Our Patient Advocates have relationships with top doctors and cancer centers and can help you schedule and expedite appointments. Oncologist and Hematologist & Contributing Writer. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. New clinical trials are testing it in combination with several anti-cancer drugs with the hope of finding a magic combination. Good research has proven it isnt effective enough on its own to use as a single therapy against mesothelioma. If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAsMedWatch Reporting System or by calling 1-800-FDA-1088. Pancreatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of pancreatitis. Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions. Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial. A Study of Tremelimumab Combined With the Anti-PD-L1 MEDI4736 Antibody in Malignant Mesothelioma (NIBIT-MESO-1). Edited By Walter Pacheco Weve gathered all of our resources into one guide with one purpose: helping you navigate mesothelioma. So far, research has proven the drug helps some people with mesothelioma. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Tremelimumab. Tremelimumab-actl, a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody, is an antineoplastic agent. dyes, preservatives, or animals. See USPI Dosing and Administration for specific details. Immediate treatment of side effects helps keep them in control. Retrieved from, ClinicalTrials.gov. Three patients also received other immunosuppressants. The most common (20%) adverse reactions occurring in patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain. The purpose of tremelimumab is to blog receptors on immune cells that normally suppress immune attacks. A study called DETERMINE assesses tremelimumab as a second or third-line treatment for malignant mesothelioma patients who ineligible for tumor-removing surgery in a randomized, double-blind study. (2016). Dont try to tough it out, even with mild side effects. For more information about any of the below clinical trials, they can be found at ClinicalTrials.gov. Lancet, 18(9), 1261-1273. doi: 10.1016/S1470-2045(17)30446-1, Kindler, H.L. IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Rachel Ernst is a content writer at Mesothelioma Hub. Retrieved on November 14, 2019, from https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/tremelimumab?redirect=true, National Cancer Institute. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with tremelimumab-actl and for 3 months after the last dose. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). Refer to the prescribing information for the agents administered in combination with tremelimumab-actl for recommended contraception duration, as appropriate. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not. The study concluded is estimated to be completed in late 2019. In animal studies, CTLA-4 blockade is associated with higher incidence of pregnancy loss. CAS number: 745013-59-6. IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. The jury is still out on whether tremelimumab will prove to be an effective mesothelioma treatment. Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain. WebTremelimumab blocks the binding of the antigen-presenting cell ligands B7.1 and B7.2 to CTLA-4, resulting in inhibition of B7-CTLA-4-mediated downregulation of T-cell activation; Tremelimumab, manufactured by AstraZeneca, is an immunotherapy treatment that helps the immune system recognize and attack cancer cells. Retrieved on November 14, 2019, from https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808, National Cancer Institute. It binds to CTLA-4, which is primarily expressed on the surface of T lymphocytes, and thus enhances T-cell activation Selby, Karen. Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab based on the severity Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.3%) adverse reactions. (2019). Our Patient Advocates can help guide you or your loved one through the steps to take after a mesothelioma diagnosis. Clinical Trials Using Tremelimumab. Would you like to speak with a Patient Advocate? Any unauthorized or illegal use, copying or dissemination will be prosecuted. 20% of patients were alive at 36 months, and 15% of patients survived for 48 months or longer. The recommended tremelimumab dose for patients weighing 30 kg or more is 75 mg IV every 3 weeks with durvalumab 1500 mg IV and platinum-based Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. In general, if combination of tremelimumab-actl and durvalumab requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Request free informational, treatment, financial or support resources to help you and your loved one after a mesothelioma diagnosis. Hypothyroidism can follow hyperthyroidism. Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions. Retrieved from, Calabro, L. et al. Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/NCT01843374, United States National Library of Medicine. For platinum-based chemotherapy or pemetrexed, refer to Prescribing Information for administration information Observe for 60 minutes following completion of infusion; then administer durvalumab as a separate IV infusion over 60 minutes on same day Combination with durvalumab: Infuse tremelimumab, followed by durvalumab on same day of dosing Advise pregnant women of the potential risk to a fetus. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Antibodies are proteins produced by plasma cells that the immune system by attaching themselves to molecules on the surface of problematic cells. Events resolved in 6 of the 9 patients. It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Several clinical trials continue to test the drug in mesothelioma patients, including Dr. David Sugarbakers trial that combines tremelimumab with durvalumab and surgery. For non-prescription products, read the label or package ingredients carefully. The major efficacy outcome was overall survival (OS). Material safety data sheet: Tremelimumab. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2022. WebOn October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with (2017). For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. WebTREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. The most common Grade 3 or 4 adverse reactions (3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%), In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy. These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. WebTremelimumab 1 mg/kg IV Durvalumab: 20 mg/kg IV Cycles 1-4 Dose interval every 3 weeks Administer tremelimumab, durvalumab and chemotherapy Cycle 5 (week 12) The problem is tremelimumab seems to work well for only a little while. