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Darolutamide plus ADT and radiation therapy reduces risk of metastasis or death by 58% in prostate cancer patients at high risk of recurrence

Bayer

Berlin, October 24, 2026 – New late-breaking data to be presented today at the European Society for Medical Oncology (ESMO) Congress 2026 will show that adding Bayer’s androgen receptor inhibitor (ARi), darolutamide, to standard-of-care androgen deprivation therapy (ADT) and locoregional radiation therapy (RT), significantly improves metastasis-free survival based on conventional imaging (MFS-CI) in prostate cancer patients with high risk of recurrence compared to placebo. Darolutamide is currently not approved for this treatment setting. These data will be presented at Presidential Symposium I at the ESMO Congress 2026 (LBA4, Saturday 24 October, 16:30 CET).

At a median follow-up of 3.8 years, the interim analysis demonstrated a 58% reduction in the risk of metastasis or death with darolutamide plus ADT and RT compared with placebo plus ADT and RT (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001). The 4-year metastasis-free survival rate was 95% for patients receiving darolutamide compared with 88% for those receiving placebo.

“Prostate cancer patients at a high risk of relapse face a considerable risk of recurrence and metastatic spread, making early, highly effective intervention vital,” said Dr. Tamim Niazi, Associate Professor of Oncology at McGill University, Radiation Oncologist at the Jewish General Hospital in Montreal, Canada. and Co-Lead Investigator of the study. “The clear improvement in metastasis-free survival seen in interim results from the DASL-HiCaP trial highlights the potential of adding darolutamide to standard androgen deprivation therapy and radiation therapy to help prevent or delay disease progression in patients who are at high risk of progression despite receiving primary curative therapy.”

Secondary endpoints also showed consistent positive trends with darolutamide, with a 53% reduction in the risk of prostate-specific antigen progression free survival (PSA-PFS; HR 0.47; 95% CI: 0.33–0.67), and a 4-year PSA-PFS rate of 91% versus 83% with placebo. Prostate cancer-specific survival (PCSS) and overall survival (OS) hazard ratios were 0.58 (95% CI: 0.17–1.97; 99% vs 99% at 4 years) and 0.88 (95% CI: 0.49–1.59; 97% vs 95% at 4 years), respectively, with follow-up ongoing.

The safety profile of darolutamide was consistent with its known tolerability, with adverse events being similar to the placebo group. Proportions of patients experiencing Grade ≥2 adverse events of special interest for darolutamide versus placebo were: fatigue/asthenia (14% vs 10%), hypertension (7% vs 9%), fractures (2% vs 3%), and cardiac events (3% vs 3%). Any Grade ≥3 adverse event occurred in 43% of patients in the darolutamide group versus 36% in the placebo group.

"These new data highlight the potential of darolutamide to make a meaningful difference for patients earlier in the course of their prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer’s Pharmaceuticals Division. “By advancing darolutamide into earlier disease settings, we aim to reach more patients across the prostate cancer care continuum. We are proud to support ANZUP, the Sydney Clinical Trials Centre, CCTG and international partners in research as we work together with the potential to improve outcomes for men living with prostate cancer.”

Follow-up of participants is continuing to provide further information on longer-term outcomes, including overall survival.

About the DASL-HiCaP trial (ANZUP1801) 
The DASL-HiCaP trial is an investigator-initiated, randomized, placebo-controlled, Phase III trial (NCT04136353) evaluating darolutamide added to standard-of-care ADT and locoregional radiation therapy in prostate cancer patients at high risk of recurrence.

DASL-HiCaP was conducted in collaboration with the University of Sydney and ANZUP Clinical Trials Group and is the fourth Phase III trial for darolutamide. Following ARAMIS, ARASENS, and ARANOTE, which demonstrated darolutamide’s efficacy and safety in advanced prostate cancer, DASL-HiCaP represents the first Phase III study of darolutamide in early prostate cancer.

A total of 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom were randomized 1:1 to receive darolutamide (600 mg twice daily) or matching placebo for 96 weeks, combined with an LHRH analog for 96 weeks and RT to the prostate/prostate bed and pelvic lymph nodes.

