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Epcoritamab plus R-CHOP halves progression risk in first-line lymphoma trial

Epcoritamab plus R-CHOP halves progression risk in first-line lymphoma trial

New Capabilities

First phase 3 bispecific antibody study to beat the 20-year R-CHOP standard in newly diagnosed diffuse large B-cell lymphoma

October 20th, 2026: AbbVie's Japanese unit restates the EPCORE DLBCL-2 result

Overview

Updated Oct 24

AbbVie and Genmab reported on October 5 that adding epcoritamab to the R-CHOP chemotherapy combination cut the risk of disease progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma. It is the first phase 3 trial of a bispecific antibody, a drug that steers the body's T cells onto cancer cells, to beat the 20-year-old R-CHOP backbone.

Roche's Polivy, the only approved first-line alternative to R-CHOP, sold 808 million Swiss francs in the first half of 2026. The epcoritamab result follows a setback in the earlier EPCORE DLBCL-1 trial, where the drug given alone improved progression-free survival but did not significantly extend overall survival. Leerink analyst Asthika Goonewardene expects a regulatory filing by the end of 2026 or early 2027, and neither company has published full efficacy or safety data yet.

Why it matters

If the data hold, this is the first frontline DLBCL regimen in 20 years to beat R-CHOP — and a test of bispecifics in community care.

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Key Indicators

51%
Reduction in risk of disease progression or death
Hazard ratio 0.49 for epcoritamab + R-CHOP versus R-CHOP alone.
0.49
Hazard ratio for progression-free survival
95% confidence interval 0.36–0.67, p-value less than 0.0001.
2–5
International Prognostic Index score of enrolled patients
Trial enrolled newly diagnosed DLBCL patients with IPI 2–5.
0.73
Hazard ratio from rival POLARIX trial (pola-R-CHP vs R-CHOP)
Benchmark win behind Roche's Polivy, in the same IPI 2–5 population.
808M CHF
Polivy global sales, first half of 2026
About $972 million for Roche's incumbent first-line alternative, the benchmark epcoritamab would challenge.

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People Involved

JW
Jan van de Winkel
Chief executive officer, Genmab
Leading Genmab's epcoritamab collaboration with AbbVie

Organizations Involved

AbbVie (Allergan)
AbbVie (Allergan)
Pharmaceutical company
Co-developer and co-commercializer of epcoritamab

American biopharmaceutical company spun off from Abbott Laboratories in 2013.
Genmab
Genmab
Biopharmaceutical company
Co-developer of epcoritamab

Danish antibody biotech, developer of the DuoBody platform used to make epcoritamab.
Roche / Genentech
Roche / Genentech
Pharmaceutical and diagnostics company
Competitor; markets Polivy, the only approved first-line alternative to R-CHOP, and is developing Columvi and glofitamab

Swiss pharma whose Polivy is the existing FDA-approved first-line DLBCL alternative to R-CHOP.
Incyte
Incyte
Biopharmaceutical company
Competitor; Monjuvi (tafasitamab) in first-line DLBCL

American biopharma that reported a phase 3 win for Monjuvi plus R-CHOP in January 2026.

Timeline

August 2002 October 2026

9 events Latest: October 20th, 2026 · 3 weeks ago
Tap a bar to jump to that date

  1. AbbVie's Japanese unit restates the EPCORE DLBCL-2 result

    Latest Company announcement

    AbbVie Japan repeats the 51% risk reduction and says detailed data will go to a future medical meeting while the companies discuss next steps with regulators.

  2. Epcoritamab + R-CHOP cuts progression risk 51%

    Clinical trial

    EPCORE DLBCL-2 topline shows hazard ratio 0.49 for progression-free survival versus R-CHOP alone; companies say they will engage regulators on next steps.

  3. Incyte reports Monjuvi phase 3 win

    Clinical trial

    Tafasitamab plus R-CHOP cuts first-line progression risk about 25%; US filing planned for H1 2026.

  4. Epkinly monotherapy misses overall survival endpoint

    Clinical trial

    In the phase 3 EPCORE DLBCL-1 study, epcoritamab given alone improved progression-free survival but did not significantly extend overall survival, the trial's sole US primary endpoint.

  5. FDA approves Epkinly in relapsed DLBCL

    Regulatory approval

    Epcoritamab wins approval in relapsed/refractory DLBCL with CRS and neurologic warnings.

  6. FDA approves Polivy for first-line DLBCL

    Regulatory approval

    Roche's pola-R-CHP becomes the first approved first-line regimen beyond R-CHOP.

  7. EPCORE DLBCL-2 trial opens

    Clinical trial

    Randomizes newly diagnosed DLBCL patients with IPI 2–5 to epcoritamab + R-CHOP or R-CHOP alone.

  8. POLARIX results published

    Clinical trial

    Polatuzumab vedotin plus R-CHP beats R-CHOP in first-line DLBCL, hazard ratio 0.73.

