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DRUG:

Imjudo (tremelimumab)

i
Other names: CP-675206, CP-675,206, CP-675, PF-06753388
Company:
AstraZeneca, Pfizer
Drug class:
CTLA4 inhibitor
2d
ESR-22-21719: Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
P2, N=0, Withdrawn, Georgetown University | N=28 --> 0 | Recruiting --> Withdrawn
Enrollment change • Trial withdrawal
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
2d
Durvalumab Plus Tremelimumab for the Treatment of Patients with Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial (clinicaltrials.gov)
P2, N=79, Terminated, Grupo Espanol de Tumores Neuroendocrinos | Trial completion date: Dec 2025 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Nov 2024; In compliance with current legislation applicable to Clinical Trials, following the instructions of the Spanish Agency for Medicines and Health Products.
Trial completion date • Trial termination • Trial primary completion date • Metastases
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
7d
Esophagomediastinal fistula during durvalumab plus tremelimumab with chemotherapy in angiotensin-converting enzyme 2-positive non-small cell lung cancer: a case report. (PubMed, Transl Lung Cancer Res)
The treatment regimen comprised durvalumab, tremelimumab, carboplatin, and nab-paclitaxel. Clinicians should be aware that COVID-19 might be associated with the development of severe irAEs and unexpectedly enhanced antitumor effects. The findings also suggest new fields of study regarding the interaction between viral infection and tumor immune response, which may inform future therapeutic approaches.
Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation
|
carboplatin • Imfinzi (durvalumab) • albumin-bound paclitaxel • Imjudo (tremelimumab)
8d
Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment (clinicaltrials.gov)
P1, N=18, Terminated, The Netherlands Cancer Institute | N=34 --> 18 | Trial completion date: Jan 2021 --> Nov 2024 | Unknown status --> Terminated | Trial primary completion date: Jan 2021 --> Nov 2024; Based on initially defined safety rules not continued with expansion phase of study (too much toxicity with neo-adjuvant immunotherapy)
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
|
cisplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
10d
CALYPSO: MEDI4736 Combinations in Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
P2, N=69, Completed, Queen Mary University of London | Active, not recruiting --> Completed | N=181 --> 69 | Trial completion date: Mar 2023 --> Jul 2024 | Trial primary completion date: Mar 2023 --> Jul 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab) • Orpathys (savolitinib)
10d
NEXIS: Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma (clinicaltrials.gov)
P1/2, N=22, Terminated, University of Maryland, Baltimore | Trial completion date: Jun 2037 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2032 --> Jun 2024; Limited Accrual
Trial completion date • Trial termination • Trial primary completion date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
15d
WNT/β-catenin Signaling and CD8+ Tumor-infiltrating Lymphocytes in Tremelimumab Plus Durvalumab for Advanced Hepatocellular Carcinoma. (PubMed, In Vivo)
Although the present study involved a small number of patients, the findings suggest that the efficacy of tremelimumab plus durvalumab may be affected by WNT/β-catenin signaling and CD8+ TIL infiltration.
Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CD8 (cluster of differentiation 8)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
21d
A comprehensive review of immune checkpoint inhibitors for cancer treatment. (PubMed, Int Immunopharmacol)
Immune checkpoint inhibitors (ICIs) have shown great success, with FDA-approved drugs like PD-1 inhibitors (Nivolumab, Pembrolizumab, Cemiplimab), PD-L1 inhibitors (Atezolizumab, Durvalumab, Avelumab), and CTLA-4 inhibitors (Ipilimumab, Tremelimumab), alongside LAG-3 inhibitor Relatlimab. This review aims to fill this gap by providing an analysis of the current clinical status of ICIs, emerging biomarkers, mechanisms of resistance, strategies to enhance therapeutic efficacy, and assessment of adverse effects. This review is crucial to furthering our understanding of ICIs and optimizing their application in cancer therapy.
Review • Journal • Checkpoint inhibition • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CD276 (CD276 Molecule) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • BTLA (B And T Lymphocyte Associated)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Imjudo (tremelimumab) • Libtayo (cemiplimab-rwlc) • relatlimab (BMS-986016)
24d
Tremelimumab and durvalumab with chemotherapy in first-line treatment for metastatic non-small cell lung cancer: a US-based cost-effectiveness analysis. (PubMed, Transl Lung Cancer Res)
Scenario analysis confirmed the study's primary findings, with the exception of a scenario where durvalumab was offered at no cost. The findings suggests that T + D + CT may not be a cost-effectiveness first-line treatment for EGFR/ALK wild-type mNSCLC in the US, given its high ICERs and limited cost-effectiveness in the majority of PD-L1 expression subgroups.
