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Genmab and AbbVie say adding their lymphoma drug to standard chemotherapy halved the risk of progression or death in a late-stage trial
Topline results from a Phase 3 trial put epcoritamab in line for a role in first-line treatment of the most common lymphoma. Full data are not out yet, and the combination is not approved.
Sources
Based on AbbVie and Genmab's October 5, 2026 announcement; Genmab's first-half 2026 report; the ClinicalTrials.gov trial record; wire reporting; Roche's and the FDA's April 2023 Polivy announcements; and cnbc.com market data.
The trial results were announced on Monday, October 5, 2026. They are topline figures from an interim analysis; full data have not been published. Share prices are Monday closing prices and will change.
Genmab's U.S.-listed shares closed up 10.7% on Monday after the Danish drugmaker and its partner AbbVie said adding their antibody epcoritamab to standard chemotherapy cut the risk of cancer progression or death by about half in people newly diagnosed with diffuse large B-cell lymphoma, the most common form of non-Hodgkin lymphoma.
The companies said their Phase 3 trial, called EPCORE DLBCL-2, met its main goal at the first planned interim look at efficacy, and that the independent committee monitoring the data recommended unblinding the study because the benefit was large. In the trial's primary group, patients with an International Prognostic Index score of 3 to 5, a measure of higher-risk disease, the combination reduced the risk of progression or death by 51% compared with chemotherapy alone (hazard ratio 0.49). The hazard ratio was also 0.49 across all enrolled patients, with scores of 2 to 5, and the result was statistically significant in both groups.
These are topline results. The companies did not disclose response rates, survival figures or how often patients had serious side effects such as cytokine release syndrome, a known risk with this class of drug. They said only that the combination was generally well tolerated and in line with the known safety of each treatment, and that full data will be submitted to a future medical meeting. The combination is not approved for newly diagnosed patients, and the companies said they will talk to regulators about next steps.
Genmab's American depositary shares ended at $38.48, up $3.73, after touching $40.17. AbbVie, a far larger company for which the drug is one product among many, rose 1.1% to $265.76. The results came out shortly before 3 p.m. ET, hours after trading had closed in Copenhagen, where Genmab's main listing will react on Tuesday.
A first-line market that rarely changes
Diffuse large B-cell lymphoma accounts for roughly a quarter to 30% of non-Hodgkin lymphoma cases worldwide, and about 25,000 people are diagnosed with it in the U.S. each year, according to the companies. For most of them, initial treatment for about 25 years has been R-CHOP, which pairs the antibody rituximab with four chemotherapy drugs. Gilles Salles, who leads the lymphoma service at Memorial Sloan Kettering Cancer Center and worked on both the trial that established R-CHOP nearly 25 years ago and the new study, called the 51% reduction "clinically meaningful and highly relevant to everyday practice." The companies' release noted that he has financial interests related to both of them.
The last change to that first-line standard came in April 2023, when the Food and Drug Administration approved Roche's Polivy with a modified version of the regimen for previously untreated patients with a score of 2 or higher. Roche called it the first new first-line treatment for the disease in nearly 20 years. In its 879-patient trial, Polivy cut the risk of progression, relapse or death by 27% (hazard ratio 0.73).
The two numbers are not a clean comparison. Roche's trial was double-blind and placebo-controlled, while the epcoritamab study is open-label, assigned two patients to the combination for every one on chemotherapy alone, and is reporting its first interim analysis. In the new study, patients received six cycles of epcoritamab, given as an injection under the skin, plus R-CHOP, followed by two more cycles of epcoritamab alone, a fixed course rather than open-ended treatment. The study began in February 2023 and is still running; its federal registry entry lists an estimated 900 participants.
Why it matters for Genmab
Epcoritamab, sold as Epkinly in the U.S. and Japan and as Tepkinly in Europe, is approved in more than 65 countries for certain lymphomas, but not for people who have just been diagnosed. Its U.S. approval in that setting rests on response data, and studies to confirm its clinical benefit are ongoing.
