VYLOY Clinical Trial Quiz
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Questions and Answers

What was the initial dose of VYLOY administered in GLOW?

  • 600 mg/m2
  • 1000 mg/m2
  • 800 mg/m2 (correct)
  • 200 mg/m2

    • What percentage of patients experienced serious adverse reactions while on VYLOY?

  • 8%
  • 55%
  • 19%
  • 47% (correct)

    • Which of the following was the most common serious adverse reaction among patients treated with VYLOY?

  • Diarrhea
  • Nausea
  • Pneumonia
  • Vomiting (correct)

    • What proportion of patients had to permanently discontinue VYLOY due to adverse reactions?

    <p>19%</p> Signup and view all the answers

    Which adverse reaction led to the highest percentage of dose interruptions of VYLOY?

    <p>Nausea</p> Signup and view all the answers

    What was the median duration of exposure to VYLOY in combination with CAPOX?

    <p>4.4 months</p> Signup and view all the answers

    What fatal adverse reaction occurred most frequently among patients receiving VYLOY?

    <p>Sepsis</p> Signup and view all the answers

    Which of the following was NOT listed as an adverse reaction leading to discontinuation of VYLOY?

    <p>Pulmonary embolism</p> Signup and view all the answers

    What percentage of patients in the VYLOY with mFOLFOX6 group experienced progression-free survival events?

    <p>51.6%</p> Signup and view all the answers

    Which of the following represents the median overall survival for the placebo group in combination with mFOLFOX6?

    <p>15.5 months</p> Signup and view all the answers

    What was the hazard ratio for overall survival comparing VYLOY with mFOLFOX6 to placebo with mFOLFOX6?

    <p>0.750</p> Signup and view all the answers

    What was the complete response rate for the VYLOY with mFOLFOX6 group?

    <p>14%</p> Signup and view all the answers

    What percentage of patients in the placebo group experienced events during the progression-free survival endpoint?

    <p>59.2%</p> Signup and view all the answers

    What was the median duration of response for patients receiving VYLOY?

    <p>10.3 months</p> Signup and view all the answers

    What was the one-sided p-value indicating the significance of progression-free survival improvement in VYLOY group?

    <p>0.0066</p> Signup and view all the answers

    How many patients achieved a partial response in the VYLOY group?

    <p>100</p> Signup and view all the answers

    What is the primary indication for VYLOY?

    <p>First-line treatment for HER2-negative gastric or GEJ adenocarcinoma</p> Signup and view all the answers

    What is the defining characteristic for selecting patients for VYLOY treatment?

    <p>Presence of claudin 18.2 positive tumors</p> Signup and view all the answers

    What is the initial recommended dosage for VYLOY?

    <p>800 mg/m2 intravenously</p> Signup and view all the answers

    What should be the state of nausea and/or vomiting before administering VYLOY?

    <p>Resolved to Grade ≤1</p> Signup and view all the answers

    How often should subsequent doses of VYLOY be administered after the first dose?

    <p>Every 2 weeks or every 3 weeks</p> Signup and view all the answers

    Which of the following is NOT recommended as a dosage modification for VYLOY?

    <p>Increasing the infusion rate</p> Signup and view all the answers

    What type of chemotherapy is VYLOY used in combination with?

    <p>Fluoropyrimidine- and platinum-containing chemotherapy</p> Signup and view all the answers

    How is the CLDN18.2 positivity determined?

    <p>By immunohistochemical staining</p> Signup and view all the answers

    Which of the following symptoms is NOT considered a serious allergic reaction to VYLOY?

    <p>Decreased appetite</p> Signup and view all the answers

    What action should be taken if nausea or vomiting worsens after receiving VYLOY?

    <p>Consult a healthcare provider immediately</p> Signup and view all the answers

    During which treatment cycle is nausea and vomiting reported to occur more frequently?

    <p>First treatment cycle</p> Signup and view all the answers

    Which of the following side effects is associated with changes in laboratory tests during VYLOY treatment?

    <p>Changes in kidney function tests</p> Signup and view all the answers

    What is a common preventative measure against severe nausea and vomiting during VYLOY treatment?

    <p>Administering medicines before infusion</p> Signup and view all the answers

    When experiencing a serious allergic reaction to VYLOY, which symptom indicates a breathing issue?

    <p>Throat tightness</p> Signup and view all the answers

    Which of the following is NOT listed as a common side effect of VYLOY?

    <p>Severe headaches</p> Signup and view all the answers

    What might a healthcare provider do if a patient experiences certain side effects during VYLOY treatment?

    <p>Completely stop treatment</p> Signup and view all the answers

    Which laboratory abnormality was reported in more than 15% of the pooled population?

    <p>Decreased leucocyte count</p> Signup and view all the answers

    What percentage of patients experienced serious adverse reactions while treated with VYLOY in combination with mFOLFOX6?

    <p>45%</p> Signup and view all the answers

    Which serious adverse reaction occurred in the highest percentage of patients treated with VYLOY?

    <p>Vomiting</p> Signup and view all the answers

    What was the percentage of patients who experienced permanent discontinuation of VYLOY due to adverse reactions?