Journal • HEOR • PD(L)-1 Biomarker • IO biomarker • Cost-effectiveness • Cost effectiveness • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR wild-type • ALK wild-type
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
29d
Trial completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
KRAS mutation • EGFR mutation • STK11 mutation • ALK fusion • KEAP1 mutation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
29d
Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=25, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Sep 2024 --> Jan 2025
Trial completion date
|
Lynparza (olaparib) • Imfinzi (durvalumab) • Imjudo (tremelimumab)
29d
Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer (clinicaltrials.gov)
P1/2, N=79, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
Trial completion date • Trial primary completion date • Surgery
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
carboplatin • Imfinzi (durvalumab) • paclitaxel • Imjudo (tremelimumab)
30d
Trial completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
KRAS mutation • EGFR mutation • STK11 mutation • ALK fusion • KEAP1 mutation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
1m
Trial completion date • Tumor mutational burden
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
BRCA2 mutation • BRCA1 mutation
|
Lynparza (olaparib) • Imjudo (tremelimumab)
1m
Durvalumab (D) ± Tremelimumab (T) + Chemotherapy (CT) in the First-Line Treatment of Metastatic (m) NSCLC: 5-Year Survival Data (OS) Update of the POSEIDON Study (DGHO 2024)
Updated analyses from POSEIDON after median FU of >5 y showed durable long-term OS benefit with the approved regimen of T+D+CT (vs CT alone). These results support its use as a 1L treatment option for pts with mNSCLC, including harder-to-treat subgroups such as those with PD-L1 TC <1%.
Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
PD-L1 expression • KRAS mutation • EGFR wild-type • STK11 mutation • ALK wild-type • KEAP1 mutation
|
VENTANA PD-L1 (SP263) Assay
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
1m
CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors. (PubMed, Nature)
Here we show that patients with NSCLC who have mutations in the STK11 and/or KEAP1 tumour suppressor genes derived clinical benefit from dual ICB with the PD-L1 inhibitor durvalumab and the CTLA4 inhibitor tremelimumab, but not from durvalumab alone, when added to chemotherapy in the randomized phase III POSEIDON trial3. Dual ICB potently engaged CD4+ effector cells and reprogrammed the tumour myeloid cell compartment towards inducible nitric oxide synthase (iNOS)-expressing tumoricidal phenotypes that-together with CD4+ and CD8+ T cells-contributed to anti-tumour efficacy. These data support the use of chemo-immunotherapy with dual ICB to mitigate resistance to PD-(L)1 inhibition in patients with NSCLC who have STK11 and/or KEAP1 alterations.
Journal • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
STK11 mutation
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
1m
Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial (clinicaltrials.gov)
P2, N=79, Active, not recruiting, Grupo Espanol de Tumores Neuroendocrinos | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2ms
High Tumor Mutational Burden in Hepatocellular Carcinoma. (PubMed, Cureus)
The patient was treated with tremelimumab and durvalumab but passed away shortly afterward due to decompensation from her disease. In this instance, the high TMB would point toward a worse prognosis, but further study of high-TMB cases is necessary to support a correlation. Given the prevalence of HCC worldwide, any potential avenues that could help guide clinical decision-making should be explored.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden)
|
TMB-H
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2ms
Alpha-fetoprotein and des-gamma-carboxy prothrombin can predict the objective response of patients with hepatocellular carcinoma receiving durvalumab plus tremelimumab therapy. (PubMed, PLoS One)
The PFS of patients with AFP or DCP response was significantly longer than that of patients without AFP or DCP response. The study demonstrated that the use of AFP and DCP can predict the OR of patients with HCC receiving Durva/Treme therapy.
Clinical • Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
|
AFP (Alpha-fetoprotein)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2ms
Trial primary completion date • Combination therapy • Metastases
|
cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
2ms
BC3402 w/ Tremelimumab + Durvalumab (STRIDE) in Hepatocellular Carcinoma (clinicaltrials.gov)
P1/2, N=43, Not yet recruiting, Case Comprehensive Cancer Center
New P1/2 trial • Combination therapy • Metastases
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2ms
Cost-effectiveness analysis of durvalumab plus tremelimumab as first-line therapy in patients with unresectable hepatocellular carcinoma. (PubMed, Ther Adv Med Oncol)
The results of durvalumab plus tremelimumab were better in terms of costs and health outcomes in patients with HBV-related HCC and high alpha-fetoprotein levels. First-line durvalumab plus tremelimumab was estimated to be dominant for the treatment of unresectable HCC compared with sorafenib from a US payer's perspective.
