Rybrevant+ Lazertinib(Mariposa)

Rybrevant combo delivers strong long-term results in EGFR-mutated NSCLC trial(September 9, 2024)

https://www.worldpharmaceuticals.net/news/rybrevant-combo-delivers-strong-results-in-egfr-mutated-nsclc/?cf-view

Rybrevant combo delivers strong results in EGFR-mutated NSCLC

 

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.