Rybrevant (amivantamab-vmjw) / Genmab, J&J - LARVOL DELTA

Overall survival for amivantamab plus lazertinib vs osimertinib in Asian participants with first-line EGFR-mutant advanced NSCLC: MARIPOSA subgroup analysis (ESMO Asia 2025) - P3 | "Consistent with the overall population, ami+laz meaningfully reduced the risk of death vs osi among Asian pts with 1L EGFRm advanced NSCLC and is projected to provide an OS benefit of >12 mo. These results among Asian pts confirm the findings from the overall MARIPOSA population, establishing ami+laz as a new SoC."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Pragmatic trial in progress: Outcomes of enhanced AE prophylaxis in Chinese patients with EGFR-mutated advanced NSCLC receiving amivantamab-based regimens (AmiCARE) (ESMO Asia 2025) - "Cohort 1 (n=40): Ex19del / Ex21 L858R; 1L amivantamab + lazertinib + IRR, skin, and VTE prophylaxis Cohort 2 (n=42): Ex19del / Ex21 L858R; 2L amivantamab + chemo + IRR and skin prophylaxis Cohort 3 (n=40): EGFR Ex20ins; 1L amivantamab + chemo + IRR and skin prophylaxis The primary endpoint is the proportion of patients with improved or stable QoL (measured by EORTC QLQ-C30) at Month 3. Secondary endpoints include QoL at Month 6, incidence and severity of AEs, as well as exploratory efficacy outcomes such as objective response rate (ORR), progression-free survival (PFS), and time to treatment failure (TTF). Data will be collected via routine clinical documentation and patient-reported outcomes over a 12-month follow-up."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Prophylactic management of dermatologic adverse events with amivantamab + lazertinib treatment in 1L EGFR-mutated NSCLC: COCOON asian subset analysis (ESMO Asia 2025) - P2 | "Among Asian pts, COCOON DM reduced DAEI incidence & severity by Wk 12. The uncomplicated prophylactic COCOON DM regimen enhances the risk-benefit profile of 1L ami + laz for Asian pts with EGFR-mutated NSCLC."

Adverse events • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

OrigAMI-5: A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P3 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Extended Survival In A Patient With Leptomeningeal Disease Related To EGFR Exon 19 Deletion Metastatic Non-small Cell Lung Cancer: A Case Report (SNO 2025) - "She was initiated on Osimertinib...Despite treatment with stereotactic radiosurgery, she had further LMD progression, and another surgical resection was performed at 55 months, yet LMD recurred at 62 months, and she was enrolled in phase-2 WSD0922 clinical trial utilizing an oral brain-penetrant non-competitive reversible EGFR inhibitor with complete radiological resolution of LMD. At 73 months, she had LMD relapse and was initiated on intrathecal pemetrexed and intravenous amivantamab, and has thus far received 11 doses of intrathecal pemetrexed and amivantamab every two weeks with complete radiological response. At last follow-up, the patient is alive 82 months from her LMD diagnosis with excellent functional status. our case highlights that leveraging different mechanisms of action to target EGFR mutation in sequential fashion along with consideration of intrathecal chemotherapy in patients with LMD related to metastatic EGFR-mutated NSCLC can potentially help..."

Case report • Clinical • Metastases • Cough • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR

Rybrevant accepted in Scotland for lung cancer treatment (PharmaTimes) - "Johnson & Johnson has welcomed the decision by the Scottish Medicines Consortium (SMC) to accept Rybrevant (amivantamab) in combination with carboplatin and pemetrexed for use within NHS Scotland as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR exon 20 insertion mutations....The SMC’s recommendation is based on data from the phase 3 PAPILLON study..."

EGFR exon 20 • Reimbursement • Non Small Cell Lung Cancer

RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) delivers statistically significant and clinically meaningful improvement in overall survival benefit for Asian patients with EGFR-mutated non-small cell lung cancer in the Phase 3 MARIPOSA study (PRNewswire) - "These results were presented during a proffered paper session at the European Society for Medical Oncology (ESMO) Asia Congress 2025....Results from 501 participants who self-identified as Asian in the MARIPOSA trial, showed those treated with amivantamab plus lazertinib had a 26 percent lower risk of death compared with osimertinib....Median OS for the combination was not yet reached compared with 38.4 months for osimertinib (95 percent CI, 35.1-not reached). Survival projections suggest that amivantamab plus lazertinib could extend median OS to more than a year beyond that achieved with osimertinib. At three years, 61 percent of patients treated with the combination were alive compared with 53 percent of those receiving osimertinib."

