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Last update 25 Mar 2025
Sevabertinib
Last update 25 Mar 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms 3-chloro-2-methoxyanilino)-2-{3-[(2S)-1,4-dioxan-2- ylmethoxy]pyridin-4-yl}-1,5,6,7-tetrahydro-4H-pyrrolo[3,2- c]pyridin-4-one, BAY 2927088, BAY-2927088 |
Action inhibitors |
Mechanism EGFR C797S inhibitors(Epidermal Growth Factor Receptor C797S inhibitors), EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors), HER2 exon 20 inhibitors(ERBB2 Exon 20 Mutation inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Breakthrough Therapy (China), Breakthrough Therapy (United States) |
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Structure/Sequence
Molecular FormulaC24H25ClN4O5 |
InChIKeyVYQVHWNNPKOJEA-AWEZNQCLSA-N |
CAS Registry2521285-05-0 |
Related
12
Clinical Trials associated with SevabertinibCTR20250361
一项旨在携带HER2激活突变的转移性或不可切除实体瘤参与者中评价口服可逆性酪氨酸激酶抑制剂BAY 2927088的有效性和安全性的II期、开放性、篮式研究
[Translation] A Phase II, open-label, basket study to evaluate the efficacy and safety of the oral reversible tyrosine kinase inhibitor BAY 2927088 in participants with metastatic or unresectable solid tumors harboring HER2-activating mutations
研究人员正在寻找一种更好的方法来治疗具有 HER2 激活突变的实体瘤患者。在这项试验中，研究人员希望了解 BAY2927088 对不同类型的 HER2 激活突变实体瘤患者的疗效如何。这些肿瘤包括结肠或直肠、子宫和子宫颈（子宫下部）、膀胱、胆道（包括胆囊和胆管）以及其他类型的实体瘤，但晚期非小细胞肺癌（NSCLC）患者除外。某些实体瘤可能与一种名为人类表皮生长受体-2（HER2）的基因发生特定的变化或突变。这导致癌细胞中形成异常形式的 HER2 蛋白，从而导致细胞生长加快。名为 BAY2927088 的研究药物有望阻断异常的 HER2 蛋白，从而阻止癌症进展。所有参与者都将口服 BAY2927088 片剂。参与者将以每 3 周为一个周期接受治疗，并定期通过CT、 MRI等检查评估疗效，使用超声心动图或心脏磁共振成像（MRI）和心电图（ECG）检查心脏健康状况。还将采集血液和尿液并进行身体检查，检查参与者的健康状况。研究者会询问受试者的其他健康问题。
[Translation]
Researchers are looking for a better way to treat patients with solid tumors that have HER2 activating mutations. In this trial, researchers want to see how well BAY2927088 works in patients with different types of solid tumors that have HER2 activating mutations. These tumors include those in the colon or rectum, uterus and cervix (lower part of the uterus), bladder, biliary tract (including gallbladder and bile ducts), and other types of solid tumors, except for patients with advanced non-small cell lung cancer (NSCLC). Some solid tumors may be associated with specific changes or mutations in a gene called human epidermal growth receptor-2 (HER2). This causes abnormal forms of HER2 protein to form in cancer cells, which can cause cells to grow faster. The investigational drug, called BAY2927088, is expected to block the abnormal HER2 protein and thus stop the cancer from progressing. All participants will take BAY2927088 tablets by mouth. Participants will receive treatment every 3 weeks and will be regularly evaluated for efficacy with tests such as CT, MRI, and heart health will be checked using echocardiograms or cardiac magnetic resonance imaging (MRI) and electrocardiograms (ECGs). Blood and urine will also be collected and a physical exam will be done to check the health of the participants. The researchers will ask the subjects other health questions.
Start Date13 Feb 2025 |
Sponsor / Collaborator  Bayer AG [+1] |
NCT06760819
A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
In this trial, the researchers want to learn how well BAY2927088 works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).
Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.
The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.
The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.
During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
In this trial, the researchers want to learn how well BAY2927088 works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).
Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.
The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.
The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.
During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
Start Date13 Feb 2025 |
Sponsor / Collaborator |
CTR20244192
一项旨在携带HER2激活突变的局部晚期或转移性非小细胞肺癌（NSCLC）患者中评估BAY 2927088口服给药与标准治疗相比作为一线治疗的有效性和安全性的III期开放性、随机、阳性对照、多中心试验
[Translation] A Phase III open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of oral BAY 2927088 compared with standard of care as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations
在携带HER2激活突变的局部晚期或转移性非小细胞肺癌（NSCLC）的患者中， 评估BAY2927088与SoC相比作为一线治疗的有效性和安全性。
[Translation]
To evaluate the efficacy and safety of BAY2927088 compared with SoC as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations.
