Belantamab Mafodotin Receives FDA Approval for Relapsed Multiple Myeloma
GlaxoSmithKline's belantamab mafodotin (commercial name "BLENREP") has received FDA approval for the treatment of patients with relapsed or refractory multiple myeloma patients. The new treatment can be used for patients who have relapsed after using an immunomodulator (IMiD), a proteasome inhibitor an anti-CD38 antibody.
New Target, New Drug Class in Myeloma
The drug was approved to be used alone (or in other combinations) for these patients. BLENREP is the very first anti-BCMA targeted therapy in myeloma and in the world and is in a new class of drug in myeloma called an "antibody drug conjugate".
The drug uses the immune system to target BCMA, which is on the surface of most myeloma cells, to deliver a toxic payload to the myeloma cells. The approval of BLENREP was based on results from the DREAMM-2 study.
Principal investigator of the DREAMM-2 study, Dr. Sagar Lonial, MD of the Winship Cancer Institute of Emory University said:
“While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care. Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of BLENREP, the first anti-BCMA therapy, is significant for both patients and physicians alike.”
Side Effect Mitigation Strategy
Study results showed that eye issues occurred in 77% of the 218 patients. The eye issues included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Keratopathy means changes in the corneal epithelium as seen on eye examination, which can show with or without symptoms. Patients who stopped therapy in the study due to eye issues was 2.1%. Low platelet counts were also seen in 69% of patients.
Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).
Regular eye exams are an important part of drug monitoring and will be performed for patients before and after the drug is given. Dose reductions or interruptions were used by doctors in the study to mitigate side effects. Preservative-free eye drops were helpful when used. Steroid eye drops were not helpful.
Because of the eye concerns, the drug will provide additional education to prescribing doctors and patients through a Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires additional monitoring with eye exams for myeloma patients. (Additional information about the BLENREP REMS can be found at www.blenreprems.com or 1-855-209-9188.)
GSK Patient Assistance Program
GSK has a patient assistance program that can be found at www.TogetherwithGSKOncology.com or call: 1-844-4GSK-ONC (1-844-447-5662).
Having a completely new approach for patients who have relapsed after the currently available therapies is great news for myeloma patients!