The primary endpoint was metastasis-free survival based on conventional imaging (MFS-CI). Secondary endpoints included prostate-specific antigen progression free survival (PSA-PFS), prostate cancer-specific survival (PCSS), and overall survival (OS). The protocol specified an interim analysis after 87 MFS-CI events; follow-up is ongoing to evaluate long-term overall survival.

About the Sydney Clinical Trials Centre
The Sydney Clinical Trials Centre is a flagship research centre of the Faculty of Medicine and Health at the University of Sydney that designs and manages clinical trials. This includes responsibility for study coordination, monitoring, data acquisition and management and statistical analysis. The Sydney Clinical Trials Centre has health economics, biostatistics, systematic reviews and biomarker teams that work with trial data and inform healthcare providers about best practice. For further details, please visit its website at https://www.ctc.usyd.edu.au

About ANZUP Clinical Trials Group 
ANZUP (https://www.anzup.org.au) is the leading cancer-cooperative trials group bringing together all of the professional disciplines and groups involved in researching and treating urogenital cancers to conduct high-quality cancer research. ANZUP’s mission is to improve the lives of people affected by bladder, kidney, testicular, penile, and prostate cancers, towards our vision of living life without fear of cancer. ANZUP identifies gaps in evidence and areas of clinical need, collaborates with the best clinicians and researchers in genitourinary cancer and communicates frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia and research funding from Prostate Cancer Foundation of Australia.

About Prostate Cancer
Prostate cancer is the second most common cancer and the fourth most common cause of cancer death in men worldwide. Over 1.5 million men are diagnosed with prostate cancer each year and almost 420,000 die from the disease worldwide. By 2040, prostate cancer diagnoses are projected to increase to 2.9 million.

Standard therapy for prostate cancer patients at high risk of recurrence combines radiation therapy with androgen deprivation therapy (ADT). However, despite this approach, a significant proportion of patients experience treatment failure, local recurrence, or distant metastases. Intensifying therapy early with an advanced androgen receptor inhibitor aims to improve long-term disease control and delay metastatic progression.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a distinct chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans support darolutamide's low potential for blood-brain barrier penetration and low potential for clinically relevant drug-drug interactions.

Darolutamide, under the brand name Nubeqa™ plus androgen deprivation therapy (ADT), is already approved in more than 85 markets around the world, including the US, EU and China. It is approved for the treatment of adult patients with mHSPC without docetaxel in 75 markets and with docetaxel in more than 85 countries, and for adult patients with nmCRPC at high risk of developing metastatic disease in more than 85 countries.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Darolutamide demonstrated efficacy and tolerability in pivotal Phase 3 studies, supporting its indications in nmCRPC and mHSPC with and without chemotherapy, with a favorable safety profile that offers an advancement in treatment management for physicians and patients.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. Current ongoing trials include the Phase III ARASTEP trial evaluating the efficacy of darolutamide plus ADT compared to ADT alone in hormone-sensitive prostate cancer (HSPC), in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development. Bayer is focused on addressing the unique needs of patients with prostate cancer, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients can live longer, better lives.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at www.bayer.com/en/portfolio/pharmaceuticals
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

