Polatuzumab Vedotin (3) – Polivy®

• Clinical trials
  • The GO29365 trial is a completed, multicentre, open-label Phase IB/II trial comparing polatuzumab vedotin in combination with bendamustine and rituximab versus bendamustine in combination with obinutuzumab.
  • The YO41543 trial is a completed, double-blind, randomised controlled trial comparing polatuzumab vedotin in combination with bendamustine and rituximab versus bendamustine in combination with rituximab.

a) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following failure of one line of systemic therapy, who are not eligible for haematopoietic stem cell transplantation

• An additional benefit is not proven.
• Tafasitamab in combination with lenalidomide was identified as the appropriate comparator therapy.
• The pharmaceutical manufacturer presents meta-analytically summarised data from the GO29365 and YO41543 studies in the dossier for the benefit assessment. In the comparator arm of both studies, bendamustine in combination with rituximab was used in each case. The meta-analysis of studies GO29365 and YO41543 therefore does not allow for a comparison with the appropriate comparator therapy. Consequently, there are no data available to enable an assessment of additional benefit.

b1) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following failure of two or more lines of systemic therapy, who are eligible for CAR-T cell therapy and are not eligible for haematopoietic stem cell transplantation

• The additional benefit is not proven.
• Tisagenlecleucel, axicabtagen-ciloleucel or lisocabtagen maraleucel were identified as appropriate comparator therapies.
• In the dossier for the benefit assessment, the pharmaceutical manufacturer presents meta-analytically summarised data from the GO29365 and YO41543 studies. In the comparator arm of both studies, bendamustine was used in combination with rituximab. The meta-analysis of studies GO29365 and YO41543 as submitted therefore does not allow for a comparison with the appropriate comparator therapy. Consequently, there are no data available to enable an assessment of the additional benefit.

b2) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following failure of two or more lines of systemic therapy, who are not eligible for CAR-T cell therapy or haematopoietic stem cell transplantation

• An additional benefit is not proven.
• The appropriate comparator therapy was defined as treatment at the clinician’s discretion, taking into account tafasitamab in combination with lenalidomide, pixantron monotherapy and radiotherapy.
• In the dossier for the benefit assessment, the pharmaceutical manufacturer presents meta-analytically summarised data from the GO29365 and YO41543 studies. In the control arm of both studies, bendamustine was used in combination with rituximab. The meta-analysis of studies GO29365 and YO41543 as submitted therefore does not allow for a comparison with the appropriate comparator therapy. Consequently, there are no data available to enable an assessment of the additional benefit.

Courtesy translation only, please refer to the German original.