fianlimab (REGN3767) / Regeneron, Sanofi - LARVOL DELTA

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: John Kirkwood | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

ENCEFALO (GEM2301) clinical trial: Encorafenib and binimetinib followed by cemiplimab and fianlimab in BRAF-mutant melanoma and symptomatic brain metastases (ESMO-IO 2025) - P2 | "If among the first 18 pts, ≥4 had icPD at 6m or sooner, the study will stop. Accrual started in May 2025 and five patients were included by Sep 2025.Clinical trial identification EudraCT: 2024-513375-40-00; NCT06887088.Legal entity responsible for the study Grupo Español Multidisciplinar de Melanoma (GEM)."

Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • BRAF

LAG-MAPS: Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: Intergroupe Francophone de Cancerologie Thoracique

New P2 trial • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Solid Tumor

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Apr 2029 ➔ Nov 2029 | Trial primary completion date: Sep 2025 ➔ May 2026

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

LAG-BOOST: Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: University of Oklahoma

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

NACho: Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: John Strickler, M.D.

New P2 trial • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: John Kirkwood

New trial • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer (IASLC-WCLC 2025) - P2 | "Introduction : SPRINT (NCT03523702) was a multi-center Phase II trial where biomarker-selected (PD-L1 TPS ≥ 50%) locally advanced non-small cell lung cancer (LA-NSCLC) patients were treated with 3 cycles of induction therapy with the PD-1 inhibitor pembrolizumab followed by risk-adapted radiotherapy (RT), then consolidation pembrolizumab to complete a 1-year course while chemotherapy was omitted (PMID: 37988638)...Thus, we hypothesize that dual IO with the PD-1 inhibitor cemiplimab plus the LAG-3 inhibitor fianlimab administered before and after thoracic RT, as per the SPRINT approach, has valuable potential as a biomarker-driven treatment regimen for LA-NSCLC patients...Safety will be assessed via a safety-run in phase and extended adverse events collection. Additional endpoints will include ORR on CT, PFS, OS, quality of life assessments, and exploratory analyses focused on tissue and blood-based immune effector signatures."

IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3

Fianlimab + Libtayo: Initial data from P2 trial (NCT06161441) for 1L advanced NSCLC in H1 2026 (Regeneron Pharmaceuticals) - Q3 2025 Results: Data from P3 trial (NCT05352672) for 1L metastatic melanoma in H1 2026

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

Fianlimab + Libtayo: Initiation of P2 trial (NCT06769698) for HPV+/HPV- HNSCC in H1 2026 (Regeneron Pharmaceuticals) - Q3 2025 Results: Initiation of trial for perioperative HNSCC in 2026

New trial • Trial initiation date • Oncology • Squamous Cell Carcinoma of Head and Neck

A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Brian Rini

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment (clinicaltrials.gov) - P2 | N=68 | Not yet recruiting | Sponsor: University of Chicago

Minimal residual disease • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor

Fianlimab + cemiplimab in patients with advanced melanoma: Subgroup analyses by blinded independent central review (ADO 2025) - No abstract available

Clinical • Metastases • Review • Melanoma • Solid Tumor

Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Columbia University | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

R5668-ONC-1938: A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab (clinicaltrials.gov) - P1/2 | N=612 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Apr 2027 ➔ Nov 2027

Trial completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Targeting LAG-3: Relatlimab, Fianlimab, and ieramilimab reshape the landscape of cancer combination immunotherapy. (PubMed, Pathol Res Pract) - "This review discusses the biology of LAG-3, the pharmacological characteristics of Relatlimab, Fianlimab, and Ieramilimab, as well as their potential synergistic effects when combined with other ICIs. Moreover, it addresses resistance mechanisms, patient selection, and challenges with combination therapies in cancer."

Journal • Review • Melanoma • Oncology • Solid Tumor • LAG3

Fianlimab + Libtayo: Data from P3 trial (NCT05352672) for 1L metastatic melanoma in Q4 2025/Q1 2026 (Regeneron Pharmaceuticals) - Q2 2025 Results

P3 data • Melanoma • Oncology

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE) (clinicaltrials.gov) - P2 | N=79 | Not yet recruiting | Sponsor: NSABP Foundation Inc

Minimal residual disease • Monotherapy • New P2 trial • Colorectal Cancer • 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

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

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