Johnson & Johnson's dual immunotherapy combination therapy receives EU approval for first-line treatment of lung cancer, reducing risk by 30%.

Johnson & Johnson (JNJ.US) announced today that the European Commission has approved the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R mutations. The approval by the European Commission is based on the results of the phase 3 clinical trial MARIPOSA. The study evaluated the efficacy of Lazcluze in combination with Rybrevant compared to the active control osimertinib for first-line treatment of NSCLC patients with the above-mentioned EGFR mutations. Analysis showed that the combination of Rybrevant with Lazcluze can reduce the risk of disease progression or death by 30% compared to the active control drug. The median progression-free survival (PFS) in the combination therapy group and the active control drug group was 23.7 months and 16.6 months, respectively. Additionally, the median duration of response (DOR) in the combination therapy group was 9 months longer than the active control drug group (25.8 months vs. 16.7 months). On January 7, 2025, Johnson & Johnson announced positive overall survival (OS) topline results, showing that the combination of Lazcluze with Rybrevant met the pre-specified secondary endpoint, providing a statistically significant and clinically meaningful improvement in OS compared to the current standard of care. These landmark OS data will be presented at an upcoming medical conference.