  1. HealthcareBayerBayer to invest 2.2 billion U.S. dollars in a new manufacturing site in the United StatesCompanies: BayerBayer announced on Friday plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio, U.S. Building on more than seven billion dollars in U.S. pharma R&D and manufacturing spend over the past five years, the project is a central element of Bayer’s long-term growth strategy and commitment to innovation and patient access in its largest pharmaceuticals market. “Bayer has long seen the United States as a key manufacturing base and innovation hub. This landmark investment underscores our commitment,” said Bayer CEO Bill Anderson. “The new site will be home to manufacturing expertise and a skilled workforce that will strengthen our ability to deliver innovative, high-quality medicines to patients both in the United States and abroad.” “The United States is a key market for Bayer’s Pharmaceuticals division. This expansion is another important step to grow our pharmaceuticals business and to meet the demand of our customers and patients in the U.S., our fastest-growing pharmaceuticals market, and beyond,” said Sebastian Guth, Global Chief Operating Officer, Bayer Pharmaceuticals and President, Bayer U.S. Planned site to create highly-skilled jobs and support Ohio’s economic development Bayer is expected to create around 600 high-value jobs in the New Albany International Business Park and roughly 1,500 construction jobs during the facility’s construction. The flexible, modular campus is designed to combine drug substance and drug product manufacturing, leverage advanced digital and automation technologies, and support our growing portfolio initially in oncology, cardiovascular and renal care. The first module, dedicated to drug substance manufacturing, is expected to become operational in 2031. A second module for drug product manufacturing is planned to follow in 2034. The new site will complement Bayer’s U.S. pharmaceuticals headquarters in Whippany, New Jersey and its other sites in Pittsburgh, Pennsylvania; Berkeley, California; Cambridge, Massachusetts; Research Triangle Park, North Carolina; and San Diego, California. “The facility will be a strong strategic addition to our global Product Supply network. As we continue to invest in our existing manufacturing sites around the globe, our planned presence in Ohio will further enhance our ability to serve our markets with greater resilience and reliability,” said Holger Weintritt, Head of Product Supply at Bayer’s Pharmaceuticals division. The site will also form part of a new U.S. based collaboration ecosystem. The ambition is to connect cutting-edge academic innovation with advanced manufacturing expertise to create a strong ecosystem that supports future-ready pharmaceutical production. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Contact for media inquiries: Sue Ann Pentecost, phone +1 910 221 6446 Email: [email protected] Tino Andresen, +49 214 30-66048 Email: [email protected] Heidi Sylvester, phone +49 173 106-9282 Email: [email protected] Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: [email protected] www.bayer.com/en/investors/ir-team
  2. IndustrialBayer to Invest 2.2 Billion U.S. Dollars in a New Manufacturing Site in the United StatesCompanies: BayerNEW ALBANY, Ohio, October 02, 2026--Bayer announced on Friday plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio, U.S. Building on more than seven billion dollars in U.S.
  3. AIBayer to Present How it Rebuilt Global Planning with OMP at Gartner Supply Chain Planning Summit 2026Companies: BayerANTWERPEN, BELGIUM, Sept 17, 2026 - OMP, a leading provider of supply chain planning solutions, invites attendees of the Gartner Supply Chain Planning Summit 2026 in London to its joint session with multinational Bayer. Representatives of the Pharmaceutical division and the global IT department will show what it took to rebuild global planning around faster, higher-quality decisions, how Unison Planning™ supports that at scale, and where AI fits in. Rebuilding planning at Bayer's scale Bayer treated its move to Unison Planning™ as more than a system replacement, rebuilding processes, master data, and ways of working across its global manufacturing and affiliate network. During their Gartner session, Mirja Meyer, Principal Product Manager and Program Lead IT at Bayer, and Karsten Hahm, Program Lead OMP Implementation at Bayer Pharmaceuticals, will cover: What adoption actually took What changed in decision speed and quality Where AI fits on the roadmap ahead Sign up for the session Why planning leaders should attend AI-driven planning is on every agenda. Bayer's session addresses the part that usually goes unsaid: what a planning organization needs in place before an AI implementation survives the test of a real supply chain. Meet OMP and explore what it means to make decisions at the speed of change Throughout the Gartner Supply Chain Planning Summit (Oct 5-6, London), OMP is present at booth 203, demonstrating how Unison Planning™ and UnisonIQ help organizations move toward always-on supply chain orchestration. See how integrated planning, enhanced by the latest AI advancements, drives faster scenario evaluation, stronger collaboration, and measurable business results. Join OMP at Gartner to hear Bayer's journey firsthand and leave with a clearer path to faster, more confident supply chain decisions. Session at a glance Title: Inside Bayer's Global Planning Rebuild and AI Roadmap - Faster Decisions at Scale Speakers: Mirja Meyer, Principal Product Manager, Program Lead IT, Bayer Karsten Hahm, Program Lead OMP Implementation, Bayer Pharmaceuticals When: Tuesday, October 6, 11:15 - 11:45 AM GMT+1 / 12:15 - 12:45 PM CEST Where: InterContinental London - The O2, London, United Kingdom To see where you can meet OMP next, visit our events calendar. About OMP OMP helps companies facing complex planning challenges to excel, grow, and thrive by offering the best digitized supply chain planning solution on the market. Hundreds of customers in a wide range of industries - spanning consumer goods, life sciences, chemicals, metals, paper, packaging, plastics, tires, and building products - benefit from using OMP's unique Unison Planning™. Solution and product inquiries Contact OMP +32 3 650 22 11 Media inquiries Kira Perdue (Carabiner) SOURCE: OMP
