FDA approves Rybrevant for advanced lung cancer
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The FDA approved amivantamab-vmjw in combination with standard chemotherapy for the treatment of certain adults with non-small cell lung cancer, according to the agent’s manufacturer.
The indication applies to adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations whose disease progressed on or following treatment with an EGFR tyrosine kinase inhibitor.
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.
Researchers conducted the randomized phase 3 MARIPOSA-2 study to compare the efficacy and safety of three regimens, two of which contained amivantamab-vmjw.
Researchers randomly assigned 657 patients to amivantamab-vmjw plus chemotherapy; amivantamab-vmjw plus chemotherapy with lazertinib (Lazcluze, Janssen); or chemotherapy alone.
PFS assessed by blinded independent central review for the two combination treatment groups served as dual primary endpoints. Secondary endpoints included objective response rate, OS, duration of response, time to subsequent therapy, PFS2 and intracranial PFS.
Amivantamab-vmjw plus chemotherapy reduced the risk for disease progression or death by 52% compared with chemotherapy alone.
Researchers reported longer median PFS (6.3 months vs. 4.2 months) and a higher ORR (53% vs. 29%) among patients assigned amivantamab-vmjw plus chemotherapy vs. those assigned chemotherapy alone.
The safety profile of amivantamab-vmjw in combination with chemotherapy appeared consistent with that observed in prior studies. Researchers observed no new safety signals.
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