Janssen submits extension of indication for Rybrevant in combo with lazertinib to EMA in 1L NSCLC

Janssen has announced the submission of its extension of indication application for Rybrevant (amivantamab) in combination with lazertinib, for the first-line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.  

This submission is based on data from MARIPOSA (NCT04487080), a randomised, Phase 3 study evaluating amivantamab in combination with lazertinib versus osimertinib and versus lazertinib alone in first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations.The primary endpoint of the study is PFS (using RECIST v1.1 guidelines) as assessed by BICR. Secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DOR), second progression free survival (PFS2) and intracranial PFS.

Reference link: Janssen press release