  4. HealthcareBayerU.S. FDA approves finerenone for new indication in patients with chronic kidney disease associated with type 1 diabetesCompanies: BayerBayer announced today that the U.S. Food and Drug Administration (FDA) has approved Kerendia™ (finerenone), a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), for the treatment of adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). Finerenone (10mg, 20mg) is now indicated to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with chronic kidney disease associated with type 1 diabetes. Approximately 30% of people with type 1 diabetes in the U.S. develop chronic kidney disease, increasing their risk of kidney failure and cardiovascular events. Even with recommended treatments for blood glucose and blood pressure management, many patients remain at risk of kidney disease progression and cardiovascular complications. “For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression," said Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Executive Committee. "The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.” “Today’s approval in the U.S. marks an important advance for people living with chronic kidney disease associated with type 1 diabetes—a serious and often under-recognized condition. As the first new FDA-approved treatment option in more than 30 years for this patient population, Kerendia reflects Bayer’s commitment to addressing significant unmet needs and bringing meaningful new treatment options to patients,” said Christine Roth Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. In May 2026, the FDA granted Priority Review designation for Bayer’s supplemental New Drug Application for finerenone for the treatment of adult patients with CKD associated with T1D. The approval of finerenone by the FDA is based on the positive results of the Phase III FINE-ONE study, which were published in the New England Journal of Medicine in March 2026 and presented in November 2025 as “Featured High-Impact Clinical Trial” during the Opening Plenary session of the American Society of Nephrology’s (ASN) Kidney Week. These findings are supported by pooled analyses from the Phase III FIDELIO-DKD and FIGARO-DKD studies in CKD associated with type 2 diabetes (T2D), showing that more than 80% of finerenone's kidney benefit was explained by reductions in UACR. In the U.S., Kerendia has been approved since 2021 for the treatment of adult patients with CKD associated with type 2 diabetes (T2D), since 2025 for the treatment of adult patients with symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40%, and now for the treatment of adult patients with CKD associated with type 1 diabetes. About Kerendia™ / Firialta™ (finerenone) Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone so far has been studied in more than 20,000 patients across multiple populations with chronic kidney disease and/or heart failure. Finerenone is the first drug targeting the MR pathway that in five pivotal Phase III studies has demonstrated clinically proven heart and/or kidney benefits across a broad range of patient populations, for patients with HF LVEF ≥40%, CKD associated with T2D, CKD associated with T1D, and CKD without diabetes. Since 2021, finerenone is marketed as Kerendia™ or, in selected countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 100 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is also approved for the treatment of heart failure with LVEF ≥ 40% in the U.S., Europe, Japan, China, and several other markets. Applications for marketing authorization of finerenone in non-diabetic CKD have been filed in China and Japan; so far, finerenone is not approved in non-diabetic CKD in any country worldwide. With the new approval by the FDA, the U.S. are the only country where Kerendia is approved for the treatment of adult patients with CKD associated with type 1 diabetes. About FINE-ONE In FINE-ONE, 242 participants were randomized from more than 80 sites across 9 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities. FINE-ONE is a global, randomized, placebo-controlled, double-blind, multicenter Phase III study in people with CKD and T1D. In FINE-ONE, finerenone in addition to standard of care significantly reduced the primary endpoint of relative change in urine albumin-to-creatinine ratio, or UACR, by 25% over six months compared with placebo. At Month 3 and at Month 6, UACR reduction with finerenone was 22%, and 28%, respectively, compared to placebo. At any time following baseline, 68.1% of participants receiving finerenone achieved a reduction in UACR of at least 30%, compared with 46.6% receiving placebo. A reduction in UACR of 30% is a threshold established by the American Diabetes Association (ADA) as being associated with slower CKD progression in patients with CKD associated with type 2 diabetes. Reductions in UACR of this magnitude have been shown in prior Phase III studies in adults with CKD and T2D to be associated with a delay in kidney disease progression and a reduction in cardiovascular events. The safety profile of finerenone in FINE-ONE was largely consistent with the existing body of evidence in adults with chronic