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

NeoplasmsRespiratory Diseases

Active Indication

HER2 mutant non-small cell lung cancerLung CancerAdvanced Lung Non-Small Cell Carcinoma+ [5]

Inactive Indication-

Originator Organization

Bayer AG

Active Organization

Bayer AGBayer HealthCare

Bayer HealthCare Pharmaceuticals, Inc.

Inactive Organization

The Broad Institute, Inc.

License Organization

Bayer HealthCare Pharmaceuticals, Inc.

The Broad Institute, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (19 Nov 2025),

HER2 mutant non-small cell lung cancer

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Orphan Drug (Japan), Priority Review (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC24H25ClN4O5

InChIKeyVYQVHWNNPKOJEA-AWEZNQCLSA-N

CAS Registry2521285-05-0

Clinical Trials associated with Sevabertinib

NCT07102095

/ RecruitingPhase 1

A Phase 1, Open-label, Single-dose Study to Assess the Influence of Hepatic Impairment on the Pharmacokinetics of BAY 2927088

This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
Sevabertinib is an experimental drug being developed to treat certain types of cancers that have specific genetic changes called HER2 mutations. This includes lung cancer, tumors that have spread to other parts of the body (metastatic), and tumors that cannot be removed with surgery (unresectable). Before this medicine can be given to cancer patients with liver problems, researchers need to understand how liver disease might change the way the body handles the drug.
The study will include about 20 people divided into two groups: 10 people with moderate liver problems (called Child-Pugh B liver impairment) and 10 healthy people with normal liver function. The healthy volunteers will be matched to the liver patients by age, sex, and weight to make fair comparisons.
All participants will take a single 20 mg dose of sevabertinib by mouth and stay in the research clinic for 5 days. During this time, researchers will take blood samples at specific times to measure how much drug is in the blood and how long it stays in the body. They will also monitor participants closely for any side effects.
The main goal is to see if people with liver problems have different drug levels in their blood compared to healthy people. This information will help doctors determine if cancer patients with liver disease need different doses of sevabertinib to be safe and effective.
The study will also look at the safety and tolerability of sevabertinib in both groups. Participants will have follow-up visits to ensure their continued health and safety.
This research is important because many cancer patients also have liver problems, and understanding how liver disease affects this new cancer treatment will help ensure it can be used safely and effectively in all patients who might benefit from it.

Start Date24 Jul 2025

Sponsor / Collaborator

Bayer AG

NCT06760819

/ RecruitingPhase 2

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 (sevabertinib) 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 breast, 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

Bayer AG

NCT06452277

/ RecruitingPhase 3

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.
The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC.
The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations.
The study participants will receive one of the study treatments:
* BAY 2927088 twice every day as a tablet by mouth, or
* Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment.
During the study, the doctors and their study team will:
* take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer
* check the overall health of the participants by performing tests such as blood and urine tests, and checking
* heart health using an electrocardiogram (ECG)
* perform pregnancy tests for women
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Start Date28 Aug 2024

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Sevabertinib

100 Translational Medicine associated with Sevabertinib

100 Patents (Medical) associated with Sevabertinib

Literatures (Medical) associated with Sevabertinib

06 Nov 2025·NEW ENGLAND JOURNAL OF MEDICINE

Sevabertinib in Advanced HER2 -Mutant Non–Small-Cell Lung Cancer

Article

Author: Grassi, Paolo ; Ruiter, Gerrina ; Fang, Yong ; Prelaj, Arsela ; Kim, Hye Ryun ; Goh, Boon Cher ; Lu, Shun ; Miao, Liyun ; Yang, Tsung-Ying ; Novello, Silvia ; Brega, Nicoletta ; Goto, Koichi ; Loong, Herbert H. ; Bao, Weichao ; Descamps, Tine ; Zhao, Jun ; Jänne, Pasi A. ; Daniele, Gennaro ; Wu, Lin ; Kim, Tae Min ; Tan, Daniel Shao-Weng ; Le, Xiuning ; Rüttinger, Dominik ; Li, Rui ; Dong, Xiaorong ; Li, Lin ; Shinno, Yuki ; Brase, Jan Christoph ; Girard, Nicolas

BACKGROUND:

HER2 gene mutations occur in 2 to 4% of patients with non-small-cell lung cancer (NSCLC). Sevabertinib is an oral, reversible tyrosine kinase inhibitor that has shown anti-HER2 activity in preclinical models.

