SAFETY AND TOLERABILITY OF SINGLE-AGENT BELANTAMAB MAFODOTIN IN HEAVILY PRE-TREATED PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: POOLED DATA FROM DREAMM-1 AND DREAMM-2
Author(s): ,
Suzanne Trudel
Affiliations:
Princess Margaret Cancer Centre,Toronto, ON,Canada
,
Adam D. Cohen
Affiliations:
Abramson Cancer Center, University of Pennsylvania,Philadelphia, PA,United States
,
Paul G. Richardson
Affiliations:
Dana-Farber Cancer Institute,Boston, MA,United States
,
Sagar Lonial
Affiliations:
Emory University, Winship Cancer Institute,Atlanta, GA,United States
,
Joanna Opalinska
Affiliations:
GlaxoSmithKline,Upper Providence, PA,United States
,
Ira Gupta
Affiliations:
GlaxoSmithKline,Upper Providence, PA,United States
,
Julie Byrne
Affiliations:
GlaxoSmithKline,Upper Providence, PA,United States
,
Eric Zhi
Affiliations:
GlaxoSmithKline,Upper Providence, PA,United States
,
January Baron
Affiliations:
GlaxoSmithKline,Upper Providence, PA,United States
,
Lisa Morgan
Affiliations:
GlaxoSmithKline,Upper Providence, PA,United States
,
Peter M. Voorhees
Affiliations:
Levine Cancer Institute, Atrium Health,Charlotte, NC,United States
Rakesh Popat
Affiliations:
University College London Hospitals, NHS Foundation Trust,London,United Kingdom
EHA Library. Trudel S. 06/12/20; 294865; EP948
Dr. Suzanne Trudel
Dr. Suzanne Trudel
Contributions
Abstract

Abstract: EP948

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
The investigational agent belantamab mafodotin (belamaf; GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent anti-myeloma activity in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM) in both the phase 1 DREAMM-1 (NCT02064387) and phase 2 DREAMM-2 (NCT03525678) studies.

Aims
To present pooled safety and tolerability data from DREAMM-1 and DREAMM-2.

Methods
DREAMM-1 was an open-label first-in-human study of single-agent belamaf in adults with RRMM after ≥3 prior therapies and refractory to an immunomodulatory agent and a proteasome inhibitor (PI). DREAMM-2 is an ongoing single-agent belamaf (2.5 or 3.4 mg/kg Q3W) study in patients with RRMM after ≥3 prior therapies and refractory to an immunomodulatory agent, a PI, and refractory and/or intolerant to an anti-CD38 mAb. Prophylactic corticosteroid eye drops and preservative-free lubricant eye drops were used in both studies to manage corneal events. All patients provided written informed consent.

Results
This analysis included 103 patients who received 2.5 mg/kg Q3W and 161 who received 3.4 mg/kg Q3W of belamaf. Baseline demographics and characteristics were similar across both cohorts (Table). Serious adverse events (SAEs) occurred in 41% of patients in the 2.5 mg/kg group and 50% of patients in the 3.4 mg/kg group, with 13% and 19% patients, respectively, experiencing treatment-related SAEs (Table). The most common Grade 3/4 adverse events (AEs; >10%) were keratopathy (changes to the corneal epithelium; 27%; 16%), anemia (18%; 23%) thrombocytopenia (17%; 27%), and pneumonia (6%; 12%) in the 2.5 mg/kg and 3.4 mg/kg groups, respectively (Table). Fatal SAEs considered potentially related to study treatment occurred in ≤1% of patients in each group. AEs were managed with dose delays (51%; 67%) or reductions (32%; 52%) in the 2.5 mg/kg and 3.4 mg/kg groups, respectively; discontinuations due to AEs were uncommon (10%; 11%).

Conclusion
Single-agent belamaf has a manageable safety profile, with both 2.5 mg/kg and 3.4 mg/kg Q3W doses used to treat patients with heavily pretreated RRMM.

 

Funding: GlaxoSmithKline (BMA117159; 205678). Drug linker technology licensed from Seattle Genetics; mAb produced using POTELLIGENT Technology licensed from BioWa.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Immunoconjugate, Multiple myeloma, Safety

Abstract: EP948

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
The investigational agent belantamab mafodotin (belamaf; GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent anti-myeloma activity in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM) in both the phase 1 DREAMM-1 (NCT02064387) and phase 2 DREAMM-2 (NCT03525678) studies.

Aims
To present pooled safety and tolerability data from DREAMM-1 and DREAMM-2.

Methods
DREAMM-1 was an open-label first-in-human study of single-agent belamaf in adults with RRMM after ≥3 prior therapies and refractory to an immunomodulatory agent and a proteasome inhibitor (PI). DREAMM-2 is an ongoing single-agent belamaf (2.5 or 3.4 mg/kg Q3W) study in patients with RRMM after ≥3 prior therapies and refractory to an immunomodulatory agent, a PI, and refractory and/or intolerant to an anti-CD38 mAb. Prophylactic corticosteroid eye drops and preservative-free lubricant eye drops were used in both studies to manage corneal events. All patients provided written informed consent.

Results
This analysis included 103 patients who received 2.5 mg/kg Q3W and 161 who received 3.4 mg/kg Q3W of belamaf. Baseline demographics and characteristics were similar across both cohorts (Table). Serious adverse events (SAEs) occurred in 41% of patients in the 2.5 mg/kg group and 50% of patients in the 3.4 mg/kg group, with 13% and 19% patients, respectively, experiencing treatment-related SAEs (Table). The most common Grade 3/4 adverse events (AEs; >10%) were keratopathy (changes to the corneal epithelium; 27%; 16%), anemia (18%; 23%) thrombocytopenia (17%; 27%), and pneumonia (6%; 12%) in the 2.5 mg/kg and 3.4 mg/kg groups, respectively (Table). Fatal SAEs considered potentially related to study treatment occurred in ≤1% of patients in each group. AEs were managed with dose delays (51%; 67%) or reductions (32%; 52%) in the 2.5 mg/kg and 3.4 mg/kg groups, respectively; discontinuations due to AEs were uncommon (10%; 11%).

Conclusion
Single-agent belamaf has a manageable safety profile, with both 2.5 mg/kg and 3.4 mg/kg Q3W doses used to treat patients with heavily pretreated RRMM.

 

Funding: GlaxoSmithKline (BMA117159; 205678). Drug linker technology licensed from Seattle Genetics; mAb produced using POTELLIGENT Technology licensed from BioWa.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Immunoconjugate, Multiple myeloma, Safety

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