Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) / J&J, Halozyme - LARVOL DELTA

Subcutaneous Amivantamab+Lazertinib With Supportive Care in EGFRm NSCLC: Longer Follow-Up From the Pragmatic COPERNICUS Study (IASLC-WCLC 2026) - P2 | "Introduction : Intravenous amivantamab plus lazertinib significantly prolonged overall survival versus osimertinib (HR, 0.75; P =0.005) in first-line common EGFR -mutant ( EGFR m) advanced NSCLC in MARIPOSA. Reductions were observed in ARRs, rash, VTE, and AE-associated amivantamab discontinuations, despite an older population than MARIPOSA. These results demonstrate that early supportive care and subcutaneous administration Q4W can improve patient experience of amivantamab plus lazertinib in a clinical practice setting, supporting its broad use as first-line therapy."

Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Venous Thromboembolism • EGFR

Improving prevention of moderate to severe dermatologic adverse events in EGFR-mutant advanced NSCLC treated with first-line (1L) subcutaneous (SC) amivantamab + lazertinib: First results from a new COCOON cohort (ESMO 2026) - No abstract available

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

Amivantamab + pembrolizumab + carboplatin in first-line recurrent/metastatic head & neck squamous cell cancer (1L R/M HNSCC): Results from the phase 1b/2 OrigAMI-4 study (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Subcutaneous amivantamab plus lazertinib has shown long-term, clinically meaningful and durable antitumor efficacy for patients with previously untreated, EGFR-mutated, advanced…NSCLC, according to long-term findings from the PALOMA-2 trial presented in a poster at the 2026 World Conference on Lung Cancer (Cancer Therapy Advisor) - "The median follow-up was 33.1 months as of the July 2026 data cutoff. The median overall survival (OS) was not reached. The median OS rate was 83% at 24 months and 70% at 36 months....Data from cohorts 1, 5 and 6 were presented at WCLC 2026....The investigator-assessed median progression-free survival was 26.1 months. At 24 months, 56% of patients were progression-free, and at 36 months 37% were progression-free. The objective response rate was 90%. Twenty patients (9%) had complete responses and 171 (81%) patients had partial responses. The median duration of response among confirmed responders (n=163) was 25.6 months. At the data cutoff, 50% of patients had an ongoing response."

P2 data • Non Small Cell Lung Cancer

Amivantamab in HPV-unrelated recurrent/metastatic head and neck squamous cell cancer after disease progression on immune checkpoint inhibitor and chemotherapy: Pivotal results from the phase 1b/2 OrigAMI-4 study. (ASCO 2026) - P1/2 | "Funded by Janssen Research & Development, LLC, a Johnson & Johnson company Clinical Trial Registration Number: NCT06385080 Background: Prognosis is poor for patients with HPV-unrelated recurrent/metastatic (R/M) head and neck squamous cell cancer (HNSCC) after disease progression on immune checkpoint inhibitor (ICI) and chemotherapy, with participants (pts) who received cetuximab showing an objective response rate (ORR) of 24% and median progression-free survival (PFS) of 3.8 months (Fayette Clin Cancer Res 2025). SC amivantamab monotherapy demonstrated an ORR of 47%, with rapid and durable responses in pts with HPV-unrelated, R/M HNSCC after disease progression on an ICI and chemotherapy. The safety profile and tolerability are consistent with prior reports."

Checkpoint inhibition • IO biomarker • Metastases • P1/2 data • Dental Disorders • Dermatitis • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Stomatitis • MET

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

Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial. (ASCO 2024) - P3 | "PALOMA-3 (NCT05388669) evaluated SC ami+laz vs IV ami+laz for pharmacokinetics (PK), efficacy, and safety among pts with EGFR Ex19del or L858R-mutated advanced NSCLC and disease progression on osimertinib and platinum-based chemotherapy. SC ami demonstrated noninferior PK and ORR compared to IV. Unexpectedly, DoR, PFS, and OS were longer in the SC arm vs IV, suggesting that the route of administration or formulation may affect outcomes. The safety profile was improved for SC ami, with lower IRR and VTE rates."

Clinical • Combination therapy • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

COPERNICUS, a pragmatic phase 2b study of subcutaneous (SC) amivantamab (ami) + chemotherapy (chemo) with enhanced dermatologic adverse event (AE) prophylaxis in EGFR-mutated advanced NSCLC: Interim results. (ASCO 2026) - P2 | "Funded by Janssen Research & Development, LLC, a Johnson & Johnson company Clinical Trial Registration Number: NCT06667076 Background: In MARIPOSA-2, intravenous ami + carboplatin-pemetrexed chemo significantly prolonged progression-free survival (PFS) vs chemo (HR, 0.48; P<0.001) in participants (pts) with EGFR-mutated (exon 19 deletion [Ex19del]/L858R) advanced NSCLC after progression on osimertinib. Compared with MARIPOSA-2, SC ami and dermatologic prophylaxis in COPERNICUS led to substantial reductions in ARRs, dermatologic AEs, and ami interruptions, establishing the positive effect of early supportive care interventions. These interim data obtained using a pragmatic design support wide use of SC ami Q3W + chemo post-EGFR TKI progression in a diverse population."

