Janssen-Cilag International NV, a Johnson & Johnson company,announced the European Commission (EC) approval for a Type II variation indication extension for RYBREVANT▼ (amivantamab) in combination with LAZCLUZE▼ (lazertinib) as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The approval specifically addresses EGFR exon 19 deletions (ex19del) and L858R substitutions of exon 21, offering a new chemotherapy-free, multi-target therapy option for eligible patients.

The decision is based on the results of the Phase 3 MARIPOSA study (NCT04487080), which showed that the combination of amivantamab and lazertinib reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy (median PFS: 23.7 months vs. 16.6 months; HR=0.70; P<0.001). The treatment also demonstrated a nine-month improvement in the median duration of response (25.8 vs. 16.8 months), supporting its potential to become a new standard of care for EGFR-mutated NSCLC.

“Patients with advanced NSCLC and EGFR mutations urgently need new first-line treatment options,” said Dr. Enriqueta Felip, Head of the Thorax Cancer Unit at Vall d'Hebron University Hospital, Barcelona. “This combination therapy has demonstrated significant progression-free survival improvements and offers a tailored approach to managing this challenging disease, including patients with brain metastases.”

Lung cancer remains the deadliest cancer in Europe, with NSCLC accounting for 85% of cases. EGFR mutation-positive NSCLC represents a subtype caused by specific genetic mutations, including ex19del and L858R, which make up 85-90% of EGFR mutations. Despite advances in EGFR tyrosine kinase inhibitors (TKIs), resistance and recurrence remain significant challenges, underscoring the need for earlier alternative therapies.

“This approval is a major milestone for patients facing the devastating effects of EGFR-mutated NSCLC,” said Henar Hevia, M.D., Ph.D., Senior Director, Oncology Therapeutics Sector for EMEA. “The amivantamab and lazertinib combination embodies the promise of precision medicine, addressing underlying genetic factors to improve patient outcomes and delay the need for chemotherapy.”

The safety profile of the combination was consistent with prior studies, with manageable side effects. Common treatment-emergent adverse events (AEs) included paronychia (68%), infusion-related reactions (63%), and rash (62%), primarily Grade 1 or 2. The discontinuation rate due to AEs was 10%, with fewer than 3% of patients experiencing interstitial lung disease in both treatment arms.

Janssen also highlighted its collaboration with healthcare providers to maximize the reach and impact of this treatment. The approval paves the way for a new era of tailored cancer care, offering hope to patients and caregivers.

The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). A final decision on marketing authorization for lazertinib for this indication is expected soon.