Tafasitamab plus lenalidomide granted priority review by US FDA

The Biologics License Application (BLA) submitted for tafasitamab (MOR208), an anti-CD19 antibody, in combination with lenalidomide, will be given Priority Review by the United States Food & Drug Administration (FDA). The BLA is specifically for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).¹ The FDA previously granted tafasitamab and lenalidomide breakthrough therapy designation for R/R DLBCL in 2017. The submission was based on the results from the L-MIND trial and the RE-MIND trial^1,2

• L-MIND (NCT02399085): single arm, open-label, multicenter phase II study, evaluating tafasitamab and lenalidomide for patients with R/R DLBCL ineligible for autologous stem cell transplantation who had received ≤ 3 prior lines of therapy, including at least one anti‐CD20 therapy²
  • Dosing schedules²
    • Tafasitamab: 12 mg/kg as an intravenous infusion, weekly in Cycles 1–3 (with a loading dose on Day 4 of Cycle 1) and bi-weekly for Cycle 4–12, in 4-week cycles. Treatment continued until disease progression (PD), unacceptable toxicity, or discontinuation due to other reason
    • Lenalidomide: 25 mg daily on Days 1–21, in 4-week cycles. Treatment continued for up to 12 weeks in the absence of PD or unacceptable toxicity
  • 81 patients were recruited; 23% had early relapse (≤ 12 months from diagnosis) and 40% were refractory to rituximab²
  • Primary endpoint: independent review committee (IRC)‐assessed overall response rate (ORR; n = 76): 54%²
    • Complete response rate by IRC assessment: 32%
    • These figures were comparable with investigator (INV)-assessed ORR and CR rates (n = 81) of 58% and 33%, respectively
  • At a median follow‐up of 12 months, INV-assessed progression-free survival (PFS) and overall survival (OS) in the intention-to-treat (ITT) population were
    • PFS: 16.2 months (95% CI, 6.3–not reached [NR])²
    • OS: NR (95% CI, 18.6–NR)²
    • Thirty-seven patients remained on study treatment
  • Serious adverse events were experienced by 17% of patients, predominantly infection (10%) and neutropenic fever (5%)²

• RE-MIND (NCT04150328): observational retrospective cohort study in 490 patients with R/R DLBCL who were not eligible for transplant and who were treated with lenalidomide monotherapy in the real-world setting in the US and Europe. This study was designed to characterize the effectiveness of lenalidomide monotherapy and to compare to the results with the efficacy outcomes of the tafasitamab-lenalidomide combination in L-MIND^1,3
  • 76 patients from RE-MIND were matched 1:1 to patients from L-MIND based on baseline characteristics³
  • Given as tafasitamab + lenalidomide vs lenalidomide monotherapy³
    • ORR: 67.1% vs 34.2%; p < 0.0001
    • CR: 39.5% vs 11.8%; p < 0.0001
    • OS: NR vs 9.3 months, hazard ratio (HR): 0.47, 95% CI, 0.30–0.73; p<0.0008