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DRUG:

Zynyz (retifanlimab-dlwr)

i
Other names: INCMGA0012, MGA 012, MGA012, INCMGA 0012 , INCMGA00012, ZL-1306, ZL 1306, ZL1306, MGA-012
Company:
Incyte, MacroGenics
Drug class:
PD1 inhibitor
Related drugs:
1m
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201) (clinicaltrials.gov)
P2, N=107, Completed, Incyte Corporation | Active, not recruiting --> Completed
Trial completion • Metastases
|
Zynyz (retifanlimab-dlwr)
2ms
Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov)
P2, N=134, Not yet recruiting, Academic and Community Cancer Research United | Initiation date: Apr 2024 --> Sep 2024
Trial initiation date • Combination therapy
|
Avastin (bevacizumab) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Zynyz (retifanlimab-dlwr)
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)
2ms
Enrollment open • Metastases
|
Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr)
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P1, N=0, Withdrawn, University of Alabama at Birmingham | N=18 --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 Withdrawn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)
4ms
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)
5ms
Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC (clinicaltrials.gov)
P1, N=56, Recruiting, Providence Health & Services | Active, not recruiting --> Recruiting | Trial completion date: Jul 2024 --> Dec 2027 | Trial primary completion date: Dec 2023 --> Dec 2025
Enrollment open • Trial completion date • Trial primary completion date • Checkpoint inhibition • Metastases
|
CD4 (CD4 Molecule)
|
Zynyz (retifanlimab-dlwr) • DPV-001 • ragifilimab (INCAGN1876)
5ms
POD1UM-101: A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=325, Completed, Incyte Corporation | Active, not recruiting --> Completed
Trial completion • Pan tumor • Metastases
|
MSI (Microsatellite instability)
|
Zynyz (retifanlimab-dlwr)
6ms
P1 data • Journal • Mismatch repair • Microsatellite instability
|
MSI (Microsatellite instability)
|
Zynyz (retifanlimab-dlwr)
6ms
Enrollment open • Combination therapy • Metastases
|
paclitaxel • Zynyz (retifanlimab-dlwr) • Niktimvo (axatilimab-csfr)
6ms
Palbociclib and INCMGA00012 in People With Advanced Liposarcoma (clinicaltrials.gov)
P2, N=42, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
Ibrance (palbociclib) • Zynyz (retifanlimab-dlwr)
6ms
Combination therapy • Trial completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
PD-L1 expression • HER-2 positive
|
PD-L1 IHC 22C3 pharmDx
|
Herceptin (trastuzumab) • 5-fluorouracil • capecitabine • oxaliplatin • Margenza (margetuximab-cmkb) • Zynyz (retifanlimab-dlwr) • tebotelimab (MGD013)
6ms
POD1UM-304: Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer (clinicaltrials.gov)
P3, N=583, Active, not recruiting, Incyte Corporation | Trial primary completion date: Jun 2024 --> Dec 2023
Trial primary completion date • Metastases
|
cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Zynyz (retifanlimab-dlwr)
7ms
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
P1/2, N=67, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed • Checkpoint inhibition • Checkpoint block • Metastases
|
gemcitabine • docetaxel • Zynyz (retifanlimab-dlwr)
7ms
Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas (clinicaltrials.gov)
P2, N=51, Active, not recruiting, Washington University School of Medicine | Trial primary completion date: Apr 2024 --> Jul 2024
Trial primary completion date • Combination therapy
|
Avastin (bevacizumab) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360)
7ms
New P2 trial • Metastases
|
Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr)
7ms
Merkel Cell Carcinoma: Integrating Epidemiology, Immunology, and Therapeutic Updates. (PubMed, Am J Clin Dermatol)
Starting in 2017, four programmed cell death protein 1 (PD-1)/programmed cell death-ligand 1 (PD-L1) immune checkpoint inhibitors-avelumab, pembrolizumab, nivolumab (utilized in both neoadjuvant and adjuvant settings), and retifanlimab-have demonstrated efficacy in treating patients with disseminated MCC on the basis of prospective clinical trials. Nevertheless, while randomized studies directly comparing immune checkpoint inhibitors and chemotherapy in MCC are lacking, immunotherapy shows response rates comparable to those previously reported with chemotherapy but with more enduring responses. Notably, adjuvant nivolumab has proven superiority to the standard-of-care therapy (observation) in the adjuvant setting.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Bavencio (avelumab) • Zynyz (retifanlimab-dlwr)
7ms
The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies. (clinicaltrials.gov)
P2, N=10, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; A business decision due to availability of commercial drug and other options for accessing study drug treatment.
Trial termination • Metastases
|
Keytruda (pembrolizumab) • Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr)
8ms
NCI-2020-02940: INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (clinicaltrials.gov)
P2, N=25, Recruiting, Mridula George, MD | Trial primary completion date: Jan 2024 --> Jun 2024
Trial primary completion date • Oncolytic virus • IO biomarker • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
PD-L1 expression • HER-2 expression • ER expression
|
Irene (pyrotinib) • Zynyz (retifanlimab-dlwr) • Reolysin (pelareorep)
8ms
Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study. (PubMed, Lancet Oncol)
Despite a higher incidence of adverse events, combining atezolizumab with mDCF is feasible, with similar dose intensity in both groups, although the primary efficacy endpoint was not met. The predictive value of a PD-L1 combined positive score of 5 or greater now needs to be confirmed in future studies.
