Research institute publishes draft report on anti-BCMA therapies for multiple myeloma
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The Institute for Clinical and Economic Review published a draft evidence report assessing the comparative clinical effectiveness and value of B-cell maturation antigen-directed therapies for heavily pretreated multiple myeloma.
The report provides analysis and recommendations about which therapies are most effective for particular patient subgroups according to current evidence, as well as cost analyses of which therapies provide clinical benefit in terms of gains in life expectancy and quality-adjusted life years.
The institute compared two chimeric antigen receptor T-cell therapies — idecabtagene vicleucel (Bristol Myers Squibb, bluebird bio) and ciltacabtagene autoleucel (Johnson & Johnson, Legend Biotech Corp.) — in addition to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), an antibody-drug conjugate.
The FDA granted priority review status to idecabtagene vicleucel in September; however, neither CAR T-cell therapy has been approved by the FDA for any indication. The FDA approved belantamab mafodotin-blmf in August for treatment of patients with relapsed or refractory multiple myeloma who underwent at least four previous lines of treatment.
Highlights of the draft report include the following:
- Both CAR T-cell therapies were considered superior to other currently available therapies for patients with triple-class refractory multiple myeloma, based on currently available overall response and PFS data.
- Belantamab mafodotin was considered “equivalent or slightly superior” to currently available treatments for patients with quad- and penta-refractory multiple myeloma, based on currently available overall response and OS data.
- Treatment-related toxicities were common among all three therapies.
- Cost-effectiveness modeling and analyses showed both CAR T-cell therapies provided clinical benefits for life expectancy and quality-adjusted life years compared with current treatment options for patients with triple-class refractory multiple myeloma.
- BCMA-targeted therapies such as those analyzed in the report are novel, complex and come at a high cost with “significant side effects.” The draft report cautioned that “treatments with these characteristics are underutilized by historically disadvantaged populations” and could worsen health care disparities.
The draft report marks the midway point in the organization’s assessment of the three treatments. ICER has published a list of draft voting questions that are open for public comment until 5 p.m. ET on March 11.
Relevant stakeholders can submit final comments via email to publiccomments@icer.org.
ICER said the final evidence report will be the topic of a virtual public meeting April 16, when an independent council will vote on key questions raised in the report. Registration for the virtual meeting is now open.
Reference:
Institute for Clinical and Economic Review. Anti B-cell maturation antigen CAR T-cell and antibody drug conjugate therapy for heavily pre-treated relapsed and refractory multiple myeloma. Draft evidence report. Feb. 11, 2021. Available at: https://icer.org/wp-content/uploads/2020/10/ICER_Multiple-Myeloma_Draft-Report_021121.pdf. Accessed Feb. 12, 2021.
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