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

Lazertinib: a novel EGFR-TKI therapy for non-small cell lung cancer. (PubMed, Expert Opin Drug Metab Toxicol) - "Preclinical studies demonstrated its superior selectivity for mutant EGFR and blood-brain barrier penetration compared to osimertinib. Clinical trials highlight its efficacy as monotherapy and in combination with amivantamab, showing improved progression-free survival and response duration in patients with advanced NSCLC...However, emerging resistance mutations, such as C797S, underscore the need for continued innovation, including combination therapies and fourth-generation TKIs. Future research must address these challenges to optimize treatment outcomes for NSCLC patients."

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

Efficacy and safety outcomes of emerging EGFR‑TKIs for patients with non‑small cell lung cancer with EGFR exon 20 insertion mutations: A systematic review and meta‑analysis. (PubMed, Oncol Lett) - "Subgroup analysis revealed the following ORRs: 0.731 (95% CI, 0.560-0.901; I2=0%) for YK-029A; 0.608 (95% CI, 0.511-0.705; I2=0%) for sunvozertinib; 0.602 (95% CI, 0.440-0.764; I2=80.2%) for furmonertinib; 0.602 (95% CI, 0.486-0.718; I2=84.5%) for befotertinib; 0.566 (95% CI, 0.236-0.896; I2=96.3%) for amivantamab; 0.444 (95% CI, 0.215-0.674; I2=0%) for BEBT-109; and 0.256 (95% CI, 0.178-0.334; I2=75.0%) for poziotinib. In conclusion, the emerging EGFR-TKIs for NSCLC with EGFR exon 20 insertion have a promising treatment outcome with a manageable safety profile. However, further analysis is needed when more clinical data are released."

Journal • Retrospective data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

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 | Recruiting ➔ Active, not recruiting | N=100 ➔ 12 | Trial primary completion date: Feb 2025 ➔ Oct 2025

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

CS2011: A novel bispecific antibody targeting EGFR and HER3 that demonstrates promising antitumor activity in preclinical evaluation (AACR 2025) - "Approved anti-EGFR therapies, including cetuximab, pantitumumab, and necitumumab, are widely used in treating the aforementioned malignancies. Amivantamab, a bispecific antibody targeting EGFR and c-MET, has been approved for treating advanced NSCLC with EGFR mutations...Daiichi's HER3-ADC, U3-1402, has shown promising clinical results in advanced EGFR-mutant NSCLC, confirming HER3 as a valid therapeutic target... CS2011 is a promising bispecific antibody for the treatment of various advanced solid tumors. Current preclinical data support further IND-enabling development and clinical research on CS2011."

Preclinical • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • ERBB3 • MET • NRG1

Early Access Program in oncology: Retrospective study at a Portuguese hospital (ECOP 2024) - "During the study period were submitted 163 EAP requests for abiraterone, amivantamab, bevacizumab, durvalumab, encorafenib, enfortumab, everolimus, erdafitinib, lenvatinib, lurbinectedin, niraparib, nivolumab, olaparib, pembrolizumab, pertuzumab, ramucirumab, sacituzumab govitecan, selpercatinib, trifluridine/tipiracil, trametinib+dabrafenib, trastuzumab-deruxtecan and tucatinib. Conclusion Most cases correspond to metastatic disease, EAPs facilitate timely access to innovative therapies for patients with high unmet medical needs. The majority of situations were financed, which confirms the importance of EAPs in an era where oncology is constantly innovating."

Retrospective data • Gastrointestinal Disorder • Oncology

IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies (AACR 2025) - "Inhibition of EGFR signaling is clinically effective in colorectal cancer (CRC) as evidenced by the approval for Cetuximab in combination with chemotherapy or Encorafenib, a BRAF inhibitor, and the promising clinical results when combined with KRAS inhibitors, such as Adagrasib or Sotorasib...Additionally, IBI3019 incorporates a high affinity CD16A single domain antibody that mediates stronger antibody-dependent cell cytotoxicity (ADCC) than IgG1 used in Cetuximab or the low fucosylated Fc of Amivantamab, a bispecific antibody targeting c-MET and EGFR, both in vitro and in vivo...It exhibited strong synergy with Fulzerasib, a KRAS G12C inhibitor and MRTX1133, a KRAS-G12D inhibitor...IBI3019 is a highly optimized FIC molecule with enhanced EGFR blocking capability and ADCC, maximizing tumor inhibition while minimizing toxicity. Its superior efficacy and safety profile support further clinical evaluation."

Preclinical • Trispecific • Colorectal Cancer • Oncology • Solid Tumor • CDH17 • FCGR3A • KRAS • MET

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) - P3 | "Clinical Trial Registration Number: NCT06662786 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF • RAS

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) - P3 | "Clinical Trial Registration Number: NCT06750094 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF • RAS

Further-Line Treatment With Amivantamab Plus Lazertinib in EGFR-Mutant NSCLC: New Answers to Old Questions? (PubMed, J Thorac Oncol) - No abstract available