METHODS:

We conducted an open-label, multicenter, multicohort, phase 1-2 study to evaluate sevabertinib at a twice-daily dose of 20 mg in patients with locally advanced or metastatic HER2-mutant NSCLC. Three cohorts were defined according to previous therapy: cohort D comprised previously treated patients who had not received HER2-targeted therapy; cohort E, patients who had previously received HER2-directed antibody-drug conjugates; and cohort F, patients who had not previously received treatment. The primary end point was an objective response, as assessed by blinded independent central review. Secondary end points were duration of response and progression-free survival.

RESULTS:

A total of 209 patients received sevabertinib (as of June 27, 2025, the data-cutoff date); the median duration of follow-up was 13.8 months in cohort D, 11.7 months in cohort E, and 9.9 months in cohort F. Among 81 patients in cohort D, an objective response was observed in 64% (95% confidence interval [CI], 53 to 75); the median duration of response was 9.2 months (95% CI, 6.3 to 13.5), and the median progression-free survival was 8.3 months (95% CI, 6.9 to 12.3). Among 55 patients in cohort E, an objective response was observed in 38% (95% CI, 25 to 52); the median duration of response was 8.5 months, and the median progression-free survival was 5.5 months. Among 73 patients in cohort F, an objective response was observed in 71% (95% CI, 59 to 81), and the median duration of response was 11.0 months; data on progression-free survival were immature. Grade 3 or higher drug-related adverse events occurred in 31% of the patients. The most common adverse event was diarrhea (in 84 to 91%), with diarrhea of grade 3 or higher occurring in 5 to 23%. Treatment was discontinued by 3% of the patients owing to drug-related adverse events.

CONCLUSIONS:

Sevabertinib showed antitumor activity in patients with locally advanced or metastatic HER2-mutant NSCLC. Diarrhea was the most common adverse event. (Funded by Bayer; SOHO-01 ClinicalTrials.gov number, NCT05099172.).

Cancer Discovery

Sevabertinib, a Reversible HER2 Inhibitor with Activity in Lung Cancer

Article

Author: Grassi, Paolo ; Denney, Daniel ; Cherniack, Andrew D. ; Kaplan, Bethany ; Hillig, Roman C. ; Golfier, Sven ; Kotýnková, Kristýna ; Lewis, Timothy A. ; Berger, Markus ; Eis, Knut ; Goto, Koichi ; Siegel, Stephan ; Korr, Daniel ; Tomono, Haruna ; Petersen, Kirstin ; Loong, Herbert H. ; Boemer, Ulf ; Andersen, Sawyer ; Meyerson, Matthew ; Karsli Uzunbas, Gizem ; Mortier, Jérémie ; Greulich, Heidi ; Rüttinger, Dominik ; Schulze, Volker K. ; Siegel, Franziska ; Williams, Sybil

Abstract:

Exon 20 insertions of HER2, encoded by erb-b2 receptor tyrosine kinase 2 (ERBB2), and other activating HER2 mutations occur in 2% to 4% of lung adenocarcinomas, but there are only limited therapeutic options available for these patients. Sevabertinib (BAY 2927088) is a potent and reversible dual EGFR–HER2 inhibitor that is selective with respect to wild-type EGFR. In this study, we report the preclinical activity of sevabertinib in lung cancer models harboring alterations of HER2, including exon 20 insertions, point mutations, and amplification of wild-type ERBB2. We furthermore demonstrate the activity of sevabertinib in a cancer cell line dependent on a fusion of neuregulin-1, a ligand for the HER2 family member and heterodimerization partner, HER3. Finally, we report patient responses to sevabertinib from a phase 1/2 clinical trial, indicating potential benefit for patients with HER2-mutant lung cancer.

Significance::

Additional therapeutic options are needed for patients with lung cancer with HER2 activating mutations, including exon 20 insertions. Sevabertinib shows activity against ERBB2-encoded HER2 exon 20 insertions in preclinical models of lung cancer, corroborated by early data from a phase 1/2 clinical trial.