Start Date23 Dec 2024 |
Sponsor / Collaborator Bayer AG [+1] |
100 Clinical Results associated with Sevabertinib
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100 Translational Medicine associated with Sevabertinib
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100 Patents (Medical) associated with Sevabertinib
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14
News (Medical) associated with Sevabertinib06 Mar 2025
With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation.
LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's "
TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
EMD Serono's TEPMETKO (tepotinib) Overview
TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment.
Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation.
The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time.
Learn more about TEPMETKO projected market size for NSCLC @
TEPMETKO Market Potential
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently,
80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around
80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations.
Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI),
KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by
TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of
OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC.
According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from
USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034).
Discover more about the NSCLC market in detail @
Non-small Cell Lung Cancer Market Report
Emerging Competitors of TEPMETKO
The NSCLC pipeline is very robust with the promising therapies such as
Telisotuzumab vedotin (AbbVie),
Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca),
Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca),
Eftilagimod alpha (Immutep),
BNT311/GEN1046 (acasunlimab) (Genmab),
V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck),
Plinabulin + Docetaxel (BeyondSpring),
Olomorasib (LY3537982) (Eli Lilly and Company),
Zipalertinib (Cullinan Oncology/Taiho Pharma),
Ceralasertib (AZD6738) (AstraZeneca),
TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics),
Sigvotatug vedotin
(PF08046047) (Pfizer),
ANKTIVA (N-803) (ImmunityBio),
Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical),
Niraparib (GSK),
Savolitinib (AstraZeneca/Hutchison MediPharma),
TRODELVY (Gilead Sciences),
Pyrotinib (Jiangsu HengRui Medicine),
Ociperlimab (BGB-A1217) (BieGene),
Volrustomig (AstraZeneca),
Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech),
Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics),
ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics),
Divarasib (GDC-6036) (Roche/Genentech),
Tiragolumab (RG6058) (Roche),
Sacituzumab Tirumotecan (Merck and Kelun-Biotech),
JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio),
Zongertinib (BI-1810631) (Boehringer Ingelheim),
BAY 2927088 (Bayer),
Serplulimab (HLX10) (Shanghai Henlius Biotech),
Rilvegostomig (AZD2936) (AstraZeneca),
MK-1084 (Merck, Taiho Pharmaceutical, and Astex),
Domvanalimab (Arcus Biosciences and Gilead Sciences),
OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb),
Belrestotug + JEMPERLI (iTeos Therapeutics and GSK),
Firmonertinib (ArriVent BioPharma),
Sunvozertinib (DZD9008) (Dizal Pharmaceutical),
Cobolimab (GSK),
Livmoniplimab (AbbVie),
Fianlimab (REGN3767) (Regeneron Pharmaceuticals),
BNT327/PM8002 (Biotheus/BioNTech),
HS-20117 (Hansoh BioMedical),
IO102-IO103 + Pembrolizumab (IO Biotech),
Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech),
FF-10832 (FUJIFILM Corporation),
BNT116 (BioNTechSE/Regeneron Pharmaceuticals),
CAN-2409 (Candel Therapeutics),
Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla),
Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals),
DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku),
Lifileucel (Iovance Biotherapeutics),
IBI363 (Innovent Biologics),
Sotevtamab (AB-16B5) (Alethia Biotherapeutics),
Avutometinib (VS6766) (Verastem Oncology),
Vebreltinib (APL-101) (Apollomics),
LP-300 (Lantern Pharma),
JNJ-90301900 (Johnson & Johnson Innovative Medicine),
AMG 193 (Amgen),
Luveltamab tazevibulin (Sutro Biopharma),
PRT3789 (Prelude Therapeutics),
Disitamab vedotin (Seagen),
PADCEV (enfortumab vedotin) (Astellas Pharma),
RP1 (Replimune),
TIVDAK (tisotumab vedotin) (Seagen),
Zanidatamab (Jazz Pharmaceuticals),
Utidelone injectable
(UTD1) (Beijing Biostar Pharmaceuticals),
REGN5093-M114 (Regeneron Pharmaceuticals),
SLC-391 (SignalChem Lifesciences),
fulzerasib (GenFleet),
Davutamig (REGN5093) (Regeneron Pharmaceuticals),
TAS3351 (Taiho Oncology),
H002 (RedCloud Bio),
JIN-A02 (J INTS BIO),
FWD1509 (Forward Pharma),
Sabestomig (AZD7789) (AstraZeneca),
Sasanlimab (Pfizer),
Selvigaltin (GB1211) (Galecto Biotech),
Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical),
EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech),
Pamvatamig (MCLA-129) (Merus),
Zidesamtinib (NVL-520) (Nuvalent),
NVL-655 (Nuvalent),
RMC-4630 (Revolution Medicines),
REQORSA (quaratusugene ozeplasmid) (Genprex),
PDC*lung01 (PDC*line Pharma),
Evalstotug (BA3071) (BioAtla and BeiGene),
PT-112 (Promontory Therapeutics),
MRT-2359 (Monte Rosa Therapeutics),
GAIA-102 (GAIA BioMedicine),
Rigosertib (Traws Pharma),
HMBD-001 (Hummingbird Bioscience),
PLB1004 (Avistone Biotechnology),
ANS03 (Avistone Biotechnology),
MYTX-011 (Mythic Therapeutics),
A166 (Sichuan Kelun-Biotech Bio-pharmaceutical),
Atamparib (BN-2397) (Ribon Therapeutics),
DELTACEL (KB-GDT-01) (Kiromic BioPharma),
Carotuximab (ENV-105) (Kairos Pharma),
YL202 (MediLink Therapeutics), and others.
