Genmab Rina-S cuts progression or death risk 71% in trial

Q: What were the GMAB RAINFOL-02 results for PFS and OS?

Rina-S met both endpoints. PFS hazard ratios were 0.29 in ITT and 0.33 in PAS, with reported risk reductions of 71% and 67%, respectively. OS hazard ratios were 0.43 in ITT and 0.44 in PAS; all four comparisons had p<0.0001.

Q: How was Rina-S given in the GMAB RAINFOL-02 trial?

Patients were randomized 1:1 to receive Rina-S at 120 mg/m² on Day 1 of each three-week treatment cycle or one of four standard-of-care chemotherapy agents: paclitaxel, topotecan, PLD, or gemcitabine.

Q: How many patients were in the GMAB RAINFOL-02 analysis populations?

The ITT population included 584 patients, regardless of FRα expression, and the PAS was a subset of 492 patients. PAS eligibility included FRα expression and, for certain patients, prior treatment with mirvetuximab.

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Rhea-AI Filing Summary

Genmab A/S announced positive topline results from Phase 3 RAINFOL-02, in which investigational Rina-S met the primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) versus investigator’s choice chemotherapy in platinum-resistant ovarian cancer. For PFS, hazard ratios were 0.29 in the intent-to-treat (ITT) population of 584 patients and 0.33 in the primary analysis set (PAS) of 492 patients; Genmab reported 71% and 67% reductions in risk of progression or death, respectively. For OS, hazard ratios were 0.43 in ITT and 0.44 in PAS. All four comparisons had p<0.0001.

Genmab said the observed safety profile was consistent with Rina-S’s known profile, with no new safety signals or unexpected safety concerns identified. The company plans to discuss potential next steps with regulatory authorities worldwide and submit the data for presentation at a future medical meeting. Rina-S remains investigational; its safety and efficacy have not been established.

1 point · 1 major

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0 major · 0 points

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Positive

Major pointPhase 3 survival endpoints met; ITT hazard ratios: PFS 0.29, OS 0.43.

Negative

None.

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Key Figures

ITT population: 584 patients PAS population: 492 patients ITT PFS hazard ratio: 0.29 +3 more

6 metrics

ITT population 584 patients RAINFOL-02 efficacy analysis

PAS population 492 patients RAINFOL-02 efficacy analysis

ITT PFS hazard ratio 0.29 Rina-S versus investigator’s choice chemotherapy

PAS PFS hazard ratio 0.33 Rina-S versus investigator’s choice chemotherapy

ITT OS hazard ratio 0.43 Rina-S versus investigator’s choice chemotherapy

PAS OS hazard ratio 0.44 Rina-S versus investigator’s choice chemotherapy

Key Terms

progression-free survival (PFS), overall survival (OS), antibody-drug conjugate (ADC), intent-to-treat (ITT), +1 more

5 terms

progression-free survival (PFS) medical

"primary endpoint of progression-free survival (PFS)"

Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.

overall survival (OS) medical

"key secondary endpoint of 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.

antibody-drug conjugate (ADC) medical

"topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC)"

An antibody-drug conjugate (ADC) is a targeted medical treatment that combines an antibody, which acts like a guided missile seeking out specific cells, with a powerful drug to destroy those cells. It is designed to deliver medication directly to diseased cells, minimizing damage to healthy tissue. For investors, ADCs represent innovative therapies with potential for high growth, especially if they prove effective in treating difficult-to-cure conditions.

intent-to-treat (ITT) medical

"intent-to-treat (ITT) population"

Intent-to-treat (ITT) is a rule for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed the protocol. For investors, ITT matters because it gives a conservative, real-world estimate of how well a treatment works and helps reveal whether reported benefits are robust or likely to shrink when the product reaches the broader market — like scoring a team’s performance by including every player who showed up, not just those who played the whole game.

primary analysis set (PAS) medical

"primary analysis set (PAS) populations"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were the GMAB RAINFOL-02 results for PFS and OS?

