The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for Janssen's Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) as a first-line treatment for patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). This decision marks a significant step forward in the treatment landscape for this patient population, offering a new therapeutic option that has demonstrated promising clinical results.
The CHMP's recommendation is based on data from the Phase III MARIPOSA study, a clinical trial comparing the Rybrevant and Lazcluze combination to AstraZeneca's Tagrisso (osimertinib), a current standard of care. The MARIPOSA study met its primary endpoint, demonstrating a 30% reduction in the risk of disease progression or death compared to Tagrisso. Specifically, the median progression-free survival (PFS) was 23.7 months for the Rybrevant plus Lazcluze arm, compared to 16.6 months for the Tagrisso arm.
Subcutaneous Rybrevant Formulation Receives Positive Opinion
In addition to the combination therapy, the CHMP also recommended the approval of a subcutaneous formulation of Rybrevant, co-formulated with Halozyme's ENHANZE drug delivery technology. This subcutaneous option offers an alternative administration route for patients, potentially improving convenience and reducing the burden of treatment. The positive opinion was supported by data from the Phase 3 PALOMA-3 study.
Implications for NSCLC Treatment
NSCLC is a leading cause of cancer-related deaths worldwide, and EGFR mutations are present in a significant proportion of these cases. The combination of Rybrevant and Lazcluze represents a novel approach to targeting EGFR-mutated NSCLC, and the CHMP's positive recommendation paves the way for its approval and use in the European Union. The availability of a subcutaneous formulation further enhances the appeal of Rybrevant, offering patients a more convenient treatment option.
The CHMP has simultaneously recommended the approval of a Type II indication extension for amivantamab in the same combination treatment.
