Investing.com -- Genmab A/S (NASDAQ: GMAB) shares rose 11% Monday afternoon following the announcement of positive topline results from a Phase 3 trial of epcoritamab in combination with R-CHOP for newly diagnosed diffuse large B-cell lymphoma patients.

The EPCORE DLBCL-2 trial, conducted with AbbVie (NYSE: ABBV), demonstrated a statistically significant improvement in progression-free survival for patients with an International Prognostic Index score of 2 to 5. The trial showed a 51% reduction in the risk of disease progression or death, with a hazard ratio of 0.49.

This marks the first Phase 3 study of a bispecific antibody combination therapy to show such improvement in frontline diagnosed diffuse large B-cell lymphoma patients. The trial evaluated fixed treatment duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, combined with standard of care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, compared to R-CHOP alone.

Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma worldwide, accounting for approximately 25-30% of all cases. In the U.S., there are approximately 25,000 new cases diagnosed each year.

Epcoritamab has received regulatory approval under the brand names EPKINLY in the U.S. and Japan, and TEPKINLY in the EU for certain lymphoma indications in more than 65 countries. The drug is being co-developed by Genmab and AbbVie as part of their oncology collaboration.

Based on the topline results, Genmab and AbbVie will engage global regulatory authorities to determine next steps. Data will be submitted for presentation at a future medical meeting. Epcoritamab plus R-CHOP is an investigational combination not yet approved by regulatory authorities.

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