May 19 (Reuters) - GlaxoSmithKline and Danish biotech company Genmab said disappointing results from a study on treating relapsed lymphoma with their ofatumumab drug meant it was unlikely they would seek its regulatory approval.
A head-to-head phase III study of ofatumumab and another drug to fight the fast-growing blood cancer failed to meet the companies’ goals. Results showed no significant difference in progression free survival (PFS) between one treatment arm and the other, the companies said in a statement late on Monday.
“Based on today’s results we are unlikely to move forward with a regulatory filing,” Jan Van De Winkel, Genmab chief executive said in the statement.
The companies tested PFS, a measure of the health of a person taking a treatment to fight a disease, among patients using ofatumumab (Arzerra(TM)) plus chemotherapy versus rituximab plus chemotherapy for the lymphoma of the B-cells known as DLBCL.
The Orcharrd phase III study involved 447 patients who were refractory to, or had relapsed following, first-line treatment with rituximab in combination with a chemotherapy regimen containing anthracycline or anthracenedione.
Arzerra is being developed under an agreement between Genmab and GSK and is not approved or licensed anywhere in the world for the treatment of DLBCL.
GSK and Genmab said dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab plus chemotherapy arm required further analysis. (Reporting by Aashika Jain in Bangalore; editing by Andrew Hay)