Janssen-Cilag International, a Johnson & Johnson company, announced new positive follow-up data from the Phase 3 MARIPOSA study of Rybrevant (amivantamab) in combination with lazertinib in patients with advanced lung cancer.
MARIPOSA assessed Rybrevant with Lazertinib as a first-line treatment against osimertinib monotherapy in 1,074 patients.
The study involved adult patients with advanced non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. Its data revealed that the Rybrevant combination consistently benefited long-term outcomes compared to Osimertinib.
Additionally, a strong and improving trend in overall survival (OS) was observed with the amivantamab and lazertinib combination after approximately three years of follow-up.
At a median follow-up of 31.1 months, 61% of patients on amivantamab plus lazertinib were alive, compared to 53% on Osimertinib.
Overall survival will be further evaluated as a key secondary endpoint with longer follow-up. The primary efficacy outcome measure was progression-free survival (PFS).
Results further indicated that the combination showed a trend towards improved central nervous system (CNS) disease control compared to osimertinib at three years.
At the three-year mark, intracranial progression-free survival (PFS) was significantly higher with the amivantamab-lazertinib combination versus osimertinib.
As previously reported in the MARIPOSA study, the safety profile of amivantamab plus lazertinib was consistent with earlier Phase 1-2 studies.
Johnson & Johnson innovative medicine oncology EMEA therapeutic area lead and senior director Henar Hevia said: “These longer-term follow-up results from the MARIPOSA study add to the compelling body of evidence supporting the combination of amivantamab and lazertinib as a potential first-line treatment regimen for patients with EGFR-mutated advanced non-small cell lung cancer.”
As previously reported in the MARIPOSA study, the safety profile of amivantamab plus lazertinib was consistent with earlier Phase 1-2 studies.
Last month, the European Commission authorised amivantamab for advanced NSCLC with specific EGFR mutations in combination with carboplatin and pemetrexed, or as monotherapy.
Applications for expanded indications and a subcutaneous formulation were submitted in early 2024 based on the findings from the MARIPOSA study.
Last month, Rybrevant in combination with Lazcluze (lazertinib) was approved in the US as a first-line chemotherapy-free treatment for patients with EGFR-mutated NSCLC.
