ZACKS·2025-03-31 14:42Core Insights - J&J's phase III MARIPOSA study shows that the combination of Rybrevant and Lazcluze significantly extends overall survival in patients with EGFR-mutated non-small cell lung cancer compared to AstraZeneca's Tagrisso [1][2] Study Results - At a median follow-up of 37.8 months, patients on J&J's combo therapy had a median overall survival not yet reached, while those on Tagrisso had a median overall survival of 36.7 months [2] - 56% of patients on J&J's therapy were alive at 3.5 years compared to 44% on AstraZeneca's drug, indicating a potential extension of overall survival by at least one year with J&J's combination [2] Regulatory Approvals - The MARIPOSA study achieved its primary endpoint of significant improvement in progression-free survival, leading to J&J securing approval for the Rybrevant-Lazcluze combo in the U.S. and EU last year [3] - The EMA's Committee for Medicinal Products for Human Use issued a positive opinion for a subcutaneous version of Rybrevant combined with Lazcluze, with a final decision expected later this year [6] - The FDA approved the combination of Rybrevant and standard chemotherapy for advanced NSCLC after prior therapy failure, with similar approval in the EU last year [7] Competitive Landscape - J&J aims to position the Rybrevant-Lazcluze combo as the new standard of care against AstraZeneca's Tagrisso, which currently holds a significant market position due to its convenience as a once-daily pill [4] - J&J's regimen requires intravenous infusions, which may limit its adoption compared to Tagrisso [4] Future Developments - A key step for J&J is obtaining FDA approval for a subcutaneous version of Rybrevant to reduce administration time, following a previous rejection due to manufacturing concerns [5] - J&J is also exploring Rybrevant in other NSCLC settings, evaluating it in various clinical studies as monotherapy or in combination with other drugs [9]