davutamig (REGN5093) / Regeneron - LARVOL DELTA

Prevalence and Concordance Analysis of MET Amplification/Overexpression in a Phase 1 Study of Davutamig (REGN5093) in a NSCLC (IASLC-WCLC 2025) - P1/2 | "This supports the use of existing tissue samples and may reduce the need for fresh biopsies. Despite no consensus on technology assessing MET Amp, these results suggest reliable outcomes are achievable with specific cut-offs regardless of assay platform, warranting further sample analysis to validate these findings."

Discordant • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • MET

A phase I/II study of davutamig (REGN5093), a MET×MET bispecific antibody, in patients with MET-altered, advanced non-small cell lung cancer (aNSCLC): Trial in progress update (ESMO Asia 2024) - P1/2 | "Primary objectives: Ph 1, to assess the safety, tolerability, and PK of davutamig; Ph 2, to assess preliminary antitumor activity of davutamig (objective response rate per RECIST 1.1). Part 1 enrollment was completed as of Mar 7, 2023 (n=82), and the study is now enrolling pts into Part 2."

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

R5093-ONC-1863: A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=231 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | N=82 ➔ 231 | Trial completion date: Oct 2024 ➔ Jan 2032 | Trial primary completion date: Oct 2024 ➔ Jan 2032

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

MET×MET bispecific antibody davutamig (REGN5093) for MET-altered advanced non-small cell lung cancer (aNSCLC): Update from a first-in-human (FIH) study (ESMO 2024) - P1/2 | "In this FIH study of MET-altered aNSCLC, davutamig showed a favorable safety profile, with early signs of efficacy in pts with aNSCLC with MET alterations."

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

REGN5093 in Patients with MET-Altered Advanced Non-Small Cell Lung Cancer Évaluation du REGN5093 dans le traitement du cancer bronchique non àpetites cellules avancé avec altération de MET (clinicaltrialsregister.eu) - P1/2 | N=111 | Ongoing | Sponsor: Regeneron Pharmaceuticals, Inc.

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

Engineering hydrophobicity and manufacturability for optimized biparatopic antibody-drug conjugates targeting c-MET. (PubMed, MAbs) - "The resulting biparatopic anti-c-MET ADCs were comparably active on c-MET expressing tumor cell lines as REGN5093 exatecan DAR6 ADC. Structural molecular modeling of paratope combinations for preferential inter-target binding combined with protein engineering for manufacturability yielded deep insights into the capabilities of rational and library approaches. The methodologies of in silico hydrophobicity identification and sequence optimization could serve as a blueprint for rapid development of optimal biparatopic ADCs targeting further tumor-associated antigens in the future."

Journal • Oncology • MET

Predictive Biomarkers of Response to REGN5093 to Guide Patient Selection in MET-Altered Advanced Non-small Cell Lung Cancer (IASLC-WCLC 2023) - "We report biomarkers associated with clinical response and resistance to REGN5093 which may help with screening of aNSCLC pts in future combination studies of REGN5093 with other therapies."

Biomarker • Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • EGFR • JAK2 • KRAS • TP53

REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=82 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Early safety, tolerability, and efficacy of REGN5093 in patients (pts) with MET-altered advanced non-small cell lung cancer (aNSCLC) from a first in human (FIH) study (ESMO 2022) - P1/2 | "Updated data including detailed tumour response will be presented at the conference. Conclusions These early results suggest REGN5093 may have a therapeutic benefit in pts with MET-altered NSCLC and showed promising efficacy signals with an acceptable safety profile."

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

Novel Regeneron Bispecific Antibodies Show Encouraging Anti-tumor Activity in Two Advanced Solid Tumors (PRNewswire) - P1/2 | N=111 | NCT04077099 | Sponsor: Regeneron Pharmaceuticals | "Preliminary first-in-human results for REGN5093 were also published in an ESMO scientific abstract...As highlighted in the abstract, among 36 patients with MET-altered advanced NSCLC who received the highest dose tested to date, 6 experienced a partial response with 5 of these responses occurring in patients who had received prior anti-PD-1 treatment. Total exposure to treatment was approximately 467 patient-weeks. AEs that were ≥grade 3 occurred in 25% (n=11) of REGN5093-treated patients, with pneumonia and pulmonary embolism each occurring in 2 patients."

