Delving into the Latest Updates on Sevabertinib with Synapse

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, 司伐替尼, 塞伐艾替尼

+ [4]

Target

EGFR C797S x EGFR exon 20 x HER2 exon 20

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

NeoplasmsRespiratory DiseasesDigestive System Disorders+ [5]

Active Indication

HER2 mutant non-small cell lung cancerAdvanced Lung Non-Small Cell CarcinomaBile Duct Neoplasms+ [19]

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

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

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Structure/Sequence

Molecular FormulaC24H25ClN4O5

InChIKeyVYQVHWNNPKOJEA-AWEZNQCLSA-N

CAS Registry2521285-05-0

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

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100 Translational Medicine associated with Sevabertinib

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100 Patents (Medical) associated with Sevabertinib

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5

Literatures (Medical) associated with Sevabertinib

12 Jan 2026·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.

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 ; Tan, Daniel Shao-Weng ; Wu, Lin ; Kim, Tae Min ; Le, Xiuning ; Rüttinger, Dominik ; Li, Rui ; Dong, Xiaorong ; Li, Lin ; Shinno, Yuki ; Girard, Nicolas ; Brase, Jan Christoph

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.).

Biomolecules

Recent Advances in the Development and Clinical Use of HER2 Inhibitors in Non-Small Cell Lung Cancer

Review

Author: Ekyalongo, Richy ; Yamaoka, Toshimitsu ; Tsurutani, Junji

Alterations in the human epidermal growth factor receptor 2 (HER2) gene are well-recognized oncogenic drivers and therapeutic targets in non-small cell lung cancer (NSCLC). The first anti-HER2 inhibitor, trastuzumab-deruxtecan, was approved for previously treated advanced NSCLC with HER2 mutations, which accounts for 2–4% of NSCLC. The first anti-HER2 antibody, trastuzumab, was approved for HER2-positive metastatic breast cancer in 1998, and a combination therapy comprising trastuzumab, pertuzumab, and docetaxel demonstrated efficacy in the first-line setting. Some EGFR-tyrosine kinase inhibitors (TKIs) have been evaluated as pan-HER TKIs but have shown limited benefits in HER2-altered NSCLC. However, HER2-specific TKIs, such as zongertinib and BAY2927088, have demonstrated encouraging results. Zongertinib was the first HER2-specific TKI to be approved by the FDA in 2025 for previously treated ERBB2-mutated advanced NSCLC. In this narrative review, we have summarized the latest research on the biology of HER2 signaling, HER2 alterations, HER2-targeting therapies, and challenges of treating HER2-overexpressing or -mutated NSCLC. Despite different targets of HER2 mutations in NSCLC and HER2 amplification/overexpression in breast cancer, the development of HER2-targeting agents has been more advanced in breast cancer than in NSCLC. Therefore, pivotal clinical studies in breast cancer may help in identifying more effective therapies for NSCLC.

