The phase 3 MARIPOSA study has met its final pre-specified secondary endpoint of overall survival (OS) and “demonstrated clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib,” according to an announcement from Johnson & Johnson.
The randomized phase 3 study is evaluating amivantamab-vmjw (RYBREVANT®) plus lazertinib (LAZCLUZE™) versus osimertinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions (ex19del) or L858R substitution mutations.
Results from the final overall survival analysis “build upon previously reported data from the interim analysis and positive results from the progression-free survival analysis,” according to officials, who noted that the improvement in median OS with the combination treatment is “expected to exceed one year.”
Stephen Liu, MD, Associate Professor of Medicine at Georgetown University School of Medicine and Director of Thoracic Oncology and Head of Developmental Therapeutics at Georgetown’s Lombardi Comprehensive Cancer Center, weighed in on the OS results in a statement provided by Jonhson & Johnson.
“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. Liu said. “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.”
Marcia Horn, President of International Cancer Advocacy Network, reflected on how the findings may impact patients and families.
“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,” Horn said in a statement provided by Johnson & Johnson. “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.”
Johnson & Johnson officials explained the significance of the results amid the current treatment landscape for this population of patients.
“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,” Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine, said in a statement. “With less than 20 percent 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.”
These OS results will be presented at an upcoming major medical meeting and shared with global health authorities, according to Johnson & Johnson.
The combination of amivantamab-vmjw plus lazertinib was approved in the United States and Europe for the first-line treatment of patients with EGFR-mutated NSCLC, with the approval based on the phase 3 MARIPOSA study.
The phase 3 MARIPOSA trial enrolled 1,074 patients, with a primary endpoint of progression-free survival as assessed by blinded independent central review. OS was one of multiple secondary endpoints, which also included objective response rate, duration of response, second progression-free survival, and intracranial PFS.
The safety profile of the combination treatment was “generally consistent with the profiles of the individual treatments,” according to the announcement. Venous thromboembolic events were observed with the combination, but “subsequent studies showed that administering oral anticoagulant medicines prophylactically during the initial four months of the RYBREVANT® and LAZCLUZE™ regimen significantly reduced the risk of thrombosis,” officials said.
Source: Johnson & Johnson
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