Johnson & Johnson's (JNJ.US) dual-antibody combination therapy has been approved in Europe for the first-line treatment of lung cancer, potentially reducing the risk by 30%.

Johnson & Johnson today announced that the European Commission has approved Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have an epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or exon 21 L858R mutation. The European Commission's approval was based on the results of the phase 3 MARIPOSA trial, which evaluated the efficacy of Lazcluze in combination with Rybrevant versus the active comparator osimertinib in patients with NSCLC who have the aforementioned EGFR mutations. The analysis showed that the combination of Rybrevant and Lazcluze reduced the risk of disease progression or death by 30% compared to the active comparator drug.

The median progression-free survival (PFS) was 23.7 months for the combination therapy and 16.6 months for the active comparator drug. In addition, the median duration of response (DOR) was 9 months longer for the combination therapy (25.8 months) than for the active comparator drug (16.7 months). On January 7, 2025, Johnson & Johnson announced positive top-line results for overall survival (OS), showing that Lazcluze in combination with Rybrevant met the pre-specified secondary endpoint, providing a statistically significant and clinically meaningful improvement in OS compared to existing standard of care. These milestone OS data will be presented at an upcoming medical conference.