Johnson & Johnson (J&J) has reported positive topline outcomes from the Phase III MARIPOSA trial of Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combination therapy for non-small cell lung cancer (NSCLC) treatment.
The study evaluated the combo as a first-line treatment for individuals with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
J&J noted that the chemotherapy-free combination met the ‘gold standard endpoint’ of overall survival (OS), which is the final pre-specified secondary endpoint, showing a statistically ‘significant improvement’ compared to the current standard of care, osimertinib. The median OS improvement is anticipated to surpass one year.
The MARIPOSA trial, which involved 1,074 subjects, assessed the combo against osimertinib. The primary endpoint was progression-free survival (PFS), as evaluated by a blinded independent central review.
Other secondary endpoints included duration of response, second PFS, intracranial PFS, and objective response rate.
According to the company, the safety profile of the combination treatment was in line with individual treatment profiles.
Notably, venous thromboembolic events were observed, but subsequent studies indicated that prophylactic oral anticoagulants could significantly minimise thrombosis risk during the first four months of treatment.
J&J 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.
“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.”
The combination has received approval in Europe and the US based on data from the MARIPOSA trial.
Last September, the company reported outcomes from the Phase II SKIPPirr study, which focused on intravenous Rybrevant for NSCLC patients.