  9. R-CHOP becomes the frontline standard

    Clinical trial

    GELA trial shows rituximab added to CHOP beats CHOP alone; R-CHOP anchors DLBCL treatment for 20 years.

Scenarios

1

FDA approves epcoritamab plus R-CHOP for first-line DLBCL

Likely Resolves by Q2 2028

Discussed by: AbbVie and Genmab management; Truist analysts

AbbVie and Genmab said they will engage global regulators on next steps. If a filing follows and the FDA grants approval, epcoritamab becomes the first bispecific antibody approved in first-line DLBCL, joining Polivy as an alternative to R-CHOP. Adoption will hinge on full safety data: cytokine release syndrome rates, neurologic events, and whether the step-up dosing schedule works in community infusion centers.

2

ASH 2026 readout shows no OS gain; safety costs slow adoption

Uncertain Resolves by End of 2026

Discussed by: apoapenews treatment analysis; Medscape

The topline offers no overall survival, complete response, or adverse-event numbers. If the full presentation at the American Society of Hematology meeting in December 2026 shows no significant OS benefit and meaningful grade 3+ CRS or neurologic events requiring step-up dosing and hospitalization, community oncology uptake will lag. Polivy would keep the frontline lead despite its smaller hazard ratio, given its proven profile.

3

Roche's glofitamab trial reads positive, splitting the frontline market

Uncertain Resolves by End of 2027

Discussed by: apoapenews frontline-trial comparison

Roche's glofitamab plus pola-R-CHP trial (NCT06047080) enrolled 1,130 patients and is due at primary completion in October 2027. If it reports a positive PFS result, the first-line choice shifts from chemoimmunotherapy versus chemoimmunotherapy-plus-one to which bispecific on which backbone: glofitamab on the Polivy backbone or epcoritamab on R-CHOP.

4

AbbVie and Genmab file for first-line approval by mid-2027

Likely Resolves by Q2 2027

Discussed by: Leerink Partners analyst Asthika Goonewardene

Goonewardene said a filing could come by the end of 2026 or early 2027, earlier than his team's prior forecast of the first half of 2027. A submission would put epcoritamab plus R-CHOP in front of the FDA as the first bispecific regimen in first-line diffuse large B-cell lymphoma, alongside Roche's already-approved Polivy.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

August 2002

GELA LNH-98-5 trial — R-CHOP becomes the standard (2002)

The French GELA group randomized 399 previously untreated elderly DLBCL patients to CHOP chemotherapy alone or CHOP plus the anti-CD20 antibody rituximab. At five years, overall survival was 58% with R-CHOP versus 45% with CHOP, a decisive win published in the New England Journal of Medicine.

Then

R-CHOP became the frontline DLBCL backbone worldwide within a few years.

Now

It has held for over 20 years; every major first-line advance since, including Polivy, has been layered onto it.

Why this matters now

Epcoritamab aims to replicate the rituximab step-change — an immune-targeting agent that materially beats R-CHOP — for the first time since 2002.

January 2022 – April 2023

POLARIX trial — Polivy wins the first frontline DLBCL approval (2022–2023)

POLARIX randomized 879 previously untreated DLBCL patients with an IPI of 2–5 to polatuzumab vedotin plus R-CHP (vincristine dropped) or R-CHOP. At 28.2 months median follow-up, two-year PFS was 76.7% versus 70.2%, a hazard ratio of 0.73. The FDA approved the regimen in April 2023 while documenting peripheral neuropathy and no overall-survival or complete-response difference.

Then

pola-R-CHP became the first FDA-approved first-line regimen beyond R-CHOP.

Now

It set the approval benchmark and the IPI 2–5 patient population that EPCORE DLBCL-2 now mirrors.

Why this matters now

EPCORE's hazard ratio of 0.49 looks larger than POLARIX's 0.73, but the trials differ: POLARIX was blinded and placebo-controlled, EPCORE is open-label with no absolute PFS, OS, or safety figures yet published.

May 2023

Epkinly (epcoritamab) first approval (2023)

The FDA approved epcoritamab in May 2023 for relapsed/refractory DLBCL after two or more prior lines, based on an open-label trial showing durable complete responses around 40%. The label warns of cytokine release syndrome and life-threatening neurologic problems, mandates step-up dosing, and states DLBCL patients may need hospitalization after the first full dose on day 15 of cycle 1.

Then

Epkinly established the bispecific as viable in later-line DLBCL.

Now

Its safety framework — CRS monitoring, step-up dosing, hospitalization — is the template any first-line use must answer to.

Why this matters now

The same safety requirements now apply in the frontline setting, where patients are fitter and typically treated in community infusion centers rather than specialized referral hospitals.

Sources

(15)
+9
AbbVie News PR Newswire Medscape ApoApe News StockTitan / SEC EDGAR Cancer Network BioSpace European Biotechnology BioScienceDesk Genmab Investor Relations Fierce Pharma BioWorld Reuters AbbVie Japan Hematology Advisor