FDA Approves Rybrevant Combination for Advanced Non-Small Cell Lung Cancer

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The FDA has approved Johnson & Johnson’s Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. With its approval, the combination became the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.¹

"The unique combination of Rybrevant and Lazcluze demonstrated superior efficacy in the first-line treatment of certain patients with EGFR-mutated advanced NSCLC as shown with the MARIPOSA study," Alexander Spira, MD, PhD, FACP, director, Virginia Cancer Specialists Research Institute, and study investigator said in a press release. "Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib. This first-line therapy uses a targeted approach aiming to achieve the best possible patient outcomes while reserving chemotherapy for later stages of treatment when resistance becomes more complex."

The approval is based off results from the Phase III MARIPOSA study (NCT04487080), which J&J presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in late-May.² Data from the study showed treatment with Rybrevant plus lazertinib reduced the risk of disease progression or death by 30% and extended progression-free survival (PFS) by an additional seven months compared with Tagrisso.

"Building on more than three decades of oncology innovation, we are uniquely positioned to build best-in-class treatments where survival rates have remained stagnant for years," Jennifer Taubert, executive vice president, worldwide chairman, Innovative Medicine, Johnson & Johnson said in the press release. "Rybrevant plus Lazcluze establishes a new benchmark in the advanced first-line setting, and we look forward to bringing this new chemotherapy-free treatment regimen to patients."

John Reed, MD, PhD, executive vice president, Innovative Medicine, R&D, Johnson & Johnson added, "Johnson & Johnson is deeply committed to setting new standards of care for people living with some of the most devastating and complex diseases of our time. Today's FDA approval of chemotherapy-free Rybrevant plus Lazcluze in the first line is an incredible step towards our goal of altering the trajectory of lung cancer and reducing the impact of the world's leading cause of cancer mortality."

The MARIPOSA study was a randomized trial that enrolled 1,074 patients. The primary endpoint was PFS with secondary endpoints of overall survival, overall response rate, duration of response, second PFS, and intracranial PFS.

References

1. RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. News release. Johnson & Johnson. August 20, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-approved-in-the-us-as-a-first-line-chemotherapy-free-treatment-for-patients-with-egfr-mutated-advanced-lung-cancer-302226047.html

2. RYBREVANT® (amivantamab-vmjw) plus lazertinib is the only chemotherapy-free regimen showing longer progression-free survival versus osimertinib in first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer. News release. May 31, 2024. Accessed August 20, 2024. https://www.jnj.com/media-center/press-releases/rybrevant-amivantamab-vmjw-plus-lazertinib-is-the-only-chemotherapy-free-regimen-showing-longer-progression-free-survival-versus-osimertinib-in-first-line-treatment-of-patients-with-high-risk-egfr-mutated-non-small-cell-lung-cancer