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

ESMO Presentations of Libtayo (cemiplimab), Fianlimab and Novel Bispecific Antibodies Showcase Expanding Potential of Regeneron's Oncology Pipeline in Multiple Cancers (PRNewswire) - "Regeneron Pharmaceuticals...announced that new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 from September 9 to 13 in Paris. Presentations will include first-in-class efficacy and safety data from Phase 1/2 trials of two investigational bispecific antibodies – ubamatamab (REGN4018; MUC16xCD3) in advanced ovarian cancer and REGN5093 (METxMET) in advanced MET-altered non-small cell lung cancer (NSCLC) – along with presentations of investigational Libtayo® (cemiplimab) regimens in four advanced solid tumors, including a combination with investigational fianlimab (LAG-3 inhibitor)....New and updated investigational data for Libtayo as monotherapy and as a potential backbone of several combination treatments will also be presented at ESMO."

Clinical data • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer

Regeneron Reports Fourth Quarter and Full Year 2021 Financial and Operating Results (PRNewswire) - "Select 2022 Milestones...REGN5458 (BCMA and CD3 Bispecific Antibody)- Report results from potentially pivotal Phase 2 study in multiple myeloma, Initiate Phase 1 and Phase 3 studies exploring combinations with standard of care and additional combination studies; Odronextamab (CD20 and CD3 Bispecific Antibody)- Report additional results from potentially pivotal Phase 2 study in B-cell non-Hodgkin lymphoma (B-NHL), Initiate OLYMPIA Phase 3 program and additional combination studies; Solid Tumor Bispecific Antibodies - Report results from REGN4018 (MUC16 and CD3 bispecific antibody) Phase 1 study in platinum-resistant ovarian cancer, Report results from REGN5678 (PSMA and CD28 bispecific antibody) Phase 1 study in prostate cancer, Report results from REGN5093 (bispecific antibody targeting two distinct MET epitopes) Phase 1 study in MET-altered advanced NSCLC."

Clinical data • Trial status • Cervical Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2; N=111; Recruiting; Sponsor: Regeneron Pharmaceuticals; Trial completion date: Nov 2023 ➔ Oct 2024; Trial primary completion date: Nov 2023 ➔ Oct 2024

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

[VIRTUAL] A phase I/II study of REGN5093, a MET x MET bispecific antibody, in patients with MET-altered advanced non-small cell lung cancer (NSCLC). (ASCO 2020) - P1/2 | "The study is currently open for enrollment. Research Funding: Regeneron Pharmaceutical, Inc."

Clinical • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • HGF • MET • MRI • NTRK

REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2; N=111; Recruiting; Sponsor: Regeneron Pharmaceuticals; Trial completion date: Feb 2024 ➔ Nov 2023; Trial primary completion date: Feb 2024 ➔ Nov 2023

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

Regeneron presentations at ASCO 2020 showcase diverse clinical oncology portfolio (PRNewswire) - "Among the accepted abstracts are new, longer-term data for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in advanced cutaneous squamous cell carcinoma (CSCC). The data published today, which will be updated during ASCO, add to the most mature dataset for any therapy in advanced CSCC and show that median overall survival and median duration of response have yet to be reached for Libtayo-treated patients with no new safety signals observed. Additional abstracts outline the clinical trial designs for Regeneron's first costimulatory bispecific REGN5678 (PSMAxCD28) in metastatic castration-resistant prostate cancer and the company's first tumor-targeted bispecific REGN5093 (METxMET) in MET-altered advanced non-small cell lung cancer (NSCLC)."

Clinical data • Clinical protocol • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Thoracic Cancer • Urothelial Cancer

REGN 5093 (IASLC-LCTT 2020) - No abstract available

REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2; N=102; Recruiting; Sponsor: Regeneron Pharmaceuticals; Not yet recruiting ➔ Recruiting

Enrollment open

Newly added product (clinicaltrials.gov) - P1, NSCLC

Pipeline update