41

News (Medical) associated with Sevabertinib

27 Feb 2026

·www.pharmaceutical-technology.com

Boehringer inks $500m Sitryx deal, secures CPNV-driven Hernexeos approval

Boehringer has signed a licensing deal worth up to $500m with UK biotech Sitryx, while gaining accelerated approval for TKI Hernexeos in frontline, HER2-mutated NSCLC. Credit: Fagreia / Shutterstock.com. Boehringer Ingelheim has revamped its portfolio and pipeline by inking a immunology-focused licensing deal with Sitryx Therapeutics worth more than $500m, while seperately securing an expanded US approval for its cancer therapy, Hernexeos (zongertinib). At the heart of Boehringer’s deal with Sitryx is the latter’s early-stage immunometabolic programme – which includes several oral small molecule inhibitor candidates targeting an undisclosed novel mechanism. Boehringer has touted these candidates as “potentially disease-modifying” options across certain inflammatory and autoimmune conditions. In exchange for the exclusive global license to Sitryx’s preclinical programme, Boehringer will hand over an undisclosed figure in upfront and near-term payments. The British biotech could also receive development, regulatory and commercialisation milestone payments worth more than $500m through this deal, as well as tiered royalties in future sales if any drug from the partnership were to reach the market. “Autoimmune and inflammatory diseases remain areas where innovation is urgently needed,” said Carine Boustany, head of immunology and respiratory diseases research at Boehringer Ingelheim. “Sitryx’s small molecule inhibitor programme brings forward a promising new mechanism that aligns with our focus on advancing first-in-class approaches,” Boustany added. According to GlobalData’s Pharmaceutical Intelligence Center, Boehringer Ingelheim signed the largest number of licensing deals in over a decade of its history in 2025, with a large proportion (>50%) of these agreements being oncology and immunology-focused. Hernexeos progresses to frontline NSCLC Elsewhere in its business, Boehringer has posted a win for its oncology portfolio through the US accelerated approval of its tyrosine kinase inhibitor (TKI), Hernexeos (zongertinib) in frontline, HER2-mutant non-small cell lung cancer (NSCLC). This makes Hernexeos the second therapy to get the US Food and Drug Administration (FDA) greenlight through the Commissioner’s National Priority Voucher (CNPV) pilot programme, which has prompted discourse amongst experts on how voucher awards are prioritised. Boehringer previously got the FDA go-ahead for Hernexeos in chemotherapy-refractory NSCLC back in August 2025. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Hernexeos’ frontline approval was based on the results of the Phase Ib Beamion LUNG-1 trial (NCT04886804), which saw the drug trigger an objective response rate (ORR) of 76% in patients with treatment-naïve disease. To secure full approval, Boehringer is enrolling patients onto the confirmatory Beamion LUNG-2 study (NCT06151574), which the company estimates will reach primary completion in November 2026, as per ClinicalTrials.gov. Hernexeos’ label expansion sees it become the only targeted therapy approved for use in treatment-naïve patients with HER2-mutant NSCLC. However, Bayer is also looking to push its recently approved TKI , Hynruo (sevabertinib), into the first-line setting through the Phase III, open-label SOHO-02 study (NCT06452277). The current standard of care in HER2-mutant NSCLC is chemotherapy with or without immunotherapy. According to board chair and head of human pharma at Boehringer Ingelheim, Shashank Deshpande, Hernexeos’ approval will “mark a shift towards personalised care” in patients with this type of lung cancer. A 2024 paper published in Clinical Lung Cancer estimates that 1% to 7% of patients with NSCLC have HER2-mutated disease. In conversation with Clinical Trials Arena , sister company of Pharmaceutical Technology , practicing oncologist and NSCLC expert, Balazs Halmos, noted that it will be hard as a physician to prioritise either Bayer’s TKI, sevabertinib, or Hernexeos based on efficacy and safety.

Phase 3Clinical ResultLicense out/inImmunotherapyPhase 1

26 Feb 2026

·endpoints.news

Voucher holder Boehringer wins sped-up approval for first-line use of lung cancer drug

The FDA greenlit an expanded label for Boehringer Ingelheim’s lung cancer drug Hernexeos, marking the first use of the Commissioner’s National Priority Voucher for a new indication. Boehringer won an accelerated approval for use of Hernexeos in advanced non-small cell lung cancer patients with certain HER2 mutations who haven’t previously been treated. In August, the agency granted accelerated approval for use of the drug in patients who have been treated with other therapies. The decision gives Boehringer an advantage over its rival Bayer, which is studying its HER2-targeted pill Hyrnuo in first-line patients. Bayer has neither received the Commissioner’s voucher nor announced an FDA submission in the first-line indication. A spokesperson for Bayer didn’t immediately respond to a request for comment. The commissioner’s voucher is a pilot program meant to significantly speed the review of drugs from “companies supporting US national interests.” Health policy experts and some former FDA officials have raised concerns over whether the program is politicizing the drug approval process. “The FDA is on the hunt for game-changing therapies that can qualify for a priority review. In this case a final decision was rendered 44 days after the filling date,” FDA Commissioner Marty Makary said in a statement on Thursday. A Boehringer spokesperson told Endpoints News in early December that it anticipated “hearing news within the coming weeks” on the Hernexeos decision. On Dec. 16, the company told Endpoints that its supplemental application “is currently under review within the parameters of this pilot program.” Last October, both Boehringer and Bayer presented data at the biggest European cancer conference, ESMO, concerning the use of their rival drugs in first-line patients. Those data showed similar efficacy, though a smaller proportion of patients who received Boehringer’s drug experienced diarrhea. About 2% to 4% of non-small cell lung cancer cases bear HER2 mutations. Boehringer and Bayer contend their drugs can provide a potentially safer and more convenient targeted treatment option for those patients compared to other HER2 therapies, such as AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu. The first commissioner’s voucher recipient to get an approval was USAntibiotics in December for Augmentin XR, an extended-release form of the antibiotic amoxicillin. GSK’s version of the antibiotic initially won US approval in 2002, but it was later pulled from the market for commercial reasons. Boehringer was one of 17 drugmakers that the Trump administration called out in July as part of its “most favored nation” push around drug pricing.

