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2020-02-16| R&DTrials & Approvals

GSK Wins EMA Approval to Market Multiple Myeloma Treatment

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

Multiple myeloma is the second most common blood cancer, as more than 48,000 people in the European Union were diagnosed with it in 2018. Multiple myeloma is treatable, but not curable. The high number of diagnoses and the limitations in current treatment options warrant greater R&D and investment opportunities for developing a potential panacea for the illness.

Belantamab mafodotin (GSK2857916) is a new multiple myeloma treatment developed by GlaxoSmithKline (GSK), a global healthcare company. It is an investigational, antibody-drug conjugate for which GSK had sought approval from regulatory bodies in the US and Europe. At the start of this month, the drug received marketing authorization and an accelerated assessment by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP). The drug had earned EMA’s PRIME designation back in 2017. PRIME is a program seeking to expedite the development of investigational medicines that demonstrate clinical promise for both urgent and inadequate existing medical needs. GSK’s new multiple myeloma therapy actualizes its mission because this medical breakthrough maximizing patient survival through transformation medicines and R&D on immunology and oncology.

Inhibition Mechanism of Belantamab Mafodotin

Belantamab mafodotin is an immune-conjugate comprising a humanized anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The linker is licensed from Seattle Genetics; monoclonal antibody is produced by licensed technology from BioWa. BCMA promotes plasma cell survival by the transduction of signals from two ligands, APRIL (a proliferation-inducing ligand) and BAFF (B-cell activating factor), under normal conditions. The signal transduction induced by BCMA is simultaneously an important pathway for the growth and survival of myeloma. As evidenced, BCMA expression is discovered at varying rates in myeloma patients and BCMA membrane expression exists in myeloma cell lines.

DREAMM Clinical Trials

The DREAMM-2 (Driving Excellence in Approaches to Multiple Myeloma) clinical trial included 196 patients who had relapsed multiple myeloma and suffered ineffective treatments, such as immunomodulatory drug, proteasome inhibitor and anti-CD-38 antibody therapy. Published in The Lancet Oncology, the study’s results presented a 31% overall response rate (ORR) with a 2.5mg/kg regimen of single-agent belantamab mafodotin in heavily pre-treated patients with multiple myeloma who have experienced refractory and ineffective treatments. The tolerability and safety profile of belantamab mafodotin is congruent with previously presented data in DREAMM-1, the first Phase I human study that evaluated the drug. At an upcoming scientific meeting, the efficacy and safety results from the DREAMM-2 study will be submitted for presentation. With all these positive impacts, Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK expressed unbridled excitement.

“I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment. We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease” he said.

Extensive Information of DREAMM Clinical Trials

GSK has also planned to conduct a slew of additional trials that would evaluate the drug with combination therapies to combat multiple myeloma. The details are as follows.

 

Trial Name GSK ID / NCT ID Status Design
DREAMM-1 117159/ NCT02064387 Active, not recruiting A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK285791) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA
DREAMM-2 205678/ NCT03525678

 Active, not recruitingA Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 AntibodyDREAMM-3207495PlannedA Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple MyelomaDREAMM-4205207/ NCT03848845RecruitingA Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple MyelomaDREAMM-5208887PlannedA Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple MyelomaDREAMM-6207497/ NCT03544281RecruitingA Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple MyelomaDREAMM-7207503PlannedA Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in participants with relapsed/refractory multiple myelomaDREAMM-8207499PlannedA Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple MyelomaDREAMM-9209664PlannedA Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for TransplantDREAMM-10207500PlannedA Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoCISS / GSK Co-Sponsored Study209418RecruitingISS / GSK Co-Sponsored Study

209418

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor

Related Article: Empliciti®(elotuzumab) combination – New IO approval for relapsed Multiple Myeloma

References

  1. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-european-medicines-agency-ema-accepted-marketing-authorisation-application-for-belantamab-mafodotin-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma/
  2. https://us.gsk.com/en-us/media/press-releases/gsk-announces-positive-headline-results-from-the-pivotal-dreamm-2-study-for-multiple-myeloma/
  3. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30788-0/fulltext

 

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