GSK and Genmab announce positive interim results for ofatumumab Phase III

UK Pharma major GlaxoSmithKline (LSE: GSK) and Danish biotechnology company Genmab (OMX: GEN) have said that an interim analysis of a Phase III study of ofatumumab met predefined levels to prove its efficacy.

The analysis demonstrated that treating chronic lymphocytic leukemia (CLL) patients with ofatumumab improved progression-free survival. The study was intended to evaluate the effect of ofatumumab as maintenance therapy versus no further treatment in patients with relapsed CLL.

The analysis did not identify any new safety signals and will continue to monitor patients until the study is complete. Rafael Amado, head of oncology research and development at GSK, said: “This interim result from the PROLONG study demonstrated that maintenance therapy with ofatumumab lowered the risk of disease progression in patients who responded to treatment at relapse. We look forward to sharing the results of the interim analysis with regulatory agencies to evaluate the potential for future regulatory filings.”