REGN5093-M114 / Regeneron - LARVOL DELTA

Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer (clinicaltrials.gov) - P1 | N=30 | Terminated | Sponsor: Regeneron Pharmaceuticals | Phase classification: P1/2 ➔ P1 | Trial completion date: Oct 2027 ➔ Oct 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2027 ➔ Oct 2025; Sponsor decision

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

Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=237 ➔ 30 | Trial completion date: Feb 2030 ➔ Oct 2027 | Trial primary completion date: Feb 2030 ➔ Aug 2027

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

Anti-MET Antibody Therapies in Non-Small-Cell Lung Cancer: Current Progress and Future Directions. (PubMed, Antibodies (Basel)) - " Amivantamab, a bispecific EGFR/MET antibody was approved to treat EGFR exon 20 insertion and now has recently been extended to target classical EGFR mutations with progression on osimertinib. Other important anti-MET targeted therapies in development include antibody drug conjugates such as telisotuzumab vedotin, REGN5093-M114, and AZD9592 and emibetuzumab, which is a humanized immunoglobulin G4 monoclonal bivalent MET antibody...Future research should focus on developing novel MET antibody drugs and exploring new therapeutic combinations to enhance treatment efficacy and overcome resistance in NSCLC. Refining biomarker-driven approaches to ensure precise patient selection is also critical to optimizing treatment outcomes."

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

REGN5093-M114: can an antibody-drug conjugate overcome the challenge of resistance to epidermal growth factor receptor and mesenchymal epithelial transition tyrosine kinase inhibitors in non-small cell lung cancer? (PubMed, Transl Lung Cancer Res) - No abstract available

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

Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer (clinicaltrials.gov) - P1/2 | N=237 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=83 ➔ 237 | Trial completion date: Dec 2026 ➔ Feb 2030 | Trial primary completion date: Dec 2026 ➔ Feb 2030

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

A Phase 1/2 Study of REGN5093-M114, a METxMET Antibody-Drug Conjugate, in Patients with MET-Overexpressing NSCLC (IASLC-WCLC 2023) - P1/2 | "Currently, this study is enrolling patients. As of 30 March 2023 17 patients across the five dose levels (table 1).Dose Level (DL)Number of patients enrolledDL11DL23DL33DL44DL56"

Clinical • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A MET targeting biparatopic antibody-drug conjugates (ADC), REGN5093-M114, has an antitumor efficacy in NSCLC harboring MET gene alterations (AACR 2022) - "We evaluated the antitumor activity of REGN5093-M114 in patient-derived tumor xenograft (PDX) models from EGFR-mutant NSCLC patients with acquired resistance to osimertinib plus savolitinib, including acquired MET p.Y1230C mutation. Finally, we determined whether REGN5093-M114 is able to overcome acquired resistance to the MET-TKI, tepotinib, using PDC from METex14 mutant NSCLC patients. In acquired MET-amplified EGFR-TKI resistant PDCs, PDOs, ATCC cell lines and PDX models, REGN5093-M114 alone exhibited a significant antitumor efficacy compared to MET-TKI or the MET x MET biparatopic antibody (REGN5093), but had no effect on some models with same MET copy number as the sensitive models... REGN5093-M114 has the potential to be a novel therapeutic option in NSCLC harboring MET genetic alterations, and further clinical application is highly warranted."

Clinical • Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PTEN

A phase 1/2 study of REGN5093-M114, a METxMET antibody-drug conjugate, in patients with mesenchymal epithelial transition factor (MET)-overexpressing NSCLC. (ASCO 2022) - P1/2 | "The secondary objectives of both phases of the study include an evaluation of treatment durability, and the immunogenicity of REGN5093-M114. This study is currently open to enrollment."

Clinical • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

GSH research team proves strong ADC potency against resistant NSCLC mutations (Korea Biomedical Review) - "Gangnam Severance Hospital (GSH) researchers demonstrated that antibody drug conjugate (ADC), REGN5093-M114, can overcome mesenchymal-epithelial transition (MET) gene-based EGFR target mutant non-small cell lung cancer (NSCLC)....REGN5093-M114 demonstrated strong anti-tumor activity in MET-based EGFR-targeted therapy resistance models and tumor models that acquired resistance to MET TKIs."

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

Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer (clinicaltrials.gov) - P1/2; N=83; Recruiting; Sponsor: Regeneron Pharmaceuticals; Not yet recruiting ➔ Recruiting

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

Preclinical study of a biparatopic METxMET Antibody-Drug Conjugate, REGN5093-M114, overcomes MET-driven acquired resistance to EGFR TKIs in EGFR-mutant NSCLC. (PubMed, Clin Cancer Res) - "Altogether, REGN5093-M114 is a promising candidate to overcome the challenges facing functional MET pathway blockade."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PTEN

"Regeneron $REGN REGN5093-M114 anti-METxMET+maytansinoid #ADC #ASCO22 update https://t.co/ppeu4i17PU" (@char1eylu)

Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer (clinicaltrials.gov) - P1/2; N=83; Not yet recruiting; Sponsor: Regeneron Pharmaceuticals

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