Johnson & Johnson Announces Positive Phase III MARIPOSA-2 Trial Results for Amivantamab-Based Combination Therapy in Second-Line NSCLC

On September 6, Johnson & Johnson announced that the Phase III MARIPOSA-2 study of Rybrevant (amivantamab), an EGFR/c-MET bispecific antibody, in combination with the third-generation EGFR inhibitor lazertinib and chemotherapy for the treatment of non-small cell lung cancer (NSCLC) patients who are resistant to osimertinib, has obtained positive topline data.

MARIPOSA-2 is a randomized, open-label Phase III study designed to evaluate the efficacy and safety of amivantamab + lazertinib + carboplatin + pemetrexed (LACP, Group A) versus carboplatin + pemetrexed (CP, Group B) in patients with locally advanced or metastatic NSCLC harboring common EGFR mutations (Exon19 del/Exon21 L858R) after resistance to osimertinib. Meanwhile, the study also includes an additional arm of amivantamab + carboplatin + pemetrexed (ACP, Group C) to comparatively assess the therapeutic effect of lazertinib in patients treated with LACP. The primary endpoint of the study is progression-free survival (PFS); key secondary endpoints include objective response rate (ORR), overall survival (OS), duration of response (DoR), intracranial PFS, etc.

The data results show that the MARIPOSA-2 study met the dual primary endpoints, with statistically significant and clinically meaningful improvements in PFS in both experimental groups (Group A and Group C) compared to the chemotherapy-alone group (Group B).In terms of safety, the data are consistent with previous studies, and no new safety signals were observed. Johnson & Johnson plans to release these results at an upcoming scientific conference, including details on secondary endpoints such as OS, ORR, and DoR.

Amivantamab is an EGFR/c-MET bispecific antibody developed by Johnson & Johnson. In May 2021, amivantamab was first approved by the FDA for the treatment of patients with advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose disease had progressed after platinum-based chemotherapy. This drug is also the world's first approved EGFR/c-MET bispecific antibody. Previously, on July 17, Johnson & Johnson announced positive results from the Phase III PAPILLON study of amivantamab in patients with newly diagnosed EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC, meeting the primary endpoint of PFS ().

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