New data show Rybrevant plus Lazcluze extends overall survival in patients with EGFR-mutated non-small cell lung cancer, with the median survival benefit expected to exceed one year compared to osimertinib.
RT’s Three Key Takeaways:
- Overall Survival Improvement: The MARIPOSA study demonstrates that the combination of Rybrevant and Lazcluze improves overall survival, with a median benefit expected to exceed one year compared to osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
- Chemotherapy-Free Regimen: The Rybrevant-Lazcluze combination offers a non-chemotherapy treatment option with a safety profile consistent with previous findings, including reduced risk of thrombosis when paired with prophylactic anticoagulants.
- Study Results Presented: Data from the MARIPOSA trial highlight a statistically significant survival advantage, with findings set to be presented at an upcoming major medical meeting.
Johnson & Johnson announced positive topline results for the gold standard endpoint in cancer treatment of overall survival from the phase 3 MARIPOSA study, evaluating Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) as a first-line therapy for 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.
The chemotherapy-free combination regimen, approved by the US Food and Drug Administration last year, met the final pre-specified secondary endpoint of overall survival and demonstrated clinically meaningful and statistically significant improvement in overall survival versus the current standard of care osimertinib. Improvement in median overall survival is expected to exceed one year.
Unlike progression-free survival, which tracks the time a treatment keeps a patient’s cancer from progressing, overall survival helps patients understand the impact therapy could have on the ability to live longer from the start of treatment. Extending life expectancy is the most meaningful indicator of a treatment’s impact.
“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,” says 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, in a 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.”
Results Build on Previous Progression-Free Survival Analysis
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. MARIPOSA, which enrolled 1,074 patients, is a randomized, phase 3 study evaluating Rybrevant in combination with Lazcluze versus osimertinib as a first-line treatment of patients with EGFR-mutated NSCLC. The study’s primary endpoint was progression-free survival (using RECIST v1.1 guidelines) as assessed by blinded independent central review. Secondary endpoints included overall survival, objective response rate, duration of response, second progression-free survival, and intracranial progression-free survival.
The safety profile of Rybrevant plus Lazcluze was generally consistent with the profiles of the individual treatments. Adverse event rates were consistent in this arm as compared to other Rybrevant regimens. Venous thromboembolic events were observed with the combination. 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.
“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,” says Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head of oncology at Johnson & Johnson Innovative Medicine, in a release. “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.”
These overall survival results will be presented at an upcoming major medical meeting and will be shared with global health authorities. Ryprevant combined with Lazcluze is approved in the United States and Europe for the first-line treatment of patients with EGFR-mutated NSCLC based on the MARIPOSA phase 3 study.
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