^
    23d
    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)
    24d
    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)
    1m
    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)
    1m
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    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)
    5ms
    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)
    5ms
    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)
    6ms
    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)
    6ms
    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) • linvoseltamab (REGN5458)
    6ms
    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)
    6ms
    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)
    7ms
    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)
    7ms
    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)
    7ms
    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)
    9ms
    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)
    9ms
    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)
    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, Not yet recruiting, Regeneron Pharmaceuticals
    New P3 trial • Metastases
    |
    Libtayo (cemiplimab-rwlc) • Opdualag (nivolumab/relatlimab-rmbw) • fianlimab (REGN3767) • relatlimab (BMS-986016)
    10ms
    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)
    11ms
    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)
    11ms
    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)
    11ms
    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
    11ms
    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)
    12ms
    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)
    12ms
    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) • linvoseltamab (REGN5458)
    12ms
    Phase 1 Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced NSCLC (IASLC-NACLC 2023)
    No abstract available
    P1 data • Combination therapy • Metastases
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1year
    What role can LAG-3-blocking antibodies play in melanoma therapy? (PubMed, Expert Opin Biol Ther)
    No abstract available
    Journal
    |
    LAG3 (Lymphocyte Activating 3)
    |
    fianlimab (REGN3767) • relatlimab (BMS-986016)
    1year
    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)
    1year
    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)
    1year
    A Phase 1 study of fianlimab (anti-LAG-3) in combination with cemiplimab (anti-PD-1) in patients with advanced melanoma: poor prognosis subgroup analysis (COSA 2023)
    Fianlimab plus cemiplimab showed high activity in patients with advanced melanoma and poor prognosis features at baseline; ORR and DCR observed compare positively with available data for approved ICI combinations in the same clinical setting. A Phase 3 trial (NCT05352672) of fianlimab plus cemiplimab in treatment-naïve advanced melanoma patients is ongoing.
    Clinical • P1 data • Combination therapy • Metastases
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=950, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: May 2031 --> Oct 2031 | Trial primary completion date: May 2031 --> Nov 2029
    Enrollment open • Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=850, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Nov 2028 --> Jan 2032 | Trial primary completion date: Nov 2028 --> Feb 2030
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    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: Sep 2029 --> Feb 2031 | Trial primary completion date: Jul 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    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)
    P1b, N=317, Recruiting, Regeneron Pharmaceuticals | Trial completion date: May 2032 --> Aug 2032 | Trial primary completion date: Oct 2026 --> Jan 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • linvoseltamab (REGN5458)
    over1year
    Phase 1 study of fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab in advanced melanoma: Expansion cohort analysis (EADO 2023)
    Fianlimab + cemiplimab demonstrated clinically meaningful efficacy among patients with anti–PD-1/ PD-L1-naive advanced melanoma across sequential ECs with a similar safety profile to cemiplimab monotherapy.
    P1 data • Combination therapy • Metastases
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    Phase 1 study of fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab in advanced melanoma: Subgroup analysis (EADO 2023)
    Despite small numbers in subgroups, the efficacy analysis from EC6+15 combined demonstrated high activity of fianlimab in combination with cemiplimab in patients with advanced melanoma and poor prognostic features at baseline.
    P1 data • Combination therapy • Metastases
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=950, Not yet recruiting, Regeneron Pharmaceuticals
    New P2/3 trial • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=850, Not yet recruiting, Regeneron Pharmaceuticals
    New P2/3 trial • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    LAG-3 PET imaging in patients with cancer before immune checkpoint inhibitor therapy (AACR 2023)
    After that, they received treatment with cemiplimab alone or combined with platinum-containing chemotherapy. Optimal imaging results were achieved with the 40 mg protein dose and imaging on day 7. 89Zr-DFO-REGN3767 shows specific accumulation in LAG-3 rich tissues and tumor lesions.
    Clinical • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    over1year
    Phase 1 study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma: Expansion cohort analysis (AAD 2023)
    Fianlimab + cemiplimab demonstrated high clinical activity among patients with anti–PD-1/PD-L1-naive advanced melanoma across sequential ECs with a similar safety profile to cemiplimab monotherapy.
    P1 data • Combination therapy • Metastases
    |
    LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)