Johnson & Johnson (J&J) has announced positive results from the Phase 3 MARIPOSA study of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) in treating advanced lung cancer.
The combination regimen was used as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The patients had epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
Rybrevant plus Lazcluze met the key overall survival (OS) endpoint, showing significant OS improvement.
This chemotherapy-free combination regimen met the final pre-specified secondary endpoint of OS and showed clinically meaningful and statistically significant improvement in OS against osimertinib, the current standard treatment.
The median OS improvement is expected to exceed one year.
Rybrevant is a fully human bispecific antibody. It is approved in the US, Europe, and other markets as monotherapy for the treatment of NSCLC with EGFR exon 20 insertion mutations.
Janssen Biotech licensed Lazcluze from Yuhan in 2018.
Last month, the European Commission (EC) approved Rybrevant plus Lazcluze to treat NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Johnson & Johnson innovative medicine oncology global therapeutic area head Yusri Elsayed said: “These new findings reinforce the clinically meaningful impact this chemotherapy-free regimen can have for patients worldwide with non-small cell lung cancer and represent the first overall survival benefit over the current standard of care.
“With less than 20% of patients living beyond five years, an incredible unmet need remains for EGFR-positive lung cancer.
“These MARIPOSA results show Rybrevant plus Lazcluze can extend survival beyond the current standard of care, providing patients with more time and hope in their fight against this devastating disease.
“Extending median overall survival by more than a year would be transformative for these patients.”
The final overall survival analysis results confirm earlier findings from the interim and progression-free survival analysis.
The MARIPOSA study enrolled 1,074 patients and compared Rybrevant plus Lazcluze to osimertinib in treating EGFR-mutated NSCLC. The study’s primary endpoint was progression-free survival (PFS).
The safety profile of Rybrevant plus Lazcluze was consistent with that of the individual treatments.
These overall survival results will be presented at a major medical meeting and shared with global health authorities.
The combination therapy is already approved in the US and Europe for the first-line treatment of EGFR-mutated NSCLC based on the MARIPOSA study.