Global sales were $312 million in the first half of 2026, up 48% from a year earlier, Genmab said in August. That is still modest beside the $1.7 billion in royalties the company collected over the same six months, mostly on Johnson & Johnson's Darzalex and Novartis's Kesimpta. Genmab and AbbVie share commercial responsibility in the U.S. and Japan, with AbbVie handling sales elsewhere, and Genmab pays AbbVie a share of the profits.
A first-line approval would put the drug in front of newly diagnosed patients rather than only those who have already relapsed or stopped responding to other treatment. Monday's result also follows a positive Phase 3 result Genmab reported earlier this year for epcoritamab with lenalidomide in relapsed or refractory disease. Genmab in August raised its 2026 revenue forecast to $4.325 billion to $4.525 billion, citing higher royalties and Epkinly sales.
A lymphoma drug added to standard treatment cut the risk of the cancer getting worse
Genmab and AbbVie tested their drug epcoritamab together with the usual chemotherapy in people who had just been diagnosed with a common, aggressive blood cancer. The companies say patients who got the extra drug were about half as likely to see their cancer worsen or die during the study. The full results have not been released yet, and regulators have not approved the combination.
Genmab, AbbVie: epcoritamab plus R-CHOP hits PFS goal in frontline DLBCL Phase 3 (HR 0.49)
EPCORE DLBCL-2 (NCT05578976), open-label, 2:1 randomized Phase 3: fixed-duration subcutaneous epcoritamab plus R-CHOP (six cycles, then two cycles of epcoritamab) vs R-CHOP (then two cycles of rituximab) in newly diagnosed DLBCL. First planned interim efficacy analysis; data monitoring committee recommended unblinding. Primary endpoint PFS in IPI 3-5: HR 0.49 (95% CI 0.35-0.69), p<0.0001. Key secondary PFS in IPI 2-5: HR 0.49 (95% CI 0.36-0.67), p<0.0001. Safety described only as generally well tolerated; no response, survival or CRS rates disclosed. Context: Polivy plus R-CHP POLARIX HR 0.73 (879 patients, double-blind), FDA approval April 2023. Epkinly/Tepkinly sales $312 million in first half of 2026 (+48%). GMAB ADS closed $38.48 (+10.7%); ABBV $265.76 (+1.1%).
What the companies have not said
The companies have not released response rates, overall survival, detailed side-effect rates or results by patient subgroup, and an interim benefit can narrow as data mature. They have not said when or where they will file for approval, and no regulator has reviewed the data.
Document trail
Sources & evidence
Sources used for this piece.
AbbVie
Company press release · 2026-10-05
Genmab A/S via GlobeNewswire
Genmab Announces Financial Results for the First Half of 2026
Company financial report · 2026-08-06
cnbc.com market data
Market data · 2026-10-05
cnbc.com market data
Market data · 2026-10-05
ClinicalTrials.gov
Clinical trial registry record · 2026-10-05
wdsm710.com (wire report)
AbbVie blood cancer drug combo cuts risk of progression or death in late-stage study
News report · 2026-10-05
Roche
Company press release · 2023-04-19
U.S. Food and Drug Administration
FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma
Official government notice · 2023-04-19
Visual brief
Verified figures
Sources & evidencehazard ratio
Progression-free survival hazard ratio 0.49 (95% CI 0.35-0.69), a 51% risk reduction vs R-CHOP
EPCORE DLBCL-2 primary endpoint (IPI 3-5)
2026-10-05
hazard ratio
Progression-free survival hazard ratio 0.49 (95% CI 0.36-0.67)
EPCORE DLBCL-2 key secondary endpoint (IPI 2-5)
2026-10-05
Epkinly/Tepkinly global net sales
$312M in the first half of 2026, up 48% from $211M
USD
2026-06-30
Genmab A/S via GlobeNewswireGenmab Announces Financial Results for the First Half of 2026Company financial report · 08-06-2026
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