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Amivantamab Plus Chemotherapy Provides PFS Benefit in EGFR-Mutated NSCLC
Topline Results From the Phase 3 MARIPOSA-2 Trial
Topline Results From the Phase 3 MARIPOSA-2 Trial
According to a press release from Janssen Pharmaceutical Companies of Johnson & Johnson, topline results from the MARIPOSA-2 trial have demonstrated amivantamab with or without lazertinib plus chemotherapy significantly improves progression-free survival (PFS) among patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions (ex19del) or L858R substitution in the post-osimertinib setting.
In this randomized, open-label phase 3 study, 657 patients who experienced disease progression on or after treatment with osimertinib were assigned to receive amivantamab with lazertinib plus chemotherapy, amivantamab plus chemotherapy, or chemotherapy alone. Prior to treatment, study participants underwent serial brain imaging. The dual primary end points were efficacy and safety, as assessed by blinded independent central review (BICR), to compare PFS in each experimental arm. Secondary end points included objective response as assessed by BICR, overall survival (OS), duration of response (DoR), time to subsequent therapy, PFS after first subsequent therapy, and intracranial PFS.
At the time of analysis, the press release states the study met its dual primary end points, with a significant and clinically meaningful PFS improvement in both experimental treatment arms, when compared to results observed in the chemotherapy arm. No additional safety signals were identified.
Full results including details on secondary end points will be presented at an upcoming scientific congress.
Source:
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-mutated non-small cell lung cancer after disease progression on osimertinib. News Release. PR Newswire. September 6, 2023. https://www.prnewswire.com/news-releases/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-la-301919084.html
