CLINICAL TRIALS PROFILE FOR SEVABERTINIB

All Clinical Trials for SEVABERTINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06452277 ↗	A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor R	RECRUITING	Bayer	PHASE3	2024-08-28	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.
NCT06760819 ↗	A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)	RECRUITING	Bayer	PHASE2	2025-02-13	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.
NCT07102095 ↗	A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose	RECRUITING	Bayer	PHASE1	2025-07-24	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.

Clinical Trial Conditions for SEVABERTINIB

Condition Name

Condition Name for SEVABERTINIB
Intervention	Trials
HER2 Mutation	2
Advanced Non-small Cell Lung Cancer	1
Advanced Solid Tumors	1
Drug Metabolism	1

Condition MeSH

Condition MeSH for SEVABERTINIB
Intervention	Trials
Gastrointestinal Stromal Tumors	1
Uterine Cervical Neoplasms	1
Biliary Tract Neoplasms	1
Gastrointestinal Neoplasms	1

Clinical Trial Locations for SEVABERTINIB

Trials by Country

Trials by Country for SEVABERTINIB
Location	Trials
United States	25
Japan	17
China	16
Italy	9
Canada	6

Trials by US State

Trials by US State for SEVABERTINIB
Location	Trials
Florida	3
California	2
Texas	2
Ohio	2
Michigan	2

Clinical Trial Progress for SEVABERTINIB

Clinical Trial Phase

Clinical Trial Phase for SEVABERTINIB
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for SEVABERTINIB
Clinical Trial Phase	Trials
RECRUITING	3

Clinical Trial Sponsors for SEVABERTINIB

Sponsor Name

Sponsor Name for SEVABERTINIB
Sponsor	Trials
Bayer	3

Sponsor Type

Sponsor Type for SEVABERTINIB
Sponsor	Trials
INDUSTRY	3

Clinical Trials Update, Market Analysis, and Projections for Sevabertinib

Last updated: April 24, 2026

What is sevabertinib and what claims does the public record support?

Sevabertinib is an investigational, oral small-molecule targeted therapy positioned as a mutant-selective EGFR inhibitor in oncology. Public disclosures place it in advanced-stage clinical evaluation across non-small cell lung cancer (NSCLC) with specific EGFR alteration types and in broader solid-tumor cohorts. The program’s commercial framing is tied to the EGFR-mutant NSCLC market and competitive efficacy and safety against the current standard of care.

Where is sevabertinib in the clinical pipeline?

Public trial reporting for sevabertinib is limited and fragmented across registries and sponsor communications. The most decision-relevant checkpoints for investors are:

• Phase progression (Phase 1/2 to Phase 2 pivotal, then Phase 3 or registrational single-arm strategy)
• Cohort maturity (objective response rate, duration of response, progression-free survival)
• Biomarker-defined enrollment (EGFR mutation subtype targeting and resistance mechanism stratification)

Clinical-trial status map (publicly trackable endpoints):

Trial stage (public view)	What investors should confirm in disclosures	Key readouts typically used for valuation
Phase 1/2 dose finding and expansion	Dose selection, safety profile, activity by EGFR mutation subtype	ORR, DOR, safety dose-limiting toxicities
Phase 2 registrational design	Comparator or historical controls, prespecified endpoints	Confirmed ORR, PFS, DOR, subgroup consistency
Phase 3 (if initiated)	Sample size, statistical design, OS or PFS primary	PFS (primary), OS (secondary), time-to-event distributions

What are the most market-relevant clinical endpoints to watch?

For EGFR-mutant NSCLC drugs, the market prices on durable disease control and tolerability that supports continuous dosing. For sevabertinib, the practical valuation levers are:

• Confirmed response depth and durability (DOR and time-to-progression)
• Progression-free survival (PFS) in biomarker-defined cohorts
• Central nervous system (CNS) activity if disclosed, since EGFR-driven disease has high CNS tropism
• Resistance profile and whether the regimen retains utility after typical EGFR resistance (programming matters for line-of-therapy placement)

What does the competitive landscape imply for sevabertinib’s pricing power?

The EGFR NSCLC arena is crowded with agents whose differentiation is anchored in:

• Mutation selectivity (exon 19 deletion, L858R, uncommon mutations, and resistance categories)
• CNS penetration and intracranial response (for stage and line-of-therapy competitiveness)
• Safety/tolerability supporting chronic use

In this context, sevabertinib’s ability to win depends on demonstrating either:

• Comparable efficacy with improved tolerability, enabling broader adoption, or
• Superior durability/PFS (and/or clinically meaningful intracranial activity) that justifies premium pricing and formulary preference.

How large is the addressable EGFR-mutant NSCLC market?

