Johnson & Johnson (JNJ) Announces RYBREVANT plus LAZCLUZE significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025

Johnson & Johnson (NYSE: JNJ) announced today that new data from its industry-leading oncology pipeline will be presented at the 2025 European Lung Cancer Congress (ELCC), including overall survival (OS) results from the Phase 3 MARIPOSA study evaluating RYBREVANT^® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) versus osimertinib in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

"Patients with EGFR-mutated non-small cell lung cancer deserve to live longer and with more hope than current treatments provide," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "These newest and compelling overall survival data for first-line treatment with RYBREVANT and LAZCLUZE are fundamentally changing treatment discussions and transforming expectations for how long patients can live."

Additional presentations will feature the first data from the Phase 2 COCOON study, evaluating a simple to use and widely accessible dermatologic regimen given prophylactically to patients receiving the RYBREVANT^® combination, and new results from the Phase 2 PALOMA-2 study evaluating the feasibility of switching to subcutaneous (SC) amivantamab.

"We are redefining the way EGFR-mutated non-small cell lung cancer is treated with therapies that improve survival and give patients more time," said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. "The chemotherapy-free regimen of RYBREVANT plus LAZCLUZE represents a major breakthrough, offering an innovative and life-extending option that can meaningfully impact lives."

ELCC 2025 Presentation Highlights:

• OS results from the Phase 3 MARIPOSA study comparing RYBREVANT^® plus LAZCLUZE™ versus osimertinib in first-line EGFR-mutant advanced NSCLC (Proffered Paper Abstract #4O).
• First presentation of data from the Phase 2 COCOON study evaluating an easy-to-use, readily available prophylactic regimen for the prevention of dermatologic reactions in the first-line treatment of EGFR-mutant advanced NSCLC in patients receiving RYBREVANT^® plus LAZCLUZE™ (Mini Oral Abstract #10MO).
• Initial results from the Phase 2 PALOMA-2 study evaluating switching to SC amivantamab among patients benefitting from IV delivery in advanced EGFR-mutated NSCLC (Poster Abstract #58P).
• Insights from the Phase 1/1b CHRYSALIS-2 study comparing RYBREVANT^® plus LAZCLUZE™ to EGFR tyrosine kinase inhibitor (TKI) monotherapy in a matched real-world cohort of atypical EGFR-mutated advanced NSCLC (Poster Abstract #59P).
• Preliminary results from a Phase 1 study evaluating the safety and feasibility of JNJ-1900 (NBTXR3), a novel radioenhancer activated by radiation therapy, in combination with anti-PD1 treatment for patients with advanced solid tumors and lung metastases (Poster Abstract #255P).

A complete list of Johnson & Johnson-sponsored abstracts is available on JNJ.com.

About RYBREVANT^®

RYBREVANT^® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.¹ In the subcutaneous formulation, amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE^® drug delivery technology.

RYBREVANT^® is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.

RYBREVANT^® is approved in the U.S., Europe and other markets around the world 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.

RYBREVANT^® is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR TKI.

In February 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of SC amivantamab and LAZCLUZE™ in Europe for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

The National Comprehensive Cancer Network^® (NCCN^®) Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for NSCLC^§ prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Guidelines include:

• Amivantamab-vmjw (RYBREVANT^®) plus lazertinib (LAZCLUZE™) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.^{2 †‡}
• Amivantamab-vmjw (RYBREVANT^®) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.^{2 †‡}
• Amivantamab-vmjw (RYBREVANT^®) plus chemotherapy as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive advanced NSCLC.^{2 †‡}
• Amivantamab-vmjw (RYBREVANT^®) as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC.^{2 †‡}

RYBREVANT^® is being studied in multiple clinical trials in NSCLC, including:

• The Phase 3 MARIPOSA (NCT04487080) study assessing RYBREVANT^® in combination with LAZCLUZE™ versus osimertinib and versus LAZCLUZE™ alone in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations.³
• The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of RYBREVANT^® (with or without LAZCLUZE™) and carboplatin-pemetrexed versus carboplatin-pemetrexed alone in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations after disease progression on or after osimertinib.⁴
• The Phase 3 PAPILLON (NCT04538664) study assessing RYBREVANT^® in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.⁵
• The Phase 3 PALOMA-3 (NCT05388669) study assessing LAZCLUZE™ with subcutaneous (SC) amivantamab compared to RYBREVANT^® in patients with EGFR-mutated advanced or metastatic NSCLC.⁶
• The Phase 2 PALOMA-2 (NCT05498428) study assessing SC amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.⁷
• The Phase 1 PALOMA (NCT04606381) study assessing the feasibility of SC amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for SC amivantamab delivery.⁸
• The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT^® in patients with advanced NSCLC.⁹
• The Phase 1/1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT^® in combination with LAZCLUZE™ and LAZCLUZE™ as a monotherapy in patients with advanced NSCLC with EGFR mutations.¹⁰
• The Phase 1/2 METalmark (NCT05488314) study assessing RYBREVANT^® and capmatinib combination therapy in locally advanced or metastatic NSCLC.¹¹
• The Phase 1/2 swalloWTail (NCT06532032) study assessing RYBREVANT^® and docetaxel combination therapy in patients with metastatic NSCLC.¹²
• The Phase 1/2 PolyDamas (NCT05908734) study assessing RYBREVANT^® and cetrelimab combination therapy in locally advanced or metastatic NSCLC.¹³
• The Phase 2 SKIPPirr study (NCT05663866) exploring how to decrease the incidence and/or severity of first-dose infusion-related reactions with RYBREVANT^® in combination with LAZCLUZE™ in relapsed or refractory EGFR-mutated advanced or metastatic NSCLC.¹⁴
• The Phase 2 COPERNICUS (NCT06667076) study combining developments in treatment administration and prophylactic supportive care in representative US patients with common EGFR-mutated NSCLC treated with SC amivantamab in combination with LAZCLUZE™ or chemotherapy.¹⁵
• The Phase 2 COCOON (NCT06120140) study assessing the effectiveness of a proactive dermatologic management regimen given with first-line RYBREVANT^® and LAZCLUZE™ in patients with EGFR-mutated advanced NSCLC.¹⁶

For more information, visit: https://www.RYBREVANT.com.

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