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

+ [7]

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 Diseases

Active Indication

HER2 mutant non-small cell lung cancerAdvanced Lung Non-Small Cell CarcinomaHER2 Mutation Lung Cancer+ [4]

Inactive Indication-

Originator Organization

Bayer AG

Active Organization

Bayer AGBayer Korea Ltd.

Bayer HealthCare Pharmaceuticals, Inc.

+ [2]

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), Orphan Drug (South Korea), Conditional marketing approval (China)

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Structure/Sequence

Molecular FormulaC24H25ClN4O5

InChIKeyVYQVHWNNPKOJEA-AWEZNQCLSA-N

CAS Registry2521285-05-0

This Phase 1 study in healthy adults looks at whether sevabertinib changes how the body handles metformin. The study is based on the idea that sevabertinib may block kidney transporters (proteins that move medicines) called MATE1 and MATE2-K, which help remove metformin from the body. Each participant receives a single dose of metformin alone, and later receives sevabertinib for several days and then takes metformin again while still taking sevabertinib. The study aims to learn how metformin, gets into, moves through, and out of the body when it is administered with sevabertinib. This is called "Pharmacokinetics". Furthermore, the study will help us learn about the safety and tolerability of sevabertinib and metformin when given alone or in combination.

Start Date21 Aug 2026

Sponsor / Collaborator

Bayer AG

NCT07102095

/ CompletedPhase 1

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

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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17

Literatures (Medical) associated with Sevabertinib

01 Dec 2026·Pharmaceutical Science Advances

Recent advances in HER2-targeted inhibitors for cancer therapy

Review

Author: Zhu, Wenjian ; Lu, Xiaoyun

HER2 (ErbB2), a ligand-independent HER family member, regulates cell growth, differentiation, and survival. Its overexpression, gene amplification, and activating mutations are oncogenic drivers in multiple malignancies. The past two decades have witnessed transformative advances in HER2-targeted therapeutics, exemplified by tyrosine kinase inhibitors (TKIs), including first-generation reversible pan-HER (e.g., lapatinib), second-generation covalent pan-HER (neratinib, pyrotinib), and novel selective HER2 inhibitors (tucatinib, sevabertinib, zongertinib). Nonetheless, the extensive molecular heterogeneity in HER2 activation (e.g., dimerization, amplification) and mutation profiles (e.g., L755S, exon 20 insertions), combined with tumor-type-specific pathogenic mechanisms, poses significant challenges to precision oncology in clinical practice. Currently, numerous promising inhibitors in preclinical and clinical development hold potential for providing more effective treatment options. This review comprehensively summarizes recent advances in HER2-targeted TKIs and their emergent resistance mechanisms, further analyzing strategies to both mitigate off-target toxicity and overcome resistance through rational design of selective HER2 inhibitors. Collectively, these insights provide a roadmap for developing next-generation precision therapies in HER2-driven cancers.

01 Aug 2026·Journal of Thoracic Oncology

ERBB2-Activating Mutations and Co-Occurring Genomic Alterations Contribute to Disease Heterogeneity in Patients With ERBB2-Mutant Lung Cancer

Article

Author: Stockhammer, Paul ; Li, Fangyong ; Schillo, Jacob L ; Politi, Katerina ; Goldberg, Sarah B ; El Zarif, Talal ; Grant, Michael J

INTRODUCTION:

ERBB2 mutations occur in 1% to 4% of all NSCLCs. Trastuzumab-deruxtecan and the novel ERBB2 tyrosine kinase inhibitors zongertinib and sevabertinib are approved by the Food and Drug Administration for the treatment of metastatic ERBB2-mutant NSCLC based on data from tumors harboring tyrosine kinase domain (TKD) mutations. The clinico-genomic characteristics of NSCLC tumors with ERBB2 mutations beyond the TKD remain largely unexplored.

