^
13d
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)
20d
New P2 trial • Combination therapy
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
3ms
Trial primary completion date • Surgery
|
Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
3ms
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)
3ms
New P3 trial • Metastases
|
Libtayo (cemiplimab-rwlc) • Opdualag (nivolumab/relatlimab) • fianlimab (REGN3767) • relatlimab (BMS-986016)
4ms
New P2 trial • Metastases
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
4ms
New P2 trial
|
Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
4ms
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)
5ms
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
5ms
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)
5ms
New P2 trial • Combination therapy • Surgery
|
cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
5ms
Phase classification • Combination therapy
|
lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab/hyaluronidase) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • linvoseltamab (REGN5458)
6ms
P1 data • Combination therapy • Metastases
|
LAG3 (Lymphocyte Activating 3)
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
6ms
Journal
|
LAG3 (Lymphocyte Activating 3)
|
fianlimab (REGN3767) • relatlimab (BMS-986016)
7ms
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)
7ms
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)
8ms
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)
11ms
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)
11ms
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)
12ms
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)
12ms
Trial completion date • Trial primary completion date • Combination therapy
|
lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab/hyaluronidase) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • linvoseltamab (REGN5458)
1year
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)
1year
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)
1year
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)
1year
New P2/3 trial • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
1year
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)
1year
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)
over1year
Phase 1 Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced NSCLC (LALCA 2023)
Fianlimab + cemiplimab demonstrated promising signs of clinical activity with durable responses among patients with anti–PD-1/L1-naive NSCLC and in patients with PD-L1 expression ≥50%, with a similar safety profile and no new safety signals compared to cemiplimab monotherapy.
P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
LAG3 (Lymphocyte Activating 3)
|
PD-L1 expression
|
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 NSCLC (ESMO-IO 2022)
LAG-3 and PD-L1 correlative biomarker analysis will be included in the presentation. Conclusions Fianlimab + cemiplimab demonstrated promising signs of clinical activity with durable responses among pts with anti–PD-1/L1-naive NSCLC and in pts with PD-L1 expression ≥50%, with a similar safety profile and with no new safety signals compared to cemiplimab monotherapy.
P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
LAG3 (Lymphocyte Activating 3)
|
PD-L1 expression
|
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 (mel): subgroup analysis (ESMO-IO 2022)
In pts with LDH>ULN at BL and any M1c, the ORR for EC6+15 was 53.8%, the DCR was 69.2%, and the mDOR was NR (95% CI, 5.7–NE). Conclusions Despite small numbers in subgroups, the efficacy analysis from EC6 and EC15 combined demonstrates high activity of fianlimab in combination with cemiplimab in pts with advanced mel and poor prognosis features at BL.
P1 data • Combination therapy
|
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, plus cemiplimab in advanced melanoma (COSA 2022)
Fianlimab plus cemiplimab in advanced melanoma had a similar safety profile to anti–PD-1 monotherapies. Clinical activity in anti–PD-(L)1–naive patients appeared higher than previously reported for anti–PD-1 monotherapy or anti–LAG-3 plus anti–PD-1. A Phase 3 trial (NCT05352672) investigating fianlimab plus cemiplimab in advanced melanoma is ongoing.
P1 data
|
LAG3 (Lymphocyte Activating 3)
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
over1year
Evaluation of anti-PD-1 Cemiplimab plus anti-LAG-3 REGN3767 in early-stage, high-risk HER2-negative breast cancer: Results from the neoadjuvant I-SPY 2 TRIAL (SABCS 2022)
Treatment included Paclitaxel 80 mg/m2 IV weekly x 12 and Cemiplimab 350 mg and REGN3767 1600 mg both given q3weeks x 4, followed by doxorubicin/cyclophosphamide (AC) every 2 weeks x 4. The I-SPY 2 study aims to assess the probability that investigational regimens will be successful in a phase 3 neoadjuvant trial. Dual immune blockade with a LAG-3 inhibitor and anti-PD1 therapy resulted in a high predicted pCR rate both in HR-/HER2- (60%) and HR+/HER2- (37%) disease. The novel Imprint signature identified a group of HR+ patients most likely to benefit from this active regimen.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • LAG3 (Lymphocyte Activating 3)
|
HR positive • HER-2 negative
|
MammaPrint
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
over1year
Phase I study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma (mel) (ESMO Asia 2022)
Conclusions Fianlimab + cemiplimab in advanced mel pts had a similar safety profile to anti–PD-1 agents; clinical activity in anti-PD-(L)1-naïve pts appears higher than previously reported for anti-PD-1 monotherapy or anti–LAG-3 + anti–PD-1. A phase 3 trial (NCT05352672) investigating fianlimab + cemiplimab in advanced mel pts is ongoing.
P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
LAG3 (Lymphocyte Activating 3)
|
Libtayo (cemiplimab-rwlc) • 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 2022 --> Sep 2024 | Trial primary completion date: Sep 2022 --> Sep 2024
Trial completion date • Trial primary completion date • IO biomarker
|
LAG3 (Lymphocyte Activating 3)
|
LAG3 expression
|
fianlimab (REGN3767)
over1year
P1 data
|
LAG3 (Lymphocyte Activating 3)
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
almost2years
Phase I study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma (mel) (ESMO 2022)
Conclusions Fianlimab + cemiplimab in advanced mel pts had a similar safety profile to anti–PD-1 agents; clinical activity in anti-PD-(L)1-naïve patients appears higher than previously reported for anti-PD-1 monotherapy or anti–LAG-3 + anti–PD-1. A phase 3 trial (NCT05352672) investigating fianlimab + cemiplimab in advanced mel pts is ongoing.
P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
LAG3 (Lymphocyte Activating 3)
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
over2years
LAG3 PET Imaging in Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=38, Recruiting, University Medical Center Groningen | Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Sep 2024 | Trial primary completion date: Jan 2024 --> Sep 2024
Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
|
LAG3 (Lymphocyte Activating 3)
|
LAG3 expression
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
over2years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P2; Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
Trial completion date • Trial primary completion date • Clinical
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
TargetPrint®
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • amcenestrant (SAR439859) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
3years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P2, N=4000, Recruiting, QuantumLeap Healthcare Collaborative | Phase classification: P1 --> P2
Phase classification
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
MammaPrint • TargetPrint®
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • amcenestrant (SAR439859) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
over3years
LAG3 PET Imaging in Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=38, Not yet recruiting, University Medical Center Groningen
Clinical • New P1/2 trial • PD(L)-1 Biomarker • IO biomarker
|
LAG3 (Lymphocyte Activating 3)
|
LAG3 expression
|
Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
over3years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P1, N=4000, Recruiting, QuantumLeap Healthcare Collaborative | Phase classification: P2 --> P1
Clinical • Phase classification • PARP Biomarker • PD(L)-1 Biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
over3years
Clinical • New P1 trial • IO biomarker
|
LAG3 (Lymphocyte Activating 3)
|
LAG3 expression
|
fianlimab (REGN3767)