Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbors specific epidermal growth factor receptor (EGFR) mutations.
This regulatory milestone marks the first challenge to AstraZeneca’s third-generation EGFR TKI, Tagrisso (osimertinib), as Rybrevant and Lazclude are the inaugural and sole multitargeted, chemotherapy-free combination to demonstrate superior efficacy over Tagrisso in first-line NSCLC treatment.
Rybrevant, a bispecific antibody, targets both EGFR and MET, and was initially approved in the US in 2021 for second-line monotherapy use in NSCLC with EGFR exon 20 insertion mutations. It received a second approval in March of this year for use in combination with chemotherapy as a first-line therapy for the same mutation type. Lazclude, akin to Tagrisso, is a third-generation EGFR inhibitor that J&J licensed from South Korea’s Yuhan Corporation in 2018. The recent approval marks Lazclude’s global debut.
The Phase III MARIPOSA study underpinned the approval, demonstrating that the Rybrevant-Lazclude combination significantly reduced the risk of disease progression or death by 30% in first-line EGFR-positive NSCLC patients, achieving a median progression-free survival (PFS) of 23.7 months compared to Tagrisso’s 16.6 months. Additionally, the combination therapy showed a notable enhancement in the secondary endpoint, with a median duration of response (DOR) of 25.8 months versus 16.7 months for Tagrisso.- Flcube.com
