Imfinzi Hcc

Imfinzi Hcc

The patients cannot be eligible for locoregional therapy. Imfinzi with tremelimumab a PD-L1 inhibitor CTLA-4 inhibitor combination is being investigated for the first-line treatment of advanced HCC in the Phase III HIMALAYA trial.

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HCC may be responsive to immunotherapy due to higher expression of immunosuppressive cells and upregulation of CTLA-4 and PD-1 immune checkpoints Gao et al 2009 Hato et al 2014 Pardee Butterfield 2012.

Imfinzi hcc. Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment EMERALD-2 The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. Imfinzi is a human monoclonal antibody a checkpoint inhibitor that binds to PD-L1 blocking the interaction of PD-L1 with PD-1 and CD80.

Have either progressed on are intolerant to or refused treatment with sorafenib or another approved TKI. Imfinzi VEGF adjuvant HCC EMERALD-2 Fasenra nasal polyps ORCHID China Japan Imfinzi CRT NSCLC PACIFIC-5 China roxadustat anemia in MDS Imfinzi post-SBRT NSCLC PACIFIC-4 Xigduo XRXigduo type-2 diabetes China 2021 Estimated key regulatory submission acceptances M E 7. Thus far sorafenib remains the standard of care for first line systemic therapy in patients with advanced HCC but patient prognosis and quality of life QOL continues to be poor.

Cytomegalovirus CMV infectionreactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Imfinzi is also being evaluated for multiple cancers either alone or in combination with other regimens including phase III trials in combination with tremelimumab in hepatocellular carcinoma. Imfinzi is not currently approved to treat HCC in any country alone or in combination with tremelimumab.

Have not received any prior systemic therapy for HCC. Confirmed HCC based on histopathological findings from tumor tissues. As part of a broad development programme Imfinzi is being tested as a monotherapy and in combination with other anti-cancer treatments for patients with NSCLC SCLC bladder cancer hepatocellular carcinoma HCC biliary tract cancer oesophageal cancer gastric and gastroesophageal cancer cervical cancer ovarian cancer endometrial cancer and other solid tumours.

On December 11 2018 we entered into a clinical supply agreement with a wholly-owned subsidiary of AstraZeneca PLC or AstraZeneca to evaluate the safety and efficacy of AstraZenecas IMFINZI durvalumab a human monoclonal antibody directed against programmed death-ligand 1 or PD-L1 in. For arm 5 only. In January 2020 Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC.

Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. Imfinzi is not currently approved to treat HCC in any country alone or in combination with tremelimumab. HIMALAYA is the first trial to test dual immune checkpoint blockade in the 1st-line advanced HCC setting.

Imfinzi is indicated for the treatment of patients with locally advanced or metastatic UBC who have disease progression during or following platinum-containing chemotherapy or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before neoadjuvant or after adjuvant surgery. Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of study drug. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.

Subjects who have received prior systemic treatment for HCC. This is a randomized open-label multi-center global Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. HCC PD-L1 Combination Trial with IMFINZI.

Imfinzi VEGF adjuvant HCC EMERALD-2 Fasenra eosinophilic esophagitis MESSINA Imfinzi post-SBRT NSCLC PACIFIC-4 Fasenra EGPA MANDARA Imfinzi cervical CALLA Fasenra HES NATRON Imfinzi adjuvant NSCLC BR31 Fasenra nasal polyps ORCHID China Japan 2022 Estimated key regulatory submission acceptances LCM NME 8 Oncology BioPharmaceuticals Note. Information from the National Library of Medicine. Investigators are looking into a combination of immunotherapy agents for patients with unresectable hepatocellular carcinoma HCC for whom there are limited treatment options in the first line.

Brain metastases or spinal cord compression. In cases of corticosteroid-refractory colitis consider repeating infectious workup to exclude alternative etiologies. Known to be Hepatitis B or C positive except HCC patients Contacts and Locations.

The trial is in first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma HNSCC whose tumors expressed high levels of PD-L1.