GlaxoSmithKline plc GSK and
Genmab A/S announced today that an Independent Data Monitoring
Committee (IDMC) interim analysis of a Phase III study, PROLONG (OMB 112517),
reached the predefined significance level for efficacy (p≤0.001). The interim
analysis demonstrated that treatment with ofatumumab (Arzerra™) met the primary
endpoint of improving progression free survival (PFS). The study evaluated
ofatumumab maintenance therapy versus no further treatment (observation) in
patients with relapsed chronic lymphocytic leukemia (CLL) who responded to
treatment at relapse.
The IDMC did not identify any new safety signals and will continue to monitor
patients for safety until all study patients complete therapy. Further analysis
of the safety and efficacy data is underway and will be shared with regulators
and the scientific community in the coming months.
“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,” said Dr. Rafael Amado, Head of Oncology R&D, GSK.
“We are very pleased that this study of ofatumumab, the first Phase III study
to evaluate maintenance therapy for relapsed CLL, met the primary endpoint at
the interim analysis. This result indicates the potential of ofatumumab in this
setting where there are currently no approved treatments. We look forward to
presenting the detailed data from this study at a future medical conference,”
said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About PROLONG
This pivotal Phase III study was designed to randomize up to 532 patients with
relapsed CLL who have responded to treatment at relapse, to either ofatumumab
maintenance treatment or no further treatment (observation). Patients in the
ofatumumab arm receive an initial dose of 300 mg of ofatumumab, followed one
week later by a second dose of 1,000 mg, then doses of 1,000 mg every 8 weeks
for up to two years, while patients in the observation treatment arm receive no
further treatment.
The primary endpoint of the study is PFS. Secondary objectives will evaluate
clinical benefit, safety, tolerability, the health-related quality of life of
subjects treated with ofatumumab versus no further treatment, and
pharmacokinetics among relapsed CLL patients receiving maintenance therapy with
ofatumumab.
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