By Fineline Cube 
The European Commission (EC) has approved the subcutaneous (SC) formulation of Johnson & Johnson’s (J&J, NYSE: JNJ) Rybrevant (amivantamab) for two new indications. The drug can now be used in combination with Lazcluze (lazertinib) as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations and as a monotherapy for patients with advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
Drug Mechanism
Rybrevant is a fully human EGFR-MET bispecific antibody (BsAb) designed to target cancer cells with specific EGFR mutations. The SC formulation offers a significant advantage in administration time, reducing it to approximately five minutes compared to around five hours for the initial intravenous (IV) infusion.
Clinical Trial Results
The approval is based on results from the Phase III PALOMA-3 study, which demonstrated the non-inferiority of SC amivantamab to IV amivantamab in terms of pharmacokinetics (PK). At a median follow-up of 7 months, the overall response rate (ORR) was 30% (95% CI, 24–37) in the SC arm versus 33% (95% CI, 26–39) in the IV arm, meeting the non-inferiority criteria. Additionally, the SC formulation showed a five-fold reduction in infusion-related reactions (IRRs).
Administration Benefits
The SC formulation of Rybrevant not only reduces administration time but also enhances patient convenience and tolerability, making it a more patient-friendly option for NSCLC treatment.-Fineline Info & Tech