Johnson & Johnson (J&J) has taken yet another step in expanding the use of Rybrevant (amivantamab-vmjw) to treat epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 

The company filed a supplemental biologics licence (sBLA) and a new drug application (NDA) to the US Food and Drug Administration (FDA) for Rybrevant’s use in combination with Leclaza (lazertinib) as a first-line treatment. These submissions are based on results from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Leclaza combination to AstraZeneca’s Tagrisso (osimertinib).  

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The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, such as those related to race of enrolled participants, type of EGFR mutation and history of brain metastasis, which revealed significant and clinically meaningful advantages for the Rybrevant combination over Tagrisso. 

The latest filing marked the third regulatory submission regarding Rybrevant in four months. In November, the company filed an sBLA  for the combination’s use with chemotherapy for NSCLC with EGFR exon 19 deletions or L858R substitutions, based on  the Phase III MARIPOSA-2 trial. The company also submitted an application seeking the drug’s approval from the European Medicines Agency (EMA) for treating NSCLC with EGFR exon 20 insertion mutations, based on data from the PAPILLON study. 

In the announcement accompanying the applications, Kiran Patel, vice president of clinical development for solid tumours, at Johnson & Johnson innovative medicine said: “This remains an area of high unmet need as patients often experience treatment resistance and disease progression on currently available therapies. 

“We believe this targeted, chemotherapy-free regimen may have the potential to transform the treatment of EGFR-mutated NSCLC.” 

MARIPOSA enrolled 1,074 NSCLC patients with EGFR exon 19 deletions (ex19del) or L858R substitution and progressed on or after treatment with Tagrisso. Rybrevant plus Leclaza reduced disease progression by 30%, compared to Tagrisso.

The FDA approval of Rybrevant could mean competition for AstraZeneca. However the FDA granted a priority review for Tagrisso plus chemotherapy as a first-line treatment for adults with locally advanced or metastatic EGFRm NSCLC in October, after receiving breakthrough therapy designation in August. Tagrisso generated $5.4bn in sales last year, as per AstraZeneca’s 2022 annual report.  

According to GlobalData’s Pharma Intelligence Center, Rybrevant is forecast to generate $2.47bn in sales by 2029, with Tagrisso projecting higher sales at $8bn in the same year. 

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