Rybrevant extends PFS in EGFR-mutant lung cancer
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Amivantamab-vmjw — with or without the addition of lazertinib — improved PFS versus chemotherapy alone in patients with EGFR-mutated non-small cell lung cancer, according to the agent’s manufacturer.
Topline data results from the randomized phase 3 MARIPOSA-2 study noted statistically significant improvement in PFS, including regimens with and without lazertinib (Leclaza; Yuhan, Janssen).
Amivantamab-vmjw (Rybrevant, Janssen) is an EGFR and mesenchymal epithelial transition (MET) factor bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications. The FDA previously granted accelerated approval to the agent for treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.
The MARIPOSA-2 trial enrolled adults with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or L858R substitutions who experienced disease progression after or while receiving osimertinib (Tagrisso, AstraZeneca).
Investigators randomly assigned study participants to receive amivantamab plus chemotherapy, amivantamab plus chemotherapy with lazertinib, or chemotherapy alone.
The trial met its dual primary endpoint by showing “statistically significant and clinically meaningful improvement in PFS versus chemotherapy alone,” the release stated.
The manufacturer said it plans to submit results for presentation at upcoming major scientific meetings, at which time it will reveal data on OS, objective response, duration of response 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,” Peter Lebowitz, MD, PhD, global therapeutic area head in oncology at Janssen Research & Development, said in the release. “Th[is] 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.”
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