Genmab: petosemtamab combo cuts death risk 50% in trial
Genmab plans to engage global regulatory authorities and submit the full trial results for presentation at a future medical meeting.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
6-K
Rhea-AI Filing Summary
Genmab A/S (GMAB) reported positive topline results from the first interim analysis of its Phase 3 LiGeR-HN1 trial of petosemtamab plus pembrolizumab versus pembrolizumab alone in first-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma. The trial met both primary endpoints: overall survival had a hazard ratio of 0.50 (95% CI, 0.37 to 0.67; p<0.0001), which Genmab described as a 50% reduction in risk of death, and objective response rate had an odds ratio of 3.17 (95% CI, 2.06 to 4.89; p<0.0001), regardless of HPV status.
Genmab said the combination’s safety profile was generally well tolerated and consistent with the previously reported profiles of the individual agents, with no new safety signals identified. Petosemtamab remains investigational, and its safety and efficacy have not been established. Genmab plans to engage global regulatory authorities and submit the full results for presentation at a future medical meeting.
1 point · 1 major0 major · 0 points
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointPhase 3 trial reported 50% reduction in risk of death.
Negative
- None.
Insights
Analyzing...
Key Figures
Reduction in risk of death: 50%
Overall survival hazard ratio: 0.50
Overall survival 95% confidence interval: 0.37 to 0.67
+5 more
8 metrics
Reduction in risk of death
50%
First interim analysis of LiGeR-HN1; petosemtamab plus pembrolizumab versus pembrolizumab
Overall survival hazard ratio
0.50
First interim analysis of LiGeR-HN1
Overall survival 95% confidence interval
0.37 to 0.67
First interim analysis of LiGeR-HN1
Overall survival p-value
p<0.0001
First interim analysis of LiGeR-HN1
Objective response rate odds ratio
3.17
First interim analysis of LiGeR-HN1; petosemtamab plus pembrolizumab versus pembrolizumab
Objective response rate 95% confidence interval
2.06 to 4.89
First interim analysis of LiGeR-HN1
Objective response rate p-value
p<0.0001
First interim analysis of LiGeR-HN1
Patient randomization
1:1
LiGeR-HN1 study design
Key Terms
overall survival (OS), objective response rate (ORR), independent data monitoring committee (IDMC), bispecific antibody, +1 more
5 terms
overall survival (OS) medical
"improvement in overall survival (OS)"
Overall survival (OS) is the length of time from the start of a treatment or clinical study until death from any cause, essentially measuring how long patients live after a therapy begins. Investors watch OS because it is the most direct evidence a treatment extends life; stronger OS results can drive regulatory approvals, wider use and higher revenue expectations, much like sales figures proving a product actually works.
objective response rate (ORR) medical
"objective response rate (ORR)"
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors shrink by a pre-set amount for a minimum time, counting both complete disappearance and meaningful partial shrinkage. Investors watch ORR because it gives an early, quantitative signal that a treatment is having a direct effect on disease—like the percent of people whose fever drops after taking a medicine—which can influence expectations for later trial success, regulatory approval, and market potential.
independent data monitoring committee (IDMC) medical
"assessed by an independent data monitoring committee (IDMC)"
An independent data monitoring committee (IDMC) is a panel of outside medical and statistical experts who periodically review the accumulating safety and effectiveness data from an ongoing clinical trial and advise whether the study should continue, be altered, or be stopped. Think of it as a neutral referee or safety inspector whose decisions can speed up, delay, or halt a drug or device program—moves that can materially affect a company’s development timeline, regulatory chances and investor expectations.
bispecific antibody medical
"fully human immunoglobulin G1 (IgG1) bispecific antibody"
A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.
antibody-dependent cell-mediated cytotoxicity (ADCC) medical
"antibody-dependent cell-mediated cytotoxicity (ADCC)"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were the LiGeR-HN1 results for GMAB?
LiGeR-HN1 met both primary endpoints at the first interim analysis: overall survival had a hazard ratio of 0.50 and objective response rate had an odds ratio of 3.17 versus pembrolizumab alone; both results had p<0.0001.
How was Genmab’s LiGeR-HN1 trial designed?
