dalmitamig (REGN7075) / Regeneron - LARVOL DELTA

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

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

A Phase 1/2 Study of REGN7075 (EGFRÃ-CD28) Combined with Cemiplimab (anti-PD-1) In NSCLC: Trial in Progress Update (IASLC-WCLC 2024) - P1/2 | "As of February 23, 2024, 122 patients were enrolled in Part 1. The study is ongoing and open to enrollment."

IO biomarker • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CD28 • EGFR • MET • PD-L1 • ROS1

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase 1/2 study of REGN7075 in combination with cemiplimab (cemi) in patients (pts) with advanced solid tumors: Efficacy and safety results. (ASCO 2024) - P1/2 | "MSS CRC is historically unresponsive to immunotherapy. REGN7075 is one of the first immune therapies to demonstrate clinical activity in pts with MSS CRC (including a pt with liver metastases), and dose escalation was completed through 900 mg with an acceptable safety profile and no DLTs. One pt experienced Grade 1 CRS, demonstrating differentiation from CD28 superagonists and CD3-targeting bsAbs."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD28 • EGFR • IFNG

Promising Anti-tumor Activity of Novel Costimulatory Bispecific Antibody REGN7075 (EGFRxCD28) in Combination with Libtayo (cemiplimab) to be Reported at ASCO (GlobeNewswire) - P1/2 | N=769 | COMBINE-EGFR-1 (NCT04626635) | Sponsor: Regeneron Pharmaceuticals | "Among 94 patients treated as of data cutoff, 65% (n=61) had MSS CRC, of which 51 MSS CRC patients were treated at an active dose level. Efficacy results among these 51 patients were as follows...6% (n=3) overall response rate (ORR) and 29% (n=15) disease control rate (DCR). This included one complete response (CR), two partial responses (PR), and 12 patients with stable disease; Among the subset of 15 patients without liver metastases, there was a 20% ORR (n=3) and 80% DCR (n=12)...REGN7075 and Libtayo showed an acceptable safety profile, and the maximum tolerated dose was not reached...Grade 3 and 4 TEAEs occurred in 35% of patients...While the dose escalation portion of the trial across multiple solid tumor types including non-small cell lung cancer, colorectal cancer, head and neck cancer and other tumor types is ongoing, expansion cohorts in several tumor types have also been initiated."

P1/2 data • Colorectal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer

Regeneron to Showcase Progress in Advancing Novel Investigational Treatment Approaches for a Broad Range of Solid Tumors and Blood Cancers at ASCO (GlobeNewswire) - "Notably, new safety and efficacy results from a Phase 1/2 trial investigating the costimulatory bispecific antibody REGN7075 (EGFRxCD28) in combination with Libtayo in patients with certain advanced solid tumors will be featured in an oral presentation....Among them are presentations on updated data and new analyses for linvoseltamab (BCMAxCD3) in multiple myeloma; odronextamab (CD20xCD3) in several lymphoma subtypes; REGN6569 (GITR) in combination with Libtayo across solid tumors; and fianlimab (LAG-3 inhibitor) in combination with Libtayo in non-small cell lung cancer, melanoma and head and neck cancer."

Clinical data • P1/2 data • Head and Neck Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Solid Tumor

A phase 1/2 study of REGN7075 (EGFRxCD28 costimulatory bispecific antibody) in combination with cemiplimab (anti–PD-1) in patients with advanced solid tumors, including colorectal cancer: Trial in progress update. (ASCO-GI 2024) - P1/2 | "This study is ongoing and currently open to enrollment. Clinical trial information: NCT04626635."

Clinical • Combination therapy • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD28

A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=769 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=434 ➔ 769 | Trial completion date: Apr 2026 ➔ Dec 2026 | Trial primary completion date: Apr 2026 ➔ Aug 2026

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer

A Phase 1/2 study of REGN7075 (EGFRxCD28 costimulatory bispecific antibody) in combination with cemiplimab (anti-PD-1) in patients with advanced solid tumors: Initial dose-escalation results (SITC 2022) - P1/2 | "Biomarker studies are ongoing. Clinical trial enrollment is ongoing; we are currently evaluating the 100mg cohort."

Clinical • Combination therapy • IO biomarker • P1/2 data • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD28 • EGFR

A phase 1/2 study of REGN7075 (EGFRxCD28 costimulatory bispecific antibody) in combination with cemiplimab (anti–PD-1) in patients with advanced solid tumors: Trial-in-progress update. (ASCO-GI 2023) - P1/2 | "This study is ongoing and currently open to enrollment. Clinical trial information: NCT04626635."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • CD28

REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=434 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer

A Phase I/II study of REGN7075 (EGFRxCD28 costimulatory bispecific antibody) in combination with cemiplimab (anti–PD-1) in patients with advanced solid tumors (SITC 2021) - P1/2 | "REGN7075 is a human immunoglobulin G4-based costimulatory bsAb designed to bridge epidermal growth factor receptor (EGFR) positive tumor cells with CD28 positive T-cells and to provide amplified T-cell receptor-CD3 complex-mediated T-cell activation within the tumor, through the activation of CD28 co-stimulation. This study is currently open to enrollment. Trial Registration ClinicalTrials.gov identifier NCT04626635."

Clinical • Combination therapy • P1/2 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • EGFR • PD-L1

REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=312; Recruiting; Sponsor: Regeneron Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=312; Not yet recruiting; Sponsor: Regeneron Pharmaceuticals

Clinical • Combination therapy • New P1/2 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer