Blenrep

Blenrep (belantamab mafodotin) instructions

Common name: belantamab mafodotin
Trade name: Blenrep
All names: Blenrep, belantamab mafodotin, GSK2857916

Indications:
BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including anti-CD38 monoclonal antibodies, proteasome inhibitors, and immunomodulators.

Usage and Dosage:
The recommended dose of BLENREP is 2.5mg/kg, once every 3 weeks, as an intravenous infusion for approximately 30 minutes, until disease progression or unacceptable toxicity occurs.
Dose adjustment for adverse reactions:
The recommended dose for adverse reactions is 1.9 mg/kg intravenously, once every 3 weeks.
Discontinue BLENREP in patients who cannot tolerate the 1.9 mg/kg dose.

Adverse Reactions:
The most common adverse reactions (≥20%) are keratopathy (changes in corneal epithelial cells during eye examination), decreased vision, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.
The most common grade 3 or 4 laboratory abnormalities (≥5%) were thrombocytopenia, lymphopenia, decreased hemoglobin, neutropenia, elevated creatinine, and elevated gamma-glutamyl transferase.

Taboos:
None.

Notes:
Ocular toxicity: Corneal disease, vision changes, etc. may occur. Patients are advised to use preservative-free eye drops at least 4 times daily. Begin with the first infusion and continue until the end of treatment. Do not use contact lenses unless directed by your eye doctor. Changes in vision may affect driving and reading, and patients are advised to use caution when driving or operating machinery. BLENREP is only available through restricted plans under REMS.
BLENREP REMS: Due to the risk of ocular toxicity, BLENREP is only available through a restricted program under the REMS called BLENREP REMS.
Decreased blood cell count. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider discontinuation and/or dose reduction based on severity
Infusion-Related Reactions: Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive care. After symptoms resolve, resume at a lower infusion rate. Then use the corresponding medicine before the injection to reduce the occurrence of adverse reactions. If infusion-related reaction is life-threatening, discontinue use immediately and provide appropriate emergency care.
Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to pregnant women because it contains a genotoxic compound (microtubule inhibitor, monomethyl golden F [MMAF]) and because it targets actively dividing cells. Pregnant women are advised to be aware of potential risks to the fetus. Advise females of childbearing potential to use an effective method of contraception during treatment with BLENREP and for 4 months after the last dose. Advise men with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose.

Storage:
Refrigerate at 2°C to 8°C

Mechanism of action:
Belantamab mafodotin-blmf is an antibody-drug conjugate (ADC). The antibody component is glycosylated IgG1 directed against BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. The small molecule component is the microtubule inhibitor MMAF. When bound to BCMA, belantamab mafodotin-blmf is internalized and then releases MMAF via proteolysis. The released MMAF disrupts the microtubule network within the cell, leading to cell cycle arrest and apoptosis. Belantamab mafodotin-blmf has anti-tumor activity against multiple myeloma cells and can mediate the killing of tumor cells through MMAF-induced apoptosis, antibody-dependent cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Safety and efficacy:
Blenrep is the first BCMA-targeted therapy approved in the world, based on data from the DREAMM clinical trial project, including the pivotal DREAMM-2 study. The overall response rate (ORR) of Blenrep 2.5mg/kg Q3W monotherapy was 31% (97.5%CI: 21-43), and the median duration of response (DoR) has not been reached, but among patients with remission (responders), 73% of patients had DoR ≥ 6 months.
At the end of May this year, GSK announced the 13-month follow-up data of the study at the 2020 American Society of Clinical Oncology Annual Meeting (ASCO). The results showed that: Blenrep (2.5mg/kg, Q3W) monotherapy has an The RR was 31% (consistent with the 6-month data), the median duration of response (DoR) was 11 months (95% CI: 4.2-not reached), and the median overall survival (OS) was 14.9 months (95% CI: 9.9-not reached). Among patients who responded, the majority (58%) achieved very good partial response or better (≥VGPR), including 2 stringent complete responses (sCR) and 5 complete responses (CR). The proportion of patients who achieved clinical benefit was 36% (95% CI: 26.6-46.5).