imfinzi mechanism of action

There are no data on the use of IMFINZI in pregnant … Apprise pregnant women of the potential risk to a fetus. The development of ADA against durvalumab appears to have no clinically relevant effect on its pharmacokinetics or safety. The PACIFIC study did not include sufficient numbers of patients aged 75 years and over to determine whether they respond differently from younger patients. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). Call your doctor for medical advice about side effects. Table 7 and Figure 1 summarizes the efficacy results for PACIFIC. Adverse effects associated with the use of Imfinzi may include, but are not limited to, the following: Adverse effects associated with the use of Imfinzi for non-small cell lung cancer (NSCLC) include : Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody. Withhold or permanently discontinue Imfinzi depending on severity, Imfinzi can cause immune-mediated thyroid disorders. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic. In the CASPIAN study, Imfinzi was administered at a dose of 1500 mg every 3 or 4 weeks. Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Action View Imfinzi mechanism of action for pharmacodynamics and pharmacokinetics details. When Imfinzi is administered in combination with chemotherapy, refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving Imfinzi, including Grade 3 (0.4%) adverse reactions. The pre-specified interim analysis of PFS based on 371 events (81% of total planned events) demonstrated a statistically significant improvement in PFS in patients randomized to Imfinzi compared to placebo. The effects of durvalumab on prenatal and postnatal development were evaluated in reproduction studies in cynomolgus monkeys. Events resolved in 43 of the 79 patients and resulted in permanent discontinuation in 24 patients. As with all therapeutic proteins, there is a potential for immunogenicity. IMFINZI is administered as an intravenous infusion over 60 minutes. Events resolved in 3 of the 5 patients and resulted in permanent discontinuation in 4 patients. Your healthcare provider will check you for these problems during your treatment with Imfinzi. This cohort consisted of 182 patients with locally advanced or metastatic urothelial carcinoma who had progressed while on or after a platinum-based therapy, including those who progressed within 12 months of receiving therapy in a neo-adjuvant or adjuvant setting. By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production. The most common adverse reactions leading to Imfinzi discontinuation were pneumonitis or radiation pneumonitis in 6% of patients. Events resolved in 20 of the 27 patients. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. 1. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 265 patients received Imfinzi 1500 mg in combination with chemotherapy every 3 weeks for 4 cycles followed by Imfinzi 1500 mg every 4 weeks until disease progression or unacceptable toxicity. What is the most important information I should know about Imfinzi? Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Interrupt, slow the rate of, or permanently discontinue Imfinzi based on the severity [see Dosage and Administration (2.2)]. Immune-mediated colitis occurred in 1.6% (31/1889) of patients receiving Imfinzi, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions. Serious adverse reactions occurred in 29% of patients receiving Imfinzi. Last updated on Feb 1, 2021. Within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy 10 mg/kg IV q2wk infused over 1 hrContinue until disease progression or unacceptable toxicity Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Of the 265 patients with ES-SCLC treated with Imfinzi in combination with chemotherapy, 101 (38%) patients were 65 years or older and 19 (7.2%) patients were 75 years or older. Systemic corticosteroids were required in all patients with immune-mediated rash or dermatitis. MIMS Class . PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). The carcinogenic and genotoxic potential of durvalumab have not been evaluated. During or following platinum-containing chemotherapy 2. Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Before you receive Imfinzi, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Systemic corticosteroids were required in 17 patients (17/28) with pneumonitis who did not receive chemoradiation prior to initiation of Imfinzi. Administration of durvalumab resulted in premature delivery, fetal loss (abortion and stillbirth), and increase in neonatal deaths. These problems may happen anytime during treatment or even after your treatment has ended. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Hypophysitis can cause hypopituitarism. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI. US License No. The median time for PFS was 16.8 months for 476 patients receiving Imfinzi compared with 5.6 months for 237 patients receiving placebo. Respiratory, thoracic and mediastinal disorders, General disorders and administration site conditions. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. 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. Advise females of reproductive potential to use effective contraception during treatment with Imfinzi and for at least 3 months after the last dose of Imfinzi [see Use in Specific Populations (8.1, 8.3)]. Human IgG1 is excreted in human milk. For Intravenous Infusion After Dilution Durvalumab was administered from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the recommended clinical dose of 10 mg/kg (based on AUC). In animal reproduction studies, administration of durvalumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased premature delivery, fetal loss and premature neonatal death. Expression of programmed cell death ligand-1 (PD-L1) can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment. Figure 1. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. … There are no data on the use of Imfinzi in pregnant women. There are no data on the use of IMFINZI in pregnant women. Withhold or permanently discontinue Imfinzi depending on severity [see Dosage and Administration (2.2)]. Hypothyroidism can follow hyperthyroidism. