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Use of RYBREVANT in Combination with Osimertinib

Last Updated: 11/08/2024

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
  • A real-world study retrospectively evaluated the use of RYBREVANT with or without osimertinib and with or without concurrent radiation therapy in patients with EGFR-mutated (EGFRm) NSCLC (N=61).2
    • Of all patients, 37 (58.7%) received concomitant osimertinib and 25 (39.1%) received concomitant radiation.
    • Of the evaluated patients who received concomitant osimertinib, 1 had a complete response (CR), 12 had a partial response (PR), 4 had stable disease (SD), 15 had progressive disease (PD), and 3 had responses that were not applicable (NA).
    • Among the 37 patients who received concomitant osimertinib and were evaluated for safety, the adverse events (AEs) documented were infusion reactions, rash, thrombocytopenia, and transaminitis (mostly grade 1-2) in addition to grade 1-2 paronychia, fatigue, edema, scalp ulcer, mucositis, nausea, and diarrhea, as well as grade 3 pneumonitis. No additional toxicities were noted except those expected with EGFR/MET inhibition.
  • OSTARA (NCT05801029) is an ongoing, phase 2, single-arm, multicenter study evaluating the efficacy and safety of first-line osimertinib in combination with RYBREVANT in adult patients with locally advanced, metastatic, or recurrent non-squamous EGFRm (Exon 19 deletion or L858R) NSCLC. The primary endpoints are safety and investigator-assessed progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.3 Efficacy and safety results have not yet been published.

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 24 October 2024.

References

1 Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953.  
2 Wang K, Du R, Myall NJ, et al. Real-world efficacy and safety of amivantamab for EGFR-mutant non-small cell lung cancer (NSCLC). J Thorac Oncol. 2024;19(3):500-506.  
3 Tan DSW, Amin N, Madondo M, et al. OSTARA: a phase II study of first-line osimertinib combined with amivantamab in EGFRm advanced non-small cell lung cancer [abstract]. J Thorac Oncol. 2023;18(11S):S338-S339.