According to Zhitong Finance APP, Johnson & Johnson (JNJ.US) announced today the top-line results of its Phase 3 MARIPOSA study. The analysis shows that, compared to the current standard treatment, its bispecific antibody Rybrevant (amivantamab) combined with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) oral medication Lazcluze (lazertinib), as a first-line therapy for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion (ex19del) or L858R substitution mutation in exon 21, can significantly improve patients' overall survival (OS) both clinically and statistically.

MARIPOSA is a randomized Phase 3 study that enrolled 1,074 patients. It evaluates the efficacy and safety of the combination of Rybrevant and Lazcluze compared to the active control osimertinib. The primary endpoint of the study is progression-free survival (PFS) assessed by independent blind central review (BICR) according to RECIST v1.1 criteria. Secondary endpoints include OS, objective response rate (ORR), duration of response (DOR), second progression-free survival (PFS2), and intracranial PFS. Previous trial results indicated that the combination therapy of Rybrevant and Lazcluze could reduce the risk of disease progression or death by up to 30% compared to the active control drug. The USA FDA granted approval last August for this combination therapy based on the PFS results of the trial for the corresponding patient population.