To know more about the number of competing drugs in development, visit @
TEPMETKO Market Positioning Compared to Other Drugs
Key Milestones of TEPMETKO
In
February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations.
In
February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
In
February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR.
In
October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations
In
March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations.
In
September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy
Discover how TEPMETKO is shaping the NSCLC treatment landscape @
TEPMETKO NSCLC
TEPMETKO Market Dynamics
TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their
efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available,
enabling better identification of patients who would benefit from targeted treatments like TEPMETKO.
A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with
Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of
once-daily dosing compared to TABRECTA's
twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally,
broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position.
Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but
reimbursement and pricing strategies vary by market. Payer policies, along with the
cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore,
real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration.
Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on
continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape.
Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @
TEPMETKO Market Drug Report
Table of Contents
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Drug ApprovalImmunotherapyPriority Review
04 Mar 2025
First patient enrolled in the Phase II panSOHO basket trial; this is the third BAY 2927088 clinical trial in patients with HER2- activating mutations
Innovative drug development candidate with promising therapeutic potential across several tumor types further strengthens Bayer’s precision oncology development portfolio
BERLIN, Germany I March 4, 2025 I
Bayer announced today that the first patient has been enrolled in the global Phase II panSOHO study, an open-label clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 in adult patients with metastatic or unresectable solid tumors harboring HER2-activating mutations. These include tumors of the colon or rectum, the uterus and the cervix, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors, excluding advanced non-small cell lung cancer (NSCLC).
“We are excited to initiate the panSOHO trial, which represents our ongoing commitment to precision oncology research and the development of innovative targeted therapies,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “This study is a critical step in evaluating a potential new treatment strategy for patients with a variety of solid tumors driven by HER2-activating mutations, who often have limited treatment options.”
Beyond the panSOHO trial, BAY 2927088 is also being investigated in patients with advanced NSCLC harboring HER2-activating mutations. The ongoing Phase III SOHO-02 trial (NCT 06452277) is evaluating BAY 2927088 as a first-line treatment option for these patients. Additionally, BAY 2927088 is being studied in the Phase I/II SOHO-01 trial for patients with advanced NSCLC and HER2-activating mutations who have received prior systemic therapy. In second-line NSCLC for patient with HER2-activating mutations, BAY 2927088 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
HER2-activating mutations can drive the growth of several types of solid tumors, and patients with these mutations often have limited treatment options. The panSOHO study, designed as a basket trial, aims to investigate whether targeting these mutations with BAY 2927088 can offer benefit to these patients. In oncology, basket trials provide the opportunity to test a new drug or treatment on patients with different cancer types that share a common genetic characteristic, like HER2-activating mutation, with the goal of identifying effective, personalized treatments.
Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.
About the panSOHO Study
PanSOHO is a global Phase II, open-label basket trial evaluating the efficacy and safety of investigational agent BAY 2927088 in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations, excluding advanced non-small cell lung cancer (NSCLC). The primary endpoint of the study is objective response rate (ORR) measured by a blinded, independent, central review. Secondary endpoints include duration of response (DOR), progression-free survival (PFS), and evaluating the safety of investigational agent BAY 2927088. More information can be found at
https://clinicaltrials.gov/study/NCT06760819
.
About Investigational Agent BAY 2927088
BAY 2927088 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with advanced NSCLC harboring HER2 activating mutations. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR.