METHODS:

Patients with NSCLC with oncogenic ERBB2 mutations included in two independent cohorts (American Association for Cancer Research Project GENIE database and the U.S.-based deidentified Flatiron Health-Foundation Medicine advanced NSCLC Clinico-Genomic Database [FH]) were studied. The clinico-genomic characteristics of patients with tumors harboring TKD, extracellular domain (ECD), or transmembrane domain (TMD)-juxtamembrane domain (JMD) ERBB2 mutations were compared, and clinical outcomes with chemoimmunotherapy were evaluated.

RESULTS:

A total of 483 patients (GENIE [Genomics Evidence Neoplasia Information Exchange] cohort) and 286 patients (FH cohort) with ERBB2-mutant NSCLC were included. In both cohorts, most patients had tumors harboring TKD (75% and 71%), followed by ECD (18% and 24%) and TMD-JMD mutations (7% and 5%). In both cohorts, male patients (p < 0.05), patients with squamous NSCLC tumors (p = 0.0001 and p = 0.0002), and patients with a smoking history (p = 0.01 and p < 0.0001) were more likely to have ECD-mutant tumors. In the GENIE cohort with detailed genomic information available, ECD- versus TKD-mutant tumors had a higher median tumor mutation burden (p < 0.0001) and higher rates of co-mutations in EGFR (p < 0.0001), KRAS (p < 0.0001), STK11 (p < 0.0001), KEAP1 (p < 0.0001), and SMARCA4 (p < 0.0001). TMD-JMD-mutant tumors had high rates of PIK3CA (24%) and RBM10 (18%) co-mutations. In the FH cohort with detailed outcome data available, among patients with advanced ERBB2-mutant NSCLC treated with first-line chemoimmunotherapy, those with ECD-mutant tumors had longer 12-month progression-free survival compared with those with TKD mutations (35% versus 18%; hazard ratio, 0.72; confidence interval, 0.54-0.94, p = 0.026). This difference persisted in a multivariate Cox regression model accounting for other variables.

CONCLUSION:

NSCLCs harboring ECD-ERBB2 mutations are associated with a unique clinico-genomic phenotype and improved outcomes with first-line chemoimmunotherapy. These findings have implications for optimizing treatment strategies in this disease.

01 May 2026·Journal of Thoracic Oncology

Emerging Targeted Therapies for HER2-Mutant NSCLC

Review

Author: Paz-Ares, Luis ; Serrano, Cristina ; Del Rio, Benedetta ; Ponce-Aix, Santiago ; Zurera, María ; Bote, Helena ; Torres-Jiménez, Javier ; Masini, Silvia ; Cáceres-Galvis, Camilo ; Zugazagoitia, Jon ; Baena, Javier ; Nuñez, Juan Antonio

HER2-mutant lung cancer represents approximately 2% to 5% of all NSCLCs and is associated with poor prognosis. Two different HER2-targeted therapeutic approaches with different mechanisms of action-antibody-drug conjugates and HER2-selective tyrosine kinase inhibitors (TKIs)-have demonstrated convincing efficacy in pretreated patients. Trastuzumab deruxtecan was the first targeted therapy approved for patients with HER2-mutant NSCLC, demonstrating robust and durable responses in approximately 50% of these patients. Toxicity, although overall manageable, includes an increased risk of interstitial lung disease (ILD), which can be problematic and requires close clinical monitoring. More novel HER2-directed antibody-drug conjugates have confirmed the solid efficacy in this tumor type, revealing variable rates of ILD as a class effect of these agents. However, novel orally available TKIs with higher specificity and inhibitory potency against HER2 than wild-type EGFR such as sevabertinib (a dual HER2/EGFR mutant-selective reversible TKI) or zongertinib (an irreversible HER2-selective TKI that spares EGFR, including mutant EGFR) have further demonstrated deep and durable responses in this disease. Toxicities with these agents are mostly related to EGFR wild-type inhibition, with significantly lower rates of ILD. Consistent with its selectivity and mechanism of action, zongertinib offers a favorable tolerability profile, with mainly low-grade adverse events including those related to wild-type EGFR inhibition. In this review, we first describe the molecular landscape and clinical features of HER2-mutant NSCLC. Then, we summarize the clinical and preclinical evidence of HER2-targeted therapies and provide a forward-looking perspective of the treatment landscape of HER2-mutant NSCLC.

