Janssen Submits New BLA for Amivantamab Plus Lazertinib as First-Line Therapy for EGFR-Mutant NSCLC, Challenging Osimertinib
Johnson & Johnson
Medical Device R&D and Manufacturer
On December 21, Johnson & Johnson announced that it had submitted an EGFR/c-MET bispecific antibody to the U.S. FDA.Amivantamab（Amivantamab/Rybrevant) New Indication Marketing Application,Combination of Third-Generation EGFR Inhibitor Lazertinib as First-Line Treatment for EGFR-Mutant Locally Advanced or Metastatic NSCLC Patients。
Source: Johnson & Johnson Official Website
This application is primarily based on the pivotal Phase IIIMARIPOSA StudyResults, aimed at evaluatingAmivantamab Efficacy and Safety of Lazertinib in Combination with Third-Generation EGFR TKI Osimertinib versus Lazertinib Monotherapy as First-Line Treatment for EGFR-Positive Advanced NSCLC.
The results showed that Amivantamab + Lazertinib significantly improved PFS compared to first-line treatment with Osimertinib in EGFR-mutated advanced NSCLC.Better performance, significantly reducedA 30% reduction in the risk of disease progression or death, benefiting patients regardless of whether they have brain metastases or not;DOR extended by 9 months, OS showed a trend of benefit.
Specifically:Median follow-up of 22.0 months,Amivantamab+Lazertinib Group MedianPFS was 23.7 months, while osimertinib was 16.6 months.(HR=0.70, P<0.001), the 2-year PFS rates were 48% and 34%, respectively.AndNoneWhether or not the patient has brain metastases,Amivantamab+Lazertinib GroupTheConsistent PFS benefit.In terms of ORR, the Amivantamab+Lazertinib group had an ORR of 86%, while Osimertinib had an ORR of 85%. The median DOR was 25.8 months and 16.8 months, respectively.
AmivantamabIs the world's firstThe EGFR/cMET bispecific antibody was approved for marketing; in May 2021, it received FDA approval based on Phase Ib clinical data for use in NSCLC with EGFR exon 20 insertion mutations that progressed after platinum-based chemotherapy.
Following this, two supplemental Biologics License Applications (sBLA) were submitted to the FDA in August and November this year, respectively, for the indications of:Combined Chemotherapy（Carboplatin-PemetrexedFirst-line treatment for patients with EGFR-mutated locally advanced or metastatic NSCLC;IntegrationTherapy for EGFR-mutated NSCLC patients with disease progression during or after treatment with osimertinib。
And this time, the declared indication is a direct "targeted attack."Osimertinib,Contest for the Billion-Dollar EGFR Market。Osimertinib was approved by the FDA in November 2015Since its launch, sales have been on the rise, reaching $5.444 billion globally in 2022. In the first three quarters of 2023, sales increased by 10% year-on-year to reach $4.38 billion, still topping AstraZeneca's product sales.
In China,Amivantamab Submitted for marketing approval in China for the first time in October this year.Combination of Carboplatin and Pemetrexed for the Treatment of Locally Advanced or Metastatic NSCLC with EGFR Exon 20 Insertion Mutations(Application No.: JXSS2300080), and submitted in December.New Indication (Acceptance No.: JXSS2300088).
