J&J Seeks FDA Approval for Rybrevant and Lazertinib Duo in Advanced Lung Cancer

Johnson & Johnson has applied to the FDA for approval of Rybrevant® and lazertinib for treating EGFR-mutated advanced non-small cell lung cancer. This combination showed a significant improvement in progression-free survival compared to current treatments.

Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) and a New Drug Application (NDA) to the US Food and Drug Administration (FDA). This submission seeks approval for the use of Rybrevant® (amivantamab-vmjw) in combination with lazertinib, aiming to treat adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations. Based on the Phase 3 MARIPOSA study, this combination could transform the current treatments for this lung cancer subtype.

The MARIPOSA Study

Central to this application is the data from the landmark Phase 3 MARIPOSA study. This study demonstrated a statistically significant and clinically meaningful improvement in progression-free survival among patients treated with the Rybrevant  and lazertinib combination compared to osimertinib, the current standard of care. Such results mark a potential paradigm shift in the first-line treatment of this lung cancer subtype.

A Novel Lung Cancer Treatment

Dr. Kiran Patel, Vice President of Clinical Development at J&J, emphasized, “The combination of Rybrevant and lazertinib demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to osimertinib in patients with previously untreated EGFR-mutated NSCLC. This remains an area of high unmet need as patients often experience treatment resistance and disease progression on currently available therapies.”

MARIPOSA Study Insights

The study involved 1,074 patients and compared the efficacy of the Rybrevant  and lazertinib combination against osimertinib and lazertinib alone. A novel aspect of this study was the mandatory serial brain imaging using MRIs, a protocol not commonly implemented in previous studies for this cancer type. This approach allowed for a comprehensive assessment of progression-free survival, including central nervous system events.

Rybrevant 's Potential Impact

Already approved for certain NSCLC cases with EGFR exon 20 insertion mutations, Rybrevant is a bispecific antibody targeting EGFR and MET with immune cell-directing activity. The combination with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor, could offer a new therapeutic pathway for patients with EGFR-mutated NSCLC.

Rybrevant  is being evaluated in various clinical trials, encompassing different stages and mutations of NSCLC. These studies continue to explore the efficacy and safety of Rybrevant in combination with other treatments, including chemotherapy and other targeted therapies.