In short
Davutamig, also known as REGN5093, is an investigational drug being studied for the treatment of advanced non-small cell lung cancer (NSCLC) with MET alterations. This article explores the ongoing clinical trials evaluating the safety, effectiveness, and potential benefits of Davutamig for patients who have exhausted other available treatment options.
At a glance
- Drug Name
- Davutamig (REGN5093)
- Type of Drug
- Bispecific antibody
- Target Condition
- Advanced non-small cell lung cancer (NSCLC) with MET alterations
- Trial Phase
- Phase 1/2
- Main Objectives
- Assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity
- Key Eligibility Criteria
- Confirmed NSCLC, exhausted available therapies, presence of MET alterations
- Primary Endpoints
- Dose-limiting toxicities, adverse events, pharmacokinetics, objective response rate
- Administration
- Intravenous infusion
What is DAVUTAMIG?
DAVUTAMIG, also known as REGN5093, is an investigational medication being developed for the treatment of advanced non-small cell lung cancer (NSCLC) with specific genetic alterations. It is classified as a bispecific antibody, which means it can target two different molecules simultaneously, potentially enhancing its effectiveness in fighting cancer.
Target Condition: MET-Altered Non-Small Cell Lung Cancer
DAVUTAMIG is specifically designed to treat MET-altered non-small cell lung cancer (NSCLC). NSCLC is a type of lung cancer that accounts for the majority of lung cancer cases. "MET-altered" refers to cancers that have specific changes in the MET gene, which can drive cancer growth. These alterations can include:
- MET-exon14 gene mutations: Changes in a specific part of the MET gene
- MET gene amplification: An increase in the number of copies of the MET gene
- Elevated MET protein expression: Higher than normal levels of the MET protein on cancer cells
These genetic changes can make the cancer more aggressive, but they also provide a target for treatments like DAVUTAMIG.
Clinical Trial Overview
DAVUTAMIG is currently being studied in a Phase 1/2 clinical trial. This trial is designed to evaluate several aspects of the drug:
Phase 1 Objectives:
- Assess the safety and tolerability of DAVUTAMIG
- Study how the drug behaves in the body (pharmacokinetics)
- Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
- Evaluate preliminary anti-tumor activity
Phase 2 Objectives:
- Assess the preliminary anti-tumor activity by measuring the objective response rate (ORR)
- Further evaluate safety and tolerability
- Continue to study the drug's behavior in the body
Both phases will also look at the drug's immunogenicity, which is the potential for the body to produce antibodies against the drug.
How DAVUTAMIG Works
As a bispecific antibody, DAVUTAMIG is designed to target the MET protein, which is often overexpressed or altered in certain types of lung cancer. By binding to MET, DAVUTAMIG may help to inhibit cancer cell growth and survival. The specific mechanism of action is still being studied as part of the ongoing clinical trial.
Eligibility Criteria
To participate in the DAVUTAMIG clinical trial, patients must meet certain criteria:
Inclusion Criteria:
- Confirmed advanced (unresectable or metastatic) NSCLC
- Have exhausted all approved available therapies
- Documented presence of MET alterations (MET-exon14 mutation, MET gene amplification, or elevated MET protein expression)
- Willing to provide tumor tissue samples
Exclusion Criteria:
- Recent treatment with other systemic therapies (within 2 weeks or 5 half-lives)
- Ongoing severe side effects from previous treatments
- Recent radiation therapy or major surgery (within 14 days)
- Untreated brain metastases or certain other central nervous system issues
- For some parts of the study, prior treatment with MET-targeted therapies may exclude participation
Potential Benefits
While the effectiveness of DAVUTAMIG is still being evaluated, the clinical trial aims to assess its potential benefits, including:
- Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment
- Duration of response (DOR): How long the cancer remains controlled after responding to treatment
- Disease control rate (DCR): The percentage of patients whose cancer shrinks or remains stable
- Progression-free survival (PFS): The length of time during and after treatment that the cancer does not grow or spread
- Overall survival (OS): How long patients live after starting treatment
Safety and Side Effects
As DAVUTAMIG is still in clinical trials, its full safety profile is not yet known. The study is carefully monitoring for any side effects, including:
- Treatment-emergent adverse events (TEAEs)
- Serious adverse events (SAEs)
- Adverse events of special interest (AESIs)
- Laboratory abnormalities
Patients in the trial are closely monitored for any potential side effects or safety concerns.
Administration
DAVUTAMIG is administered as an intravenous (IV) infusion. This means the drug is given directly into a vein. The exact dosing schedule and duration of treatment are being determined as part of the clinical trial.