
Conclusion:
As the study closed early, insights into the clinical profile of Magro combinations in RRMM are limited.
Trial Registration:
This trial was registered at www.clinicaltrials.gov as #NCT04892446.
Insights
This study investigated magrolimab combinations for relapsed/refractory multiple myeloma (RRMM). While Magrolimab plus carfilzomib/dexamethasone showed promise, overall insights are limited due to early study closure.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Pretreated relapsed/refractory multiple myeloma (RRMM) presents a significant clinical challenge with limited therapeutic options.
- There is a critical need for novel, safe, and effective treatments that offer durable responses in RRMM patients.
Purpose of the Study:
- To evaluate the efficacy and safety of magrolimab in combination with daratumumab, pomalidomide/dexamethasone, or carfilzomib/dexamethasone in patients with RRMM.
- To determine the objective response rate (ORR) as the primary efficacy endpoint for these magrolimab-based regimens.
Main Methods:
- A Phase 2 study was conducted involving RRMM patients treated with magrolimab combined with either daratumumab, pomalidomide/dexamethasone, or carfilzomib/dexamethasone.
- The primary efficacy endpoint assessed was the objective response rate (ORR). Safety was evaluated through adverse event (AE) monitoring.
Main Results:
- Objective response rates (ORR) were observed as 14.3% for magrolimab plus daratumumab, 20.0% for magrolimab plus pomalidomide/dexamethasone, and 36.4% for magrolimab plus carfilzomib/dexamethasone.
- Dose-limiting toxicities included febrile neutropenia and infusion-related reactions. Grade ≥ 3 magrolimab-related adverse events occurred in 60-64% of patients across combinations. Two deaths were AE-related, but not attributed to magrolimab.
Conclusions:
- The combination of magrolimab with carfilzomib/dexamethasone demonstrated a higher ORR compared to other regimens in this Phase 2 study.
- Due to early study termination, comprehensive clinical insights into magrolimab combinations for RRMM remain limited. Further investigation is warranted.
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