Adverse events • Metastases • P2b data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Subcutaneous amivantamab (ami) in patients (pts) with advanced solid malignancies: The PALOMA study—Updated safety and identification of the recommended phase 2 dose. (ASCO 2023) - P1b | "Ami SC was well tolerated with meaningful reductions in administration time and TEAEs. Ami SC provided a quantitative and qualitative improvement in the symptoms of IRRs vs historical IV rates. The identified RP2D for ami SC on the Q2W schedule achieved similar exposure as the approved IV dose."

Clinical • Metastases • P2 data • Cardiovascular • Hypertension • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

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

Amivantamab in recurrent/metastatic head & neck squamous cell cancer (HNSCC) after disease progression on checkpoint inhibition and chemotherapy: Results from the phase Ib/II OrigAMI-4 study (ESMO 2025) - P1/2 | "Conclusions Amivantamab demonstrated rapid and meaningful antitumor activity in pts with HPV-unrelated, previously treated R/M HNSCC after disease progression on checkpoint inhibition and chemotherapy. The early safety profile was consistent with prior studies, with no new safety signals identified."

Checkpoint inhibition • IO biomarker • Metastases • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Amivantamab plus paclitaxel in recurrent/metastatic (R/M) head & neck squamous cell cancer (HNSCC) after disease progression on checkpoint inhibition: Identification of the recommended combination dose from the phase Ib/II OrigAMI-4 study (ESMO 2025) - P1/2 | "Conclusions Ami + paclitaxel was shown to be safe, with no new safety signals identified. The combination showed rapid and meaningful antitumor activity in pts with HPV-unrelated, previously treated R/M HNSCC after disease progression on checkpoint inhibition."

Checkpoint inhibition • IO biomarker • Metastases • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Subcutaneous amivantamab and lazertinib as first-line treatment in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Results from the phase 2 PALOMA-2 study. (ASCO 2024) - P2 | "IV ami + lazertinib (laz), a 3 rd -generation EGFR TKI, demonstrated superior progression-free survival (PFS) in patients (pts) with treatment-naïve, advanced EGFR-mutated NSCLC vs osimertinib (Cho AnnOncol 2023). SC ami+laz showed a response rate similar to historic IV ami+laz in first-line EGFR-mutated NSCLC, with an improved safety profile that included significantly lower ARR rates. Further, prophylactic anticoagulation can be safely implemented and reduced incidence of VTE."

Clinical • Late-breaking abstract • Metastases • P2 data • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Venous Thromboembolism • EGFR

Subcutaneous versus Intravenous Amivantamab, both in Combination with Lazertinib, in Refractory EGFR-mutated NSCLC: Primary Results from the Phase 3 PALOMA-3 Study. (PubMed, J Clin Oncol) - "Subcutaneous amivantamab-lazertinib demonstrated noninferiority to intravenous amivantamab-lazertinib, offering a consistent safety profile with reduced infusion-related reactions, increased convenience, and prolonged survival."

Combination therapy • Journal • P3 data • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Venous Thromboembolism • EGFR

Lunch Activity/Non-CE Satellite Symposium: Perspectives in Care: Clinicians and Patient Exchange Insights on RYBREVANT FASPRO™ + LAZCLUZE® Johnson & Johnson (JADPRO 2026) - "Sponsored by Johnson & Johnson"

Clinical

Sub-Q Amivantamab and Supportive Care Minimize Discontinuation in EGFR+ NSCLC (Targeted Oncology) - "At a median follow-up of 8.3 months, the majority of AEs were grade 1 or 2, with no new safety signals reported. Rash occurred in 25% of participants, and ARRs and VTE were each reported in 3%. Overall, 8% of participants discontinued treatment because of AEs; no patients discontinued because of ARRs, and 1% discontinued because of rash or VTE....The COPERNICUS investigators cited that AEs with the IV regimen were most common during the first 4 months of treatment and included ARRs in 55% of patients, rash in 55%, and VTE in 23% in this period and 63%, 63%, and 37% overall, respectively; 34% of patients discontinued treatment because of AEs, including 5% because of ARRs and 3% because of VTE."

P2b data • Non Small Cell Lung Cancer

Amivantamab plus pembrolizumab in previously untreated recurrent/metastatic head and neck squamous cell cancer: Results from the phase 1b/2 OrigAMI-4 study. (PubMed, Clin Cancer Res) - P1/2 | "Subcutaneous amivantamab plus intravenous pembrolizumab demonstrated meaningful antitumor activity and may be a promising new option for previously untreated R/M HNSCC."

Journal • P1/2 data • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A phase II study of amivantamab hyaluronidase in MET amplification–positive stage IV or recurrent non–small cell lung cancer (Lung-MAP Sub-Study). (ASCO 2026) - P2 | "Participants must have received at least one prior line of systemic therapy; notably, patients who have received prior MET TKI therapy (e.g., crizotinib, capmatinib) or harboring other actionable alterations are excluded. Correlative studies of interest include the evaluation of concordance between tissue-based and liquid biopsy (ctDNA) next-generation sequencing for the detection of MET amplification. S1900J opened to accrual on 9/27/2024 and is actively enrolling patients."

Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

PALOMA-2: Subcutaneous Amivantamab Administered Every 4 Weeks Plus Lazertinib in First-Line EGFR-Mutated Advanced NSCLC (IASLC-WCLC 2025) - P2 | "In MARIPOSA (median follow-up, 22.0 months), intravenous amivantamab administered every 2 weeks (Q2W) plus lazertinib significantly prolonged progression-free survival (PFS) versus osimertinib (hazard ratio, 0.70; P <0.001). Conclusions : In participants with EGFR- mutated advanced NSCLC, first-line treatment with subcutaneous amivantamab Q4W plus lazertinib showed a response rate similar to historical intravenous amivantamab Q2W data with fewer ARRs; incidence of VTEs was low with prophylactic anticoagulation. The subcutaneous amivantamab Q4W regimen will potentially further improve patient convenience and overall treatment experience."

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

Subcutaneous vs Intravenous Amivantamab: Patient Satisfaction and Resource Utilization Results from the PALOMA-3 Study (IASLC-WCLC 2024) - P3 | "Methods : 418 patients with EGFR -mutated advanced NSCLC whose disease progressed on osimertinib and platinum-based chemotherapy were randomized 1:1 to subcutaneous (n=206) or intravenous amivantamab (n=212), both with lazertinib. Conclusions : Intravenous amivantamab has demonstrated superior efficacy across multiple patient populations. Subcutaneous amivantamab provides the additional advantages of lower resource utilization and significantly higher patient satisfaction, and offers a convenient mode of administration for patients and healthcare providers, improving overall treatment experience."

Clinical • HEOR • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • Thoracic Cancer • EGFR

First-line Subcutaneous Amivantamab Plus Lazertinib in EGFR -mutated Advanced NSCLC: Updated Results From the PALOMA-2 Study (IASLC-WCLC 2026) - P2 | "In PALOMA-3, subcutaneous amivantamab showed noninferior pharmacokinetics and efficacy, while substantially reducing infusion-related reactions (13% vs 66%) and administration time (≤5 minutes vs 2-5 hours) versus intravenous amivantamab after progression on/after osimertinib and chemotherapy (Leighl JCO 2024). Conclusions : First-line treatment of EGFR -mutated advanced NSCLC with subcutaneous amivantamab-lazertinib continues to demonstrate clinically meaningful and durable antitumor efficacy, with 70% of participants alive at 3 years and favorably compares with historical OS landmark data from MARIPOSA. Subcutaneous administration, along with prophylactic AE management, can further improve the overall treatment experience and allow patients to remain on treatment longer."

Clinical • Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Subcutaneous amivantamab administered every 4 weeks (Q4W) in patients with advanced solid malignancies: The phase Ib PALOMA study (ELCC 2024) - P2 | "Conclusions Ami SC Q4W had lower rates of IRRs and was better tolerated vs ami IV. The ami SC Q4W dose of 3520 mg (≥80 kg: 4640 mg) achieved comparable exposure to the approved IV dose and is being further evaluated in the phase II, PALOMA-2 (NCT05498428) study."

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line subcutaneous amivantamab plus lazertinib in EGFR-mutated advanced NSCLC: Updated results from the PALOMA-2 study (ELCC 2026) - P2 | "In MARIPOSA, first-line (1L) IV ami plus lazertinib (ami-laz) demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS; HR, 0.75; P=0.005), with the median OS improvement projected to exceed 1 year vs osimertinib (Yang NEJM 2025)...Based on data maturity, pooled data (n=135) including additional pts who received 1L SC ami-laz from Cohort 6 may be presented at the meeting.Conclusions SC ami-laz as 1L tx of EGFR-mutated advanced NSCLC demonstrated long-term durable outcomes and a safety profile consistent with MARIPOSA. SC ami further improves the overall tx experience, allowing pts to remain on tx longer."

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

Subcutaneous Amivantamab and Lazertinib in PALOMA-3: Efficacy, Safety, and Administration: A Vodcast. (PubMed, Target Oncol) - "The PALOMA-3 study investigated the noninferiority of pharmacokinetics, with other endpoints including efficacy and safety of SC versus IV amivantamab, combined with lazertinib in participants with EGFR-mutated, advanced NSCLC after disease progression on osimertinib and platinum-based chemotherapy. SC amivantamab also reduced IRR and VTE, with shorter treatment administration times and enhanced patient convenience compared with IV. Utilizing SC amivantamab, while optimizing treatment efficacy and safety through mitigating and managing adverse events, may enhance the patient experience."

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

Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer (J&J Press Release) - "The FDA’s decision to grant Priority Review is supported by results from the pivotal Phase 1b/2 OrigAMI-4 study, which showed that 42 percent of patients responded to treatment with monotherapy subcutaneous amivantamab, with more than one-third of responders achieving a complete response."

FDA filing • Priority review • Squamous Cell Carcinoma of Head and Neck