The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion this week regarding the approval of a subcutaneous (SC) formulation of Johnson & Johnson’s (J&J, NYSE: JNJ) Rybrevant (amivantamab). The recommendation covers the drug’s use in combination with Lazcluze (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. It is also recommended as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. For these indications, SC amivantamab is recommended to be administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards.
Clinical Trial Results
Amivantamab, a fully-human EGFR-MET bispecific antibody (BsAb), has obtained multiple NSCLC indication approvals from the European Commission (EC) with the intravenous (IV) formulation. CHMP’s endorsement is backed by results from the Phase III PALOMA-3 study, which demonstrated the non-inferiority of SC amivantamab to IV amivantamab in terms of pharmacokinetics (PK). Specifically, at a median follow-up of 7 months, the overall response rate (a secondary endpoint) was 30 percent (95 percent confidence interval [CI], 24–37) in the SC arm and 33 percent (95 percent CI, 26–39) for IV (relative risk, 0.92; 95 percent CI, 0.70–1.23; P=0.001), meeting the non-inferiority criteria.
Administration Advantages
Furthermore, administration time for SC amivantamab was reduced to approximately five minutes compared to around five hours for the first IV amivantamab infusion (across two days). The SC formulation also showed a five-fold reduction in infusion-related reactions (IRRs), highlighting its potential benefits in terms of patient convenience and safety.
Future Outlook
With the positive opinion from the CHMP, Johnson & Johnson is well-positioned to expand the use of Rybrevant in treating advanced NSCLC. The subcutaneous formulation offers a more convenient and potentially safer alternative to the intravenous formulation, which could enhance patient adherence and improve treatment outcomes.-Fineline Info & Tech