P3 data • Non Small Cell Lung Cancer

METalmark: A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=57 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: May 2028 ➔ Mar 2027

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non-Small Cell Lung Cancer: Results From CHRYSALIS-2. (PubMed, J Clin Oncol) - "In participants with atypical EGFR-mutated advanced NSCLC, amivantamab-lazertinib demonstrated clinically meaningful antitumor activity with no new safety signals."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

swalloWTail: A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Oct 2025 ➔ Feb 2026

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Extended Survival In A Patient With Leptomeningeal Disease Related To EGFR Exon 19 Deletion Metastatic Non-small Cell Lung Cancer: A Case Report (WFNOS 2025) - P2 | "She was initiated on Osimertinib...Despite treatment with stereotactic radiosurgery, she had further LMD progression, and another surgical resection was performed at 55 months, yet LMD recurred at 62 months, and she was enrolled in phase-2 WSD0922 clinical trial utilizing an oral brain-penetrant non-competitive reversible EGFR inhibitor with complete radiological resolution of LMD. At 73 months, she had LMD relapse and was initiated on intrathecal pemetrexed and intravenous amivantamab, and has thus far received 11 doses of intrathecal pemetrexed and amivantamab every two weeks with complete radiological response. At last follow-up, the patient is alive 82 months from her LMD diagnosis with excellent functional status. our case highlights that leveraging different mechanisms of action to target EGFR mutation in sequential fashion along with consideration of intrathecal chemotherapy in patients with LMD related to metastatic EGFR-mutated NSCLC can potentially help..."

Case report • Clinical • Metastases • Cough • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR

OrigAMI-4: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer (clinicaltrials.gov) - P1/2 | N=287 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2028 ➔ Dec 2032

Monotherapy • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Janssen Korea, the Korean pharmaceutical division of Johnson & Johnson (J&J), announced on November 10 that it will collaborate with Yuhan Corporation to co-promote the Rybrevant (amivantamab) + Leclaza (lazertinib) combination therapy in South Korea. (BioNews) - "The two companies signed an agreement on October 31, formalizing their partnership to co-promote the combination therapy....Under this new agreement, J&J will collaborate with Yuhan Corporation to co-promote the combination therapy in Korea....Johnson & Johnson will remain responsible for the distribution of Rybrevant, while Yuhan Corporation will oversee the distribution of Leclaza."

Licensing / partnership • Non Small Cell Lung Cancer

PAPILLON: A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (clinicaltrials.gov) - P3 | N=308 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2026 ➔ Sep 2026

Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

KaRAnaSa: A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Non-Small Cell Lung Cancer, Version 1.2026. (NCCN)

NCCN guideline • Non Small Cell Lung Cancer

In the 2026 version of the National Cancer Network (NCCN) guidelines for non-small cell lung cancer (NSCLC) released on the 6th...Lazcluze and Janssen’s "Rybrevant" combination therapy was officially listed as "the most recommended first-line treatment option (Preferred, Category 1)." (Maeil Business Newpaper) - "The update is interpreted as reflecting the positive results of the phase 3 clinical trial 'MARIPOSA'."

NCCN guideline • Non Small Cell Lung Cancer

Preventing Moderate to Severe Dermatologic Adverse Events in First-line EGFR-mutant Advanced NSCLC Treated with Amivantamab Plus Lazertinib: Early Success of the COCOON Trial (DGHO 2025) - P2 | "COCOON DM included oral doxycycline/minocycline (100 mg BID Wks 1–12), clindamycin 1% lotion on scalp (QD Wks 13–52), chlorhexidine 4% to wash hands & feet QD, & non-comedogenic ceramide-based moisturizer to body & face QD... With the simple, widely available, and easy to use COCOON DM regimen, ~2 out of every 3 pts did not experience any moderate to severe dermatologic AEs, and incidence of these skin AEs was reduced by 50% vs SoC DM. This regimen supported pts treatment with 1L ami + laz by reducing ami discontinuations due to AEs by ~50%."

