BEERSE, BELGIUM (27 March 2025) – Results from an interim analysis of the open-label Phase 2 COCOON study revealed an enhanced preventive regimen (the COCOON regimen) reduced moderate-to-severe dermatologic reactions (including skin and nail reactions of Grade 2 or higher) by almost 50 percent in patients receiving first-line treatment with RYBREVANT®▼(amivantamab) and LAZCLUZE®▼(lazertinib), versus standard dermatologic management.1 These data were presented as a mini oral presentation at the 2025 European Lung Cancer Congress (ELCC) (Abstract #10MO).1
“The results from the COCOON study demonstrate that we now have a way to make treatment with amivantamab plus lazertinib more manageable,” said Dr. Pascale Tomasini*, M.D., Ph.D., Professor in thoracic oncology in the Multidisciplinary Oncology and Therapeutic Innovations department in Marseille, France. “An enhanced, proactive regimen that reduces dermatologic reactions by almost half and scalp-related reactions by more than three-fold, compared to standard reactive management, is a major step forward, potentially allowing patients to stay on treatment longer.”
The study enrolled newly diagnosed 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.1 Patients were given either an enhanced preventative dermatologic regimen (the COCOON regimen, n=70), or standard dermatologic care (n=68).1 The COCOON regimen, designed to fit within a patient’s daily routine, included a twice-daily oral antibiotic (doxycycline or minocycline, 100 mg), an application of a topical antibiotic for the scalp (clindamycin 1 percent), an antiseptic wash for the hands and feet, used during regular handwashing or showering (chlorhexidine 4 percent), and a non-comedogenic ceramide-based moisturiser applied once daily.1
By Week 12, patients on the COCOON regimen had significantly fewer Grade 2 or higher dermatologic events compared to standard of care management (39 percent vs 77 percent; odds ratio [OR], 0.19; 95 percent confidence interval [CI], 0.09–0.40; P<0.0001), meeting the pre-specified endpoint of the study.1 The incidence of Grade 3 dermatologic events was reduced by more than 50 percent with the COCOON regimen (4.3 percent vs 8.8 percent).1 The larger reduction was observed in scalp-related Grade 2 or higher events which were reduced by more than three-fold, and only one patient receiving the COCOON regimen experienced a Grade 3 scalp adverse reaction.1
Nearly two out of three patients on the COCOON regimen had no moderate to severe skin-related reactions.1 Patients receiving the COCOON regimen also experienced lower rates of treatment discontinuations (11 percent vs 19 percent) on amivantamab and lazertinib due to any adverse reactions compared to patients receiving standard of care.1
“Being diagnosed with EGFR-positive non-small cell lung cancer is hard enough — none of us signed up for it. But making treatment more manageable from the start makes a big difference,” said Jill Feldman**, lung cancer survivor and co-founder of the EGFR Resisters, a patient advocacy group. “Easing potential dermatologic effects improves the whole treatment experience — allowing us to focus on what really matters: our families, our passions, and truly living.”
“At Johnson & Johnson, we are committed to not only improving outcomes for people living with lung cancer, but also the overall treatment experience,” said Henar Hevia, PhD., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “We are encouraged by the results of the COCOON study, which demonstrate that by incorporating preventative steps into daily routines, we can help manage skin and nail reactions, which may make it easier for patients to continue their treatment for longer.”
The study protocol is being amended to also evaluate the impact of different interventions for the treatment of new-onset or persistent dermatologic reactions in patients receiving amivantamab and lazertinib with the COCOON regimen. The study is also expanding to include a new cohort (Cohort C) to evaluate the COCOON regimen and early intervention with the subcutaneous formulation of amivantamab, administered every four weeks. This cohort aims to assess whether initiating reactive treatment at the first signs of skin and nail reactions (Grade 1) can improve outcomes, rather than waiting for symptoms to progress.
About the COCOON Study
COCOON (NCT06120140) is a Phase 2, randomised, open-label, multicenter study evaluating the effectiveness of a prophylactic dermatologic regimen in reducing the incidence of skin and nail adverse reactions commonly associated with EGFR-targeted therapies. The fully enrolled study includes 201 patients, divided into two groups (Arm A vs Arm B).2 Arm A received an enhanced dermatologic care regimen designed to prevent skin and nail adverse reactions, while Arm B received standard dermatologic care.2 The enhanced regimen includes an oral antibiotic (doxycycline or minocycline) administered twice daily for 12 weeks, followed by a topical antibiotic (clindamycin 1 percent), an antibacterial wash (chlorhexidine 4 percent), and a ceramide-based noncomedogenic moisturiser applied once daily alongside amivantamab and oral lazertinib as first-line treatment.2 The primary endpoint of the study is the incidence of Grade 2 or higher dermatologic reactions within the first 12 weeks of treatment.2 Key secondary endpoints include the incidence and severity of various dermatologic toxicities during the first year of treatment, their impact on patients’ quality of life, and progression-free survival, among others.2
About Amivantamab
Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system.3,4,5,6
The European Commission (EC) has approved amivantamab in the following indications:6
Intravenous amivantamab:
- In combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
- In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, after failure of prior therapy including an EGFR TKI.
- In combination with carboplatin and pemetrexed, for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations.
- As monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy.
In February 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended an extension of marketing authorisation for a subcutaneous (SC) formulation of amivantamab, in combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with 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.7 This extension is currently pending EC approval.
Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.8
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics.6
▼ In line with EU regulations for new medicines, amivantamab is subject to additional monitoring.
About Lazertinib
In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib (marketed as LACLAZA in South Korea). Lazertinib is an oral, third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.9 An analysis of the efficacy and safety of lazertinib from the Phase 3 study LASER301 was published in The Journal of Clinical Oncology in 2023.9
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using lazertinib, please refer to the Summary of Product Characteristics.10
▼ In line with EU regulations for new medicines, lazertinib is subject to additional monitoring.
About Non-Small Cell Lung Cancer
In Europe, it is estimated that 484,306 people were diagnosed with lung cancer in 2022.11 NSCLC accounts for 85 percent of all lung cancer cases.12 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.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.12,13 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.14,15,16,17 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations.18 The five-year survival rate for patients with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent and between 25-32 percent of patients receiving the current first-line standard of care, osimertinib, do not survive long enough to reach second-line treatment.19,20,21
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Learn more at https://innovativemedicine.jnj.com/emea/. Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea/. Janssen-Cilag International NV, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab or lazertinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Biotech, Inc., Janssen-Cilag, S.A. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Biotech, Inc., Janssen-Cilag, S.A. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
©Janssen-Cilag International NV, Inc. 2025. All rights reserved.
*Dr. Pascale Tomasini, M.D., Ph.D., has served as a consultant to Janssen-Cilag International NV; she has not been paid for any media work.
**Jill Feldman has served as a consultant to Johnson & Johnson; she has not been paid for any media work.
CP-509935
March 2025