Median overall survival was 11.3 months on epcoritamab and 10.3 months on chemotherapy in DLBCL

In the randomized Phase 3 EPCORE DLBCL-1 trial, median overall survival was 11.3 months on epcoritamab and 10.3 months on investigator's choice chemotherapy in relapsed or refractory diffuse large B-cell lymphoma, the trial registry record shows. The stratified hazard ratio for death was 0.96 (95% confidence interval 0.77 to 1.20), and the sponsor, Genmab, posted the results with 483 randomized participants. The record now holds the overall survival comparison for the subcutaneous bispecific antibody against R-GemOx or BR.

Epcoritamab and chemotherapy arms in EPCORE DLBCL-1

Arm	Participants	Median overall survival	Deaths from any cause	Serious adverse events
Epcoritamab	241	11.3 months (95% confidence interval 7.8 to 15.7)	162 of 241 participants	163 of 236 participants
Investigator's choice chemotherapy	242	10.3 months (95% confidence interval 9.0 to 12.5)	169 of 242	77 of 237

From the trial registry record NCT04628494, results first posted November 3, 2026.

Why it matters

The FDA label for EPKINLY (epcoritamab-bysp) covers adults with relapsed or refractory DLBCL, not otherwise specified, after two or more lines of systemic therapy, and the label says that indication is approved under accelerated approval based on response rate and durability of response. This trial asked a different question: the record's summary says it was designed to find out if epcoritamab is safe and works well compared with chemotherapy in participants who had at least 1 prior systemic cancer therapy. The label version is dated Jun 30, 2026, before these results were posted. The record gives overall survival numbers for both arms.

Overall survival results

The record lists results first posted on November 3, 2026.

Epcoritamab: 241 participants, median overall survival 11.3 months (95% confidence interval 7.8 to 15.7).
Investigator's choice chemotherapy: 242 participants, median overall survival 10.3 months (95% confidence interval 9.0 to 12.5).
Stratified hazard ratio: 0.96 (95% confidence interval 0.77 to 1.20), with a superiority comparison by stratified log-rank test and p = 0.7285.

The record defines overall survival as the time from randomization to death due to any cause. Participants still alive at the clinical cut-off date were censored at the last date known to be alive. The time frame is up to approximately 4 years, 9 months, and the analysis population is the intention-to-treat set, which included all randomized participants.

Trial design

Genmab sponsors the study with AbbVie listed as a collaborator. The record describes it as a randomized, open-label, multicenter, global Phase 3 trial with parallel arms and no masking. It started on January 13, 2021, and primary completion was October 13, 2025. The overall status is active, not recruiting.

Participants had to have relapsed or refractory disease after at least 1 line of systemic antineoplastic therapy that included an anti-CD20 monoclonal antibody, and previous high-dose therapy with autologous stem cell transplant had to have been unsuccessful, or they had to be ineligible for it at screening. The record names these eligible histologies: DLBCL not otherwise specified, double-hit or triple-hit DLBCL, follicular lymphoma grade 3B, and T-cell/histiocyte-rich large B-cell lymphoma.

Epcoritamab is given as a subcutaneous injection in 28-day cycles: once weekly in cycles 1 to 3, every 2 weeks in cycles 4 to 9, then once every 4 weeks, until disease progression or unacceptable toxicity.
R-GemOx is given by intravenous infusion every 2 weeks in 28-day cycles for 4 cycles.
BR is given intravenously every 3 weeks in 21-day cycles for 6 cycles.

The record says overall survival is the primary outcome in the United States and in China. Outside those two, overall survival and progression-free survival are dual-primary outcomes. The results section posts overall survival as the primary outcome.

Participants

Of the 483 randomized participants, 241 were assigned to epcoritamab and 242 to chemotherapy. In the epcoritamab arm 236 received at least 1 dose, and in the chemotherapy arm 237 did. The record lists 354 participants aged 65 years or older (185 on epcoritamab and 169 on chemotherapy), and mean age was 69.9 years on epcoritamab and 68 years on chemotherapy. The baseline table lists 9 participants in the United States, 70 in France, 65 in Japan and 40 in Spain.

Safety and deaths

Deaths are counted among all randomized participants. Adverse events are counted among participants who received at least 1 non-zero dose of any trial drug, so the totals differ.

Deaths from any cause: 162 of 241 participants on epcoritamab and 169 of 242 on chemotherapy.
Serious adverse events: 163 of 236 participants on epcoritamab and 77 of 237 on chemotherapy.
Other adverse events: 229 of 236 on epcoritamab and 224 of 237 on chemotherapy.
Serious Covid-19 events: 44 participants on epcoritamab and 15 on chemotherapy.

What remains uncertain

The record states that primary completion data are reported and that final analysis data are reported after study completion, so the full follow-up is not in the registry yet (registry record). The record also lists a China sub-study under NCT07226752, which carries its own registration.