amivantamab SC (Ami-LC) / J&J, Halozyme - LARVOL DELTA

PALOMA-2: Subcutaneous Amivantamab Administered Every 4 Weeks Plus Lazertinib in First-Line EGFR-Mutated Advanced NSCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

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

First-Line Subcutaneous Amivantamab Plus Chemotherapy in EGFR Exon 20 Insertion-Mutated Advanced NSCLC: Results From PALOMA-2 (IASLC-WCLC 2025) - P2 | "Introduction : Intravenous amivantamab plus chemotherapy (carboplatin-pemetrexed)is approved for first-line treatment of patients with EGFR exon 20 insertion(Ex20ins)-mutated advanced non-small cell lung cancer (NSCLC), based on the resultsof the PAPILLON study. Discontinuationof amivantamab due to treatment-related AEs was 12%. Conclusions : Among participants with EGFR Ex20ins-mutatedadvanced NSCLC, first-line treatment with subcutaneous amivantamab Q3W plus chemotherapydemonstrated a response rate and safety profile consistent with historical intravenousamivantamab Q3W data, with a reduced incidence of ARRs."

Clinical • EGFR exon 20 • Metastases • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • EGFR

COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2026 ➔ Jan 2032 | Trial primary completion date: Nov 2025 ➔ May 2027

Adverse events • Trial completion date • Trial primary completion date • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

PALOMA-3: A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=418 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2025 ➔ Jun 2026

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

Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated non-small cell lung cancer: Patient satisfaction and resource utilization results from the PALOMA-3 study. (PubMed, Eur J Cancer) - "In PALOMA-3, subcutaneous amivantamab, which simplifies and shortens administration, reduces resource utilization, and enhances treatment experience, was a preferred option for patients who received amivantamab-lazertinib."

HEOR • Journal • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • Venous Thromboembolism • EGFR

COPERNICUS: A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=480 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2029 ➔ Nov 2030

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

CAPT-HN: Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=192 | Recruiting | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Recruiting | Trial completion date: Oct 2025 ➔ Apr 2027

Enrollment open • Trial completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • MET

PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=192 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • MET

OrigAMI-3: A randomized, phase 3 study of amivantamab plus FOLFIRI vs cetuximab or bevacizumab plus FOLFIRI in participants with recurrent, unresectable, or metastatic RAS/BRAF wild-type colorectal cancer. (ASCO 2025) - P1/2, P3 | "Eligible pts will be WT for KRAS, NRAS, and BRAF, have recurrent unresectable or mCRC, and must have had disease progression on one prior line of systemic therapy for metastatic disease (prior regimen must be fluoropyrimidine-based and oxaliplatin-based therapy)...Approximately 700 pts will be randomly assigned 1:1 to receive subcutaneous amivantamab (co-formulated with recombinant human hyaluronidase [rHuPH20]) plus FOLFIRI vs intravenous cetuximab or bevacizumab (investigator's choice, per local guidelines) plus FOLFIRI...Secondary endpoints include objective response rate, duration of response, and patient-reported outcomes. Safety assessments will include monitoring adverse events and laboratory abnormalities."

Clinical • IO biomarker • Metastases • P3 data • Colorectal Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • MET • MSI • NRAS • RAS

OrigAMI-2: A randomized, phase 3 study of amivantamab vs cetuximab, both in combination with FOLFOX or FOLFIRI, as first-line treatment in left-sided RAS/BRAF wild-type metastatic colorectal cancer. (ASCO 2025) - P1/2, P3 | "Approximately 1000 participants will be randomly assigned 1:1 to receive subcutaneous amivantamab (co-formulated with recombinant human hyaluronidase [rHuPH20]) or intravenous cetuximab, both combined with FOLFOX or FOLFIRI (investigator's choice)...Secondary endpoints include overall survival, objective response rate, duration of response, and patient-reported outcomes. Safety assessments will include monitoring adverse events and laboratory abnormalities."

Clinical • Combination therapy • Metastases • P3 data • Colorectal Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • MET • MSI • NRAS • RAS

PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=390 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Oct 2025 ➔ Aug 2027

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

COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Recruiting | N=201 ➔ 300

Adverse events • Enrollment change • Enrollment open • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=390 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2026 ➔ Aug 2027

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

A phase 2b study of subcutaneous amivantamab with lazertinib as first-line treatment, or with chemotherapy as second-line treatment, for EGFR-mutated non-small cell lung cancer (NSCLC): COPERNICUS (AACR 2025) - P2 | "In Cohort 1, participants must not have received any prior systemic therapy and will receive SC amivantamab and oral lazertinib; in Cohort 2, participants must have had disease progression after EGFR-TKI monotherapy and will receive SC amivantamab and chemotherapy (carboplatin-pemetrexed). COPERNICUS aims to evaluate the efficacy and safety of SC amivantamab regimens using a pragmatic study design to enroll participants with diverse backgrounds and combine advancements in supportive care to prevent and proactively manage AEs."

Clinical • P2b data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

European Commission approves subcutaneous RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer (GlobeNewswire) - "Janssen-Cilag International NV...today announced that the European Commission (EC) has approved an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT(amivantamab), in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) 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. For these indications, it is recommended that SC amivantamab is administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards....The EC approval is supported by positive results from the Phase 3 PALOMA-3 study..."

EGFR exon 20 • EMA approval • Evidence highlight • Non Small Cell Lung Cancer • EGFR

COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=200 ➔ 300

Enrollment change • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov) - P2 | N=201 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | N=300 ➔ 201 | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment change • Enrollment closed • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Recruiting

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

COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov) - P2 | N=201 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

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

COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jul 2025 ➔ Nov 2025

Adverse events • Trial primary completion date • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: ORIC Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: ORIC Pharmaceuticals

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

CHMP recommends subcutaneous RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer (GlobeNewswire) - "Janssen-Cilag International NV...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT(amivantamab), in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (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. For these indications, it is recommended that SC amivantamab is administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards...The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study..."

CHMP • EGFR exon 20 • Non Small Cell Lung Cancer

LUNG-MAP SUB-STUDY: Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial) (clinicaltrials.gov) - P2 | N=88 | Recruiting | Sponsor: SWOG Cancer Research Network | Trial completion date: May 2029 ➔ May 2028

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • MET • NTRK • RET • ROS1