P2 data • Journal • Metastases
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • docetaxel • 5-fluorouracil • Bavencio (avelumab) • Zynyz (retifanlimab-dlwr)
8ms
New P1/2 trial • Combination therapy • Metastases
|
paclitaxel • Zynyz (retifanlimab-dlwr) • Niktimvo (axatilimab-csfr)
8ms
Enrollment open • Metastases
|
Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov)
P1, N=54, Completed, Incyte Corporation | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
CD8 (cluster of differentiation 8)
|
Zynyz (retifanlimab-dlwr) • INCB106385
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
BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Initiation date: Oct 2023 --> Feb 2024
Trial initiation date • Metastases
|
ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
9ms
A phase II study of retifanlimab, a humanized anti-PD-1 monoclonal antibody, in patients with solid tumors (POD1UM-203). (PubMed, ESMO Open)
Retifanlimab demonstrated durable antitumor activity in patients with melanoma, NSCLC, UC, or RCC. The efficacy and safety of retifanlimab were as expected for a PD-(L)1 inhibitor. These data support further study of retifanlimab in solid tumors.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Zynyz (retifanlimab-dlwr)
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)
10ms
The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies. (clinicaltrials.gov)
P2, N=10, Active, not recruiting, Incyte Corporation | Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
Trial completion date • Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr)
11ms
Enrollment open • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
Erbitux (cetuximab) • Zynyz (retifanlimab-dlwr)
11ms
Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
|
temozolomide • carmustine • Zynyz (retifanlimab-dlwr)
11ms
Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=57, Active, not recruiting, Incyte Corporation | Trial completion date: Jan 2024 --> Jun 2025 | Trial primary completion date: Jan 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
CD8 (cluster of differentiation 8)
|
Zynyz (retifanlimab-dlwr) • INCA00186 • INCB106385
11ms
MAHOGANY: Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (clinicaltrials.gov)
P2/3; Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
Combination therapy • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
PD-L1 expression • HER-2 positive
|
PD-L1 IHC 22C3 pharmDx
|
Herceptin (trastuzumab) • 5-fluorouracil • capecitabine • oxaliplatin • Margenza (margetuximab-cmkb) • Zynyz (retifanlimab-dlwr) • tebotelimab (MGD013)
11ms
New P1 trial • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
Erbitux (cetuximab) • Zynyz (retifanlimab-dlwr)
11ms
A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
P1, N=84, Active, not recruiting, Incyte Corporation | Phase classification: P1a/1b --> P1 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
Phase classification • Trial completion date • Trial primary completion date • Metastases
|
FLT3 (Fms-related tyrosine kinase 3) • MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
|
MSI-H/dMMR • FLT3-ITD mutation • FLT3 wild-type • IDH wild-type
|
Zynyz (retifanlimab-dlwr) • INCB81776
12ms
New P2 trial • Combination therapy
|
Avastin (bevacizumab) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Zynyz (retifanlimab-dlwr)
12ms
A phase 1 trial of combined MEK, STAT3 and PD-1 inhibition in metastatic pancreatic ductal adenocarcinoma (PDAC). (ASCO-GI 2024)
NCT05440942 is an open-label, prospective, single-institution phase 1 trial testing the safety, preliminary efficacy, and biomarkers of response to the combination of trametinib (MEKi), ruxolitinib (JAK2/STAT3 inhibitor) and retifanlimab (PD-1 inhibitor) in patients with metastatic PDAC. These results will be correlated with clinical response to therapy to determine biomarkers of response and resistance. Clinical trial information: NCT05440942.
P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
|
JAK2 (Janus kinase 2) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • STAT3 (Signal Transducer And Activator Of Transcription 3) • CD34 (CD34 molecule) • CXCL1 (Chemokine (C-X-C motif) ligand 1)
|
Mekinist (trametinib) • Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)
12ms
New P1/2 trial • Metastases
|
Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
12ms
Enrollment closed • Enrollment change
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
almost1year
NCI-2020-02940: INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (clinicaltrials.gov)
P2, N=25, Recruiting, Mridula George, MD | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Jan 2024
Trial completion date • Trial primary completion date • Oncolytic virus • IO biomarker • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
PD-L1 expression • HER-2 expression • ER expression
|
Irene (pyrotinib) • Zynyz (retifanlimab-dlwr) • Reolysin (pelareorep)
1year
Enrollment closed • Enrollment change • Combination therapy
|
Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
1year
Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1, N=35, Recruiting, Peter Hosein, MD | Active, not recruiting --> Recruiting
Enrollment open • Metastases
|
TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability)
|
BRCA2 mutation • BRCA1 mutation • MSI-H/dMMR
|
Mekinist (trametinib) • Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)
1year
Enrollment open
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase) • CD8 (cluster of differentiation 8)
|
IDH2 mutation • MGMT promoter methylation • IDH wild-type
|
Zynyz (retifanlimab-dlwr) • neoantigen DNA vaccine