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Of the 476 patients treated with Imfinzi in the PACIFIC study, 45% were 65 years or older, while 7.6% were 75 years or older. Durvalumab (Imfinzi) These drugs have also been shown to be helpful in treating different types of cancer, and are being studied for use against others. However, this approval was withdrawn in February of 2021 following a failure to meet endpoints in the phase 3 post-approval DANUBE clinical study. Wilmington, DE 19850, By: AstraZeneca UK Limited Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Imfinzi can cause immune-mediated hypophysitis. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur. Imfinzi is a prescription medicine used to treat adults with: It is not known if Imfinzi is safe and effective in children. Page 6of 56 The recommended dose of IMFINZI depends on the indication. ATC Classification . Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Tell your healthcare provider about all the medicines you take, We comply with the HONcode standard for trustworthy health information -, Drug class: anti-PD-1 monoclonal antibodies, Voluntary Withdrawal of Imfinzi Indication in Advanced Bladder Cancer in the US. What are the possible side effects of Imfinzi? injection. Single-dose vial. Each mL contains durvalumab, 50 mg, L-histidine (2 mg), L-histidine hydrochloride monohydrate (2.7 mg), α,α-trehalose dihydrate (104 mg), Polysorbate 80 (0.2 mg), and Water for Injection, USP. The trial had two primary endpoints comparing experimental arms to SoC. Among the total 31 responding patients, 1s (45%) had ongoing responses of 6 months or longer and five (16%) had ongoing responses of 12 months or longer. Initiate symptomatic treatment including hormone replacement as clinically indicated. As reported in the literature, the PD-1/PD-L1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the fetus. The safety of Imfinzi in combination with etoposide and either carboplatin or cisplatin in previously untreated ES-SCLC was evaluated in CASPIAN, a randomized, open-label, multicenter, active-controlled trial. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids. The recommended dose is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Advise pregnant women of the potential risk to a fetus. Other adverse reactions occurring in less than 10% of patients treated with Imfinzi were dysphonia, dysuria, night sweats, peripheral edema, and increased susceptibility to infections. Urothelial Carcinoma The recommended dose of IMFINZI … Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, water for injection, USP. Medically reviewed by Drugs.com. Imfinzi was discontinued due to adverse reactions in 7% of the patients receiving Imfinzi plus chemotherapy. Checkpoint inhibitor drugs that target CTLA-4. Events resolved in 15 of the 28 patients and resulted in permanent discontinuation in 5 patients. Table 4 summarizes the laboratory abnormalities that occurred in at least 20% of patients treated with Imfinzi. No overall differences in safety or effectiveness were observed between patients 65 years or older and younger patients. Investigator-assessed PFS (96% of total planned events) showed a HR of 0.78 (95% CI: 0.65, 0.94), with median PFS of 5.1 months (95% CI: 4.7, 6.2) in the Imfinzi plus chemotherapy arm and 5.4 months (95% CI: 4.8, 6.2) in the chemotherapy alone arm. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Problems can also happen in other organs and tissues. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD-L1 blocking antibody. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Each mL contains durvalumab, 50 mg, L-histidine (2 mg), L-histidine hydrochloride monohydrate (2.7 mg), α,α-trehalose dihydrate (104 mg), Polysorbate 80 (0.2 mg), and Water for Injection, USP. Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. A total of 475 patients received Imfinzi 10 mg/kg intravenously every 2 weeks. The data also reflect exposure to Imfinzi in combination with chemotherapy in 265 patients from the CASPIAN study (a randomized, open-label study in patients with ES-SCLC). Imfinzi can cause immune-mediated nephritis. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Kaplan-Meier Curves of Overall Survival in the PACIFIC Study. In these trials, Imfinzi was administered at a dose of 10 mg/kg every 2 weeks. Expression of PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment. Imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Imfinzi can cause immune-mediated hepatitis. Based on the modeling of pharmacokinetic data and exposure relationships for safety, there are no anticipated clinically meaningful differences in efficacy and safety for the doses of 1500 mg every 4 weeks compared to 10 mg/kg every 2 weeks in patients weighing > 30 kg with NSCLC. The investigator-assessed confirmed ORR was 68% (95% CI: 62%, 73%) in the Imfinzi plus chemotherapy arm and 58% (95% CI: 52%, 63%) in the chemotherapy alone arm. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. For these reasons, comparison of the incidence of antibodies to durvalumab to the incidence of antibodies to other products may be misleading. Immune-mediated adrenal insufficiency occurred in 0.4% (7/1889) of patients receiving Imfinzi, including Grade 3 (<0.1%) adverse reactions. Various grades of visual impairment to include blindness can occur. There are no data on the use of IMFINZI in pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Of 2280 patients who received Imfinzi 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks as a single-agent, 69 patients (3%) tested positive for treatment-emergent anti-drug antibodies (ADA) and 12 (0.5%) tested positive for neutralizing antibodies. Do not freeze or shake. Select one or more newsletters to continue. Based on its mechanism of action, fetal exposure to durvalumab may increase the risk of developing immune-mediated disorders or altering the normal immune response and immune-mediated disorders have