Rina-S met both endpoints. PFS hazard ratios were 0.29 in ITT and 0.33 in PAS, with reported risk reductions of 71% and 67%, respectively. OS hazard ratios were 0.43 in ITT and 0.44 in PAS; all four comparisons had p<0.0001.

How was Rina-S given in the GMAB RAINFOL-02 trial?

Patients were randomized 1:1 to receive Rina-S at 120 mg/m² on Day 1 of each three-week treatment cycle or one of four standard-of-care chemotherapy agents: paclitaxel, topotecan, PLD, or gemcitabine.

How many patients were in the GMAB RAINFOL-02 analysis populations?

The ITT population included 584 patients, regardless of FRα expression, and the PAS was a subset of 492 patients. PAS eligibility included FRα expression and, for certain patients, prior treatment with mirvetuximab.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 10/23/2026 - 11:59 AM EDT Accepted by SEC EDGAR 10/23/2026 - 11:58 AM EDT

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)

Carl Jacobsens Vej 30

2500 Valby

Denmark

+45 70 20 27 28
(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 23, 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 23, 2026

Exhibit 99.1

Genmab Announces Rinatabart Sesutecan (Rina-S®) Demonstrates Statistically Significant Improvement in Progression-Free Survival and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer

Company Announcement

COPENHAGEN, Denmark; October 23, 2026

•Phase 3 RAINFOL™-02 trial met its primary endpoint of progression-free survival (PFS) and its key secondary endpoint of overall survival (OS) with rinatabart sesutecan (Rina-S®) compared to investigator’s choice chemotherapy

•Results demonstrated statistically significant and clinically meaningful improvement in PFS and OS in patients with platinum-resistant ovarian cancer (PROC)

•Data will be submitted for presentation at a future medical meeting and discussed with regulatory authorities worldwide

Genmab A/S (Nasdaq: GMAB) announced today positive topline results from the global Phase 3 RAINFOL™-02 trial of rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), in patients with platinum-resistant ovarian cancer (PROC) regardless of FRα expression level or prior treatment with mirvetuximab. The trial met its primary endpoint of progression-free survival (PFS), with Rina-S demonstrating a statistically significant and clinically meaningful improvement compared with investigator’s choice chemotherapy in the intent-to-treat (ITT) and in the primary analysis set (PAS) populations.

The ITT population (N=584) comprised of all randomized patients with PROC, regardless of FRα expression. The PAS population (N=492) mandated patients with FRα expression ≥75% PS2+ to have been treated with mirvetuximab.

In the ITT population, Rina-S demonstrated a 71% reduction in the risk of disease progression or death (HR 0.29; 95% CI, 0.23-0.37; p<0.0001). In the PAS population, Rina-S demonstrated a 67% reduction in the risk of disease progression or death (HR 0.33; 95% CI, 0.26–0.42; p<0.0001).

The study also met its key secondary endpoint of overall survival (OS), demonstrating a statically significant and clinically meaningful improvement in the ITT population (HR 0.43; 95% CI, 0.31–0.59; p<0.0001) and in the PAS population (HR 0.44; 95% CI, 0.31–0.63; p<0.0001).

The observed safety profile was consistent with the known profile of Rina-S, with no new safety signals or unexpected safety concerns identified.

“As the first Phase 3 readout from our Rina-S program, the positive topline results from RAINFOL-02 mark a significant milestone for Genmab and strengthen our confidence in Rina-S’s potential for patients with platinum-resistant ovarian cancer. These results advance our ambition to become a leader in gynecologic oncology and reflect our commitment to improving the lives of patients with high unmet medical needs,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to discussing these results and potential next steps with regulatory authorities worldwide. We are deeply grateful to the patients, caregivers, and investigators whose participation made this study possible.”


Genmab A/S Carl Jacobsens Vej 30 2500 Valby, Denmark			Tel: +45 7020 2728 www.genmab.com			Company Announcement no. 43 Page 1/4 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122

Based on these results, Genmab plans to engage with regulatory authorities worldwide regarding potential next steps. The data will also be submitted for presentation at a future medical meeting.

