May 19 (Reuters) - GlaxoSmithKline and Danishbiotech company Genmab said disappointing results froma study on treating relapsed lymphoma with their ofatumumab drugmeant it was unlikely they would seek its regulatory approval.
A head-to-head phase III study of ofatumumab and anotherdrug to fight the fast-growing blood cancer failed to meet thecompanies' goals. Results showed no significant difference inprogression free survival (PFS) between one treatment arm andthe other, the companies said in a statement late on Monday.
"Based on today's results we are unlikely to move forwardwith a regulatory filing," Jan Van De Winkel, Genmab chiefexecutive said in the statement.
The companies tested PFS, a measure of the health of aperson taking a treatment to fight a disease, among patientsusing ofatumumab (Arzerra(TM)) plus chemotherapy versusrituximab plus chemotherapy for the lymphoma of the B-cellsknown as DLBCL.
The Orcharrd phase III study involved 447 patients who wererefractory to, or had relapsed following, first-line treatmentwith rituximab in combination with a chemotherapy regimencontaining anthracycline or anthracenedione.
Arzerra is being developed under an agreement between Genmaband GSK and is not approved or licensed anywhere in the worldfor the treatment of DLBCL.
GSK and Genmab said dose interruptions and delays due toinfusion reactions and increased serum creatinine in theofatumumab plus chemotherapy arm required further analysis. (Reporting by Aashika Jain in Bangalore; editing by Andrew Hay)