Sizing in this space typically relies on:

• Total NSCLC incidence and EGFR mutation prevalence
• Proportion of patients eligible by mutation subtype and line of therapy
• Adoption penetration based on regulatory approvals and payer coverage

Market sizing framework used by oncology forecasting models:

Component	Typical modeling approach	Why it matters for sevabertinib
EGFR-mutant prevalence	Apply EGFR mutation fraction to NSCLC incidence, then split by mutation subtype	Determines the “biomarker-addressable” TAM
Line-of-therapy window	Estimate how many patients reach first-line, second-line, and later lines	Determines peak-treated share timing
Penetration curve	Use forecasted uptake by guideline inclusion and clinical differentiation	Determines revenue ramp and peak sales
Pricing and reimbursement	Model net price vs list price using geography and launch segment	Determines revenue per treated patient

What market scenarios should be modeled for projections?

Valuation under uncertainty in oncology almost always collapses into scenario-driven forecasts. For sevabertinib, the plausible scenarios center on trial-readiness and regulatory timing.

Three-scenario projection structure (used in pipeline-backed models):

Scenario	Clinical evidence threshold	Commercial result
Upside	Strong, durable PFS/DOR by mutation subtype; favorable safety; potential CNS signal	Faster uptake, higher treated share, premium net pricing
Base case	Activity consistent with efficacy benchmarks; acceptable tolerability	Moderate adoption, standard oncology pricing
Downside	Mixed efficacy by cohort; safety tradeoffs or weaker durability	Slow uptake, coverage limitations, price pressure

When could sevabertinib reach commercial scale?

Commercial timing depends on:

• Completion of pivotal/regulatory-enabling evidence
• Filing and approval schedules
• Launch sequencing by geography and line-of-therapy

Without complete, consolidated public evidence of Phase 3 initiation and registrational primary endpoints, projections should treat approval timing as the key risk driver rather than efficacy alone. (Public trial data for sevabertinib remains insufficient in widely indexed sources to support a single, definitive “launch year” statement here.)

What revenue model inputs drive the projection?

A robust sevabertinib forecast uses patient-flow and adoption dynamics rather than only peak penetration. The model inputs that dominate outcomes are:

• Treated patient count by geography (US, EU5, Japan, China, RoW) and by line-of-therapy
• Net price per treated patient (after discounts/rebates and tender dynamics)
• Time-to-peak adoption (guideline adoption and competitive position)
• Drop-off after label expansions or subsequent competitors enter

What does the competitive intensity suggest about adoption risk?

EGFR competitors include multiple generations of targeted therapies and combination strategies. Adoption risk increases if sevabertinib:

• Cannot secure a clear survival or durability advantage
• Has safety signals that constrain continuous dosing
• Faces payer resistance due to comparative economics

How should investors interpret trial-update cadence?

For a drug like sevabertinib, investors should treat each clinical disclosure as moving one of two variables:

• Regulatory probability (does the evidence set satisfy endpoints that regulators and payers value)
• Commercial adoption probability (does the drug become a preferred therapy for a specific mutation category)

Clinical transparency in endpoint reporting (maturity, number of events, confirmed responses, intracranial reporting) is the proxy for these shifts.

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Key Takeaways

• Sevabertinib is an investigational EGFR-mutant NSCLC therapy in a high-competition oncology segment where durable PFS/DOR and tolerability drive adoption and pricing.
• Public information supports that the program is biomarker-defined, but full registrational-readiness and endpoint maturity must be inferred from trial disclosures; current publicly indexed materials do not support a precise, single-point approval timing call here.
• Market projections should be scenario-based with the approval timeline and cohort maturity as primary drivers, and uptake modeled via line-of-therapy access plus mutation-specific differentiation.

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FAQs

1. What endpoints most impact sevabertinib’s market valuation?
   ORR (confirmed), DOR, and PFS by EGFR mutation subtype, plus any disclosed intracranial activity and safety allowing continuous dosing.

2. Why do biomarker-defined cohorts matter for adoption?
   EGFR NSCLC prescribing depends on mutation subtype and guideline alignment; differentiation by the target alteration determines whether sevabertinib becomes a preferred option.

3. What competitive factors decide whether sevabertinib gains share?
   Durability of response, tolerability, and any clinically meaningful intracranial outcomes against established EGFR therapies.

4. What drives the revenue ramp most?
   Speed to regulatory-enabling evidence, approval timing, and the time-to-peak adoption shaped by guideline inclusion and payer coverage.

5. How should investors structure projections under uncertainty?
   Use upside/base/downside scenarios anchored to the probability of meeting prespecified endpoints and the maturity of efficacy datasets at the time of regulatory filing.

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References

[1] ClinicalTrials.gov. “Sevabertinib” (search results and trial records). U.S. National Library of Medicine.
[2] World Health Organization (WHO). Global cancer observatory resources and NSCLC/Epidemiology context (for incidence and burden baselines).
[3] FDA Oncology Drug Guidance and endpoint frameworks (general regulatory endpoint value in oncology submissions). U.S. Food and Drug Administration.
[4] EMA oncology scientific guidance (general regulatory context for time-to-event endpoints and evidence expectations). European Medicines Agency.