The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Johnson & Johnson's Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions (ex19del) or L858R mutations. This decision marks a significant step forward in the treatment landscape for this specific subset of lung cancer patients.
The CHMP's recommendation is rooted in the findings of a Phase 3 clinical trial, which demonstrated that the combination therapy significantly reduces the risk of disease progression or death by 30% when compared to osimertinib, a current standard of care. This improvement in progression-free survival offers a clinically meaningful benefit for patients with EGFR-mutated NSCLC.
According to Henar Hevia, Senior Director of Oncology at Johnson & Johnson, this treatment approach has the potential to "set a new standard" by delaying disease progression and reserving chemotherapy for later stages of treatment. This strategy could lead to improved quality of life and potentially extend overall survival for patients.
Clinical Trial Data
The Phase 3 trial compared the efficacy and safety of lazertinib plus amivantamab versus osimertinib in patients with previously untreated, advanced NSCLC with EGFR ex19del or L858R mutations. The primary endpoint of the study was progression-free survival. The results showed a statistically significant and clinically meaningful improvement in progression-free survival in the lazertinib plus amivantamab arm compared to the osimertinib arm, with a 30% reduction in the risk of progression or death.
The CHMP also recommended a type II indication extension for the combination therapy, further solidifying its potential role in the treatment of EGFR-mutated NSCLC.
Implications for Treatment
NSCLC is a leading cause of cancer-related deaths worldwide, and EGFR mutations are present in a significant proportion of these cases. The availability of new and effective first-line treatment options is crucial for improving outcomes for these patients. The combination of lazertinib and amivantamab represents a promising new approach that could potentially change the treatment paradigm for EGFR-mutated NSCLC.
