Johnson & Johnson (NYSE: JNJ) reported results from the Phase 2b COPERNICUS study showing low rates of adverse events in patients with advanced non-small cell lung cancer (NSCLC) treated with subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) plus Lazcluze (lazertinib) alongside prophylactic strategies. The data were presented at the International Association for the Study of Lung Cancer 2026 World Conference on Lung Cancer in Seoul, South Korea.

The study enrolled 214 U.S. patients with previously untreated advanced NSCLC carrying common epidermal growth factor receptor (EGFR) mutations. At a median follow-up of 8.3 months, rash was reported in 25% of patients, while administration-related reactions and venous thromboembolism (VTE) were each reported in 3% of patients. Eight percent of patients discontinued treatment due to adverse events overall, and fewer than 1% discontinued due to rash or VTE individually. No patients discontinued due to administration-related reactions. The majority of adverse events were Grade 1 or 2, with no new safety signals observed.

These figures are numerically lower than those recorded in the Phase 3 MARIPOSA study, which used intravenous Rybrevant plus Lazcluze without the same prophylactic approach. In MARIPOSA, rash, administration-related reactions, and VTE during the first four months were reported in 55%, 55%, and 23% of patients, respectively. MARIPOSA also demonstrated a statistically significant overall survival benefit over osimertinib, with a hazard ratio of 0.75 (P=0.005).

The COPERNICUS study incorporated once-every-four-weeks dosing, oral anticoagulation for VTE prevention, and an enhanced skin care regimen evaluated in the separate COCOON study. The trial enrolled patients across academic and community sites, with a median patient age of 67 years. The study population included 27% Asian, 10% African American, and 10% Hispanic/Latino patients.

Rybrevant Faspro received U.S. FDA approval in December 2025. COPERNICUS has a target enrollment of 300 previously untreated patients, according to a Johnson & Johnson press release.