Low Rates of Treatment-Related Events with RYBREVANT FASPRO and LAZCLUZE in NSCLC Study

Johnson & Johnson announced new findings from the Phase 2b COPERNICUS study, which evaluated the subcutaneous administration of RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) combined with LAZCLUZE (lazertinib) in patients with previously untreated advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations. The study, presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC), showed consistently low rates of treatment-related events and adverse effects.

The COPERNICUS study, designed to reflect everyday clinical practice, enrolled 214 U.S. patients with EGFR-mutated NSCLC. The regimen included prophylactic strategies to reduce the risk of blood clots and skin-related side effects. At a median follow-up of 8.3 months, the majority of adverse events were Grade 1 or 2, with no new safety signals observed. Only 8% of patients discontinued treatment due to adverse events. Rash was reported in 25% of patients, while administration-related reactions (ARRs) and venous thromboembolism (VTE) were each reported in 3% of patients. No patients discontinued due to ARRs, and one percent discontinued due to rash and VTE.

These findings represent a significant improvement over those observed in the Phase 3 MARIPOSA study, where rash, ARRs, and VTE during the first four months of treatment were reported in 55% of patients, respectively. The COPERNICUS study also demonstrated that patients with advanced EGFR-mutated NSCLC treated with the first-line regimen lived longer than those treated with osimertinib, with a statistically significant overall survival benefit (hazard ratio [HR], 0.75; P=0.005).

RYBREVANT FASPRO, approved in December 2025, is the only subcutaneous therapy approved for EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing.

"COPERNICUS brings those learnings together in a study designed around the realities of clinical care. It reflects our commitment to continually innovate across the treatment journey so that scientific advances can make a meaningful difference for more patients."

The COPERNICUS study is one of the largest global studies conducted in patients with EGFR-mutated NSCLC, with a target enrollment of 300 previously untreated patients. The study uses a pragmatic design to more closely reflect real-world clinical practice, with participation from academic and community sites and reduced visit frequency. The primary endpoint is investigator-assessed progression-free survival per RECIST v1.1. Secondary endpoints include safety and tolerability measures, including VTE and dermatologic adverse events and administration-related reactions, as well as overall survival and overall response rate.

The effectiveness of RYBREVANT FASPRO is supported by the established clinical profile of RYBREVANT, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE in first-line advanced EGFR-mutated NSCLC.

Worldwide, lung cancer is one of the most common cancers, with non-small cell lung cancer (NSCLC) making up 80 to 85 percent of all lung cancer cases. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division. EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients. EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations. The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent. EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation. Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.