LAZCLUZE™ (lazertinib)

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RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer
Prnewswire· 2025-03-26 15:45
Core Insights - Johnson & Johnson announced that RYBREVANT® (amivantamab-vmjw) in combination with LAZCLUZE™ (lazertinib) significantly improves overall survival (OS) compared to osimertinib in the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][2][3] Group 1: Study Results - The Phase 3 MARIPOSA study demonstrated that the median OS for RYBREVANT® plus LAZCLUZE™ has not yet been reached, while the median OS for osimertinib was 36.7 months [2][3] - At a median follow-up of 37.8 months, 56% of patients treated with RYBREVANT® and LAZCLUZE™ were alive at three and a half years compared to 44% for those on osimertinib [2] - Projections suggest that RYBREVANT® plus LAZCLUZE™ could extend median OS by at least 12 months compared to osimertinib [2] Group 2: Secondary Endpoints - The combination therapy also showed prolonged benefits in secondary endpoints, including intracranial progression-free survival (PFS) and time to symptomatic progression (TTSP), which was extended by more than 14 months compared to osimertinib [2][3] - The study met its primary endpoint in October 2023, indicating a statistically significant improvement in PFS compared to osimertinib [3] Group 3: Safety Profile - The safety profile of RYBREVANT® plus LAZCLUZE™ was consistent with previous analyses, with adverse event rates comparable to other RYBREVANT® regimens [2][3] - Most adverse events occurred early during treatment, and no new safety signals were identified with longer-term follow-up [2] Group 4: Regulatory Status - RYBREVANT® plus LAZCLUZE™ is approved in the U.S., Europe, and other markets for first-line treatment of patients with locally advanced or metastatic NSCLC with specific EGFR mutations [3][6] - The results from the MARIPOSA study will be shared with health authorities globally [3]
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Prnewswire· 2025-03-20 12:00
Core Insights - Johnson & Johnson announced promising overall survival data from the Phase 3 MARIPOSA study, indicating that the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) may significantly improve survival rates compared to osimertinib for patients with EGFR-mutated non-small cell lung cancer (NSCLC) [1][6][9] - The company aims to redefine treatment expectations for patients with EGFR mutations, emphasizing the potential for longer survival and improved quality of life with the new treatment regimen [2][3] Company Developments - The Phase 3 MARIPOSA study results will be presented at the 2025 European Lung Cancer Congress, showcasing the efficacy of RYBREVANT® plus LAZCLUZE™ in first-line treatment for advanced NSCLC [1][6] - Additional studies, including the Phase 2 COCOON study, will present data on a dermatologic regimen aimed at enhancing patient experience during treatment [2][6] Industry Context - NSCLC accounts for 80 to 85 percent of all lung cancer cases, with EGFR mutations being a significant driver of the disease [13] - The five-year survival rate for advanced NSCLC patients with EGFR mutations treated with current therapies remains low, highlighting the need for innovative treatment options like RYBREVANT® and LAZCLUZE™ [13][30]