The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that the Phase III MARIPOSA clinical trial of Rybrevant (amivantamab-vmjw) plus lazertinib for non-small cell lung cancer (NSCLC) met the primary endpoint.
The open-label, randomised trial analysed Rybrevant plus lazertinib against osimertinib, as well as lazertinib alone, as a first-line therapy.
It enrolled 1,074 patients with locally advanced or metastatic epidermal growth factor receptor-mutated NSCLC with exon 19 deletions (ex19del) or substitution mutations.
Progression-free survival was the trial’s primary endpoint, while the secondary endpoints comprised overall survival, objective response rate and duration of response, among others.
The positive topline trial data showed that the Rybrevant combination treatment provided statistically significant and clinically meaningful improvements in PFS compared with osimertinib, meeting the primary endpoint.
The Rybrevant and lazertinib combination was also found to have a safety profile in line with the findings reported earlier.
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A favourable trend towards the use of combination regimens versus osimertinib was observed in an interim OS assessment.
Janssen Research and Development Oncology global therapeutic area head Peter Lebowitz said: “Positive topline results from the MARIPOSA study reinforce the potential of the Rybrevant and lazertinib combination in frontline EGFR-mutated non-small cell lung cancer as a future standard of care.
“As a combination targeted regimen, Rybrevant and lazertinib inhibit critical oncogenic driver pathways and activate the immune system to address disease in multiple ways.”
A fully human bispecific antibody, Rybrevant acts on EGFR and mesenchymal-epithelial transition.
In May 2023, the company reported new safety and efficacy findings from a Phase III trial of Tremyfa (guselkumab) for moderately to severely active ulcerative colitis.