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

+ [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)

Login to view timeline

Structure/Sequence

Molecular FormulaC24H25ClN4O5

InChIKeyVYQVHWNNPKOJEA-AWEZNQCLSA-N

CAS Registry2521285-05-0

This is a single-center, observational, bidirectional cohort study evaluating the real-world effectiveness, safety, and quality of life associated with sevabertinib in Chinese adults with HER2-mutant advanced non-small cell lung cancer receiving sevabertinib as second-line or later-line therapy. The study will include both retrospectively identified patients and prospectively enrolled patients. The primary objective is to evaluate real-world progression-free survival. Additional assessments include tumor response, overall survival, safety, and patient-reported quality of life.

Start Date30 Sep 2026

Sponsor / Collaborator

Ruijin Hospital

NCT07753252

/ Not yet recruitingPhase 1

Phase 1, Open-label, Fixed-sequence Crossover Study to Investigate the Effect of Sevabertinib on the Pharmacokinetics of Metformin in Healthy Participants

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

100 Clinical Results associated with Sevabertinib

Login to view more data

100 Translational Medicine associated with Sevabertinib

Login to view more data

100 Patents (Medical) associated with Sevabertinib

Login to view more data

15

Literatures (Medical) associated with Sevabertinib

01 Oct 2026·Journal of Thoracic Oncology

Emerging Targeted Therapies for HER2-Mutant NSCLC

Review

Author: Paz-Ares, Luis ; Serrano, Cristina ; Del Rio, Benedetta ; Zurera, María ; Ponce-Aix, Santiago ; 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.

01 Oct 2026·International Journal of Clinical Oncology

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; sevabertinib for lung cancer, gemcitabine intravesical system and durvalumab for bladder cancer, azacitidine for leukemia, cemiplimab for skin cancer, and ropeginterferon alfa-2b for essential thrombocythemia

Author: Matsumura, Noriomi

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.

54

News (Medical) associated with Sevabertinib

14 Sep 2026

·allsci.com

Enhertu Phase III win supports first-line expansion in HER2-mutant NSCLC

Trastuzumab deruxtecan (Enhertu) cut the risk of disease progression or death by 37% compared with pembrolizumab plus platinum-pemetrexed chemotherapy as first-line therapy in patients with HER2-mutant advanced non-small cell lung cancer (NSCLC). The drug is jointly developed by AstraZeneca and Daiichi Sankyo, with the DESTINY-Lung04 Phase III results presented at the IASLC 2026 World Conference on Lung Cancer in Seoul. Median progression-free survival (PFS) was 14.3 months with trastuzumab deruxtecan monotherapy versus 8.3 months with the chemoimmunotherapy comparator (hazard ratio 0.63; 95% CI 0.50–0.79; p<0.0001), as assessed by blinded independent central review. The objective response rate (ORR) was 70.0% versus 44.5%, with a median duration of response of 13.4 months versus 9.7 months. The PFS benefit was consistent across prespecified subgroups including brain metastases, liver metastases, smoking status, HER2 mutation type (exon 19 or exon 20), and de novo or recurrent disease. Overall survival (OS) data were 46.9% mature at the data cut-off of June 9, 2026, and no formal hypothesis testing was performed. Median OS was 29.3 months with trastuzumab deruxtecan versus 33.1 months with chemoimmunotherapy (HR 1.15; 95% CI 0.88–1.52). AstraZeneca and Daiichi Sankyo noted that imbalanced use of subsequent HER2-directed therapies — 48.0% in the control arm versus 23.3% in the trastuzumab deruxtecan arm — could complicate interpretation of the immature OS findings. Formal OS testing is planned at later analyses. Despite longer median treatment exposure with trastuzumab deruxtecan, Grade 3 or higher treatment-related adverse events were similar between arms at 34.1% and 33.6%. ILD or pneumonitis remained a notable toxicity, occurring in 20.8% of trastuzumab deruxtecan-treated patients; most events were Grade 1 or 2, but four Grade 5 events were reported, corresponding to a 1.8% fatal ILD rate. Trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate (ADC) that delivers the topoisomerase I inhibitor DXd directly to HER2-expressing tumor cells, inducing DNA double-strand breaks. The drug is already approved in the US for previously treated HER2-mutant NSCLC under accelerated approval, based on single-arm data from DESTINY-Lung02. DESTINY-Lung04 evaluates trastuzumab deruxtecan in the first-line setting and could support expansion of the label into previously untreated disease. The competitive landscape in HER2-mutant NSCLC has shifted materially over the past year. Boehringer Ingelheim's Hernexeos (zongertinib), a selective HER2 tyrosine kinase inhibitor, received FDA accelerated approval in February 2026 for treatment-naive patients with HER2-mutant advanced non-squamous NSCLC, based on single-arm Phase II data. Sevabertinib, another HER2 kinase inhibitor, received accelerated approval in November 2025 for the previously treated setting and is being evaluated in the first-line Phase III SOHO-02 trial. DESTINY-Lung04 provides the first randomized Phase III PFS data in the first-line setting for this molecularly defined population, though cross-trial comparisons between the ADC and oral TKI approaches are constrained by differing trial designs, patient populations, and data maturity. HER2 mutations occur in approximately 2–4% of NSCLC cases and have historically been associated with poor responses to chemoimmunotherapy, with median PFS on pembrolizumab-based regimens typically under nine months in this subgroup. The 14.3-month median PFS reported in DESTINY-Lung04 represents a six-month improvement over the control arm. AstraZeneca and Daiichi Sankyo said they intend to share the data with regulatory authorities globally to support potential label expansions into the first-line setting. Spot something wrong? Report an issue with this article

