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FDA approves tafasitamab in combination with lenalidomide as second-line treatment for patients with R/R DLBCL
On July 31, 2020, the U.S. Food and Drug Administration (FDA) approved tafasitamab in combination with lenalidomide as second-line treatment for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).1
Tafasitamab, is an anti-CD19 monoclonal antibody, and in combination with lenalidomide has previously obtained FDA breakthrough therapy and priority review designations for R/R DLBCL. The approval was based on the results from the open-label, multicenter, single arm, phase II L-MIND trial (NCT02399085). This trial evaluated tafasitamab in combination with lenalidomide in adult patients with R/R DLBCL, who had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), and who were not eligible for high-dose chemotherapy or refused subsequent ASCT. Results from this study, showed2:
- Overall response rate: 55% (primary endpoint)
- Complete response rate: 37%
- Partial response rate: 18%
- Median duration of response: 21.7 months (key secondary endpoint)
Possible side effects of tafasitamab included2:
- Infusion-related reactions, 6%
- Serious or severe myelosuppression:
- Neutropenia, 50%
- Thrombocytopenia, 18%
- Anemia, 7%
- Infections (73%)
The most common adverse reactions (≥ 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.2
The FDA decision represents the first approval of a second-line treatment for adult patients with R/R DLBCL. The European Medicines Agency (EMA) has recently validated a marketing authorization application for tafasitamab in combination with lenalidomide in the EU, and the submission is currently under review for the treatment of adult patients with R/R DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.2
Tafasitamab is under investigation as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.
References
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