News (Medical) associated with Sevabertinib

20 Nov 2025

·www.einpresswire.com

FDA approves first cancer drug based on Broad Institute science

The US Food and Drug Administration has approved the first cancer drug based on discoveries from Broad Institute scientists. The drug, sevabertinib, was developed by Bayer Healthcare Pharmaceuticals in close collaboration with the Broad, and is the first FDA-approved medicine from the long-standing Broad-Bayer oncology research alliance. Sevabertinib is a new oral treatment option for a type of non-small-cell lung cancer, the most common type of lung cancer. The medicine is a pill that patients can take at home and is approved for adult patients with certain HER2 mutations in their tumors and who have already received chemotherapy or immunotherapy. This translates to roughly 4,000 to 8,000 lung cancer patients in the US every year who could potentially benefit from this new drug. Many of these patients are women, including younger women who have never smoked. The drug's approval is based on data from Bayer’s Phase I/II clinical trial, which found that over 70 percent of the patients studied in one cohort saw their tumors shrink or disappear. Many patients experienced profound and durable responses. This achievement is the result of discoveries made by Broad scientists two decades ago and of the collaboration between Broad and Bayer Pharmaceuticals, which began in 2013 . The team's clinical success demonstrates that long-term academic-industry partnerships can close the gap between biological discoveries and new medicines that improve health. "The whole idea of the Broad Institute when it was founded more than 20 years ago was to bring the power of human genome science and high-throughput research to solving human disease," said Matthew Meyerson , a lead cancer biologist on the project, institute member at the Broad, the Charles A. Dana Chair in Human Cancer Genetics at Dana-Farber Cancer Institute, and professor of genetics and medicine at Dana-Farber and Harvard Medical School. "Today, with our industry partners at Bayer, we're now able to see the fruits of these efforts in a new drug that we hope can help many patients by extending their lifespan and improving their quality of life." New option for lung cancer patients Lung cancer is the leading cause of cancer-related deaths in the US, and non-small-cell lung cancer (NSCLC) accounts for more than 85 percent of lung cancer cases. Up to 4 percent of NSCLC cases carry a HER2 gene mutation, which causes the HER2 protein to become overactive and spur abnormal cell growth. Sevabertinib halts the activity of HER2 proteins with certain mutations, inhibiting the growth of tumors. Approved as a second-line treatment, it may serve a patient population that until recently had no remaining options after chemotherapy or immunotherapy for treating their cancer. The FDA granted sevabertinib a Breakthrough Therapy designation in 2024, signifying that the compound may provide substantial improvement over existing therapies in an area of high unmet medical need. In 2025, sevabertinib was additionally granted Priority Review status , meaning the FDA would aim to take action on an application within six months (compared to ten months under standard review). A research success story This milestone began with work first published in 2005 led by Meyerson and Heidi Greulich , an institute scientist and senior group leader in the Cancer Program at the Broad. In 2005, the Broad team reported that some lung cancer patients who didn't respond to existing drugs had a mutation in their tumors known as an “exon 20 insertion” — an extra bit of DNA tucked in at a specific location in the gene EGFR . Developing a drug to target this mutation was one of the first projects for the Broad-Bayer alliance when it launched in 2013, and the work soon evolved into creating a drug to target a similar mutation in HER2 , a gene closely related to EGFR that’s involved in lung and other cancers. "We've been collaborating closely with the Bayer team on sevabertinib and its precursor compounds for 12 years now,” said Greulich. “It really shows how the power of persistence can be brought to bear on difficult problems to help patients." A Phase III clinical trial is continuing to evaluate sevabertinib as a first-line treatment option for patients with NSCLC carrying HER2 mutations. The drug is also being studied in patients with other metastatic or unresectable solid tumors, beyond lung cancer, that have HER2 mutations. "We're in an extraordinary time for the development of new medicines to treat cancer patients," said Meyerson. "And I think that, with our industry partners, we have a huge opportunity to repeat this success not once, not twice, but many, many times over." Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalImmunotherapyBreakthrough TherapyPhase 3Priority Review

20 Nov 2025

·www.einpresswire.com

Q&A: How an academic-industry alliance is reshaping the way research can lead to new medicines