“Platinum-resistant ovarian cancer remains one of the greatest challenges in gynecologic oncology, with patients often facing a poor prognosis and limited effective treatment options. The Phase 3 RAINFOL-02 results set a new benchmark in addressing this urgent unmet need regardless of FRα expression,” said Angeles Alvarez Secord, MD, MHSc, the study’s lead investigator for the Gynecologic Oncology Group (GOG) and Professor of Obstetrics and Gynecology at the Duke Cancer Institute. “The 71% reduction in the risk of disease progression and 57% reduction in the risk of death underscore the potential of Rina-S to change clinical practice if approved by offering a therapeutic option for a broad patient population.”

Rina-S is being evaluated in a broad clinical development program spanning multiple gynecologic cancers and other solid tumors. The program includes five Phase 3 trials evaluating Rina-S in PROC (RAINFOL-02; NCT06619236), recurrent or progressive endometrial cancer (RAINFOL-03; NCT07166094), platinum-sensitive ovarian cancer (PSOC) maintenance therapy (RAINFOL-04; NCT07225270), second-line PSOC (RAINFOL-07; NCT07564141), and in first-line ovarian cancer as maintenance therapy (RAINFOL-10; NCT07859215). Additional studies include the Phase 1/2 RAINFOL-01 trial (NCT05579366) and Phase 2 trials in non-small cell lung cancer (RAINFOL-05; NCT07288177) and advanced gastrointestinal cancers (RAINFOL-09; NCT07539311).

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 RAINFOL-02 Trial RAINFOL-02 (NCT06619236) is a randomized, open-label, multicenter Phase 3 study evaluating the efficacy and safety of Rina-S versus investigator’s choice chemotherapy in 582 patients with PROC regardless of FRα expression level. Patients are randomized 1:1 to receive either Rina-S 120 mg/m² on Day 1 of each three-week treatment cycle or one of four standard-of-care chemotherapy agents: paclitaxel, topotecan, PLD, or gemcitabine. The primary endpoint is investigator-assessed PFS. Key secondary endpoints are OS and objective response rate (ORR). Other secondary endpoints include PFS by blinded independent central review, duration of response, incidence of adverse events and laboratory abnormalities, time from randomization to second disease progression or death, and change from baseline in global health status/quality of life. Efficacy is evaluated in two populations. The ITT population (N = 584) includes all randomized patients, regardless of FRα expression level. The PAS (N=492), a subset of the ITT population, includes only patients with FRα expression <75% PS2+ and patients previously treated with mirvetuximab if eligible based on FRα expression ≥75% PS2+ and available in the region.

About Ovarian Cancer Ovarian cancer (OC) is a major global health issue, more than 320,000 new cases diagnosed annually worldwide.[i] It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.[ii] The disease is often diagnosed at an advanced stage because its symptoms, including abdominal bloating, pelvic pain and difficulty eating, can be subtle and nonspecific.[iii] Approximately 70-90% of women with advanced-stage OC worldwide experience a recurrence after initial treatment.[iv] OC has a


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low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.[v],[vi]

About Rinatabart Sesutecan (Rina-S; GEN1184)

Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial, and other cancers with unmet need.

The safety and efficacy of Rina-S have not been established. 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.

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, X, Facebook and Instagram.

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.


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[i] World Cancer Research Fund International. https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/. Accessed Oct 2025.

[ii] World Ovarian Cancer Coalition. https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/. Accessed Oct 2025.

[iii] Dilley, James et al. Ovarian cancer symptoms, routes to diagnosis and survival - Population cohort study in the 'no screen' arm of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecologic oncology vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002.

[iv] Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/

[v] European Institute of Women's Health. https://eurohealth.ie/policy‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/. Accessed Oct 2025.

[vi] American Cancer Society. Stages of Ovarian Cancer. https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html. Accessed Oct 2025.


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