Adverse events • Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Amivantamab Plus Lazertinib vs Osimertinib in First-line (1L) EGFR-mutant (EGFRm) Advanced NSCLC: Final Overall Survival (OS) from the Phase 3 MARIPOSA Study (DGHO 2025) - P3 | "Ami+laz is the first and only treatment to significantly reduce the risk of death vs osi in pts with 1L EGFRm advanced NSCLC. While the median has not yet been reached for ami+laz, it is expected to provide an OS benefit of at least 12 mo. These results further establish ami+laz as a new SoC in this population."

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Amivantamab-Chemotherapy in Non-Small Cell Lung Cancer with EGFR Exon 20 Insertions: Impact of Treatment Crossover and Other Endpoints from the Phase III PAPILLON Study. (PubMed, Target Oncol) - P3 | "In PAPILLON, TTD and TTST were substantially longer for amivantamab-chemotherapy versus chemotherapy at primary analysis (cut-off on 3 May 2023). Crossover-adjusted analyses of the planned interim overall survival demonstrated a greater benefit for amivantamab-chemotherapy versus chemotherapy, further supporting amivantamab-chemotherapy as the first-line standard of care in EGFR exon 20 insertion-mutated non-small cell lung cancer."

Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

OrigAMI-4: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer (clinicaltrials.gov) - P1/2 | N=287 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jul 2026 ➔ Dec 2027

Monotherapy • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

OrigAMI-1: A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=225 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: May 2029 ➔ Oct 2031

Monotherapy • Trial completion date • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Subcutaneous (SC) after intravenous (IV) amivantamab in advanced NSCLC: Initial results from PALOMA-2 (JADPRO 2025) - P1/2 | "The safety profile of participants who switched to amivantamab SC with lazertinib from IV AMV to SC AMV therapy was consistent with the profile previously observed with AMV SC monotherapy, demonstrating that the IV to SC switch occurred safely. Most participants were satisfied with AMV SC with or without rHuPH20, found it convenient, and preferred it over prior intravenous IV AMV."

Metastases • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

JADPRO Live 2025: Investigating Improved Dermatologic Management for Patients Undergoing Treatment for EGFR-Mutated NSCLC (Cancer Nursing Today) - "The clinical cutoff for data was November 13, 2024, and the median follow-up point was 7.1 months. At the primary end point of 12 weeks, the incidence of grade 2 or higher adverse events was “significantly lower” with enhanced dermatologic management (42%) versus the standard of care (75%) (odds ratio, 0.24; 95% CI, 0.13-0.45; P<0.0001). The investigators highlighted safety results from the trial, which showed that the safety profile of amivantamab plus lazertinib “was consistent with previous studies, and no new safety signals were observed."

P2 data • Non Small Cell Lung Cancer

BEYOND THE CESAREAN: UNRAVELING THE UNEXPECTED DISCOVERY OF LUNG CANCER IN THE POSTPARTUM PERIOD (CHEST 2025) - "Her EGFR-mutated stage IV non-small cell lung cancer was treated with dual targeted therapy with Amivantamab and Lazertinib, as recommended by the MARIPOSA trial and National Comprehensive Cancer Network(NCCN) guidelines...The supportive care she received, including steroids and colchicine, helped manage her symptoms, contributing to her stabilization... This case highlights the rare and multifactorial complications that can arise in the postpartum period, especially when underlying malignancy is present. A multidisciplinary team is indispensable for coordinating care, ensuring potential complications are addressed. Further research is needed to better understand the complex interplay between pregnancy, immune modulation, and cancer progression, as well as to develop optimal management strategies for pregnant postpartum women with underlying malignancy."

IO biomarker • Hypertension • Immune Modulation • Immunology • Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Postpartum Hemorrhage • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Venous Thromboembolism • EGFR • NKX2-1 • PD-L1