Prime Highlights:

The European Commission has approved the combination of Rybrevant (amivantamab) and Lazcluze (lazertinib) for treatment-naive patients with advanced NSCLC and specific EGFR mutations.

This approval will present patients with EGFR-mutated NSCLC an option-free chemotherapy and which is an exciting alternative to traditional treatments.

According to the Phase 3 MARIPOSA study, this combined therapy reduces the risk of progressive disease or death caused by the disease by about 30% as compared with osimertinib alone.

Key Background:

Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has announced that the European Commission has approved Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) harboring specific EGFR mutations. This approval is a significant step forward in the treatment of EGFR-mutated NSCLC, which is known for its poor prognosis.

There’s renewed hope among those suffering from lung cancer and among them are EGFR-positive metastatic or nonsmall-cell cases. The Thoracic Cancer Unit at Vall d’Hebron University Hospital, led by Dr. Enriqueta Felip, emphasizes the urgent need for new treatment options. Dr. Felip explained, “Patients often experience failure with both first- and second-generation therapies. The combination of amivantamab and lazertinib, as utilized by various researchers, has demonstrated significantly improved outcomes and progression-free survival, particularly for patients with brain metastases.”

Lung cancer is the leading cause of death from cancers in Europe, accounting for 85% of all lung cancers. A subgroup of NSCLC is associated with mutations of EGFR, including the most common ex19del and exon 21 L858R mutations. But till now, no treatment approach can overcome the problem of resistance. Therefore, innovation in treatment is the key to handling the disease.

Dr. Henar Hevia, Senior Director at Janssen, noted that this approval marks a significant advancement in the treatment of EGFR-mutated NSCLC, a condition often associated with poor prognosis. The combination of amivantamab and lazertinib offers targeted precision medicine, addressing the underlying genetic drivers of the disease and delaying the need for chemotherapy. The approval is based on the Phase 3 MARIPOSA study, which demonstrated that the combination therapy reduced the risk of disease progression or death by 30% compared to osimertinib alone. Additionally, the combination therapy resulted in a median progression-free survival of 23.7 months, compared to 16.6 months with osimertinib. This approval represents a

breakthrough in Europe and sets a promising new standard of care, offering chemotherapy-free treatment for eligible patients with EGFR-mutated NSCLC.