All rights reserved. Immune-Mediated Colitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated colitis that is frequently associated with diarrhea. Oncologist and Hematologist & Contributing Writer. Immune checkpoint inhibitors in malignant pleural mesothelioma: promises and challenges. Support and resources for HCPs and patients. Retrieved March 4, 2023, from https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. endstream endobj startxref A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma. Imfinzi [package insert]. 5-Year Mesothelioma Survivor Motivated by Family, Mesothelioma Survivors Treatment Journey Continues, A Post-Cancer Letter to Pre-Cancer Tamron. Would you like to speak with a Patient Advocate? Cardiac/vascular: Myocarditis, pericarditis, vasculitis. Global Health Status/QoL and Functioning Scales, Adverse Reactions and Discontinuation Rates. She is a registered nurse with a background in oncology and thoracic surgery and was the regional director of a tissue bank before becoming a Patient Advocate at The Mesothelioma Center. (2009, November 19). In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. (2019). Researchers estimate the study will be completed in late 2019. Rachel Ernst is a content writer at Mesothelioma Hub. Tremelimumab granted Orphan Drug Designation by US FDA for treatment of malignant mesothelioma. Pediatric . Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. No overall differences in safety or efficacy of tremelimumab-actl have been observed between patients 65 years or older and younger adult patients. These immune cells kill cancer cells. AHFSfirstRelease. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. It is not a substitute for professional medical advice, diagnosis or treatment. Events resolved in 12 of the 29 patients and resulted in permanent discontinuation in 9 patients. (2015, April 15). One cycle is defined as every 4 weeks. The largest study to date of tremelimumab in mesothelioma patients did not reach its goal of extending overall survival. Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/NCT01843374, United States National Library of Medicine. For those weighing less than 30 kg, the recommended tremelimumab dose is 4 mg/kg IV as a single dose in combination with durvalumab 20 mg/kg IV, followed by durvalumab 20 mg/kg IV every 4 weeks. Since then, multiple studies have tested the drug on several types of cancer. 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. Study participants with malignant pleural mesothelioma either received MEDI4736, known as durvalumab, or durvalumab and tremelimumab in this phase 2 trial. Eventually, the cancer returned and McWhorter had to leave that trial in search of other options to control his cancer. Thank you for your feedback. Calling this number connects you with a Patient Advocate at The Mesothelioma Center, the nation's most trusted mesothelioma resource. Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Pharmacodynamics. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions. The recommended tremelimumab dose for patients weighing 30 kg or more is 300 mg IV as a single dose in combination with durvalumab 1500 mg at Cycle 1/Day 1, followed by durvalumab 1500 mg IV every 4 weeks. IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Research in mesothelioma patients shows tremelimumab has the potential to cause life-threatening side effects. Tremelimumab plus durvalumab retreatment and 4-year outcomes in patients with mesothelioma: a follow-up of the open label, non-randomised, phase 2 NIBIT-MESO-1 study. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. The medication was first studied as a treatment for metastatic melanoma. Events resolved in 6 of the 9 patients. Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding. Asbestos.com, 24 Feb 2023, https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. al. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. Events resolved in 15 of the 18 patients. Around half of the patients lived at least a year in both studies. For example, two small Italian studies reported tremelimumab stopped cancer growth in about half of the mesothelioma participants. Tremelimumab which has no brand name yet has not been approved by the U.S. Food and Drug Administration (FDA) to treat any cancer or disease. Update your browser for more security, speed and compatibility. Medically Reviewed By Dr. Daniel A. Landau. 5-star reviewed mesothelioma and support organization. The most frequent serious adverse reactions (2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). You may report side effects related to AstraZeneca products by clicking here. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDAs assessment. Thyroiditis can present with or without endocrinopathy. Immediate treatment of side effects helps keep them in control. 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. Each infusion will take approximately 1 hour. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. Immune mediated pneumonitis occurred in 1.3% (5/388) of patients receiving tremelimumab-actl in combination with durvalumab, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. This is a staff of compassionate and knowledgeable individuals who respect what your family is experiencing and who go the extra mile to make an unfortunate diagnosis less stressful. Refer to the prescribing information for the agents administered in combination with tremelimumab-actl for recommended contraception duration, as appropriate. 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%). Lancet, 18(9), 1261-1273. doi: 10.1016/S1470-2045(17)30446-1, Kindler, H.L. (2015, October 27). Tremelimumab has produced promising anticancer responses in early clinical trials. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Clinical trials on tremelimumab have been conducted on cancer patients in an attempt to study the prevention, detection, or treatment of multiple diseases. Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients. Tremelimumab-actl injection is used in combination with durvalumab to treat liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC). Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. 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. Immune-Mediated Pneumonitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated pneumonitis, which may be fatal. Download Guide. Tremelimumab is a human antibody that helps the immune system fight cancer. Retrieved from. Systemic corticosteroids were required in all 9 patients and of these, 7 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. Clinical trials are testing the drug on several different cancers including mesothelioma. Researchers suggested more trials that combine drugs are necessary to see how well tremelimumab may work against mesothelioma. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Tremelimumab-actl is a monoclonal antibody that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, thereby removing inhibition of the immune response. Immune-Mediated Dermatology Reactions: Tremelimumab-actl in combination with durvalumab can cause immune-mediated rash or dermatitis. Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Drug class: anti-CTLA-4 monoclonal antibodies. Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. New clinical trials are testing it in combination with several anti-cancer drugs with the hope of finding a magic combination. Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/record/NCT02592551?view=record. The results led the researchers to conclude that the treatment combination was associated with long-term survival. Call your doctor right away if you notice any mild or serious side effects. Orphan designation does not mean the drug is safe or effective. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors. Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO. 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; Initial studies of the drug produced impressive results that havent been replicated in larger clinical trials. (2006). More than 30 contributors, including mesothelioma doctors, survivors, health care professionals and other experts, have peer-reviewed our website and written unique research-driven articles to ensure you get the highest-quality medical and health information. Immune-mediated Hypothyroidism: Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving tremelimumab-actl in combination with durvalumab. Follow patients closely for evidence of transplant-related complications and intervene promptly. Infusion-related reactions occurred in 10 (2.6%) patients receiving tremelimumab-actl in combination with durvalumab. Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. AHFS Drug Information. Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. This study used the drug alone rather than in combination with other drugs. Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.5%) adverse reactions. Weve gathered all of our resources into one guide with one purpose: helping you navigate mesothelioma. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. Last Modified: September 22, 2022, Created: July 6, 2022. In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. (2021, September). %PDF-1.7 % Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis.