Late-stage data for Novartis cancer drug Arzerra shows that it could provide a progression-free survival benefit in patients with relapsed chronic lymphocytic leukaemia.
The Swiss drugs giant said top-line results from the Phase III COMPLEMENT 2 study show that treatment with Arzerra (ofatumumab) plus fludarabine and cyclophosphamide significantly improved PFS in patients with relapsed CLL versus the latter two drugs alone.
Also, the drug’s safety profile seemed consistent with that seen in other trials, with no new safety signals observed, Novartis said.
Alessandro Riva, global head of Novartis Oncology Development and Medical Affairs, said the firm is “encouraged” by the data, which it plans to share with regulatory agencies to assess the potential for future filings.
In the US, Arzerra is currently approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. Across the Pond, the European Union issued a green light for its use in combination with chlorambucil or bendamustine to treat the same subset of patients.
But most CLL patients experience disease progression despite initial response to therapy and may require additional treatment, Novartis noted, highlighting the need for new options.