Journal • HEOR • Cost-effectiveness • Cost effectiveness
|
AFP (Alpha-fetoprotein)
|
Imfinzi (durvalumab) • sorafenib • Imjudo (tremelimumab)
2ms
Trial completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
KRAS mutation • EGFR mutation • STK11 mutation • ALK fusion • KEAP1 mutation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
2ms
Trial completion • Metastases
|
Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
2ms
CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab (clinicaltrials.gov)
P2, N=21, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | N=30 --> 21 | Trial completion date: Dec 2024 --> Aug 2024
Trial completion • Enrollment change • Trial completion date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2ms
NCI-2018-01240: Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
P2, N=120, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Sep 2025
Enrollment closed • Trial completion date • Trial primary completion date
|
PPP2R1A (Protein Phosphatase 2 Scaffold Subunit Aalpha)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2ms
Durvalumab With or Without Tremelimumab in Combination With Chemotherapy in First-Line Metastatic NSCLC: Five-Year Overall Survival Outcomes from the Phase 3 POSEIDON Trial. (PubMed, J Thorac Oncol)
After median follow-up of >5 years, T+D+CT showed durable long-term OS benefit versus CT, supporting its use as first-line treatment in mNSCLC, including in patient subgroups with harder-to-treat disease.
P3 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
PD-L1 expression • KRAS mutation • EGFR wild-type • STK11 mutation • ALK wild-type • KEAP1 mutation
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2ms
Trial completion • Metastases
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
FoundationOne® CDx • TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
|
Imjudo (tremelimumab)
2ms
New P2 trial
|
Loqtorzi (toripalimab-tpzi) • Imjudo (tremelimumab)
3ms
HIMALAYA: Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
P3, N=1324, Active, not recruiting, AstraZeneca | Trial completion date: Aug 2024 --> Aug 2026
Trial completion date
|
Imfinzi (durvalumab) • sorafenib • Imjudo (tremelimumab)
3ms
Trial completion date
|
Imjudo (tremelimumab)
3ms
Early Changes in Alpha-Fetoprotein and Des-γ-Carboxy Prothrombin Are Useful Predictors of Antitumor Response to Durvalumab Plus Tremelimumab Therapy for Advanced Hepatocellular Carcinoma. (PubMed, Curr Oncol)
Early changes in tumor markers after Dur/Tre initiation were associated with antitumor response. In particular, changes in AFP and DCP at 4 weeks may offer useful biomarkers for early prediction of both response and progressive disease following Dur/Tre.
Retrospective data • Journal • PD(L)-1 Biomarker • Metastases
|
AFP (Alpha-fetoprotein)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
3ms
Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma (clinicaltrials.gov)
P1/2, N=52, Recruiting, Baylor College of Medicine | Not yet recruiting --> Recruiting
Enrollment open
|
cisplatin • carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
3ms
Kinetic Profiling of RAS Mutations With Circulating Tumor DNA in the Canadian Cancer Trials Group CO.26 Trial Suggests the Loss of RAS Mutations in Neo-RAS-Wildtype Metastatic Colorectal Cancer Is Transient. (PubMed, JCO Precis Oncol)
We identified a 3.2%-6.3% prevalence of the neo-RAS-WT phenomenon in the CO.26 trial. However, 67% of apparent cases were transient with subsequent re-emergence.
Journal • PD(L)-1 Biomarker • Circulating tumor DNA • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
3ms
New P1 trial
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab) • Hiltonol (poly-ICLC)
3ms
Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
AFP (Alpha-fetoprotein)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
3ms
Durvalumab With or Without Tremelimumab in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=52, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Jun 2024 --> Dec 2024
Trial completion date • Metastases
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
3ms
ADRIATIC: Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy (clinicaltrials.gov)
P3, N=730, Active, not recruiting, AstraZeneca | Trial completion date: Sep 2024 --> Mar 2026 | Trial primary completion date: Sep 2024 --> Mar 2026
Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
3ms
Imjudo & Imfinzi PMS (clinicaltrials.gov)
P=N/A, N=246, Not yet recruiting, AstraZeneca
New trial
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
4ms
New P2 trial • Metastases
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
4ms
Adverse Events of PD-1, PD-L1, CTLA-4, and LAG-3 Immune Checkpoint Inhibitors: An Analysis of the FDA Adverse Events Database. (PubMed, Antibodies (Basel))
For PD-1 inhibitors, the most common AEs were diarrhea, fatigue, and pyrexia, with notable instances of neutropenia and hypothyroidism, particularly with toripalimab and dostarlimab...CTLA-4 inhibitors predominantly resulted in diarrhea and colitis, with ipilimumab frequently causing pyrexia and rash, while tremelimumab exhibited unique AEs such as biliary tract infection. The LAG-3 inhibitor relatlimab reported fewer AEs, including pyrexia and pneumonia...This study provides a detailed overview of the 25 most common AEs associated with ICIs, offering valuable insights for clinical decision-making and AE management. Further research is necessary to elucidate the mechanisms underlying these AEs and to develop targeted interventions to enhance the safety and efficacy of ICI therapy in patients with cancer.
Journal • Adverse events • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Yervoy (ipilimumab) • Loqtorzi (toripalimab-tpzi) • Imjudo (tremelimumab) • Jemperli (dostarlimab-gxly) • relatlimab (BMS-986016)
4ms
Enrollment change • Trial withdrawal • Combination therapy • IO biomarker • Metastases
|
BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab) • Kimmtrak (tebentafusp-tebn)