Median overall survival 7.7 months on epcoritamab and 9.0 on chemotherapy in a China lymphoma trial

In a randomized Phase 3 sub-study in China, median overall survival was 7.7 months with epcoritamab and 9.0 months with investigator's choice chemotherapy in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the study record shows. The stratified hazard ratio was 0.91 (95% confidence interval 0.53 to 1.55). Genmab, the sponsor, now has posted results for the 72 participants who were randomized.

Overall survival by arm

Arm	Participants	Median overall survival	95% confidence interval	All-cause deaths
Epcoritamab	37	7.7 months	4.8 to 13.1	28 of 37 participants
Investigator's choice chemotherapy	35	9.0 months	5.0 to 18.9	27 of 35 participants

From the study record NCT07226752, results first posted November 10, 2026.

Why it matters

The record says the purpose of this Chinese sub-study is to find out if epcoritamab is safe and works well in participants whose DLBCL is not responding to treatment, has grown or has come back after at least 1 prior systemic cancer therapy. It is a sub-study of the master protocol GCT3013-05 (NCT04628494). The EPKINLY (epcoritamab-bysp) label, version published Jun 30, 2026, lists EPKINLY for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy, under accelerated approval based on response rate and durability of response. The label says continued approval for that indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Results posted November 10, 2026

The record lists results first posted on November 10, 2026. Overall survival was the primary outcome. The record defines it as the time from randomization to death from any cause; participants still alive at the clinical cut-off date were censored at the last date known to be alive. The analysis set held all randomized participants.

Epcoritamab (37 participants): median overall survival 7.7 months (95% confidence interval 4.8 to 13.1).
Investigator's choice chemotherapy (35 participants): median overall survival 9.0 months (95% confidence interval 5.0 to 18.9).
Stratified hazard ratio: 0.91 (95% confidence interval 0.53 to 1.55).

The record counts all-cause deaths in the same set: 28 of 37 participants on epcoritamab and 27 of 35 on chemotherapy. Nine participants on epcoritamab and 7 on chemotherapy were ongoing in the trial.

Trial design

The trial is open label and randomized, and the record lists it as Phase 3. Participants were assigned to epcoritamab or to a pre-specified investigator's choice (standard of care) chemotherapy, either rituximab, gemcitabine and oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). Epcoritamab is injected under the skin in 28-day cycles, once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. The chemotherapy is given intravenously.

Eligible adults had relapsed or refractory disease after at least 1 line of systemic antineoplastic therapy that included an anti-CD20 monoclonal antibody, and an ECOG performance status of 0 to 2. They had either had a previous high-dose therapy and autologous stem cell transplant or were not eligible for one. The record lists study dates from October 8, 2022, and primary completion on October 13, 2025.

Participants

All 72 participants enrolled in China, and all are listed as Asian. Mean age was 54 years (standard deviation 11.3) on epcoritamab and 56.4 years (standard deviation 11.8) on chemotherapy. Of the epcoritamab group, 19 were female and 18 male; of the chemotherapy group, 17 were female and 18 male. In all, 37 were assigned to epcoritamab and 35 to chemotherapy; 34 of the 35 on chemotherapy received at least 1 dose of trial treatment.

Safety measures

The record counts participants, not events. Serious adverse events affected 28 of 37 participants on epcoritamab and 10 of 34 on chemotherapy. Cytokine release syndrome was reported as a serious adverse event in 17 participants on epcoritamab and in none on chemotherapy. Other adverse events affected 37 of 37 participants on epcoritamab and 32 of 34 on chemotherapy.

What remains uncertain

The record states that this trial is ongoing: primary completion data are reported, and final analysis data are reported after trial completion (study record).