What is BLENREP?
BLENREP, also known as belantamab mafodotin, is a first-in-class B-cell maturation antigen (BCMA)–directed antibody and microtubule inhibitor conjugate (ADC). BLENREP is manufactured by GlaxoSmithKline.
Uses
How is BLENREP used?
BLENREP is used for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.What types of patients can benefit from BLENREP?
In a phase 2 clinical trial, BLENREP as a single agent was shown to be effective in:- Patients who received at least four prior therapies
- Patients who were refractory to their previous treatment(s)
- Patients who previously received high-dose chemotherapy and stem cell transplant
How does BLENREP work?
BLENREP binds to BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. Upon binding to BCMA, BLENREP is internalized by the myeloma cell, which leads to release of a microtubule inhibitor called monomethyl auristatin F (MMAF). The release of MMAF inside the myeloma cells disrupts its microtubule network, leading to cell death.
Dosing and Administration
How is BLENREP administered?
BLENREP is given intravenously at a dose of 2.5 mg/kg over 30 minutes once every 3 weeks until disease progression.
Side Effects
What are BLENREP side effects?
The most common side effects seen in a clinical study with BLENREP included:- Keratopathy (corneal epithelium change on eye exam)
- Decreased visual acuity
- Nausea
- Blurred vision
- Fever
- Infusion-related reactions
- Fatigue
- Low platelet counts (thrombocytopenia)
- Low lymphocyte counts (lymphopenia)
- Low hemoglobin
- Low neutrophil counts (neutropenia)
- Increased creatinine
- Increased gamma-glutamyl transferase (an enzyme found in the liver)
- Pneumonia
- Fever
- Renal impairment
- Sepsis
- High calcium levels (hypercalcemia)
- Infusion-related reactions
- Embryo-fetal toxicity
BLENREP is available only through a program called BLENREP Risk Evaluation and Mitigation Strategies (REMS) due to the risk of ocular toxicity. Patients must be enrolled and comply with monitoring in order to take BLENREP.
How are side effects of BLENREP managed?
To minimize the impact of ocular toxicity, patients receive ophthalmic examinations at baseline (within 3 weeks prior to the first dose), prior to each dose, and promptly for worsening symptoms. Follow-up examinations occur at least 1 week after the previous dose and within 2 weeks prior to the next dose. Patients are advised to use preservative-free lubricant eye drops at least four times a day starting with the first infusion and continuing until end of treatment. Patients should also avoid use of contact lenses unless directed by an ophthalmologist.
Clinical Studies
What have BLENREP clinical trials shown?
The approval of BLENREP was based on results from the DREAMM-2 trial, a multicenter trial to determine the efficacy of BLENREP in patients with RRMM. The study included 97 patients at the approved dose of 2.5 mg/kg; response to BLENREP treatment was seen in 31% of patients.How is BLENREP currently being studied in myeloma?
BLENREP is being evaluated in several clinical trials in the U.S.
- Phase 3 trials include:
- Single agent BLENREP vs Pomalyst (pomalidomide, BMS) and dexamethasone for patients with RRMM (NCT04162210)
- Pomalyst and dexamethasone with or without BLENREP for patients with RRMM (DREAMM-8 trial; NCT04484623)
- Velcade (bortezomib, Takeda Oncology), Revlimid (lenalidomide, BMS), and dexamethasone with or without BLENREP for patients with newly diagnosed myeloma who are ineligible for autologous stem cell transplant (NCT04091126)
- BLENREP, Velcade, and dexamethasone vs Darzalex (daratumumab, Janssen), Velcade, and dexamethasone for patients with RRMM (DREAMM-7 trial; NCT04246047)
- Phase 1 and 2 trials include:
- BLENREP in combination with several anti-cancer treatments for patients with RRMM (DREAMM-5 platform trial; NCT04126200)
- Single agent BLENREP to investigate safety, tolerability, pharmacokinetics, and immunogenicity in patients with RRMM (NCT04177823)
- Single-agent BLENREP for myeloma patients with normal and impaired hepatic function (NCT04398680)
- Single-agent BLENREP for myeloma patients with normal and impaired renal function (NCT04398745)
Interested in learning more about BLENREP clinical trials? Talk to an MMRF patient navigator or use our clinical trials finder: FIND CLINICAL TRIALS
Created August 2020
Please visit the sponsor’s official patient site for up-to-date information on BLENREP.