1,2
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 Cell Intrinsic Pathways, Targeted Radionuclide Therapies, and selected 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to
www.bayer.com
.
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References:
1. Siegel F, Karsli-Uzunbas G, Kotynkova K, et al, Preclinical activity of BAY 2927088 in HER2 mutant non-small cell lung cancer. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4035.
2. Siegel F, Siegel S, Graham K, et al. BAY 2927088: The first non-covalent, potent, and selective tyrosine kinase inhibitor targeting EGFR exon 20 insertions and C797S resistance mutations in NSCLC. European Journal of Cancer. 2022;174:S9-S10.
SOURCE:
Bayer
Phase 2Breakthrough Therapy
15 Jan 2025
WHIPPANY, NJ, USA I January 14, 2025 I
On the occasion of the 43rd J.P. Morgan Healthcare Conference in San Francisco, Bayer AG announces further progress in its pharmaceutical growth strategy with multiple regulatory filing submissions underway for key growth drivers darolutamide, finerenone, and elinzanetant.
“We are successfully delivering on our ambitious business goals despite significant headwinds. At the same time, the value of our pipeline is growing by accelerating breakthrough innovations,” said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. “Our new operating model is visibly becoming a key enabler to drive growth and efficiency gains.”
Topline improved and poised for future growth
Bayer continues to strengthen its leadership position in prostate cancer with the anticipated launch of a third indication in 2025 for the oral androgen receptor inhibitor (Ari)darolutamide, marketed under the brand name NUBEQA
®
,supported by data from the ARANOTE trial. Darolutamide plus androgen deprivation therapy (ADT) now has positive data both with and without chemotherapy (docetaxel) based on two pivotal Phase III studies (ARASENS and ARANOTE) in metastatic hormone-sensitive prostate cancer (mHSPC). Bayer recently submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for this third indication for darolutamide in addition to filings in the U.S. and the EU earlier in 2024. NUBEQA achieved global blockbuster status in September 2024 after crossing the threshold of one billion euros in annual sales. Additionally, NUBEQA is now the fastest growing androgen receptor inhibitor in the U.S., with nearly 45,000 patients in the U.S. and 100,000 patients globally treated as of the end of 2024. For important risk and use information about NUBEQA, please see the full
Prescribing Information
.
In Cardiovascular, Bayer submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and CDE of China’s NMPAfor finerenone, marketed as KERENDIA
®
, for the treatment of patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, initiating a major step forward in expanding its reach. Further regulatory filings are planned with a potential market launch by the end of 2025. Filing submissions are based on positive results from the Phase III FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% in patients with HF and a LVEF of ≥40% compared to placebo in addition to a patients’ prescribed treatment regimen. The robust data from Kerendia’s clinical development program underscore its potential to become a pillar of therapy for patients with chronic kidney disease associated with Type 2 Diabetes and patients with heart failure with an LVEF of ≥40%. For important risk and use information about KERENDIA, please see the full
Prescribing Information
.
In Women´s Healthcare, another significant clinical milestone for investigational compound elinzanetant was secured in early 2025 following three positive Phase III readouts in 2024 (OASIS 1,2,3). OASIS 4, which was conducted outside of the U.S., is a Phase III study evaluating elinzanetant as a non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing breast cancer. Elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effects over the study period. The detailed results from OASIS 4 are planned to be presented at an upcoming scientific congress. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause.
In Radiology, Bayer is advancing its pipeline. A significant milestone was achieved with its Phase III QUANTI clinical development program, which evaluated the investigational compound gadoquatrane. The first data from the program showed that gadoquatrane successfully achieved its primary endpoint, highlighting its potential to offer a low dose contrast agent option to patients. The QUANTI program showcases Bayer’s leadership in radiology and its commitment to advancing innovation in medical imaging.
Pipeline value improved and early lead positions strengthened
Bayer is making significant progress with its cell and gene therapy platform, achieving important clinical trial milestones, especially in the field of Parkinson´s disease.
Bemdaneprocel will directly advance to Phase III clinical development in Parkinson’s disease, based on positive data from the Phase I exPDite trial. Bemdaneprocel is an investigational stem cell-based therapy that surgically implants dopamine-generating nerve cell precursors into the brain. The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation for its innovative potential in treating Parkinson’s disease.
AB-1005 is advancing in Phase II with the randomization of participants in the REGENERATE-PD clinical trial focusing on patients with moderate-stage Parkinson’s disease. AB-1005 is an investigational AAV-based gene therapy that delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to the brain to potentially protect and restore dopamine-generating neurons. AB-1005 has received U.S. FDA Fast Track and UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport designations, highlighting its potential to address significant unmet medical needs.