Phase 3Clinical ResultDrug ApprovalAccelerated ApprovalPhase 2

10 Sep 2026

·www.pharmaceutical-technology.com

Bayer’s Hyrnuo set for the NSCLC frontlines on accelerated FDA label expansion

Hyrnuo is now indicated for frontline use in a specific type of HER2-mutant NSCLC. Credit: UA Creative Microstocks / Shutterstock.com. Bayer has landed an accelerated US approval for its non-small cell lung cancer (NSCLC) therapy, Hyrnuo (sevabertinib), expanding the drug’s role into the frontline treatment setting within an indication linked to poor patient prognosis. As per the US Food and Drug Administration’s (FDA) recommendation, Hyrnuo will now become available as a frontline treatment option for adults with locally advanced or metastatic, non-squamous NSCLC – specifically if they have HER2 (ERBB2) tyrosine kinase domain-activating mutations, as determined by an FDA-approved test. This accelerated approval marks a move up the treatment paradigm for Hyrnuo, an oral tyrosine kinase inhibitor (TKI), which was previously indicated for use in patients who had relapsed after systemic therapy. The agency gave Hyrnuo the regulatory blessing based on the outcomes of the open-label, single-arm SOHO-01 study (NCT05099172), in which the drug demonstrated an objective response rate (ORR) of 75%. Of the patients that were classified as responders, 73% continued to respond at the six-month timepoint, while 38% were found to be responsive to treatment at the 12-month mark. With Hyrnuo only securing the FDA’s blessing on an accelerated basis, Bayer will have to further demonstrate the therapy’s effectiveness through its ongoing post-marketing confirmatory trial, dubbed SOHO-02 (NCT06452277). This study is pitting Hyrnuo against standard of care (SoC) in untreated patients with advanced, HER2-mutant NSCLC. Fulfilling unmet needs in HER2-mutated NSCLC According to a 2026 paper published in Lung Cancer , HER2 mutations are found in between 1.8%-5.6% of NSCLC cases, though their presence is often linked to poor outcomes in patients due to their association with brain metastases. Because of this, Bayer’s EVP of global product strategy and commercialisation, Christine Roth notes that Hyrnuo’s tentative frontline approval is an “important milestone” for patients, who are in “critical need for additional treatment options.” Hyrnuo’s debut in the frontline treatment paradigm is also notable due to the requirement for a patient to receive molecular testing before receiving the drug – a theme that is becoming increasingly prevalent with the advent of personalised medicine that is catered to a patient’s specific tumour profile. Thus far, multiple tissue and liquid biopsy-based tests have secured the FDA go-ahead for identifying HER2 mutations in NSCLC. This includes Guardant Health’s Guardant360 CDx , despite its recent embroilment in a patent battle with TwinStrand, and Life Technologies Corporation’s Oncomine Dx Target Test, which secured the FDA’s approval alongside Boehringer Ingelheim’s rival TKI, Hernexeos (zongertinib) . HER2-mutated NSCLC market heats up While Hyrnuo has become the latest targeted therapy to secure a frontline approval in this subset of NSCLC, it will have to compete with Boehringer’s Hernexeos, which has the first-to-market advantage following its February 2026 accelerated approval in the frontline setting. In previous conversation with Clinical Trials Arena, sister publication to Pharmaceutical Technology, thoracic oncologist Dr Balasz Halmos noted that it would be hard to separate between the efficacy and safety of Hyrnuo and Hernexeos. Meanwhile, Dr Roy Herbst, chief of medical oncology at Yale New Haven Hospital previously touted the first-line response rates linked to Hyrnuo as “extremely high”, though he stated that it would likely be best to combine the drug with chemotherapy, “especially after the positive results of the FLAURA-2 trial looking at Tagrisso plus chemotherapy.”

