Johnson & Johnson’s (J&J’s) Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combination therapy is projected to increase overall survival (OS) by one year above the standard of care (SOC) in non-small cell lung cancer (NSCLC).
J&J presented new OS data on 26 March from the pivotal Mariposa trial (NCT04487080) at the 2025 European Lung Cancer Congress (ELCC) in Paris, France.
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The Phase III trial, which enrolled 1,074 patients, pitted the combination of Rybrevant and Lazcluze against AstraZeneca’s Tagrisso (osimertinib), which is considered the SOC, as a first-line treatment for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
At the median follow-up of 37.8 months, the Rybrevant and Lazcluze combination had not met the gold standard oncology endpoint of OS. Meanwhile, the median OS for patients treated with Tagrisso was 36.7 months. The pharma giant added that 56% of patients treated with Rybrevant and Lazcluze were alive at 3.5 years, compared to 44% of patients on Tagrisso.
J&J states that projections based on survival data suggest the NSCLC combination therapy could extend median OS by at least 12 months compared to Tagrisso.
Trial investigator and head of medical oncology at Institut Curie, Professor Nicolas Girard said: “The survival curve tells a clear story. Rybrevant and Lazcluze help patients live longer, and the benefit keeps growing over time. We see the gap between the survival curves continue to widen, which is exactly what we want to see in lung cancer treatment to improve outcomes for patients.”
New data further supports approval
J&J previously announced the combination met the primary endpoint of progression-free survival (PFS) in the Mariposa study in October 2023. The therapy was given accelerated approval for its use in NSCLC by the US Food and Drug Administration (FDA) in 2021 and has since received full approval based on the PFS data. The combination has also been approved in Europe and other markets globally. The OS data from Mariposa will be shared with these global authorities.
Other key secondary endpoints were announced during the ELCC presentation, including a benefit from the combination in intracranial PFS, which was 25.4 months in the Rybrevant and Lazcluze group compared to 22.2 months with Tagrisso. Intracranial duration of response (DOR) was also higher in the combination group, 35.7 months compared to 29.6 months.
The therapy has remained well tolerated, with the most common adverse event (AE) being a rash. Treatment for this AE is being investigated as part of J&J’s Phase II Cocoon study, evaluating a simple to use and widely accessible dermatologic regimen given prophylactically to patients receiving the combination therapy. J&J announced the therapy met the primary endpoint in the Phase II trial in January 2025. Data from the study will be presented at ELCC later this week.
Rybrevant is expected to generate $4bn in sales by 2030, as per GlobalData estimates. Meanwhile, Lazcluze is set to bring in $6.06bn in the same year.
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J&J is evaluating Rybrevant beyond NSCLC, including in a Phase I colorectal cancer study where it has also shown an improved response rate. A subcutaneous version of the therapy is also in clinical trials and could offer a more convenient dosing schedule to patients.