LiGeR-HN1 is a randomized, open-label, global, multicenter Phase 3 study. Patients are randomized 1:1 to petosemtamab plus pembrolizumab or pembrolizumab alone, with overall survival and objective response rate as co-primary endpoints.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF OCTOBER 2026
COMMISSION FILE NUMBER 001-38976
Genmab A/S
(Exact name of Registrant as specified in its charter)
(Exact name of Registrant as specified in its charter)
Carl Jacobsens Vej 30
2500 Valby
Denmark
+45 70 20 27 28
(Address of principal executive offices)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F Form 40-F
This report on Form 6-K shall be deemed to be incorporated by reference in Genmab A/S’s registration statements on Form S-8 (File No. 333-232693, 333-253519, 333-262970, 333-277273, 333-284876 and 333-293505) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
| Exhibit | Description of Exhibit | ||||
| 99.1 | Company Announcement Dated October 28, 2026 | ||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| GENMAB A/S | ||||||||
| BY: | /s/ Anthony Pagano | |||||||
| Name: Anthony Pagano | ||||||||
| Title: Executive Vice President & Chief Financial Officer | ||||||||
DATE: October 28, 2026
Exhibit 99.1
Genmab Announces Statistically Significant, Clinically Meaningful Improvement in Overall Survival and Objective Response with Petosemtamab Combination at First Interim Analysis in First-Line R/M Patients with PD-L1+ Head and Neck Cancer
Company Announcement
COPENHAGEN, Denmark; October 28, 2026
•Phase 3 LiGeR-HN1 trial of Petosemtamab in combination with pembrolizumab versus pembrolizumab alone met both primary endpoints, reducing the risk of death by 50% in patients with PD-L1 positive head and neck squamous cell carcinoma (HNSCC), regardless of HPV status
•Genmab plans to engage global regulatory authorities and will submit full results for presentation at a future medical meeting
Genmab A/S (Nasdaq: GMAB) today announced positive topline results from the global Phase 3 LiGeR-HN1 trial (NCT06525220) evaluating petosemtamab, an investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with pembrolizumab versus pembrolizumab in patients with first-line (1L) PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Based on the first interim analysis assessed by an independent data monitoring committee (IDMC), treatment with the petosemtamab combination demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 50%, and objective response rate (ORR) versus pembrolizumab [OS: HR 0.50 (95% CI, 0.37, 0.67); p<0.0001; ORR: odds ratio 3.17 (95% CI, 2.06, 4.89; p<0.0001), meeting its dual primary endpoints, regardless of HPV status.
The safety profile of petosemtamab when administered in combination with pembrolizumab was generally well tolerated and consistent with the previously reported safety profiles of the individual agents (petosemtamab and pembrolizumab). No new safety signals were identified.
“Patients with recurrent or metastatic head and neck cancer face a disease that can profoundly affect both survival and some of the most essential aspects of daily life, making progress in treatment urgently needed. As the first positive Phase 3 study in this patient population in several years, LiGeR-HN1 represents a major milestone with the potential to redefine care,” said Everett E. Vokes, MD, Chair, Department of Medicine and Physician-in-Chief, University of Chicago Medicine. “Meeting its dual primary endpoints of overall survival and objective response rate at the first interim analysis underscores the potential of petosemtamab plus pembrolizumab to transform first-line treatment for patients with PD-L1-positive disease, regardless of HPV status. These results suggest this chemotherapy-free combination could reshape the treatment of this devastating disease by establishing a new therapeutic option.”
“These topline Phase 3 results represent a defining milestone for Genmab and further strengthen our conviction in petosemtamab as a potential first-in-class treatment option for patients with this difficult-to-treat cancer,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Meaningful innovation is measured not only by scientific discovery, but by its potential to improve outcomes for patients. The LiGeR-HN1 topline findings mark an important step toward potentially bringing petosemtamab to patients with recurrent or metastatic head and neck cancer, and we look forward to engaging with regulatory authorities globally and sharing the full dataset with the medical community.”
Based on these positive topline results, Genmab plans to engage global regulatory authorities and will submit the full results from LiGeR-HN1 for presentation at a future medical meeting.
Beyond LiGeR-HN1, petosemtamab is being evaluated in multiple Phase 3 trials, including LiGeR-HN2 (NCT06496178) in patients with second- and third-line recurrent/metastatic HNSCC, and two Phase 3
| Genmab A/S Carl Jacobsens Vej 30 2500 Valby, Denmark | Tel: +45 7020 2728 www.genmab.com | Company Announcement no. 44 Page 1/3 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 | ||||||
Genmab Announces Statistically Significant, Clinically Meaningful Improvement in Overall Survival and Objective Response with Petosemtamab Combination at First Interim Analysis in First-Line R/M Patients with PD-L1+ Head and Neck Cancer
studies, LiGeR-CRC1 (NCT07702032) and LiGeR-CRC2 (NCT07775287), in patients with previously treated, recurrent, unresectable or metastatic colorectal cancer.
On Wednesday, October 28 at 5:00 p.m. CET/12:00 p.m. EDT, Genmab will host an investor update. To register, visit genmab.com/events-presentations.