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. Tremelimumab-actl is available in the following dosage form(s) and strength(s): Injection: 25 mg/1.25 mL (20 mg/mL) solution in Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. In her free time, Rachel likes to be outdoors, watch movies, and spend time with her animals. The information on this website is proprietary and protected. Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). (2021, September). Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, and immune thrombocytopenia. Withhold or discontinue tremelimumab-actl in combination with durvalumab based on the severity. Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). hbbd```b``y"3@$>K mX
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Refer to the prescribing information for agents administered in combination with tremelimumab-actl for breastfeeding recommendations, as appropriate. This website and its content may be deemed attorney advertising. Selby, K. (2023, February 24). Retrieved on November 14, 2019, from https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tremelimumab, Ribas, A., et. Systemic corticosteroids were required in 2 patients (2/6) with immune-mediated thyroiditis, of these 1 patient required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). An increase in activated killer T cells helps a persons immune system fight cancer. Would you like to speak with a Patient Advocate? (2019). Clinical trials began testing tremelimumab on mesothelioma in 2013. Early results in the Phase 2b study have suggested that the drug fails to improve lifespan. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Adrenal Insufficiency: Tremelimumab-actl in combination with durvalumab can cause primary or secondary adrenal insufficiency. While immune-mediated adverse reactions usually manifest during treatment, immune-mediated adverse reactions can also manifest after discontinuation of tremelimumab-actl and/or durvalumab. An orphan drug typically treats uncommon illnesses, and cannot make much of a profit. Tremelimumab is a human antibody that helps the immune system fight cancer. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Each page includes all sources for full transparency. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. Tremelimumab plus durvalumab demonstrated a statistically significant and clinically meaningful improvement in OS compared to sorafenib (stratified hazard ratio [HR] of 0.78 [95% CI: 0.66, 0.92], 2-sided p value = 0.0035); median OS was 16.4 months (95% CI: 14.2, 19.6) versus 13.8 months (95% CI: 12.3, 16.1). Karen Selby, RN Three patients also required endocrine therapy. Infusion-related reactions occurred in 10 (2.6%) patients receiving tremelimumab-actl in combination with durvalumab. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. These immune cells kill cancer cells. Written by ASHP. AHFSfirstRelease. Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO. Researchers estimate the study will be completed in late 2019. Registered oncology nurse with more than 30 years experience, Expertise in mesothelioma, health effects of asbestos, cancer therapy and immunotherapy, Assisted surgeons with lung resections, lung transplants and pneumonectomies, Ran tissue procurement program at the University of Florida, Calabro, L. et al. Tremelimumab for the treatment of malignant mesothelioma. (2006). There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl). In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Withhold or permanently discontinue tremelimumab-actl and durvalumab depending on severity. However, combining tremelimumab and durvalumab has proven more effective against lung cancer than tremelimumab alone. However, as required by the new California Consumer Privacy Act (CCPA), you may record your preference to view or remove your personal information by completing the form below. Tremelimumab-actl works as a form of immunotherapy and blocks the activity of T-lymphocyte-associated- antigen 4 (CTLA-4) a molecule found on T cells that Advise the patient to read the FDA-approved patient labeling (Medication Guide). Retrieved on November 14, 2019, from https://www.sciencedirect.com/topics/neuroscience/tremelimumab, Mayo Clinic. Retrieved from, ClinicalTrials.gov. Fatal adverse reactions occurred in a total of 4.2% of patients, In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). Brand name: Imjudo Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. endstream
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Prior results do not predict a similar outcome. (2018, January 4). Immune-Mediated Hepatitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hepatitis, which may be fatal. Most common adverse reactions ( 20%) of patients with uHCC receiving tremelimumab-actl are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. Thyroiditis can present with or without endocrinopathy. Medically Reviewed By Dr. Daniel A. Landau. The trial was suspended in late 2019 after criteria were not met, but doctors and researchers estimate completion in 2024. Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (3.6%) adverse reactions. Hypophysitis can cause hypopituitarism. One patient (1/5) required other immunosuppressants. The side effects range from mild to severe. Calling this number connects you with a Patient Advocate at The Mesothelioma Center, the nation's most trusted mesothelioma resource. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. (n.d.). 5-star reviewed mesothelioma and support organization. Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma. This Tremelimumab. WebThe STRIDE Regimen (Single Tremelimumab Regular Interval Durvalumab): A single priming dose of IMJUDO 300 mg followed by IMFINZI 1500 mg on Day 1 of Cycle 1; For information on the COVID-19 pandemic, see the following resources: Follow the Oncology Center of Excellence on Twitter@FDAOncology. All patients received systemic corticosteroids, and 20 of the 23 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Last modified February 24, 2023. https://www.asbestos.com/treatment/immunotherapy/tremelimumab/.