47

News (Medical) associated with Sevabertinib

17 Aug 2026

·allsci.com

Enhertu becomes first HER2-directed therapy to beat chemoimmunotherapy in 1st-line lung cancer

Trastuzumab deruxtecan (Enhertu) has become the first HER2-directed therapy to demonstrate a progression-free survival (PFS) benefit over the global standard of care in a Phase III trial for first-line HER2-mutant advanced non-small cell lung cancer (NSCLC), according to AstraZeneca and Daiichi Sankyo. The DESTINY-Lung04 result could move the antibody-drug conjugate (ADC) earlier in the treatment pathway as competition intensifies for this molecularly defined lung cancer population. DESTINY-Lung04 enrolled 454 patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 exon 19 or 20 mutations. Patients were randomized 1:1 to trastuzumab deruxtecan at 5.4 mg/kg or platinum-pemetrexed chemotherapy plus Merck's Keytruda (pembrolizumab), the current global standard of care. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS by blinded independent central review, the companies said. No hazard ratio, median PFS values, or p-values were disclosed in the top-line announcement, with full results due at a forthcoming medical meeting. The safety profile was consistent with trastuzumab deruxtecan's known profile, with no new safety concerns identified. Overall survival continues to be assessed as a secondary endpoint. Trastuzumab deruxtecan is a HER2-directed ADC carrying a topoisomerase I inhibitor payload. The drug already has accelerated US FDA approval for previously treated HER2-mutant metastatic NSCLC, based on single-arm clinical data. DESTINY-Lung04 provides randomized Phase III evidence that could support expansion into first-line treatment while also adding confirmatory evidence for its existing lung cancer indication. HER2 mutations occur in approximately 2–4% of non-squamous NSCLC and have historically lacked targeted first-line treatment options. That landscape is now changing rapidly. Boehringer Ingelheim's Hernexeos (zongertinib), an oral HER2-selective tyrosine kinase inhibitor (TKI), received accelerated US FDA approval in February 2026 for previously untreated HER2-mutant advanced NSCLC, becoming the first targeted therapy approved in this setting. Bayer's Hyrnuo (sevabertinib), already approved for previously treated disease, is also under US FDA Priority Review for first-line use. DESTINY-Lung04 therefore positions an IV ADC against an emerging group of oral HER2-targeted TKIs. Cross-trial efficacy comparisons will have to await the full trastuzumab deruxtecan results, but the Phase III study has an important evidentiary distinction: it directly compared the ADC with established first-line chemoimmunotherapy, whereas the accelerated approvals of the HER2 TKIs have been supported by response data from non-randomized studies. The result adds to the expanding clinical evidence base for trastuzumab deruxtecan across HER2-driven cancers, following FDA approvals in HER2-positive early breast cancer in May 2026 and an EU CHMP recommendation for trastuzumab deruxtecan plus pertuzumab in first-line HER2-positive metastatic breast cancer in July. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Phase 3Priority ReviewDrug ApprovalClinical ResultAccelerated Approval

