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First-line Rybrevant plus Lazcluze improved survival versus the current standard of care in patients with mutated advanced or metastatic NSCLC.
First-line Rybrevant plus Lazcluze generates improves in mutated advanced or metastatic NSCLC.
Among patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, first-line treatment with Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) resulted in improvements in overall survival (OS) versus treatment with the current standard of care, Tagrisso (osimertinib), according to findings from the phase 3 MARIPOSA study.
Study findings were announced in a news release from manufacturer Johnson and Johnson, which noted that the regimen resulted in an improvement in median OS that is expected to be greater than one year.
The combination of Rybrevant plus Lazcluze was approved by the Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations in 2024. This regulatory approval was based on findings from the MARIPOSA trial which evaluated 1,074 patients showing a median progression-free survival (PFS) of 23.7 months in patients who received the drug combination versus16.6 months in the Tagrisso group.
"The combination of these two agents previously demonstrated an improvement in progression-free survival, but this does not always capture the impact on the entire treatment course. Evaluation of overall survival can better demonstrate the benefit of a first-line treatment regimen," Dr. Stephen Liu stated in the news release. "Seeing this increase in overall survival in a trial with mature data is powerful and reaffirms that first-line treatment with Rybrevant and Lazcluze can lead to better patient outcomes."
Overall survival (OS): the time a patient lives, regardless of disease status.
Progression-free survival (PFS): the time a patient lives without their disease spreading or worsening.
Thromboembolic events: When a blood clot blocks blood flow through a blood vessel.
Dr. Liu is an associate professor of medicine at Georgetown University School of Medicine and serves as director of Thoracic Oncology and head of Developmental Therapeutics at Georgetown Lombardi Comprehensive Cancer Center, located in Washington, DC.
The OS results, according to the news release, will be presented at an upcoming medical meeting and will be shared with global health authorities.
“Every milestone in clinical trials and every approval of a new drug or regimen brings hope and progress for EGFR-positive patients and their families," said Marcia Horn, president of International Cancer Advocacy Network, in the news release. "These topline data from the MARIPOSA trial offer renewed optimism in the journey to extend life for EGFR-mutated patients, adding another important option for patients and oncologists."
Rybrevant, a type of bispecific antibody, binds to receptors for the EGF and MET proteins found on some types of cancer cells, and blocking these proteins may help cancer cells from growing, according to the National Cancer Institute.
Lazcluze is a tyrosine kinase inhibitor that blocks proteins made by the EGFR gene, which may help prevent cancer cells from growing and may kill them, the National Cancer Institute explained.
The safety profile of Rybrevant plus Lazcluze, Johnson and Johnson reported, was found to be generally consistent with the profiles of both treatments individually. While venous thromboembolic events were observed with the combination, later studies showed oral anticoagulant medications administered during the initial four months of the regimen reduced thrombosis risk, according to the news release.
"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," said Dr. Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "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 could be transformative for these patients."
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