fianlimab (REGN3767) / Regeneron, Sanofi - LARVOL DELTA

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) - P2/3 | "Clinical Trial Registration Number: NCT06190951 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P2 data • Melanoma • Oncology • 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 | "Clinical Trial Registration Number: NCT06769698 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Phase 2 peri-operative study of fianlimab + cemiplimab + chemotherapy versus cemiplimab + chemotherapy in resectable early-stage non-small cell lung cancer (NSCLC). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06161441 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Fianlimab + cemiplimab in patients (pts) with advanced (adv) melanoma (Mel): Subgroup analyses by blinded independent central review (BICR) (AACR 2025) - "Abstract is embargoed at this time."

Clinical • Late-breaking abstract • Metastases • Review • Melanoma • 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) - No abstract available

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

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

89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL) (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Mar 2025 | Trial primary completion date: Sep 2025 ➔ Mar 2025

IO biomarker • Trial completion • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Fianlimab + cemiplimab in patients with advanced melanoma: Subgroup analyses by blinded independent central review (BICR) (EADO-WCM 2025) - P1 | "Conclusions With longer follow-up, fianlimab + cemiplimab continues to demonstrate high clinical activity in subgroups of pts with adMEL with a generally acceptable safety profile. While the AE of AI is reported in 12% of pts treated with the combination, we report higher efficacy rates in pts who experienced AI than the overall study population."

Clinical • IO biomarker • Metastases • Review • Endocrine Disorders • Melanoma • Nephrology • Oncology • Renal Disease • Solid Tumor • BRAF • PD-L1

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=98 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Melanoma • Oncology • Solid Tumor

A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Feb 2028 | Trial primary completion date: Dec 2026 ➔ Feb 2028

Enrollment open • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • 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). (ASCO-GU 2025) - P2 | "Recruitment will begin January 2025. Clinical trial registration: NCT06571708"

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

Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Columbia University | Initiation date: Nov 2024 ➔ Jun 2025

Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Development of an ex-vivo platform to model immunotherapy in kidney cancer. (ASCO-GU 2025) - "Treatment groups included: i) cabozantinib (cabo) alone, ii) cabo with cemiplimab (cemi, a PD-1 inhibitor), iii) cemi with fianlimab (fin, a LAG-3 inhibitor), and iv) the triplet regimen of cabo, cemi, and fin... This study characterizes an organotypic, patient-derived model based on the culture of tumor slices from primary renal cancers, where we have optimized for extended viability of PCTS in ex vivo culture. The drug treatment experiments conducted on the slices demonstrate the potential of PCTS as a preclinical tool for screening effective therapies for primary ccRCC, including immunotherapeutic approaches, which has been challenging in previous animal models. Our findings suggest that the triplet regimen (cabo+cemi+fin) may offer greater efficacy compared to the cabo+cemi or cemi+fin."

Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • LAG3

Fianlimab + Libtayo: Launch for melanoma in 2026 (Regeneron Pharmaceuticals, 43rd Annual J.P. Morgan Healthcare Conference)

Launch • Melanoma • Oncology

Fianlimab + Libtayo: Launch for melanoma in 2026 (Regeneron Pharmaceuticals, 43rd Annual J.P. Morgan Healthcare Conference)

Launch • Melanoma • Oncology

A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

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

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "Libtayo (cemiplimab) exceeded $1 billion in sales for 2024 and remains foundational to Regeneron’s oncology portfolio....Fianlimab (LAG3) for melanoma: Combining fianlimab and Libtayo, two potentially best-in-class checkpoint inhibitors, has the potential for differentiated efficacy and safety versus the current standard-of-care. Results from the first Phase 3 study in first-line metastatic melanoma are expected in the second half of 2025, with a potential BLA submission to follow....Linvoseltamab (BCMAxCD3) for multiple myeloma: Linvoseltamab has potential to be the best-in-class BCMAxCD3 bispecific with its differentiated clinical profile, dosing regimen and administration method. The linvoseltamab BLA has been resubmitted following resolution of third-party manufacturing issues, with launch anticipated in mid-2025."

FDA filing • Launch US • P3 data • Sales • Melanoma