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.