Drug ApprovalPriority ReviewAccelerated Approval

26 Feb 2026

·firstwordpharma.com

Commissioner's voucher powers Boehringer's Hernexeos to frontline NSCLC nod

Boehringer Ingelheim's Hernexeos (zongertinib) is the second recipient of a Commissioner's National Priority Voucher (CNPV) to win an OK from the FDA, with the US regulator granting the oral tyrosine kinase inhibitor (TKI) accelerated approval in certain patients with lung cancer. The first FDA approval sped up by a CNPV went to a US-manufactured version of the antibiotic Augmentin XR (amoxicillin-clavulanate potassium) in December. Hernexeos takes the lead in TKI raceThursday's clearance, which allows Hernexeos to be used as a frontline treatment for HER2-mutated, advanced non–small-cell lung cancer (NSCLC), comes less than a year after it was initially greenlit in the second-line setting. The latest approval gives Hernexeos another leg up over rival HER2-targeting TKI, Hyrnuo (sevabertinib) from Bayer. While both clinched US accelerated approvals in the post-platinum setting last year based on near-identical efficacy, experts have been more impressed by the safety of Boerhinger's drug (see – Spotlight On: Boehringer looks to get jump on Bayer in first-line HER2-positive lung cancer race).Speaking with FirstWord last year, Patrick Forde, director of the Thoracic Cancer Clinical Research Program at Johns Hopkins, described Hernexeos as "the best small-molecule therapeutic so far for HER2-mutant disease."At the European Society for Medical Oncology (ESMO) congress last year, Boehringer presented data from the Phase Ib Beamion LUNG-1 trial demonstrating that Hernexeos achieved a confirmed objective response rate (ORR) of 77% in treatment-naïve patients. For Hyrnuo's part, it has shown an ORR in treatment-naïve patients in the 60% to 70% range, but a higher rate of grade ≥3 adverse events, about 30%, as well as drug-related diarrhoea.The CNPV received by Boehringer in November served to widen the gap between the rival TKIs by putting Hernexeos on a regulatory fast-track. While the application's review faced a short delay, Hernexeos seems to have clinched an accelerated approval before Bayer submitted a supplemental NDA for Hyrnuo. Beamion LUNG-2, a confirmatory Phase III trial of Hernexeos in the first-line setting, is now enrolling patients.

Phase 3Drug ApprovalClinical ResultAccelerated ApprovalNDA

100 Deals associated with Sevabertinib

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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 Pharmaceuticals, Inc.	19 Nov 2025
HER2 mutant non-small cell lung cancer	United States	Bayer HealthCare	19 Nov 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
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
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	Bayer AG	28 Aug 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05099172 (SOHO-01, ESMO_ASIA2025)	Phase 1/2	HER2 mutant non-small cell lung cancer First line HER2-activating mutations	140	Sevabertinib 20 mg (naïve to HER2-targeted therapy)	izsobojdiw(fksfoznxct) = yxtcwbuegr ziolgelaeb (boadzpfeow, 47.6 - 74.0) View more	Positive	05 Dec 2025
				Sevabertinib 20 mg (previously received HER2-targeted antibody-drug conjugates)	izsobojdiw(fksfoznxct) = ldrxtpvyxa ziolgelaeb (boadzpfeow, 29.1 - 65.3) View more
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)	dpqszrymdq(rggkugzict) = rthzsmqbeo isjkuqiaec (ftgcnjjjvp, 59 - 82) View more	Positive	19 Nov 2025
				HYRNUO (NSCLC Previously Treated, Including Prior HER2 Targeted Antibody Drug Conjugates (ADCs): Group E)	dpqszrymdq(rggkugzict) = dlqgoznogg isjkuqiaec (ftgcnjjjvp, 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)	azhhpglxay(vwbvbungfi) = zjjkbfrwva hybyxujicf (tptzfbyyzy, 53 - 75) View more	Positive	06 Nov 2025
				Sevabertinib 20mg (cohort E: previously received HER2-directed ADC)	azhhpglxay(vwbvbungfi) = ryqhcnywaq hybyxujicf (tptzfbyyzy, 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)	kyuxvwrdfi(cwywoopiex) = zzqontklyv hxhivwgzyn (mbjdnwxinf )
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)	ilvimxmzul(cgmlryqtot) = bsohkqprqt cjfmrsdakw (nnguqsqqdo, 53 - 75) View more	Positive	17 Oct 2025
				Sevabertinib 20 mg (previous HER2-targeted antibody-drug conjugates)	ilvimxmzul(cgmlryqtot) = uqjsbkozij cjfmrsdakw (nnguqsqqdo, 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)	emmsvaofjl(brmbbspmvo) = observed in 96.7% of patients xiwhxjptzl (rxnswpgiww ) 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	hkveenkprk(eooulyfkxb) = xdlwqhlguc ujdyibwgfq (ddlydvponz ) View more	Positive	26 Mar 2025
				Placebo	hkveenkprk(eooulyfkxb) = efiriytsam ujdyibwgfq (ddlydvponz ) 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	foxtzgzjwu(kykqcerjgh) = The most common were diarrhea (85%; mainly grade 1-2) and rash (47%; grade 1-2). diqzgslryj (acbxyetvic )	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	owurqkfapn(ttuoaoqqrp) = fkgdrqaaux yyvetjnxek (xyccsolcuq ) View more	Positive	22 Oct 2023
				BAY 2927088 (pts with HER2 ex20ins mutant disease)	icqeezgayc(abbteotkqw) = mifqaxwzis garewapwlm (vejyvzlill )