Genmab said it is halting a Phase III trial comparing the cancer drug ofatumumab, being co-developed with Novartis, to Roche’s rituximab in patients with follicular lymphoma.
Genmab yesterday cited a planned interim analysis of data by the study’s independent data monitoring committee, which concluded that ofatumumab was unlikely to show superiority to rituximab if the trial were to be completed.
The Phase III study assessed the efficacy of ofatumumab compared to that of rituximab in patients with follicular non-Hodgkin’s lymphoma (NHL) that has relapsed at least six months after completion of treatment with a regimen that contained rituximab. The primary endpoint was progression-free survival.
The pivotal trial was designed to randomize up to 516 patients to receive ofatumumab (1,000 mg) or rituximab (375 mg/m2) by intravenous infusion for four weekly doses. Patients whose disease was stable or responsive to treatment then received single infusions of ofatumumab or rituximab every two months for four additional doses for a total of eight doses over nine months.
No new safety signals for ofatumumab were identified, according to Genmab.
“The outcome of the interim analysis in this study is disappointing as we had hoped to see superiority of ofatumumab,” Genmab CEO Jan van de Winkel, Ph.D., said in a statement.
Dr. Winkel added that data from the study will be presented at a future scientific conference.
The end of the follicuilar lymphoma study has no impact on other ongoing studies of ofatumumab, Genmab said.
The Phase III failure comes some three months after Novartis acquired all remaining rights to ofatumumab—marketed under the name Arzerra®—from GlaxoSmithKline for up to $1 billion, of which $300 million was paid upfront.
Until then, GSK owned autoimmune disease rights to ofatumumab, with Novartis owning oncology rights it obtained after agreeing last year to buy GSK’s cancer business for up-to-$16 billion, in a deal completed in March.
Ofatumumab is a human monoclonal antibody designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the U.S., Arzerra is approved for use in combination with chlorambucil for previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.