Belantamab mafodotin

Unassigned

New Medicines

Relapsed or refractory multiple myeloma (MM) - monotherapy of adults whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody

Information

New molecular entity
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)
Yes
Yes
Feb 20 · Filed in the EU with accelerated assessment status [8].
Dec 19 · Biologics License Application (BLA) submitted to US FDA for the 2.5 mg/kg dosage.[6]
May 19 · Has orphan drug status in EU & US [4].
Nov 17 · FDA grants Breakthrough Therapy designation to GSK-2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent [4].
Oct 17 · EMA grants PRIME designation to GSK 2857916 for treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody [4].

Category

Humanised IgG1 monoclonal antibody-drug conjugate (ADC) consisting of an antibody that targets the B-cell maturation antigen (BCMA), linked to monomethyl auristatin F (mcMMAF), an anti-tubulin agent.
The incidence in Europe of MM is 4.5-6.0 per 100,000 per year with a mortality rate of 4.1 per 100,000 per year [1].
Relapsed or refractory multiple myeloma (MM) - monotherapy of adults whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody
Intravenous infusion

Trial or other data

Dec 19 · Positive data from PIII DREAMM-2 trial (n=97) published in The Lancet Oncology. Pts who had actively progressing and refractory MM were randomised to receive belantamab mafodotin 2.5 mg/kg or 3.4 mg/kg every 3 weeks. Belantamab mafodotin showed a clinically meaningful overall response rate (ORR) of 31% with 2.5 mg/kg and of that subgroup, 18 acheived very good partial response or better, with 3 pts acheiving complete responses. Overall survival data are not yet available.[6,7]
Sep 19 · PI/II DREAMM-6 trial to evaluate safety, tolerability, and clinical activity of GSK-2857916 administered in combination with lenalidomide plus dexamethasone (arm A), or bortezomib plus dexamethasone (arm B) in participants with relapsed or refractory MM starts (NCT03544281). The open-label trial is enrolling approximately 90 patients in the US. Collection of primary outcome data (complete response and safety data) is due to complete Jun 20 [2,3].
Aug 19 · GSK announces results from pivotal DREAMM-2 PII open-label, randomised study of two doses of belantamab mafodotin for multiple myeloma. The 196 trial pts had relapsed multiple myeloma, were refractory to an immunomodulator, proteasome inhibitor, and an anti-CD38 antibody. The two-arm study met its primary objective and demonstrated clinically meaningful overall response rate. Safety and tolerability were consistent with DREAMM-1 [5].
Jun 18 · PII DREAMM-2 trial to evaluate safety and efficacy of GSK-2857916 in patients with MM who had three or more prior lines of treatment, are refractory to a proteasome inhibitor and an immunomodulatory agent and have failed an anti-CD38 antibody treatment starts (NCT03525678). 155 patients will be recruited in the US, Australia, Canada, France, Germany, Italy, Spain & UK. Primary outcome is overall response rate; collection of these data is due to complete Jun 19 [3].

Evidence based evaluations