Genmab/Novatis’ Arzerra fails to hit NHL targets

The Phase III COMPLEMENT A+B trial enrolled 346 patients with indolent B cell NHL who were unresponsive to Rituxan (rituximab) or a Rituxan-containing regimen to receive up to eight cycles of Treanda (bendustamine) in combination with 12 doses of Arzerra (ofatumumab), or Treanda alone.

But Genmab has revealed that top-line results failed to show any significant benefit on PFS.

"We are disappointed that the ofatumumab treatment regimen did not meet the primary endpoint in this trial," said Genmab’s chief executive Jan van de Winkel, adding that the full data set "will be submitted for publication at a future medical conference and we hope that these will provide a better understanding of this result."

Arzerra is a human mAb against CD20 is approved to treat chronic lymphocytic leukemia (CLL).

Novartis holds worldwide co-development and commercialisation rights to the drug.

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