Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA) has granted approval for its EGFR/c-MET bispecific antibody, Rybrevant (amivantamab-vmjw), in combination with standard chemotherapy, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R substitution mutations, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
This approval follows the FDA’s accelerated approval in May 2021 for Rybrevant as a single-agent therapy for adult patients with EGFR exon 20 insertion mutations in NSCLC after platinum-based chemotherapy. The drug has also been conditionally approved in March of this year in the US for the treatment of EGFR exon 20 insertion mutations in locally advanced or metastatic NSCLC.
The FDA’s decision was supported by positive results from the Phase III MARIPOSA-2 (NCT04988295) study, which evaluated the efficacy and safety of Rybrevant in combination with chemotherapy in adult patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations who had progressed following treatment with osimertinib. The study showed a 52% reduction in the risk of disease progression or death (progression-free survival, PFS) with Rybrevant plus chemotherapy compared to chemotherapy alone, which was the primary endpoint. The median PFS was 6.3 months for patients receiving Rybrevant plus chemotherapy versus 4.2 months for those on chemotherapy alone. Additionally, the objective response rate (ORR) was 53% for the combination therapy and 29% for chemotherapy alone. The safety profile of Rybrevant in combination with chemotherapy was consistent with the known safety profiles of the individual treatments.- Flcube.com
