Novartis is evaluating a potential regulatory filing for Arzerra in relapsed chronic lymphocytic leukaemia after the drug was shown to significantly increase progression-free survival in a Phase III trial.

Data from the COMPLEMENT 2 study show that a combination of Arzerra (ofatumumab), fludarabine and cyclophosphamide boosted progression-free survival by 54% compared to therapy with the latter two drugs alone (28.9 months versus 18.8 months, respectively).

Also, patients receiving the drug as well as existing CLL treatments had a higher overall response rate (84% vs 68%) than fludarabine and cyclophosphamide alone, and no new safety signals were observed, the Swiss drug giant noted.

The findings have raised hopes that Novartis might be able to bring patients who have stopped responding to first-line therapies a much-needed new treatment option. 

Data will be shared with regulators

The drugmaker, which picked up Genmab-parterned Arzerra via its asset swap with GlaxoSmithKline earlier this year, said it plans to share the data 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, as well as for CLL patients who have not responded to Genzyme Corp’s Campath (alemtuzumab) or the chemotherapy fludarabine. In Europe, its use in combination with chlorambucil or bendamustine is approved for patients who can’t take fludarabine. 

However, most CLL patients experience disease progression despite initial response to therapy and may require additional treatment, Novartis noted, underscoring the need for new options.