RARITAN, N.J. - Johnson & Johnson (NYSE:JNJ) announced today that its Phase 3 MARIPOSA study met the final pre-specified secondary endpoint of overall survival (OS) for its RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) combination regimen. The study evaluated the treatment as a first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) harboring specific mutations.
The combination therapy showed a statistically significant and clinically meaningful improvement in median OS, expected to exceed one year compared to the current standard of care, osimertinib. The MARIPOSA trial enrolled 1,074 patients, and its primary endpoint was progression-free survival (PFS), with OS as a key secondary endpoint. With annual revenues of $87.7 billion and a healthy gross profit margin of 69%, Johnson & Johnson continues to demonstrate its ability to bring innovative treatments to market.
Stephen Liu, M.D., Associate Professor of Medicine at Georgetown University School of Medicine, highlighted the importance of OS as a measure, stating that it provides a better demonstration of the benefit of a first-line treatment regimen. Marcia Horn, President of International Cancer Advocacy Network, expressed optimism for EGFR-positive patients, noting the potential of the new regimen to extend life.
Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, at Johnson & Johnson, underscored the regimen's potential to fulfill an unmet need for EGFR-positive lung cancer patients, with less than 20 percent living beyond five years.
The safety profile of the combination was consistent with the profiles of the individual treatments, with venous thromboembolic events observed. Prophylactic oral anticoagulant medicines during the initial four months of treatment significantly reduced the risk of thrombosis.
RYBREVANT® and LAZCLUZE™ are 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. The OS results will be presented at an upcoming major medical meeting and shared with global health authorities.
This article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson is facing some significant developments. The company is currently dealing with over 62,000 lawsuits alleging that its talc products were contaminated with asbestos. The U.S. Food and Drug Administration (FDA) has proposed standardized testing for asbestos in talc cosmetics, which could potentially decrease consumers' exposure to this harmful contaminant. On a positive note, RBC Capital has maintained its Outperform rating on Johnson & Johnson, highlighting promising results from the 2024 American Society of Hematology presentations for its drugs DARZALEX, CARVYKTI, and TECVAYLI. These drugs are expected to significantly contribute to the company's sales in the coming years. Johnson & Johnson has also submitted applications to the FDA for the use of its drug TREMFYA® in treating children with specific conditions. Amid these developments, the company reported a robust Q3 result with operational sales growth of 6.3%, reaching $22.5 billion.
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