May 19 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)