About the LiGeR-HN1 Trial (NCT06525220) LiGeR-HN1 (NCT06525220) is a randomized, open-label, global, multicenter Phase 3 study evaluating the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ HNSCC. Patients are randomized 1:1 to receive either petosemtamab plus pembrolizumab or pembrolizumab alone. The study's co-primary endpoints are overall survival (OS) and objective response rate (ORR). Key secondary endpoints include progression-free survival, duration of response, time to response, safety and patient-reported outcomes.
About Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma (HNSCC) is a group of biologically similar cancers that arise from the tissue lining the surfaces of the oral cavity, pharynx and larynx and represent more than 90% of all head and neck cancers.[i] It is the seventh most common cancer globally.[ii] Risk for HNSCC is approximately two to four times higher in men than women.[iii] Treatment options vary depending on individual factors, including the location of the tumor, stage of the tumor and a person’s overall health.iii Despite current treatment options, there remains a high patient need for additional therapies, as approximately 50% of patients with locally advanced HNSCC will experience disease recurrence following initial treatment. Recurrent or metastatic HNSCC is associated with a median overall survival of approximately 10-12 months.[iv]
About Petosemtamab (GEN1158)
Petosemtamab is an investigational low-fucose, fully human immunoglobulin G1 (IgG1) bispecific antibody with an active Fc domain that binds to EGFR and LGR5 on tumor cells. LGR5 is expressed on a population of cancer stem-like cells implicated in tumor initiation, treatment resistance, and recurrence. Petosemtamab exerts anti-tumor activity through three distinct and complementary mechanisms. Binding to EGFR blocks ligand binding and inhibits EGFR signaling functions regardless of LGR5 expression. In tumor cells co-expressing LGR5 and EGFR, simultaneous binding to LGR5 and EGFR enables degradation of EGFR through the natural internalization process of LGR5. In addition, engagement with tumor cells facilitates their destruction by innate immune cells, such as natural killer (NK) cells, through antibody-dependent cell-mediated cytotoxicity (ADCC). Petosemtamab is currently being evaluated for the potential treatment of head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including metastatic colorectal cancer (mCRC). The safety and efficacy of petosemtamab have not been established. Petosemtamab has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the first-line treatment of patients with recurrent or metastatic PD-L1-positive HNSCC in combination with pembrolizumab and for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following platinum-based chemotherapy and anti-PD-1 therapy. Please visit https://clinicaltrials.gov/ for more information.
About Genmab
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, ADCs, immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.
| Genmab A/S Carl Jacobsens Vej 30 2500 Valby, Denmark | Tel: +45 7020 2728 www.genmab.com | Company Announcement no. 44 Page 2/3 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 | ||||||
Genmab Announces Statistically Significant, Clinically Meaningful Improvement in Overall Survival and Objective Response with Petosemtamab Combination at First Interim Analysis in First-Line R/M Patients with PD-L1+ Head and Neck Cancer
Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Contact: Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect®, KYSO® and RAINFOL™; Rina-S® is a trademark of ProfoundBio, US, Co. and Genmab (Suzhou) Co., Ltd.
[i] Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. “Head and neck squamous cell carcinoma.” Nat Rev Dis Primers, 2020 Nov 26;6(1):92. doi: 10.1038/s41572-020-00224-3. Erratum in: Nat Rev Dis Primers. 2023 Jan 19;9(1):4. doi: 10.1038/s41572-023-00418-5. PMID: 33243986; PMCID: PMC7944998.
[ii] Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. “Epidemiology, Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma.” Med Sci (Basel), 2023 Jun 13;11(2):42. doi: 10.3390/medsci11020042. PMID: 37367741; PMCID: PMC10304137.
[iii] Cancer Research Institute. “Head and Neck Cancer a Promising Treatment?” Accessed June 4, 2026. https://www.cancerresearch.org/immunotherapy-by-cancer-type/head-and-neck-cancer.
[iv] Ionna F, Bossi P, Guida A, Alberti A, Muto P, Salzano G, Ottaiano A, Maglitto F, Leopardo D, De Felice M, Longo F, Tafuto S, Della Vittoria Scarpati G, Perri F. “Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: A Big and Intriguing Challenge Which May Be Resolved by Integrated Treatments Combining Locoregional and Systemic Therapies.” Cancers (Basel), 2021 May 14;13(10):2371. doi: 10.3390/cancers13102371. PMID: 34069092; PMCID: PMC8155962.
| Genmab A/S Carl Jacobsens Vej 30 2500 Valby, Denmark | Tel: +45 7020 2728 www.genmab.com | Company Announcement no. 44 Page 3/3 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 | ||||||