Genmab (GMAB) on Friday announced that its bispecific antibody epcoritamab, marketed as Epkinly in partnership with AbbVie (ABBV), extended patient survival without tumor progression in a late-stage trial for diffuse large B-cell lymphoma (DLBCL).
However, Genmab (GMAB) lost ~7% after the readout, while AbbVie (ABB) traded flat.
Epcoritamab is currently available in the U.S. under the FDA’s accelerated approval pathway for DLBCL patients whose cancer has come back (relapsed) or failed to respond to two or more treatments (refractory).
Citing topline data from a Phase 3 trial called EPCORE DLBCL-1, the Danish biotech said that epcoritamab as a single agent also improved patients’ complete response rates, duration of response, and time to next therapy.
However, there was no statistically significant improvement for overall survival, the gold standard used to measure the efficacy of a cancer therapy. The 483-patient global trial enrolled R/R DLBCL patients who had received at least one prior line of therapy.
The injectable indicated a tolerability profile consistent with its known safety findings, Genmab (GMAB) said, adding that it will meet with global regulators to discuss the next steps for the program.