J&J Submits Regulatory Applications to FDA and EMA for Amivantamab Plus Lazertinib as First-Line Treatment in EGFR-Mutated NSCLC

▎WuXi

Edited by Kant Content Team

Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) and a New Drug Application (NDA) to the U.S. FDA, seeking approval for Rybrevant (amivantamab) in combination with lazertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) oral medication, for first-line treatment.

EGFR

Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring exon 19 deletions (ex19del) or L858R substitution mutations. Johnson & Johnson simultaneously submitted a Marketing Authorization Application (MAA) for this indication to the European Medicines Agency (EMA) today.

This submission is primarily based on the results of the Phase 3 MARIPOSA clinical trial announced at this year's European Society for Medical Oncology (ESMO) Congress.Analysis shows that amivantamab combined with lazertinib, compared to the active control TKI drug Tagrisso (osimertinib),As a first-line therapy for treating

In patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or L858R mutations, the risk of disease progression or death can be reduced by 30% (HR=0.70; 95% CI: 0.58-0.85; p<0.001).

Moreover, the combination of amivantamab and lazertinib showed a favorable trend in overall survival (OS) compared to the active control drug in these patients (HR=0.80; 95% CI: 0.61-1.05; p=0.11).

During the median follow-up period of 22 months,The median progression-free survival (PFS) for amivantamab and lazertinib was 23.7 months, compared to 16.6 months for the active control drug (HR=0.70; 95% CI: 0.58-0.85; p<0.001).In predefined patient subgroups, other secondary endpoints showed consistent and clinically meaningful benefits of the amivantamab and lazertinib combination therapy compared to the active control.

When examining the first progression of the central nervous system (CNS) in patients, the median PFS for the combination of amivantamab and lazertinib was 27.5 months, compared to 18.5 months for the active control drug (HR=0.68; 95% CI: 0.56–0.83; p<0.001).Compared with the active control drug, the median duration of response (DOR) for patients receiving amivantamab plus lazertinib was significantly longer, improving by 9 months. DOR refers to the length of time during which a tumor continues to respond to treatment without cancer growth or spread.The median DOR for the combination therapy group and the active drug group were 25.8 months and 16.8 months, respectively.

The safety profile of the combination therapy with amivantamab and lazertinib is consistent with the safety profiles of the individual therapies, with most adverse events being grade 1 or 2.

Amivantamab is a humanized EGFR/MET bispecific antibody. It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signaling pathways but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications.Amivantamab was approved by the U.S. FDA in May 2021.Accelerated Approval, used to treat conditions detected by FDA-approved tests

Adult patients with locally advanced or metastatic NSCLC who have EGFR exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.

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References:

[1] Johnson & Johnson Submits Supplemental BiologicsLicense Application and New Drug Application to U.S. FDA Seeking Approval ofRYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patientswith EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC). Retrieved December 21,2023 from https://www.jnj.com/johnson-johnson-submits-supplemental-biologics-license-application-and-new-drug-application-to-u-s-fda-seeking-approval-of-rybrevant-amivantamab-vmjw-plus-lazertinib-for-the-treatment-of-patients-with-egfr-mutated-non-small-cell-lung-cancer-nsclc

[2] Janssen Submits Marketing Authorisation Application tothe European Medicines Agency Seeking Approval of Lazertinib, in combinationwith RYBREVANT® (amivantamab), for the First-Line Treatment of Patients withEGFR-Mutated Non-Small Cell Lung Cancer. Retrieved December 21, 2023 from https://www.jnj.com/janssen-submits-marketing-authorisation-application-to-the-european-medicines-agency-seeking-approval-of-lazertinib-in-combination-with-rybrevant-amivantamab-for-the-first-line-treatment-of-patients-with-egfr-mutated-non-small-cell-lung-cancer

[3] Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw)Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progressionor Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small CellLung Cancer. Retrieved December 21, 2023 from https://www.jnj.com/landmark-phase-3-mariposa-study-shows-rybrevant-amivantamab-vmjw-plus-lazertinib-resulted-in-30-percent-reduction-in-risk-of-disease-progression-or-death-compared-to-osimertinib-in-patients-with-egfr-mutated-non-small-cell-lung-cancer

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