Contributions to this project were also made by colleagues in the Broad’s technology platforms, including the Genetic Perturbation Platform , the Center for the Development of Therapeutics , and the Proteomics Platform , and by colleagues in the Broad’s Cancer Program . What were some of the challenges you faced in developing this new medicine? HG: We encountered many challenges during the course of this project, so it wasn't smooth sailing all the way through. In fact, when we started the project, there were no cellular models available so we had to come up with a cellular assay that we could use to test early compounds. Our initial cell assay was unstable, but heroic efforts from senior research associate Bethany Kaplan helped to stabilize the assay so that it was robust enough for compound testing. In addition, our chemistry colleagues at Bayer worked for years to improve the potency, selectivity, and stability of the compounds to eventually develop sevabertinib. How did two decades of basic cancer research contribute to the development of the new drug? MM: The development of sevabertinib is a real testament to the power of long-term collaborative partnerships. Heidi and I have been working together on EGFR and HER2 for 22 years now, and we've developed a lot of knowledge of these molecules and how they behave. Before that, Bill Sellers and I worked to explore alterations of tyrosine kinase enzymes in human cancer that led to the EGFR discovery. And going back even further, Bill and Broad Institute director Todd Golub and I worked to understand what happens in the genomes of human cancers more broadly. These long-term scientific collaborations and all the biological insight that came from them, along with our deep and continued commitment to solving the same problems, have really helped us to get to where we are today with the development of sevabertinib. What’s next for sevabertinib and similar efforts? MM: It is an extraordinary time to make many new treatments for patients with cancer and other diseases as well. The success of sevabertinib is a real proof-of-concept that we can do this again. If we can keep targeting the genomic causes of cancer in a disciplined and persistent way, we will continue making further advances in cancer treatment, so it’s important that we keep this momentum going forward. Here at the Broad, with our industry partners, we could do this again, not just once, not just twice, but many, many more times, and I’m looking forward to our opportunities to do that. Seeing this effort come to fruition after so many years of hard work, what are your reflections on this milestone? MM: As a cancer researcher, it's just an incredible honor and privilege to be part of a team that has brought forward a new medicine that can help people with the terrible disease of lung cancer. HG: Not all academic scientists have the opportunity to initiate and execute a drug discovery project that directly benefits patients, so we’ve been incredibly fortunate in this respect. The development of sevabertinib is also really meaningful for me personally. Both my parents passed away from cancer, and my father from lung cancer in particular. So the fact that I've made a contribution to help other lung cancer patients resonates with me and makes me really glad I come to work every day at the Broad. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Cell Therapy

20 Nov 2025

·www.businesswire.com

Thermo Fisher Scientific’s Oncomine Dx Target Test Receives FDA Approval as a Companion Diagnostic to Identify Patients Eligible for Newest Targeted Therapy for Non-Small Cell Lung Cancer

CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients who may be eligible for treatment with HYRNUO™ (sevabertinib), a new HER2-directed therapy developed and commercialized by Bayer. The test enables clinicians and pathologists to identify non-small cell lung cancer (NSCLC) tumors with certain HER2/ERBB2 tyrosine kinase domain (TKD) activating mutations, helping determine which patients may benefit from HYRNUO™ therapy. The FDA also approved HYRNUO™ on November 19 for the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD activating mutations. The contemporaneous approval of Bayer’s therapy and Thermo Fisher’s companion diagnostic helps close access gaps, ensuring labs have access to essential companion testing as soon as the drug is available. Lung cancer remains the leading cause of cancer death worldwide, with NSCLC representing approximately 87 percent of all lung cancer cases.1 For patients with NSCLC presenting with HER2 mutations, this approval represents an opportunity to provide more targeted treatment for a disease that has traditionally had limited therapeutic options as well as poor prognosis with a survival rate of less than 10% for metastatic disease.2 Historically, nearly 50% of eligible patients miss out on targeted therapies due to testing and report delays, access limitations or lab bottlenecks3, creating gaps that hinder precision medicine progress. “We are committed to advancing innovation for patients with difficult-to-treat cancers, and this approval marks another step forward in ensuring all patients with cancer have access to optimal treatment options,” said Emmanuelle Di Tomaso, VP, Global Head of Translational Sciences Oncology at Bayer. “Collaborating with Thermo Fisher to leverage the Oncomine Dx Target Test allows us to ensure clinical teams can identify patients who are most likely to benefit from sevabertinib, supporting timely and informed treatment decisions in real-world clinical settings.” The Oncomine Dx Target Test received its first approval by the FDA as a next-generation sequencing (NGS) CDx in 2017, followed by regulatory approvals in 20 countries for 11 biomarkers and over 20 targeted therapies (availability of these approvals vary per region). “The power of precision medicine starts with accurate, timely genomic insights that help providers match patients to the right therapies,” said Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific. “Our experience as a companion diagnostics partner of choice for pharmaceutical companies allows us to support the development of new therapies, accelerate access and help clinicians make the best possible decisions for their patients.” Broad reimbursement coverage—including the U.S., Europe, Japan, South Korea, and Israel—makes the Oncomine Dx Target Test accessible to more than 550 million people worldwide. In the U.S., the Oncomine Dx Target Test is authorized for use alongside multiple therapies for NSCLC and a range of other tumor types, such as cholangiocarcinoma (CC), astrocytoma (AC) and oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC), and thyroid cancer (TC). For more information on the Oncomine Dx Target Test and Thermo Fisher’s leadership in companion diagnostics, please visit thermofisher.com/cdx. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Drug ApprovalDiagnostic Reagents

100 Deals associated with Sevabertinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 mutant non-small cell lung cancer	United States	Bayer HealthCare	19 Nov 2025
HER2 mutant non-small cell lung cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	19 Nov 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lung Cancer	NDA/BLA	Canada	Bayer AG	01 May 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Argentina	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Austria	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Belgium	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	Bayer AG	28 Aug 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Bulgaria	Bayer AG	28 Aug 2024

