SUMMARY

• RYBREVANT (amivantamab-vmjw) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).¹
• LAZCLUZE (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor (TKI).²
• The recommended dosage of RYBREVANT is based on baseline body weight and administered as an intravenous (IV) infusion after dilution.³
  • Administer RYBREVANT in combination with chemotherapy weekly for 4 weeks, with the initial dose as a split infusion in Week 1 on Day 1 and Day 2, then administer every 3 weeks (Q3W) starting at Week 7.
  • Administer RYBREVANT in combination with lazertinib or RYBREVANT as a single agent weekly for 5 weeks, with the initial dose as a split infusion in Week 1 on Day 1 and Day 2, then administer every 2 weeks starting at Week 7.
• Please refer to product labeling for complete dosage and administration information.

PRODUCT LABELING

• RYBREVANT (amivantamab-vmjw) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf.
• LAZCLUZE (lazertinib) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/LAZCLUZE-pi.pdf.

MISSED DOSE

The information provided in this section summarizes how investigators in the PAPILLON, MARIPOSA-2, MARIPOSA, and CHRYSALIS studies were instructed to manage missed doses. These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician.

RYBREVANT in Combination with Chemotherapy

PAPILLON Study

• RYBREVANT should typically be administered Q3W but if its dosing needs to align with a delayed dose of chemotherapy, then it can be administered at an interval between 2 and 4 weeks.⁴
• If a dose is delayed on Cycle 1 Day 8 and/or Cycle 1 Day 15, it will not be made up. If a dose is delayed in Cycle 2 or beyond, then the dates of the subsequent doses will be scheduled based on the timing of the previous dose of RYBREVANT. If RYBREVANT is delayed for ≥6 weeks from the last dose, a discussion is to occur with the Medical Monitor prior to redosing.⁴

MARIPOSA-2 Study

• If delays in initiation of therapy leave insufficient time on Cycle 1 Day 1 for full RYBREVANT dosing, then the initial split dose of RYBREVANT (Cycle 1 Day 1 and Day 2) may be delayed (until Cycle 1 Day 2 and Day 3), with corresponding changes to scheduled activities (pharmacokinetics and vital signs) and premedications.⁵
• If RYBREVANT dosing on Day 1 of the cycle is delayed, but retreatment criteria for chemotherapy are met, dosing with chemotherapy should continue as planned and participants should be evaluated weekly for retreatment with RYBREVANT.⁵
• If both chemotherapy and RYBREVANT must be delayed, participants should be re-evaluated weekly for retreatment.⁵
  • Dosing with RYBREVANT may proceed once retreatment criteria are met, whether on Day 8 or Day 15 of the cycle. The dosing of both chemotherapy and RYBREVANT may resume on the subsequent cycle once retreatment criteria for pemetrexed ± carboplatin are met, as described above.

RYBREVANT in Combination with Lazertinib

MARIPOSA Study

• Starting with Cycle 2, RYBREVANT infusions delayed >7 days cannot be made up. The delayed dose should be skipped, and the participant dosed at the next scheduled visit.⁶

RYBREVANT as a Single Agent

CHRYSALIS Study

• For weekly Cycle 1, and biweekly Cycle 2 and beyond dosing schedule, a missed dose is defined as failure to administer RYBREVANT within 3 days of the scheduled dosing date in Cycle 1, or failure to administer RYBREVANT within 7 days of the scheduled dosing date in Cycle 2 and beyond. If a dose is missed, as defined above, it will not be made up. Administration may resume at the next planned dosing day.⁷

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 16 August 2024.