    <p>20%</p> Signup and view all the answers

    Which of the following laboratory abnormalities indicates increased creatinine levels?

    <p>Increased creatinine</p> Signup and view all the answers

    Which of the following was NOT among the common adverse reactions leading to dose interruption?

    <p>Diarrhea</p> Signup and view all the answers

    What was the range of median exposure to VYLOY in combination with mFOLFOX6?

    <p>1 day to 40.9 months</p> Signup and view all the answers

    Which fatal adverse reaction had the highest occurrence percentage among patients treated with VYLOY?

    <p>Sepsis</p> Signup and view all the answers

    What is included in the stratification factors for the Kaplan-Meier estimate?

    <p>Region</p> Signup and view all the answers

    How should VYLOY be stored prior to use?

    <p>In the original carton refrigerated at 2ºC to 8ºC</p> Signup and view all the answers

    What is the risk associated with administering VYLOY?

    <p>Anaphylaxis</p> Signup and view all the answers

    What should patients be advised to do if they experience severe nausea or vomiting while on VYLOY?

    <p>Contact their healthcare provider immediately</p> Signup and view all the answers

    What is the recommended action regarding breastfeeding during treatment with VYLOY?

    <p>Do not breastfeed during treatment and for 8 months after the last dose</p> Signup and view all the answers

    What type of reactions can VYLOY cause that require immediate medical attention?

    <p>Infusion-related reactions</p> Signup and view all the answers

    In what form is VYLOY supplied for injection?

    <p>As a lyophilized powder in single-dose vials</p> Signup and view all the answers

    What is the dosage form in which VYLOY is available?

    <p>100 mg single-dose vial</p> Signup and view all the answers

    Study Notes

    VYLOY (zolbetuximab-clzb) for Injection

    • Indications: First-line treatment for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with claudin (CLDN) 18.2-positive tumors.
    • Mechanism of Action: Claudin 18.2-directed cytolytic antibody. Depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
    • Dosage: Initial dose 800 mg/m², followed by 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks, intravenously.
    • Administration: IV infusion only, do not administer as an IV push or bolus. Premedicate with antiemetics prior to each infusion for nausea and vomiting prevention.
    • Contraindications: None listed.
    • Warnings and Precautions:
      • Hypersensitivity Reactions: Serious anaphylaxis and infusion-related reactions have occurred. Monitor patients during and for at least 2 hours after infusion. Interrupt, slow, or permanently discontinue infusion based on reaction severity. Premedicate with antihistamines for subsequent infusions after hypersensitivity reactions.
      • Severe Nausea and Vomiting: Premedicate with antiemetics. Interrupt or discontinue based on severity. Manage with antiemetics or fluid replacement.
    • Adverse Reactions: Common adverse reactions in trials include nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia. Common laboratory abnormalities include decreased neutrophil and leucocyte counts, decreased albumin, increased creatinine, and decreased hemoglobin.

    Dosage Modifications

    • No dose reduction is recommended for VYLOY.
    • Adverse reactions are managed by adjusting infusion rate, interruption, dose withholding, or permanent discontinuation based on severity, as detailed in Table 1.

    Preparation and Dilution

    • Calculate the dose based on body surface area and number of vials needed.
    • Reconstitute each vial by adding 5 mL of Sterile Water for Injection.
    • Slowly swirl until dissolved. Do not shake.
    • Visually inspect for particulate matter and discoloration. Discard vials with visible particles.
    • Store reconstituted vials at room temperature (15°C to 30°C) for up to 5 hours if unused immediately.
    • Transfer reconstituted solution to an infusion bag with 0.9% Sodium Chloride Injection to a concentration of 5 mg/mL.
    • Visual inspection of the diluted solution is required prior to use.
    • Storage of diluted solution is at room temperature (15°C to 30°C) for up to 6 hours or refrigerated (2°C to 8°C) for up to 16 hours. Do not freeze.

    Administration

    • Administer VYLOY intravenously only.
    • Do not administer as an intravenous push or bolus.
    • If administering VYLOY with chemotherapy, administer VYLOY first.
    • Use compatible infusion devices and tubing.
    • Follow infusion rates in Table 2.
    • Start infusion slowly (30-60 minutes) and increase as tolerated if no adverse reactions occur.
    • If the infusion time exceeds the recommended storage time, discard the bag and prepare a new infusion bag.

    Use in Specific Populations

    • Pregnancy: Not recommended unless benefit outweighs risk.
    • Lactation: Advise patients not to breastfeed during treatment and for 8 months after the last dose.
    • Pediatric: Safety and effectiveness not established.
    • Geriatric: No significant differences in safety or effectiveness observed in patients aged 65 years and older compared to younger patients.
    • Females/Males of Reproductive Potential: Refer to the Full Prescribing Information of any associated chemotherapy for pregnancy testing, contraception, and fertility information.

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    Related Documents

    VYLOY (zolbetuximab-clzb) for Injection, 2024 PDF

    Description

    Test your knowledge about the VYLOY clinical trial results. This quiz covers dosages, adverse reactions, and survival rates among patients treated with VYLOY in combination with various chemotherapy regimens. Challenge yourself with questions that assess your understanding of the trial's findings and implications.

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