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

Unveiling the Synergistic Potential: Bispecific Antibodies in Conjunction with Chemotherapy for Advanced Non-Small-Cell Lung Cancer Treatment. (PubMed, Curr Oncol) - "Recent clinical trials have shown improved progression-free survival and overall survival when bsAbs such as amivantamab are combined with chemotherapy, underscoring their potential to transform NSCLC treatment. Many other clinical trials are underway that are evaluating newer bsAbs, such as ivonescimab, which targets PD1 and VEGF. This review also discusses ongoing clinical trials investigating various bsAbs targeting EGFR, PD-1, PD-L1, HER2, and other pathways, highlighting the future directions of bsAb-based therapies. As the field evolves, bsAbs are poised to become a cornerstone of multimodal NSCLC treatment, offering more effective and personalized therapeutic options for patients with advanced disease."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

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

Current treatment landscape for patients with non-small cell lung cancer with common EGFR mutations. (PubMed, Respir Investig) - "Among EGFR-TKIs, third-generation agents such as osimertinib have shown marked efficacy and favorable safety profiles and have become the standard of care in the first-line setting...Similarly, the MARIPOSA trial demonstrated clinical benefit of the combination of the EGFR-MET bispecific antibody, amivantamab, with the third-generation EGFR-TKI, lazertinib, further supporting the use of combination therapies as first-line treatment for EGFR-mutated NSCLC...Analysis of such biomarkers can facilitate dynamic and personalized therapeutic adjustments, potentially improving outcomes. This review provides a comprehensive overview of the latest clinical evidence supporting therapeutic advances in the management of EGFR-mutated NSCLC, emphasizing the importance of tailoring treatment strategies based on tumor biology, patient-specific factors, and evolving therapeutic options."

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

Plain language summary of MARIPOSA-2: amivantamab-chemotherapy either with or without lazertinib for treatment of non-small-cell lung cancer. (PubMed, Future Oncol) - No abstract available

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

Evolving treatment for advanced Non-small cell lung cancer harbouring common EGFR activating mutations. (PubMed, Crit Rev Oncol Hematol) - "Efforts to extend disease control have led to various upfront intensification strategies, including combining EGFR TKIs with antiangiogenics or chemotherapy (e.g., the FLAURA-2 trial), and pairing novel bispecific antibodies such as amivantamab with third-generation TKIs...Emerging therapies targeting MET amplification (e.g., savolitinib plus osimertinib), leveraging antibody-drug conjugates (e.g., patritumab deruxtecan), or adding immunotherapy and antiangiogenics have shown preliminary promise in overcoming resistance...Ultimately, the evolving landscape of EGFR-mutant NSCLC underscores the need for refined biomarker-driven approaches and personalized regimens to achieve further gains in survival. In this review, we discuss these strategies in detail, highlighting current evidence and future directions for EGFR-mutant NSCLC treatment."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Rechallenge with amivantamab, an EGFR-MET bispecific antibody, after disease progression on prior EGFR inhibitor in left-sided RAS/BRAF wild-type metastatic colorectal cancer: Updated results from OrigAMI-1 (ESMO-GI 2025) - No abstract available

Metastases • Colorectal Cancer • Oncology • Solid Tumor • BRAF

EGFR-driven NSCLC and radiotherapy - contra (ESTRO 2025) - "Third generation EGFR-TKI such as osimertinib have now become standard of care as an adjuvant treatment for fully resected stage IB-IIIA EGFR mutated NSCLC, or for EGFR-mutated stage III NSCLC treated with chemoradiation. In the metastatic setting, they can be given as monotherapy or in combination with chemotherapy or with amivantamab, a bispecific antibody against EGFR and MET. With the improving outcomes of systemic therapy, I will argue in this contra presentation, that radiotherapy should not automatically have a place in the treatment paradigm of EGFR-mutated NSCLC. I will focus on data in all disease settings with EGFR-TKI, special situations such as brain metastases and the risk of toxicity by combining EGFR-TKI with radiotherapy."

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

Risk of pulmonary toxicities in patients with EGFR-mutant non-small cell lung cancer (NSCLC) treated with amivantamab: A systematic review and meta-analysis of phase 3 randomized controlled trials. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Effectiveness and safety of the amivantamab to lazertinib versus lazertinib alone in EGFR mutant metastatic non-small-cell lung cancer: Systematic review and meta-analysis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Metastases • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Real-world treatment patterns and outcomes among patients with advanced NSCLC treated with amivantamab. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Incidence of venous thromboembolism (VTE) events in patients with EGFR-mutant non-small cell lung cancer (NSCLC) treated with amivantamab: A systematic review and combined meta-analysis of phase 3 randomized controlled trials. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

P3 data • Retrospective data • Review • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Venous Thromboembolism • EGFR

Amivantamab plus chemotherapy vs chemotherapy in EGFR-mutant advanced NSCLC after disease progression on osimertinib: Outcomes by osimertinib resistance mechanisms in MARIPOSA-2. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04988295 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Dermatologic prophylaxis and impact on patient-reported outcomes in first-line EGFR-mutant advanced NSCLC treated with amivantamab plus lazertinib: Results from the phase 2 COCOON trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06120140 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Patient reported outcomes • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT04036682 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Amivantamab for recurrent/metastatic adenoid cystic carcinoma: A multicenter, single-arm, phase 2 clinical trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05074940 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Adenoid Cystic Carcinoma • Oncology

Amivantamab treatment and intra-tumoral gene expression and immune cell changes in refractory metastatic colorectal cancer (mCRC): Whole transcriptome RNA-sequencing analysis from the OrigAMI-1 study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05379595 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Immune cell • Metastases • Colorectal Cancer • Oncology • Solid Tumor