On Friday, Genmab A/S (NASDAQ:GMAB) released topline results from the Phase 3 EPCORE DLBCL-1 trial of epcoritamab for diffuse large B-cell lymphoma (DLBCL).

The trial evaluated epcoritamab to the investigator’s choice of chemotherapy, either rituximab plus gemcitabine plus, and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), for relapsed or refractory DLBCL.

The global study enrolled 483 patients with at least one prior line of therapy who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started in January 2021 and is ongoing.

Data

The study demonstrated an overall survival (OS) of HR: 0.96, which did not reach statistical significance.

The company on Friday said that the T-cell-engaging bispecific antibody administered subcutaneously demonstrated an improvement in progression-free survival (PFS) in patients treated with epcoritamab monotherapy.

Additionally, improvements were observed in the complete response rate, duration of response, and time to next treatment among patients treated with epcoritamab monotherapy.

The adverse events observed in this study appear consistent with the known safety profile of epcoritamab.

Further analysis of the results is ongoing, including the potential impact of various factors, such as the COVID-19 pandemic and increasing availability of novel anti-lymphoma therapies.

What Next?

The full trial results will be submitted for presentation at a future medical meeting. Genmab and AbbVie Inc. (NYSE:ABBV) will engage with global regulatory authorities to discuss next steps.

The company anticipates data from two Phase 3 trials evaluating fixed-duration epcoritamab for DLBCL in 2026.

Epcoritamab is approved as Epkinly in the U.S. and Japan, and as Tepkinly in the European Union.

Analyst Take

William Blair on Friday said that the EPCORE DLBCL-1 trial failing to hit on OS is unfortunate and has raised investors’ questions/concerns about whether the current r/r DLBCL indication approved under accelerated approval is at risk.

Analyst Matt Phipps writes that the strong Phase 2 results with Epkinly plus R-CHOP give confidence in the frontline EPCORE DLBCL-2 trial reading out in 2026, which will support expansion into the largest segment of DLBCL.

With multiple pivotal readouts in 2026 across Epkinly, Rina-S, and petosemtamab, analyst Phipps adds that Genmab has significant upside and reiterates an Outperform rating.

“We believe it is unlikely Epkinly would lose accelerated approval in DLBCL, given that Columvi still has an accelerated approval despite receiving a complete response letter from the FDA for the confirmatory STARGLO trial, and ongoing Phase 3 trials have the potential to provide confirmatory evidence for Epkinly.

Columvi (glofitamab) is a prescription bispecific antibody medicine from Roche Holdings AG (OTC:RHHBY).

GMAB Price Action: Genmab shares were down 2.36% at $31.49 at the time of publication on Tuesday, according to Benzinga Pro data.

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