fianlimab (REGN3767) / Regeneron, Sanofi - LARVOL DELTA

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

A phase 2 study of fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) versus cemiplimab plus placebo in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) with positive PD-L1 expression. (ASCO 2025) - P2 | "The primary endpoint is ORR per investigator assessment. The secondary endpoints are progression-free survival, disease control rate, duration of response, safety, pharmacokinetics, and immunogenicity."

Clinical • IO biomarker • Metastases • P2 data • Head and Neck Cancer • Oncology • Otorhinolaryngology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

ENCEFALO: Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Grupo Español Multidisciplinar de Melanoma | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

A randomized phase 2 peri-operative (neoadjuvant plus adjuvant) study of fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) versus anti–PD-1 alone in patients with resectable stage III and IV melanoma. (ASCO 2025) - P1, P2 | "The primary endpoint is pCR rate by blinded independent pathological review performed centrally. The secondary endpoints are pCR rate (by local assessment), major pathological response (by local and central review), EFS, overall survival, distant metastasis-free survival, relapse-free survival, ORR, safety, pharmacokinetics, immunogenicity, and patient-reported outcomes."

Clinical • P2 data • Melanoma • Oncology • Solid Tumor

LINKER-MM2: A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments (clinicaltrials.gov) - P1 | N=317 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jan 2033 ➔ Sep 2034 | Trial primary completion date: Mar 2027 ➔ Apr 2028

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=22 ➔ 33

Enrollment change • MSI-H • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor

LAG3 PET Imaging in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=41 | Active, not recruiting | Sponsor: University Medical Center Groningen | Trial completion date: Sep 2024 ➔ Nov 2025 | Trial primary completion date: Sep 2024 ➔ Nov 2025

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase 2 peri-operative study of fianlimab + cemiplimab + chemotherapy versus cemiplimab + chemotherapy in resectable early-stage non-small cell lung cancer (NSCLC). (ASCO 2025) - P1, P2 | "Primary endpoint: pathological complete response as determined by blinded independent pathological review (BIPR). Key secondary endpoints: event-free survival and tumor response by investigator assessment, major pathological response by BIPR, safety, pharmacokinetics, immunogenicity, and patient-reported outcomes."

IO biomarker • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Apr 2028 ➔ Dec 2028 | Trial primary completion date: Apr 2028 ➔ Dec 2028

Platinum resistant • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

R3767-ONC-2208: A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Phase classification: P2/3 ➔ P2 | N=520 ➔ 150 | Trial completion date: Jun 2033 ➔ Apr 2031 | Trial primary completion date: Sep 2028 ➔ Mar 2027

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment (clinicaltrials.gov) - P2 | N=48 | Enrolling by invitation | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Enrolling by invitation | N=98 ➔ 48

Enrollment change • Enrollment open • Melanoma • Oncology • Solid Tumor

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery (clinicaltrials.gov) - P3 | N=1564 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor

Regeneron to Highlight Advances at ASCO with Phase 3 Adjuvant Libtayo (cemiplimab) CSCC Updates and Promising Early Blood Cancer Data with Linvoseltamab Combination (GlobeNewswire) - "Eighteen presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma...Notable presentations at ASCO on Regeneron’s oncology pipeline include detailed efficacy and safety findings from the Phase 3 C-POST trial evaluating the adjuvant use of the PD-1 inhibitor Libtayo in post-surgical high-risk cutaneous squamous cell carcinoma (CSCC). The results will be presented in an oral session on Saturday, May 31...Regeneron will debut results from two cohorts of the LINKER-MM2 trial...which will be featured in two rapid oral presentations on Monday, June 2...In addition, the results of a cooperative group study reporting on the primary analysis of a randomized Phase 2 trial of vidutolimod..."

Clinical data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Lymphoma • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

N-PLANC: Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

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

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF GEMCITABINE/CISPLATIN PLUS CEMIPLIMAB (REGN2810, ANTI-PD-1) WITH OR WITHOUT FIANLIMAB (REGN3767, ANTI-LAG-3) FOR ORGAN PRESERVATION IN PATIENTS WITH LOCALIZED MUSCLE-INVASIVE BLADDER CANCER (NEOSTOP-IT) (AUA 2025) - P2 | "The study will be stopped, at any time during the study, if we observe 70% or more probability that the serious treatment-related adverse event rate is >30%. Enrollment is expected to begin in April 2025."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Fianlimab + Libtayo: Data from P2 trial (NCT05785767) for advanced NSCLC in Q1 2026 (Regeneron Pharmaceuticals) - Q1 2025 Results

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Fianlimab + cemiplimab in patients (pts) with advanced (adv) melanoma (Mel): Subgroup analyses by blinded independent central review (BICR) (AACR 2025) - P1 | "With longer follow-up, fianlimab + cemiplimab continued to demonstrate high clinical activity and a generally acceptable safety profile in subgroups of pts with adv Mel. AI was reported in 12% of pts receiving the Tx; efficacy rates were higher in pts who experienced AI than in the overall study population.Regeneron - Internal"

Clinical • IO biomarker • Late-breaking abstract • Metastases • Review • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients (clinicaltrials.gov) - P2 | N=65 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

N-PLANC: Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Mayo Clinic

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

ENCEFALO: Encorafenib and BiNimetinib Followed by CEmiplimab and FiAnLimab in Patients with BRAF Mutant MelanOma and Symptomatic Brain Metastases (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Grupo Español Multidisciplinar de Melanoma

New P2 trial • Melanoma • Oncology • Solid Tumor

R2810-ONC-1622: Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=146 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2030 ➔ Sep 2027

Enrollment closed • Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology

A Phase 3 trial of fixed-dose combination of fianlimab + cemiplimab vs relatlimab + nivolumab in patients with unresectable or metastatic melanoma (EADO-WCM 2025) - P1, P3 | "Methods This is a randomised, open-label, multicentre (in ∼80 sites across North America), Phase 3 trial (NCT06246916), the fixed-dose combination (FDC) of fianlimab + cemiplimab versus the FDC of relatlimab + nivolumab will be compared in pts with unresectable/metastatic melanoma. Additional endpoints include duration of response, disease control rate, investigator-assessed ORR and PFS, safety, pharmacokinetics and immunogenicity. Results N/A Conclusions N/A"

Clinical • Metastases • P3 data • Melanoma • Oncology • Solid Tumor • PD-L1

A Phase 3 trial of fianlimab + cemiplimab versus pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic melanoma (EADO-WCM 2025) - P1, P3 | "The study is currently open for enrolment. Results N/A Conclusions N/A"

Clinical • Metastases • P3 data • Melanoma • Oncology • Solid Tumor

Fianlimab + Libtayo: Initial data from P2 trial (NCT06161441) for 1L advanced NSCLC in H1 2025 (Regeneron Pharmaceuticals, 43rd Annual J.P. Morgan Healthcare Conference)

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Fianlimab + Libtayo: Initial data from P2 trial (NCT06161441) for 1L advanced NSCLC in H1 2025 (Regeneron Pharmaceuticals, 43rd Annual J.P. Morgan Healthcare Conference)

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology