Tafasitamab (1) – Minjuvi®

• Clinical trials
  • The L-MIND trial is an ongoing, multicentre, open-label, single-arm Phase II trial.
  • The RE-MIND2 trial enrolled patients with relapsed and refractory DLBCL who, according to the trial protocol, were treated with a personalised therapy as determined by their doctor.
  • The RE-MIND trial included patients with relapsed or refractory DLBCL who were treated exclusively with lenalidomide monotherapy.

Adults with relapsed or refractory diffuse large B-cell lymphoma for whom autologous stem cell transplantation (ASCT) is not an option

• Hint for a non-quantifiable additional benefit, as the scientific data do not permit quantification.
• The strength of the evidence provides a hint about the established additional benefit.
• mortality
  • In the L-MIND study, 41 (51.3%) deaths were observed, with a median survival time of 33.5 months.
  • As no suitable comparative data are available, no conclusions can be drawn regarding the extent of the additional benefit.
• Morbidity – Progression-free survival (PFS)
  • PFS was assessed as a secondary endpoint in the L-MIND study and defined as the time from the first administration of study medication until the occurrence of progression or death from any cause (whichever occurs first).
  • Notwithstanding this, no conclusions can be drawn regarding the extent of the additional benefit based on the results of the L-MIND study for the PFS endpoint, as no suitable comparative data are available.
  • The PFS endpoint is presented for supplementary information.
• Morbidity – Objective Response Rate (ORR)
  • The objective response rate was assessed as the primary endpoint in the L-MIND study and is defined as the proportion of patients achieving a complete response (CR) or a partial response (PR) up to disease progression, based on central radiological and clinical assessments.
  • In the present operationalisation, the objective response rate is assessed as not directly relevant to patients.
• Morbidity – B-symptoms
  • B-symptoms were not defined as a standalone endpoint in the L-MIND study; however, the symptoms covered by B-symptoms were recorded at the start of each treatment cycle.
  • Notwithstanding this, no conclusions can be drawn regarding the extent of the additional benefit based on the results of the L-MIND study for the endpoint ‘B-symptoms’, as no suitable comparative data are available.
• morbidity
  • When considering the results on morbidity as a whole, no conclusions can be drawn regarding the extent of the additional benefit, as no suitable comparative data are available.
• quality of life
  • Quality of life is not assessed in the L-MIND study.
• Side effects – Total adverse events (AEs)
  • All patients included in the study experienced at least one adverse event.
  • The results are presented in the appendix.
• Side effects – Serious adverse events (SAEs)
  • At least one serious adverse event (SAE) occurred in 43 out of 81 patients (53.1%).
  • The most common SAE was ‘infections and parasitic diseases’.
• Side effects – Severe adverse events (CTCAE grade ≥ 3)
  • At least one severe AE with a CTCAE grade of ≥ 3 occurred in 63 out of 81 study participants (77.8%).
  • The most common AEs of grade ≥ 3 were ‘blood and lymphatic system disorders’ and ‘infections and parasitic diseases’.
• Side effects – Therapy discontinuation due to adverse events
  • Twenty patients (24.7%) experienced an adverse event that led to discontinuation of at least one active component of the study medication.
• Side effects – AEs of particular interest
  • In 37% of study participants, “skin rash” occurred as a post-hoc identified adverse event of particular interest.
  • In addition, ‘urinary tract disorders’ should be noted in particular as a further post-hoc AE of special interest.
• Side effects
  • An overall assessment of the results regarding side effects does not allow any conclusions to be drawn regarding the extent of the additional benefit, as no suitable comparative data are available.
• Overall assessment / Conclusion
  • For the benefit assessment of tafasitamab in combination with lenalidomide, followed by tafasitamab, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), for whom autologous stem cell transplantation is not an option, results are available from the single-arm, pivotal Phase II L-MIND trial on overall survival, morbidity and side effects.
  • Overall, the indirect comparisons between the studies are subject to considerable uncertainty, arising in particular from the question of whether the study populations are sufficiently comparable with regard to the relevant prognostic factor ‘time between initial diagnosis of DLBCL and first relapse’.
  • Due to these uncertainties, the indirect comparisons are not suitable for drawing conclusions about the extent of the additional benefit and are not used for the benefit assessment.
  • Overall, for tafasitamab in combination with lenalidomide, followed by tafasitamab for the treatment of relapsed or refractory DLBCL in adults who are not eligible for autologous stem cell transplantation, a non-quantifiable additional benefit has been identified, as the scientific evidence does not permit quantification.

Courtesy translation only, please refer to the German original.