Drug ApprovalAccelerated ApprovalClinical ResultClinical Study

09 Sep 2026

·www.fiercepharma.com

FDA clears Bayer’s Hyrnuo in first-line lung cancer, amping up Hernexeos rivalry

In an accelerated decision , the FDA expanded Bayer’s Hyrnuo indication, granting first-line approval for a rare tumor type in patients with non-small cell lung cancer. Before the expansion, Hyrnuo was available only after other NSCLC treatments failed. But the FDA’s latest go-ahead makes the tyrosine kinase inhibitor (TKI) an initial therapy option for any patient with locally advanced or metastatic non-squamous NSCLC whose tumors test positive for HER2 tyrosine kinase domain activating mutations. The expanded indication was won using data from Bayer’s ongoing phase 1/2 Soho-01 trial, in which Hyrnuo demonstrated a 75% objective response rate in previously untreated patients. Six percent of patients showed a complete response, and 70% showed a partial response to the twice-daily oral medication, Bayer said Wednesday. Responses lasted more than six months for 73% of patients. This subtype of lung cancer patients are often non-smokers and “historically have a poor prognosis,” said Soho-01 lead investigator, Xiuning Le, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center, in a statement. “This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time,” added Christine Roth, executive vice president, global product strategy and commercialization at Bayer. The accelerated approval means Bayer will have to continue to prove Hyrnuo’s clinical benefit through post-marketing confirmatory studies. The latest approval may hinge on the outcome of Bayer's phase 3 trial, Soho-02, which is evaluating Hyrnuo versus standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC. The Hyrnuo expansion follows a similar first-line approval for the drug's main competitor , Boehringer Ingelheim’s oral TKI Hernexeos, in February. Because HER2 mutations represent only 2% to 4% of the NSCLC patient population, the battle for market share between the two drugs is expected to be fierce. Both Bayer and Boehringer's target the same mutated tumors, although Hyrnuo is specifically designated for locally advanced or metastatic non-squamous NSCLC, while Boehringer’s label holds a small distinction for unresectable or metastatic cancer. Hyrnuo received initial FDA approval last November , just three months after Hernexeos. In that instance, the FDA signed off on the medicine as a second-line treatment after Hyrnuo logged a 71% objective response rate in the phase 1/2 Soho-01 trial in patients who received prior systemic therapy but not one that specifically targets HER2 mutations. Earlier this year, Hyrnuo was approved in China as a second-line treatment for unresectable, locally advanced or metastatic HER2-mutant NSCLC. The drug was also granted breakthrough therapy designation in the country to expedite its potential use as a first-line treatment, and it has also secured a first-line nod in Japan.

