fianlimab (REGN3767) / Regeneron, Sanofi - LARVOL DELTA

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

ENCEFALO (GEM2301) clinical trial: Encorafenib and Binimetinib Followed by Cemiplimab and Fianlimab in BRAF-Mutant Melanoma and Symptomatic Brain Metastases (ESMO-IO 2025) - No abstract available

Clinical • Melanoma • Oncology • Solid Tumor • BRAF

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

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