Approval Probability
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Also known as Sevabertinib (BAY 2927088)
Sevabertinib · 3 trials · 6 indications
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
To assess the influence of hepatic impairment on sevabertinib exposure. AUC from time zero to the last data point larger than the lower limit of quantification (LLOQ) (AUC(0-tlast) and the unbound AUC(0-tlast) will be used as the main parameters if AUC cannot be reliably determined in all participants.
To assess the influence of hepatic impairment on sevabertinib exposure.
To assess the influence of hepatic impairment on sevabertinib exposure.
| Arm | Type | Description |
|---|---|---|
| Sevabertinib | EXPERIMENTAL | Participants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. |
| Standard of care (SoC) | ACTIVE_COMPARATOR | Participants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression. |
| Metformin + Sevabertinib | EXPERIMENTAL | Single 500 mg oral dose of metformin on Day 1 (Intervention Period 1) in healthy participants. Sevabertinib pre-treatment period (days -4 to -1) when sevabertinib is administered alone. Single 500 mg oral dose of metformin co-administered during ongoing sevabertinib 20 mg BID regimen on Day 1 of Intervention Period 2; sevabertinib continued on Day 2 |
| Arm A: Moderate Hepatic Impairment | EXPERIMENTAL | Approximately 10 participants with moderate impaired hepatic function (Child-Pugh B) to achieve approximately 8 evaluable participants |
| Arm B: Normal Hepatic Function | EXPERIMENTAL | Approximately 10 matched control participants for Arm A with normal hepatic function |
| Name | Type | Description |
|---|---|---|
| Sevabertinib | DRUG | Tablet, oral |
| Pembrolizumab | DRUG | Intravenous (IV) infusion |
| Cisplatin | DRUG | IV infusion |
| Carboplatin | DRUG | IV infusion |
| Pemetrexed | DRUG | IV infusion |
| Metformin | DRUG | Immediate-release tablet, 500 mg; administered as a single 500 mg oral dose in Intervention Period 1 (Day 1) and as a single 500 mg oral dose in Intervention Period 2 (Day 1 of the combination phase, after sevabertinib pre-treatment) |
| Sevabertinib (BAY 2927088) | DRUG | Film-coated tablet, 10 mg; administered as 20 mg BID (oral) pre-treatment in Intervention Period 2 and continued 20 mg BID during co-administration with metformin |
Inclusion Criteria: * Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent. * Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for defi...
Sevabertinib is an investigational small molecule being studied for advanced non-small cell lung cancer (NSCLC) with HER2 mutations. It is also being evaluated in clinical trials for hepatic insufficiency and in healthy participants for pharmacokinetic studies. The drug is in Phase 3 development for the NSCLC indication.
Sevabertinib is a kinase inhibitor, as indicated by its -tinib suffix. It is being studied in patients with HER2-mutant advanced non-small cell lung cancer, meaning it targets the HER2 receptor tyrosine kinase. The drug is designed to interfere with signaling pathways driven by HER2 mutations.
Sevabertinib is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various patient populations.
Sevabertinib is in Phase 3 clinical development for advanced non-small cell lung cancer with HER2 mutations. It is also being studied in earlier-phase trials for hepatic impairment and drug interaction assessments. The drug is investigational and has not been approved by regulatory authorities.
Sevabertinib is being evaluated in a Phase 3 trial (NCT06452277) comparing it to standard treatment in 444 patients with HER2-mutant advanced NSCLC. Additional trials include a Phase 1 hepatic impairment study (NCT07102095) and a Phase 1 drug interaction study with metformin (NCT07753252).
Yes, Sevabertinib is also known as BAY 2927088. Both names refer to the same investigational drug developed by Bayer AG. The compound is being studied primarily for its potential role in treating HER2-mutant non-small cell lung cancer.