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Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05099172 (SOHO-01, FDA_CDER) Manual	Phase 1/2	HER2 mutant non-small cell lung cancer ERBB2 Mutation (Activating)	122	HYRNUO (NSCLC Previously Treated, Naïve to HER2-Targeted Therapy: Group D)	awaeebbkxl(cdvefyhjzh) = msbbkamdqj ykigohulwa (hoowtlyxjm, 59 - 82) View more	Positive	19 Nov 2025
				HYRNUO (NSCLC Previously Treated, Including Prior HER2 Targeted Antibody Drug Conjugates (ADCs): Group E)	awaeebbkxl(cdvefyhjzh) = saalyaybdf ykigohulwa (hoowtlyxjm, 25 - 53) View more
NCT05099172 (SOHO-01, Pubmed \| N Engl J Med) Manual	Phase 1/2	HER2 mutant non-small cell lung cancer ERBB2 Mutation	209	Sevabertinib 20mg (cohort D: previously treated, naïve to HER2-targeted therapy)	mcgwyrdplr(bsjvojthpy) = oodivznxvc zjippcmhgj (uqpbcxqhch, 53 - 75) View more	Positive	06 Nov 2025
				Sevabertinib 20mg (cohort E: previously received HER2-directed ADC)	mcgwyrdplr(bsjvojthpy) = ujfrvvibww zjippcmhgj (uqpbcxqhch, 25 - 52) View more
NCT05099172 (SOHO-01, ESMO2025)	Phase 1	HER2 mutant non-small cell lung cancer HER2-mutant	136	Sevabertinib	-	Positive	17 Oct 2025
				Sevabertinib (HER2 mutations in the tyrosine kinase domain)	feviffrmkf(sckpkmfxnu) = jvjizgeqcn cjcimvkajd (rtqovpjydn )
NCT05099172 (SOHO-01, ESMO2025)	Phase 1/2	HER2 mutant non-small cell lung cancer HER2-mutant	209	Sevabertinib 20 mg (previous systemic therapy but naïve to HER2 ex20ins-targeted therapy)	lnkcrkhupy(fbpuarxveu) = wacvtwemwf wsireuknzt (awwuoygdwu, 53 - 75) View more	Positive	17 Oct 2025
				Sevabertinib 20 mg (previous HER2-targeted antibody-drug conjugates)	lnkcrkhupy(fbpuarxveu) = bxzqhenopo wsireuknzt (awwuoygdwu, 25 - 52) View more
NCT05099172 (SOHO-01, ASCO2025) Manual	Phase 1/2	HER2 mutant non-small cell lung cancer ERBB2 Mutation (Activating)	120	BAY 2927088 20 mg twice daily (patients had disease progression following ≥1 systemic therapies and were naïve to HER2-targeted therapy)	xvauryzwpe(pobuaotnjy) = observed in 96.7% of patients wynejxvhfi (vclpmwhqsy ) View more	Positive	30 May 2025
				BAY 2927088 20 mg twice daily (patients had not received any systemic therapy for locally advanced or metastatic disease)
NCT05099172 (SOHO-01, ESMO_ELCC2025)	Phase 1/2	HER2 mutant non-small cell lung cancer HER2-activating mutations	-	BAY 2927088 20 mg twice daily	vfrrchtgwg(oviiurhwyc) = hshqfvukxx qgzbfwihyv (fwupyeagxw ) View more	Positive	26 Mar 2025
				Placebo	vfrrchtgwg(oviiurhwyc) = cgniwebqkp qgzbfwihyv (fwupyeagxw ) View more
NCT05099172 (SOHO-01, ASCO2024) Manual	Phase 1/2	HER2 mutant non-small cell lung cancer Second line \| Third line HER2-activating mutation	33	BAY 2927088	ojhxtpsqay(eyetacnivu) = The most common were diarrhea (85%; mainly grade 1-2) and rash (47%; grade 1-2). nrupuiiqre (vfbpbyyzon )	Positive	02 Jun 2024
NCT05099172 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	HER2 ex20ins mutation in non-small cell lung cancer HER2 Expression	76	BAY 2927088	unhkusuayj(ybzrukipjd) = axnrhclrkk qdwirtswwi (lwsponbmhg ) View more	Positive	22 Oct 2023
				BAY 2927088 (pts with HER2 ex20ins mutant disease)	duzbuitfch(jeqoeqcoaz) = ezozmxnien galhwtmmaw (pdqblzjpor )

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