RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib) - (COPERNICUS)
- Indication
- Advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations
- Stage
- phase2
- Event
- Phase 2b
- Details
Sept. 14, 2026: Johnson & Johnson (NYSE: JNJ) reported IASLC 2026 WCLC data from the Phase 2b COPERNICUS study of subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib) with prophylactic anticoagulation and dermatologic management in previously untreated advanced EGFR-mutated NSCLC.
In the reported U.S. cohort of 214 patients, at median follow-up of 8.3 months, most adverse events were Grade 1/2 and no new safety signals were seen. Treatment discontinuation due to adverse events was 8%. Rash occurred in 25% of patients, administration-related reactions in 3%, and venous thromboembolism in 3%; no patients discontinued due to administration-related reactions, and 1% discontinued due to rash or VTE.
The company said these rates were numerically lower than with intravenous RYBREVANT plus LAZCLUZE in Phase 3 MARIPOSA, where first-four-month rates were 55% for rash, 55% for infusion-related reactions, and 23% for VTE. The release also cited MARIPOSA overall survival benefit versus osimertinib (HR 0.75; P=0.005).
COPERNICUS (NCT06667076) is ongoing, targeting 300 first-line patients; the primary endpoint is investigator-assessed progression-free survival.
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