kidney disease associated with type 2 diabetes. About Chronic Kidney Disease associated with Type 1 Diabetes Type 1 Diabetes (T1D) is a chronic autoimmune disorder characterized by destruction of pancreatic beta cells leading to insulin deficiency and requiring lifelong insulin treatment. Among the US population overall, crude estimates for 2018 indicated that 1.4 million adults aged 20 years or older (or 5.2% of all US adults with diagnosed diabetes), reported both having T1D and using insulin. CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. CKD affects approximately 30% of people with T1D. The 2017 global prevalence of CKD due to T1D was an estimated 32.5 per 100,000 individuals. The clinical course of CKD in people with T1D is characterized by an increased urinary albumin excretion rate, which is a first sign of kidney damage and may progress to macroalbuminuria and decrease in kidney function as measured by estimated glomerular filtration rate (eGFR). The treatment of T1D consists of insulin treatment to control hyperglycemia. In people with T1D, blood glucose intervention targeting HbA1c levels ≤7% can slow onset and progression of kidney disease. Despite guideline-recommended treatment with ACEIs and ARBs, residual risk remains high in people with CKD and T1D, with up to a quarter progressing to end-stage-kidney-disease. CKD associated with T1D significantly increases the risk of kidney failure and cardiovascular events, contributing to CKD being a leading cause of death in T1D. About Bayer’s Commitment in Cardiovascular, Kidney and Cerebrovascular Diseases Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments for cardiovascular, kidney and cerebrovascular diseases with high unmet medical needs. The company has set a clear focus on developing therapies to treat such diseases (e.g., heart failure, cardiomyopathies, chronic kidney disease, and stroke), and it is its ambition to take a leading role in the care of patients with these diseases. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular, kidney, and cerebrovascular diseases are diagnosed and treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
  5. Apollo Global Management, Inc. NEW YORK andApollo Funds Complete €3 Billion Capital Solution for BayerCompanies: Apollo Global ManagementBayerKKR & Co.KKR joins Apollo as a minority participant
  6. HealthcareBayerU.S. FDA grants accelerated approval to Bayer’s targeted therapy sevabertinib as a first-line treatment option for adults with HER2-mutant non-small cell lung cancerCompanies: BayerFollowing Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib as a first-line treatment option for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI). “The FDA’s accelerated approval of sevabertinib marks an important advance for treatment-naïve patients with HER2-mutated NSCLC who historically have a poor prognosis,” said SOHO-01 lead investigator, Xiuning Le, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. “This milestone also underscores the critical importance of comprehensive molecular testing at diagnosis, including for activating HER2 mutations, to ensure patients receive the most appropriate treatment as early as possible.” The FDA approved this indication for sevabertinib under accelerated approval based on objective response rate (ORR) and duration of response (DOR) demonstrated in a cohort of treatment-naïve patients (N=69) in the ongoing Phase I/II SOHO-01 trial (NCT05099172), evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC. In this cohort, the ORR was 75% including complete responses in 6% of patients and partial responses in 70% of patients, with 73% of responders maintaining response for at least six months. The safety profile of sevabertinib was consistent with previous findings. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase III SOHO-02 confirmatory trial (NCT06452277), which is evaluating sevabertinib versus standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC. “Today’s FDA approval of sevabertinib as an initial treatment option for locally advanced or metastatic non-squamous HER2-mutated NSCLC is an important milestone for patients and a powerful validation of Bayer’s commitment to advancing precision oncology in areas with the highest unmet needs,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Lung cancer remains the leading cause of cancer-related deaths worldwide and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options. This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time.” In November 2025, sevabertinib received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial (from cohort D - previously treated patients who had not received HER2-targeted therapy and cohort E - patients who had previously received HER2-directed antibody-drug conjugates). Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. The approval follows the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation for this patient population. The CDE has also granted sevabertinib Breakthrough Therapy Designation to expedite its development for first-line use in patients with advanced HER2-mutant NSCLC. Sevabertinib has also recently been approved as the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment, by the Ministry of Health, Labour, and Welfare in Japan. About sevabertinib Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human HER2, including HER2 exon 20 insertions and HER2 point mutations. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs. Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with HER2-mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors with HER2-activating mutations, excluding advanced NSCLC. About Non-Small Cell Lung Cancer (NSCLC) Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.