As part of its transformation, Bayer has sharpened its focus in R&D to build a highly differentiated pipeline for long-term growth in oncology, cardiology and renal diseases, neurology and rare diseases, and immunology. Through rigorous assessment and prioritization, Bayer Pharmaceuticals is now fully focused on the areas of greatest unmet need and highest value potential.
Targeted investments in R&D and platform companies in recent years are already strengthening Bayer’s early and late pipelines. With Vividion´s acquisition of the precision oncology platform company Tavros Therapeutics, Bayer continues to leverage its chemoproteomics platform technology to unlock traditionally undruggable targets with precision small-molecule therapeutics. It has initiated Phase I trials with oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies and has IND-enabling programs including a RAS-P13KCA program for RAS-driven cancers.
Additionally in the field of precision oncology, investigational BAY 2927088, an oral, small molecule, tyrosine kinase inhibitor as a potential new targeted therapy for patients with non-small cell lung cancer (NSCLC) harboring HER2 activating mutations, showed promising results as a second line therapy in the ongoing Phase I/II SOHO-01 study evaluating safety and efficacy. Its potential is underscored by Breakthrough Therapy Designations from both the FDA and Chinese CDE. Beyond the SOHO-01 trial, BAY 2927088 is also being assessed for its potential as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations in the SOHO-02 trial. Further, a Phase I clinical trial with BAY3498264, an investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor, has recently been initiated (outside of the US). The open-label, first-in-human, dose escalation study will evaluate patients with KRAS G12C-mutated metastatic cancer. This innovative approach has the potential to enhance the treatment options available for patients, offering the possibility to reduce or stop tumor progression.
Targeted Radionuclide Therapy (TRT) is a strategic area of focus in Oncology precision drug development at Bayer, building on more than 10 years of real-world experience with radium Ra 223 dichloride injection therapy, marketed as XOFIGO
®
, for patients with metastatic castration-resistant prostate cancer. Bayer´s evolving TRT portfolio includes novel targeting approaches which combine alpha radionuclides such as actinium-225 with different targeting moieties, including antibodies, small molecules or peptide-based molecules.
225
Ac-pelgifatamab (BAY 3546828) and
225
Ac-PSMA-Trillium (BAY 3563254), two candidates targeting PSMA (prostate specific membrane antigen), are currently in Phase I clinical trials in patients with advanced metastatic castration resistant prostate cancer (mCRPC). For important risk and use information about XOFIGO, please see the full
Prescribing Information
.
In the field of cardiovascular diseases, Bayer is making progress with its Phase II assets. With BAY3283142, an investigational soluble guanylate cyclase (sGC) activator in patients with chronic kidney disease (CKD), Bayer has entered into a Phase II clinical study. By modulating sGC via a heme-independent pathway, the investigational sGC activator now represents a new class of potential future drugs that could offer an advantage in conditions of high oxidative stress such as in diabetic nephropathy.
With the anti-alpha2 antiplasmin antibody program, Bayer is developing a new modality and mechanism of action-based thrombolytic agent. Based on investigational research, the antibody works by specifically blocking the endogenous plasmin inhibitor, α2AP, potentially leading to the lysis of acute embolic or thrombotic clots with a tolerable safety profile. The investigational antibody is currently being evaluated in Phase II in patients with deep vein thrombosis and could be used for indications of high medical relevance.
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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to
www.bayer.com
.
©
2025 Bayer
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SOURCE:
Bayer
Phase 3Clinical ResultPhase 1Phase 2Drug Approval
100 Deals associated with Sevabertinib
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | United States | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | China | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Japan | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Argentina | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Australia | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Austria | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Belgium | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Brazil | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Bulgaria | 28 Aug 2024 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Canada | 28 Aug 2024 |
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Clinical Result
Clinical Result
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View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1/2 | 33 | pdeouhvzdw(awstjhygyj) = The most common were diarrhea (85%; mainly grade 1-2) and rash (47%; grade 1-2). acqrhjwhdn (ydxfuqsdtq ) | Positive | 02 Jun 2024 | |||
Phase 1 | HER2 ex20ins mutation in non-small cell lung cancer HER2 Expression | 76 | ecfdlanyuy(lhudntnznw) = zwssvqbltg eqounjbbhx (gemyxxzzok ) View more | Positive | 22 Oct 2023 | ||
(pts with HER2 ex20ins mutant disease) | jiiygrvyhz(lyftmkcnqt) = hbgggzsbqr djklejgjpi (sduozqvgzb ) |
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