Drug ApprovalClinical ResultAccelerated ApprovalPhase 3Breakthrough Therapy

100 Deals associated with Sevabertinib

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D13098	-	-	-

R&D Status

Approved

10 top approved records.

Login

to view more data

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.

Login

to view more data

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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05099172 (SOHO-01, ESMO2026)	Phase 2	HER2 mutant non-small cell lung cancer First line HER2 TKD mutations	139	Sevabertinib (Cohort F (treatment-naïve))	yudgnqypdu(zdfovvauyw) = shytczahns cuaoqrruiz (izebvnjujc, 64 - 85) View more	Positive	23 Oct 2026
				Sevabertinib (Cohort D (previously treated))	yudgnqypdu(zdfovvauyw) = rkcjiebbil cuaoqrruiz (izebvnjujc, 61 - 83) View more
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)	pmfgvgysar(ndiwjofphe) = ibsywjnocz jowdpkgxuw (bkxmzvkgov )	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	pwdvbhnkxs(raoxdffavp) = bvuoivomkd wjumxctexj (sqkohzvcbk, 55.3 - 76.8) View more	Positive	29 May 2026
				Sevabertinib 20 mg	pwdvbhnkxs(raoxdffavp) = eaqhplbgvy wjumxctexj (sqkohzvcbk, 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	frflpqxseo(knoyzqjjcr) = xnxjnzrujc nggydfbtbn (pfldoaiciw ) View more	Positive	25 Mar 2026
				Sevabertinib 20 mg	frflpqxseo(knoyzqjjcr) = oqcizepnjq nggydfbtbn (pfldoaiciw ) View more
NCT05099172 (SOHO-01, ESMO_ELCC2026)	Phase 1/2	Non-Small Cell Lung Cancer HER2-activating mutations	154	Sevabertinib 20 mg	vzyqtplgwy(fakuatlwvb) = ybcpeseabe ogcjubthgq (fxeqmchqtx ) View more	Positive	25 Mar 2026
				Sevabertinib 20 mg	vzyqtplgwy(fakuatlwvb) = uqfovsfbyh ogcjubthgq (fxeqmchqtx ) 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)	wdhgscfsub(ormeihmcwf) = zygzwdcjxy qcuybarcnm (xlnjtitovx, 47.6 - 74.0) View more	Positive	05 Dec 2025
				Sevabertinib 20 mg (previously received HER2-targeted antibody-drug conjugates)	wdhgscfsub(ormeihmcwf) = mxpvwikhsv qcuybarcnm (xlnjtitovx, 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)	cjjpfkoobt(qvnhhrbsyk) = rafoyfwkpu giwalehwpb (asyjlmytfp, 59 - 82) View more	Positive	19 Nov 2025
				HYRNUO (NSCLC Previously Treated, Including Prior HER2 Targeted Antibody Drug Conjugates (ADCs): Group E)	cjjpfkoobt(qvnhhrbsyk) = elihtgzolm giwalehwpb (asyjlmytfp, 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)	gqcsakvzvr(tntzaujkkr) = ziebypuhpp fywqirtiso (zozfgrhity, 53 - 75) View more	Positive	06 Nov 2025
				Sevabertinib 20mg (cohort E: previously received HER2-directed ADC)	gqcsakvzvr(tntzaujkkr) = sljoxlpewv fywqirtiso (zozfgrhity, 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)	cjuxtlgoeq(wakkdcltid) = lidihayreq ozsguxyfun (lxwwtzxgtr )
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)	xjkzyqvtnm(odxwedqoin) = wsxhkwcssb hunmzxjbys (ykkhndgwxs, 53 - 75) View more	Positive	17 Oct 2025
				Sevabertinib 20 mg (previous HER2-targeted antibody-drug conjugates)	xjkzyqvtnm(odxwedqoin) = xwrqzrkqic hunmzxjbys (ykkhndgwxs, 25 - 52) View more