^
    16d
    Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    17d
    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, Mayo Clinic
    New P2 trial • Checkpoint inhibition
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    25d
    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, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Mar 2030 --> Sep 2027
    Enrollment closed • Trial completion date
    |
    Yervoy (ipilimumab) • gemcitabine • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1m
    89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P1, N=7, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Mar 2025 | Trial primary completion date: Sep 2025 --> Mar 2025
    Trial completion • Trial completion date • Trial primary completion date • IO biomarker
    |
    fianlimab (REGN3767)
    1m
    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, Grupo Español Multidisciplinar de Melanoma
    New P2 trial
    |
    Mektovi (binimetinib) • Braftovi (encorafenib) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    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, Regeneron Pharmaceuticals
    New P2 trial
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Columbia University | Initiation date: Nov 2024 --> Jun 2025
    Trial initiation date
    |
    cisplatin • gemcitabine • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=10, Recruiting, 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
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=220, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial
    |
    Avastin (bevacizumab) • pegylated liposomal doxorubicin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • ubamatamab (REGN4018) • Kevzara (sarilumab)
    4ms
    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, Regeneron Pharmaceuticals
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    5ms
    A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial • Metastases
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    6ms
    R3767-ONC-2011: Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=1535, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Aug 2032 --> Jun 2031 | Trial primary completion date: Mar 2026 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    6ms
    Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients (clinicaltrials.gov)
    P2, N=73, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Feb 2031 --> Mar 2030
    Trial completion date
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    6ms
    Deciphering LAG-3: unveiling molecular mechanisms and clinical advancements. (PubMed, Biomark Res)
    Currently, with the approval of relatlimab, a LAG-3 blocking antibody, a third player, has been used in the fight against cancer...However, the complex biology of LAG-3 may hinder its full development as a therapeutic alternative. In this review, we provide in-depth insight into the biology of LAG-3 and its current and future development in cancer treatment.
    Review • Journal
    |
    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    favezelimab (MK-4280) • fianlimab (REGN3767) • relatlimab (BMS-986016)
    6ms
    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)
    P2/3, N=520, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    7ms
    A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma (clinicaltrials.gov)
    P2, N=88, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    Yervoy (ipilimumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    8ms
    A Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Columbia University
    New P2 trial
    |
    cisplatin • gemcitabine • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    9ms
    A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=560, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Libtayo (cemiplimab-rwlc) • Opdualag (nivolumab/relatlimab-rmbw) • fianlimab (REGN3767) • relatlimab (BMS-986016)
    9ms
    Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) (clinicaltrials.gov)
    P2, N=0, Withdrawn, Regeneron Pharmaceuticals | N=140 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    10ms
    Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma. (PubMed, J Clin Oncol)
    The current results show a promising benefit-risk profile of fianlimab/cemiplimab combination for patients with advanced melanoma, including those with previous anti-PD-1 therapy in the adjuvant, but not advanced, setting.
    P1 data • Journal • Combination therapy • Metastases
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    11ms
    R3767-ONC-2011: Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=1590, Recruiting, Regeneron Pharmaceuticals | Phase classification: P2/3 --> P3
    Phase classification • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    11ms
    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, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting | Initiation date: Mar 2024 --> Jun 2024
    Enrollment open • Trial initiation date • Combination therapy • Surgery
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    11ms
    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, Regeneron Pharmaceuticals | Trial completion date: Aug 2032 --> Jan 2033
    Trial completion date • Combination therapy
    |
    lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • Lynozyfic (linvoseltamab)
    11ms
    Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer (clinicaltrials.gov)
    P2, N=22, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    12ms
    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)
    P2/3, N=520, Not yet recruiting, Regeneron Pharmaceuticals | Phase classification: P2 --> P2/3 | N=360 --> 520 | Trial completion date: Dec 2030 --> Jun 2033 | Initiation date: Feb 2024 --> Jul 2024 | Trial primary completion date: Dec 2030 --> Sep 2028
    Phase classification • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    12ms
    R3767-ONC-1613: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers (clinicaltrials.gov)
    P1, N=333, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1year
    Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial • Combination therapy
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1year
    Incidence and time to onset of immunotherapy-related adrenal insufficiency in the I-SPY2 trial. (ASCO 2024)
    Treatment included weekly paclitaxel (T) plus ICI-based tx x 4 cycles, followed by doxorubicin/cyclophosphamide (AC) every 2-3 weeks x 4. 6 completed investigational arms included ICIs: T+pembro x 4, T+pembro x 8 (+/- AC), T+pembro+SD101 (TLR9 agonist), T+durvalumab+olaparib, T+cemiplimab (cemi), and T+cemi+REGN3767 (anti-LAG-3)... The incidence of AI in EBC is higher than has previously been reported in advanced disease, with higher rates observed in those tx with dual immune modulation. No correlation was observed with age; correlation of AI with response predictive subtype and other clinicopathologic features is ongoing and will be presented. Given the high incidence of AI in EBC, close monitoring in the peri/postoperative setting and education of pts and providers is critical, as risk persists even after completion of tx.
    PD(L)-1 Biomarker • PARP Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    MammaPrint
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • nelitolimod (SD-101)
    1year
    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=1530, Recruiting, Regeneron Pharmaceuticals | Trial primary completion date: Feb 2030 --> May 2028
    Trial primary completion date • Surgery
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1year
    Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P2/3, N=1925, Recruiting, Regeneron Pharmaceuticals | Phase classification: P3 --> P2/3 | Trial completion date: Apr 2031 --> Aug 2032
    Phase classification • Trial completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1year
    A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=560, Not yet recruiting, Regeneron Pharmaceuticals
    New P3 trial • Metastases
    |
    Libtayo (cemiplimab-rwlc) • Opdualag (nivolumab/relatlimab-rmbw) • fianlimab (REGN3767) • relatlimab (BMS-986016)
    over1year
    Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer (clinicaltrials.gov)
    P2, N=22, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P2 trial • Metastases
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Pembrolizumab in Adult Participants With Resectable Stage 3 or 4 Melanoma (clinicaltrials.gov)
    P2, N=360, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    LAG3 PET Imaging in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=41, Active, not recruiting, University Medical Center Groningen | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer (clinicaltrials.gov)
    P1/2, N=60, Recruiting, University of Wisconsin, Madison | N=39 --> 60 | Trial completion date: Apr 2025 --> Dec 2028 | Trial primary completion date: Apr 2025 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition • Checkpoint block
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Libtayo (cemiplimab-rwlc) • Firmagon (degarelix) • fianlimab (REGN3767) • MVI-118
    over1year
    A phase 1 study of fianlimab (anti-LAG-3) in combination with cemiplimab (anti-PD-1) in patients with advanced ccRCC. (ASCO-GU 2024)
    Fianlimab + cemiplimab demonstrated promising signs of clinical activity with durable responses among patients with anti–PD-1/PD-L1-naïve (cohort 3) and anti–PD-1/L1-experienced (cohort 4), with an acceptable safety profile. Clinical trial information: NCT03005782.
    Clinical • P1 data • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    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, Not yet recruiting, Regeneron Pharmaceuticals
    New P2 trial • Combination therapy • Surgery
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    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, Regeneron Pharmaceuticals | Phase classification: P1b --> P1
    Phase classification • Combination therapy
    |
    lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • Lynozyfic (linvoseltamab)
    over1year
    89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=20 --> 7
    Enrollment closed • Enrollment change • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3)
    |
    LAG3 expression
    |
    fianlimab (REGN3767)
    over1year
    89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P1, N=20, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3)
    |
    LAG3 expression
    |
    fianlimab (REGN3767)