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Tafasitamab-cxix

(Monjuvi®)

Monjuvi®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 200 mg)
Drug ClassCD19-directed cytolytic antibodies
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Tafasitamab (TAFA) combined with lenalidomide (LEN) showed a median overall survival (OS) of 45.7 months in second-line treatment and 15.5 months in third-line treatment, significantly outperforming other therapies like Bendamustine-Rituximab (median OS 11.49 months, euro23 958 (BR)) with 11.49 months in second-line and Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) with 12.0 months in third-line settings. TAFA + LEN also had significantly better OS compared to polatuzumab vedotin plus bendamustine and rituximab (POLA + BR) (hazard ratio (HR) 0.41; p = 0.026) and BR (HR 0.39; p = 0.014).
  • Progression-free survival (pooled data: HR 0.39 (95% confidence interval (CI) 0.29, 0.53 (PFS)) was improved in the tafasitamab group, with a 1-year PFS of 0.47 (95% CI, 0.37 to 0.57), higher than CAR T-cell therapy (0.40; 95% CI, 0.35 to 0.46) in autologous stem-cell transplant (ASCT)-ineligible patients. TAFA + LEN also showed a significantly better PFS compared to BR (HR 0.39; p < 0.001).
  • TAFA + LEN demonstrated a longer duration of response (DOR) compared to POLA + BR (HR 0.34; p = 0.045) and BR (HR 0.35; p < 0.001), along with an improved complete response rate (CRR) over BR (odds ratio 2.43; p = 0.004).
  • The reviewed studies did not explicitly mention safety outcomes or adverse effects related to tafasitamab-cxix or other drugs, so there is no safety information available.
  • Evidence highlights a distinction in effectiveness outcomes between ASCT-eligible and ASCT-ineligible groups. The 1-year progression-free survival (PFS) for tafasitamab in the ASCT-ineligible group was 0.47 (95% CI, 0.37 to 0.57), outperforming other therapies, including CAR T-cell therapy (PFS: 0.40, 95% CI, 0.35 to 0.46). No significant difference in PFS was observed between CAR T-cell therapy and chemotherapy followed by ASCT in the ASCT-eligible group.