17 Jul 2026

·allsci.com

Bayer adds Henry Ford Health to expanding US clinical research network

Bayer and Detroit-based Henry Ford Health announced a clinical trials partnership designed to connect more patients with investigational medicines, positioning Henry Ford as one of just four US academic health systems selected for Bayer’s strategic research network. The tie-up spans cardiovascular and renal disease, oncology and women’s health — three areas central to Bayer’s current pipeline — and reflects a broader industry shift toward embedding drug developers directly within health systems that serve large, diverse patient populations. Financial terms were not disclosed, and no specific drug candidate, technology platform or clinical trial identifier was named in the announcement. Under the agreement, Bayer will combine its clinical development capabilities with Henry Ford Health’s trial infrastructure, electronic health record data and patient population to improve trial design, identify eligible participants and generate real-world evidence. The companies also plan to collaborate on data science training. No specific investigational therapies or clinical studies were disclosed. The Henry Ford agreement is the second of its kind for Bayer within two weeks. On July 7, Bayer formed its first-ever academic medical center alliance with the University of Colorado Anschutz, UCHealth and Children’s Hospital Colorado, covering a similar mix of therapeutic areas along with neurodegenerative disease and cell and gene therapy. That deal marked Bayer’s first structured academic health system research network, and the Henry Ford partnership confirms the company is now executing a repeatable model rather than a one-off collaboration. With two of four planned network partners now named, Bayer appears to be assembling a distributed clinical trial infrastructure that spans multiple US regions and patient populations, though the identities of the remaining two systems have not been disclosed. The timing aligns with Bayer’s broader pharmaceutical strategy update from January, in which the company detailed a modality-rich pipeline spanning oncology assets such as darolutamide (Nubeqa) and sevabertinib (Hyrnuo), cardiovascular programs including asundexian and finerenone (Kerendia), and women’s health therapy elinzanetant (Lynkuet). Embedding clinical trial access within large health systems supports patient enrollment for this expanding portfolio, particularly as Bayer pushes multiple Phase III cardiovascular and oncology programs toward regulatory milestones in the coming years. For Henry Ford Health, the Bayer partnership adds to a growing list of external collaborations tied to its research and data capabilities, including its earlier work with BD on pharmacy automation and its role within the Truveta real-world data consortium. The health system’s chief scientific officer, David Lanfear, framed the Bayer collaboration as an effort to reduce participation barriers and accelerate treatment development, while Bayer’s Christoph Koenen pointed to community-embedded research as a way to reach patients where they already receive care. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team. Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Clinical Study

22 May 2026

·allsci.com

Boehringer Ingelheim’s Hernexeos receives conditional approval in China for HER2-mutant advanced NSCLC

Boehringer Ingelheim has received conditional approval from China’s National Medical Products Administration (NMPA) for zongertinib (Hernexeos) as a first-line monotherapy in adults with unresectable, locally advanced or metastatic HER2-mutant NSCLC, marking the first targeted oral therapy cleared for this population at initial diagnosis in China. The decision, based on a 75.7% objective response rate in treatment-naïve patients from the Phase Ib Beamion LUNG-1 trial, follows the drug’s US FDA accelerated approval in February 2026 and extends zongertinib’s regulatory footprint to the US, China, Hong Kong, and Japan. Beamion LUNG-1 is an open-label Phase Ib dose-escalation and expansion study evaluating zongertinib across HER2-aberrant solid tumors. The China NMPA approval drew on data from a cohort of 74 treatment-naïve patients with HER2 (ERBB2) tyrosine kinase domain activating mutations, in which zongertinib produced an ORR of 75.7%, comprising a 10.8% complete response rate and a 64.9% partial response rate. The median duration of response was 15.2 months. These data were presented at the European Lung Cancer Congress 2026 and published in the New England Journal of Medicine. In a pooled safety population of 177 patients with HER2-mutant NSCLC enrolled in Beamion LUNG-1, treatment-related adverse events were predominantly low-grade; dose reductions occurred in 9% of patients and dose discontinuations in 6%. The conditional approval requires confirmation of clinical benefit from an ongoing trial before full approval is granted. Competitive context Zongertinib is an irreversible TKI that selectively inhibits HER2 while sparing wild-type EGFR, a design intended to reduce the diarrhea and rash associated with pan-HER inhibitors. The primary approved alternative in HER2-mutant NSCLC is AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), an intravenous antibody-drug conjugate approved by the FDA in 2022 for previously treated patients; cross-trial comparisons are limited, but zongertinib’s 75.7% first-line ORR compares favorably in absolute terms to the roughly 37–38% ORR reported for trastuzumab deruxtecan in the second-line DESTINY-Lung02 setting, with the caveat that patient populations and trial designs differ materially. Bayer’s Hyrnuo (sevabertinib), a reversible oral HER2 TKI, received FDA accelerated approval in November 2025 for previously treated patients, adding a second oral option in the post-platinum setting. The confirmatory Phase III Beamion LUNG-2 trial, evaluating zongertinib as initial treatment in HER2 TKD-mutant advanced NSCLC, is ongoing and will provide the randomized data needed to support full approval in both China and the US. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Drug ApprovalPhase 3Accelerated ApprovalClinical ResultADC

