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Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy With and Without Lazertinib versus Chemotherapy Alone in Patients with EGFR+ NSCLC after Disease Progression on Osimertinib

*September 2023*

RARITAN, N.J., Sept. 6, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the three-arm Phase 3 MARIPOSA-2 study evaluating RYBREVANT® (amivantamab-vmjw), a bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), given with and without lazertinib, an oral, third-generation EGFR tyrosine kinase inhibitor (TKI), combined with chemotherapy (carboplatin and pemetrexed) versus chemotherapy alone. MARIPOSA-2 enrolled patients with locally advanced or metastatic EGFR exon 19 deletions (ex19del) or L858R substitution NSCLC after disease progression on or after osimertinib. The study met its dual primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS versus chemotherapy alone in both experimental treatment arms. No new safety signals were found for the addition of RYBREVANT® to chemotherapy.1 Janssen plans to submit these results for presentation at upcoming scientific congresses, including details on secondary endpoints such as overall survival (OS), objective response, duration of response (DoR) and intracranial PFS.

“MARIPOSA-2 provides the first Phase 3 study data of RYBREVANT-based regimens in the broader EGFR-mutated non-small cell lung cancer population,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “The study builds on the significant innovation of RYBREVANT, a first-in-class bispecific antibody targeting two major oncogenic driver pathways, with clinically meaningful results that may change the treatment paradigm.” Read more.