- Low rates of rash, blood clots and administration-related reactions were observed with subcutaneous treatment and prophylaxis

- Fewer than 1% of patients discontinued treatment due to treatment-related events at one year

- New findings from Johnson & Johnson build on the MARIPOSA survival benefit and strengthen evidence for RYBREVANT FASPRO plus LAZCLUZE as first-line treatment

SEOUL, South Korea, Sept. 14, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new results from the Phase 2b COPERNICUS study evaluating how subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib), with less frequent dosing and prophylactic strategies, can improve the treatment experience for patients with previously untreated advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations. Early results show consistently low rates across key treatment-related events and treatment discontinuation.1

COPERNICUS was designed to reflect everyday clinical practice, enrolling a racially and ethnically diverse patient population across both academic and community sites. The data were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) (Abstract #M012.09).1

RYBREVANT FASPRO dual-targets EGFR and mesenchymal-epithelial transition (MET), two key drivers of tumor growth and treatment resistance, while also engaging the immune system.2,3,4,5 It is approved across multiple EGFR-mutated advanced NSCLC treatment settings and, for eligible patients, offers once-monthly dosing following initial weekly dosing.6

Advancing the treatment experience with RYBREVANT-based regimens

"RYBREVANT plus LAZCLUZE has already shown that patients with EGFR-mutated lung cancer can live longer, and these latest results mark an important evolution in the treatment approach," said Balazs Halmos, M.D., M.S., Director of Thoracic Oncology and Associate Director of Clinical Science, Montefiore Einstein Comprehensive Cancer Center. "With subcutaneous administration, less frequent dosing and prophylactic strategies, the regimen has been developed with the treatment experience in mind, helping patients start treatment and stay on it."

"Our work with RYBREVANT in EGFR-mutated lung cancer has continued to evolve with each new piece of evidence, from extending survival to advancing how treatment is delivered and managed," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "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."

Detailed study results

In this analysis, 214 U.S. patients received the recently approved RYBREVANT FASPRO plus LAZCLUZE regimen with prophylactic strategies to reduce the risk of blood clots with oral anticoagulation and skin-related side effects with an enhanced, easy-to-use skin care regimen evaluated in the COCOON study.1,7

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 eight percent of patients discontinued treatment due to adverse events. Rash was reported in 25 percent of patients, while administration-related reactions (ARRs) and venous thromboembolism (VTE) were each reported in three percent. No patients discontinued due to ARRs, and one percent discontinued due to rash and VTE.1

These findings represent lower numerical rates than observed with intravenous RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE in the Phase 3 MARIPOSA study, where rash, ARRs and VTE during the first four months of treatment were reported in 55 percent, 55 percent and 23 percent of patients, respectively. MARIPOSA also demonstrated that patients with advanced EGFR-mutated advanced 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).8

COPERNICUS is one of the largest global studies conducted in patients with EGFR-mutated NSCLC, with a target enrollment of 300 previously untreated patients. Of the population reported here, median age was 67 years, 22 percent were age 75 or older, 27 percent were Asian, 10 percent were African American and 10 percent were Hispanic/Latino.1

This study reflects Johnson & Johnson's continued focus on improving the treatment experience for people with cancer, including how treatments are delivered and managed in everyday care.

About the COPERNICUS study

COPERNICUS (NCT06667076) is a Phase 2b, single-arm study evaluating RYBREVANT FASPRO plus LAZCLUZE with prophylactic strategies in patients with EGFR-mutated advanced non-small cell lung cancer. Cohort 1 evaluates the regimen in the first-line setting, incorporating once-every-four-weeks dosing, venous thromboembolism (VTE) and enhanced dermatologic prophylaxis.

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.9

About non-small cell lung cancer

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.10,11 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.12 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.13 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.10,11,14,15,16,17 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.18 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.19,20 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.21 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.22

About RYBREVANT FASPRO and RYBREVANT

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE (lazertinib) 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. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.

RYBREVANT FASPRO is approved in the U.S. for the same indications as intravenous RYBREVANT (amivantamab-vmjw) across multiple markets. RYBREVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.

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.

The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 23 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ ||

The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||

Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.

The legal manufacturer for RYBREVANT FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.

INDICATIONS

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:

- in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.