^
2ms
Enrollment closed • Enrollment change • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
|
PD-L1 expression • MSI-H/dMMR • FGFR mutation • FGFR1 mutation
|
Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
3ms
PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
P1, N=0, Withdrawn, University of Alabama at Birmingham | N=18 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
5ms
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
P2, N=176, Active, not recruiting, Incyte Biosciences International Sàrl | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: May 2024 --> Feb 2025
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
9ms
PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
P1, N=18, Not yet recruiting, University of Alabama at Birmingham
New P1 trial • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
9ms
Optimus: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (clinicaltrials.gov)
P2, N=30, Terminated, Incyte Corporation | Trial completion date: Jun 2024 --> Jan 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Jan 2024; Business Decision. No safety concerns contributed to this decision.
Trial completion date • Trial termination • Trial primary completion date • Combination therapy
|
Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
12ms
Enrollment closed • Enrollment change
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
1year
Enrollment closed • Enrollment change • Combination therapy
|
Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
1year
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
|
PD-L1 expression • MSI-H/dMMR • FGFR mutation • FGFR1 mutation
|
Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
1year
Trial primary completion date • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
over1year
Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • LAG3 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
2years
Enrollment open • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
2years
A PHASE 2 UMBRELLA STUDY OF RETIFANLIMAB (INCMGA00012) ALONE OR IN COMBINATION WITH OTHER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC ENDOMETRIAL CANCER (POD1UM-204) (IGCS 2022)
Approximately 220 patients enroll into 4 treatment Groups: A—CPI-naive MSI-H EC receiving retifanlimab monotherapy (up to 100 patients); B—CPI-naive dMMR or POLE-positive EC receiving retifanlimab monotherapy (up to 40 patients); D—EC with activating fibroblast growth factor receptor (FGFR1, 2 or 3) mutations or alterations outside of the kinase domain and regardless of prior CPI treatment receiving retifanlimab plus pemigatinib (up to 40 patients); F—CPI-experienced MSI-H EC receiving retifanlimab, INCAGN02385 (LAG-3 inhibitor), and INCAGN02390 (TIM-3 inhibitor) (up to 40 patients). Trial in progress: there are no available conclusions at the time of submission.
Clinical • P2 data • Combination therapy • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
|
MSI (Microsatellite instability) • FGFR1 (Fibroblast growth factor receptor 1) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
|
MSI-H/dMMR • FGFR1 mutation
|
Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
2years
Trial completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
|
PD-L1 expression • MSI-H/dMMR • FGFR mutation • FGFR1 mutation
|
Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
2years
Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
over2years
Phase II trial of retifanlimab (anti–PD-1) in combination with INCAGN02385 (anti–LAG-3) and INCAGN02390 (anti-TIM-3) as first-line treatment in patients with PD-L1-positive recurrent/metastatic squamous cell carcinoma of the head and neck (ESMO 2022)
The primary endpoint is progression-free survival (defined per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1). Secondary endpoints are objective response per RECIST v1.1, duration of response, disease control, overall survival and safety.
Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • LAG3 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
over2years
First-in-human phase I study of INCAGN02385, a LAG-3 monoclonal antibody antagonist in patients with advanced malignancies (ESMO 2022)
Conclusions INCAGN02385 monotherapy was generally well tolerated and exhibited linear PK. The 350 mg Q2W dose is selected for further investigation in phase 1b/2 studies in combinations with other immunotherapies (NCT04370704, NCT05287113).
Clinical • P1 data • IO biomarker
|
LAG3 (Lymphocyte Activating 3) • CD4 (CD4 Molecule)
|
tuparstobart (INCAGN2385)
over2years
Trial completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
over2years
Enrollment change • Combination therapy
|
BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
|
BRAF mutation • LAG3 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
over2years
New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
over2years
Enrollment change • Trial completion date • Combination therapy
|
BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
|
BRAF mutation • LAG3 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
4years
Enrollment open • Combination therapy
|
BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
|
BRAF mutation • LAG3 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
over4years
New P1/2 trial • Combination therapy
|
BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
|
BRAF mutation • LAG3 expression
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)