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Hans C. Lee, MD: FDA Approval of Belantamab Mafodotin-blmf for R/R Multiple Myeloma

Hans C. Lee, MD.

For patients with relapsed or refractory (R/R) multiple myeloma (MM), a new treatment has just been recently FDA approved: belantamab mafodotin-blmf (BLENREP®, GlaxoSmithKline). In an interview with i3 Health, Hans C. Lee, MD, of The University of Texas MD Anderson Cancer Center, speaks about the significance of this approval and what the future may look like on treating these patients.

What are the most challenging aspects of treating patients with R/R MM?

Hans C. Lee, MD: While there have been significant advances in the treatment of myeloma in the last 10-15 years with improved survival of patients, myeloma is still largely considered incurable and a patient's myeloma will eventually become more resistant to available therapies. When myeloma becomes resistant to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies, otherwise known as "triple class refractory" myeloma, it becomes very challenging to treat with drugs that are both efficacious and well tolerated.

Can you comment on the significance of the approval of belantamab mafodotin-blmf for R/R MM?

Dr. Lee: The approval of belantamab mafodotin-blmf (belamaf) is very significant in that it is the first-in-class antibody-drug conjugate approved to treat myeloma, and from a broader standpoint, it is the first BCMA-targeted drug that has gained regulatory approval in myeloma. We have known for a while that BCMA is an important target in myeloma, and it is great that we now finally have a commercially-available drug to offer our patients with R/R myeloma that goes after this new target in triple-class refractory myeloma. While there are cellular therapeutic approaches targeting BCMA in development, belamaf also has the advantage of being "off-the-shelf" and available for immediate dosing in an outpatient setting.

What are the unmet needs that still exist in this patient population?

Dr. Lee: Still two thirds of patients won't respond to belamaf therapy for the FDA-approved indication based on the DREAMM-2 study data, and we need to continue to identify new targets and new therapeutic modalities to improve responses and response durability in triple-class refractory myeloma.

How do you see the treatment landscape evolving in the coming years?

Dr. Lee: Other immunotherapeutic approaches targeting BCMA and other cell surface proteins using chimeric antigen receptor (CAR) T-cells and bispecific T-cell engagers will hopefully soon gain regulatory approval in myeloma over the next 1-2 years. These will offer new and potentially even more effective options for patients with R/R myeloma. Moreover, as these new drugs get approved for R/R myeloma, the next step is to evaluate them in earlier lines of therapy and even at diagnosis to see if we can prolong remission times and even cure some patients.

Do you have any advice for community oncologists who treat this patient population?

Dr. Lee: For R/R myeloma, I would recommend enrolling patients into a clinical trial as a first option or referring patients to a myeloma center for evaluation of potential clinical trials if this is feasible for the patient. When using belamaf, it is generally a well-tolerated drug, but treating oncologists need to carefully monitor for potential ocular toxicity, which is a unique and common side effect observed in the clinical trials with belamaf. It is important for oncologists to work in close collaboration with eye care specialists (ophthalmologists or optometrists) to monitor for keratopathy and visual changes as part of the REMS program which is managed effectively by belamaf dose holds and dose reductions as needed based on ocular exam findings and symptoms.

About Dr. Lee

Hans C. Lee, MD, is an Assistant Professor in the Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas. His research focuses on multiple myeloma clinical and translational research with an emphasis on early phase clinical trials and novel therapeutic approaches to high-risk multiple myeloma.

For More Information

Blenrep® (belantamab mafodotin-blmf) prescribing information (2020). GlaxoSmithKline. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf

Clinicaltrials.gov (2020). A study to investigate the efficacy and safety of two doses of GSK2857916 in participants with multiple myeloma who have failed prior treatment with an anti-CD38 antibody. NLM Identifier: NCT03525678

Lonial S, Lee HC, Badros A, et al (2020). Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomized, open-label, phase 2 study. Lancet Oncol, 21(2):207-221. DOI:10.1016/S1470-2045(19)30788-0

Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of i3 Health. 


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