100 Deals associated with Sevabertinib

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External Link

KEGG	Wiki	ATC	Drug Bank
D13098	-	-	-

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, WCLC2026)	Phase 1/2	HER2 mutant non-small cell lung cancer HER2 mutations	73	Sevabertinib (HER2-mutant NSCLC + Acquired Resistance Biomarker Analysis)	doteqezlag(yftdhgbany) = sdeqjfbywu sdmlylsghw (blwuoxvdku )	Positive	12 Sep 2026
NCT05099172 (SOHO-01, ASCO2026)	Phase 1/2	HER2 mutant non-small cell lung cancer HER2 tyrosine kinase domain-activating mutations	154	Sevabertinib 20 mg	cwdasveeba(iipqevodug) = jikdhbmfeu bzhswhokvj (ubzpguwnol, 55.3 - 76.8) View more	Positive	29 May 2026
				Sevabertinib 20 mg	cwdasveeba(iipqevodug) = kxobcollgh bzhswhokvj (ubzpguwnol, 63.9 - 84.7) View more
NCT05099172 (SOHO-01, HOPA2026)	Phase 1/2	HER2 mutant non-small cell lung cancer HER2-activating mutations	120	Sevabertinib 20 mg	efbzzvancm(wmhsvfkygc) = mbcbauftqx mxsfhnjuxr (vkgzkztzxi ) View more	Positive	25 Mar 2026
				Sevabertinib 20 mg	efbzzvancm(wmhsvfkygc) = wsfmzjtora mxsfhnjuxr (vkgzkztzxi ) View more
NCT05099172 (SOHO-01, ESMO_ELCC2026)	Phase 1/2	Non-Small Cell Lung Cancer HER2-activating mutations	154	Sevabertinib 20 mg	ngnhuaxzat(idfljymjyx) = jzyvpjvmtr fvryvuqggo (kavkqlbeck ) View more	Positive	25 Mar 2026
				Sevabertinib 20 mg	ngnhuaxzat(idfljymjyx) = kefjvpffdc fvryvuqggo (kavkqlbeck ) View more
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)	svnmmlmdfv(qzjjpjuotv) = dljgyxxumu eonbqucucl (bxcbiigglc, 47.6 - 74.0) View more	Positive	05 Dec 2025
				Sevabertinib 20 mg (previously received HER2-targeted antibody-drug conjugates)	svnmmlmdfv(qzjjpjuotv) = krzbfcvegc eonbqucucl (bxcbiigglc, 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)	kwekbchwfl(hzphrirfsv) = tlfxfexmnx nynnvpmxle (qkfeqxnsnz, 59 - 82) View more	Positive	19 Nov 2025
				HYRNUO (NSCLC Previously Treated, Including Prior HER2 Targeted Antibody Drug Conjugates (ADCs): Group E)	kwekbchwfl(hzphrirfsv) = avvehxivhy nynnvpmxle (qkfeqxnsnz, 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)	xcqvmpeolh(sanbutqlrc) = epvddyojud vjzjpsxywq (wicbiirkqt, 53 - 75) View more	Positive	06 Nov 2025
				Sevabertinib 20mg (cohort E: previously received HER2-directed ADC)	xcqvmpeolh(sanbutqlrc) = ueaepszowp vjzjpsxywq (wicbiirkqt, 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)	vgnwosvlkp(trytkhslqm) = tcyxglqsnc kyogefbxls (okdsbkmsju )
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)	lciyokwtgd(pyxmdjejhu) = aegapxmzoe wmswodinwy (kmocsglmel, 53 - 75) View more	Positive	17 Oct 2025
				Sevabertinib 20 mg (previous HER2-targeted antibody-drug conjugates)	lciyokwtgd(pyxmdjejhu) = reitjyyceq wmswodinwy (kmocsglmel, 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)	mnipljqnpq(swzymkzqlt) = observed in 96.7% of patients yrttccbkxb (shutknryqg ) 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)