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European Commission Approves Amivantamab-Lazertinib Combination for First-Line Treatment of EGFR-Mutated NSCLC

NextEdge Admin

03 Jan 2025

2 min 20 sec

Janssen-Cilag International NV announced the European Commission's (EC) approval of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions (ex19del) or exon 21 L858R mutations.

This decision is based on the Phase 3 MARIPOSA trial, which demonstrated a significant progression-free survival (PFS) benefit. At 22 months of median follow-up, the combination reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy (median PFS: 23.7 vs. 16.6 months; HR=0.70; P<0.001). The median duration of response (DOR) was also extended by nine months (25.8 vs. 16.8 months).

The combination’s safety profile was manageable, with most adverse events (AEs) being Grade 1 or 2. Common treatment-emergent AEs included paronychia (68%), infusion-related reactions (63%), and rash (62%). The discontinuation rate due to treatment-related AEs was 10%.

Amivantamab is a fully-human bispecific antibody targeting EGFR and MET mutations, addressing resistance and activating mutations. Its approval exemplifies the shift toward precision medicine in oncology, offering a tailored approach for patients with EGFR-mutated NSCLC.

An EC decision on marketing authorisation for lazertinib as part of this combination is pending. Additionally, Janssen has submitted an application for a subcutaneous formulation of amivantamab for use with lazertinib in first-line settings.

This approval marks a significant advance for patients with EGFR-mutated NSCLC, providing a new first-line option aimed at delaying chemotherapy and improving survival outcomes.