been reported in PD-1 knockout mice. PD-L1 and PD-1 knockout mice have also shown decreased survival following infection with lymphocytic choriomeningitis virus. The study population characteristics were: median age of 64 years (range: 23 to 90), 45% age 65 years or older, 70% male, 69% White, 27% Asian, 75% former smoker, 16% current smoker, and 51% had WHO performance status of 1. ALT or AST increases to more than 3 and up to 8 times the ULN, total bilirubin increases to more than 1.5 and up to 3 times ULN, ALT or AST increases to more than 8 times ULN, total bilirubin increases to more than 3 times the ULN, AST or ALT is more than 1 and up to 3 times ULN at baseline and increases to more than 5 and up to 10 times ULN, AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more than 8 and up to 10 times ULN, AST or ALT increases to more than 10 times ULN, Total bilirubin increases to more than 3 times ULN, Withhold until clinically stable or permanently discontinue depending on severity, ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal. Please see drug label for treatment modifications. 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%). Eligible patients had WHO Performance Status of 0 or 1 and were suitable to receive a platinum-based chemotherapy regimen as first-line treatment for SCLC. Hypothyroidism: Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving Imfinzi, including Grade 3 (<0.1%) adverse reactions. Systemic corticosteroids were required in all patients with adrenal insufficiency; of these, the majority remained on systemic corticosteroids. The pharmacokinetics of durvalumab as a single agent was studied in patients with doses ranging from 0.1 mg/kg (0.01 times the approved recommended dosage) to 20 mg/kg (2 times the approved recommended dosage) administered once every two, three, or four weeks. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Imfinzi can cause primary or secondary adrenal insufficiency. Withhold or discontinue Imfinzi based on the severity, Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis, Imfinzi can cause immune-mediated rash or dermatitis. For more information, call 1-800-236-9933 or go to www.Imfinzi.com, This Medication Guide has been approved by the U.S. Food and Drug Administration. Systemic corticosteroids were required in all patients with immune-mediated nephritis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In the chemotherapy alone arm, 57% of the patients received 6 cycles of chemotherapy, and 8% of the patients received PCI. Signs and symptoms of infusion reactions may include: Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). In the exploratory subgroup analyses of OS based on the planned platinum chemotherapy received at cycle 1, the HR was 0.70 (95% CI 0.55, 0.89) in patients who received carboplatin, and the HR was 0.88 (95% CI 0.55, 1.41) in patients who received cisplatin. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. The trial excluded patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants [see Clinical Studies (14.3)]. Durvalumab is a programmed cell death ligand 1 (PD-L1) blocking antibody. Based on its mechanism of action and data from animal studies, Imfinzi can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. This patient-friendly article is about chemotherapy drug, Durvalumab also known by its trade name Imfinzi; it is used in treating urothelial carcinoma (bladder cancer) and stage III non-small … Imfinzi was tested against placebo. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. There were no clinically meaningful differences in safety or efficacy between patients 65 years or older and younger patients. Dosage Form: injection, solution. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Imfinzi (durvalumab) Injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution, free from visible particles. In Patients Who did Not Receive Recent Prior Radiation. Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics … Imfinzi was previously granted accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Human immunoglobulin G1 (IgG1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus. Imfinzi is supplied as an infusion for intravenous administration. Results also showed an increased confirmed objective response rate in the Imfinzi plus SoC arm (68% versus 58% for SoC alone). Hypothyroidism can follow hyperthyroidism. IMFINZI is a medicine that may treat certain cancers by working with your immune system. If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue Imfinzi based on recommendations for hepatitis with no liver involvement. Randomization was stratified by the planned platinum-based therapy in cycle 1 (carboplatin or cisplatin). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Based on its mechanism of action and data from animal studies, Imfinzi can cause fetal harm when administered to a pregnant woman. Selective, high affinity antibody that blocks PD-L1 binding to PD-1 and CD80, allowing T cells to recognize and kill tumor cells. Table 5 summarizes the adverse reactions that occurred in patients treated with Imfinzi plus chemotherapy. Monitor for signs and symptoms of infusion-related reactions. Hypophysitis can cause hypopituitarism. Randomization was stratified by sex, age (< 65 years vs. ≥ 65 years), and smoking history (smoker vs. non-smoker). Research by scientists at Götte’s lab found that the use of polymerase enzyme extracted from coronavirus, MERS noting that the enzymes can incorporate … The geometric mean (CV%) terminal half-life, based on baseline CL was approximately 18 (24%) days. Systemic corticosteroids were required in 9 patients (9/27) with immune-mediated hyperthyroidism, while 21 patients (21/27) required endocrine therapy. The following adverse reactions are discussed in greater detail in other sections of the labeling. Thyroiditis: Immune-mediated thyroiditis occurred in 0.4% (7/1889) of patients receiving Imfinzi. The data described in this section reflect exposure to Imfinzi in patients with Stage III NSCLC enrolled in the PACIFIC study and in patients with ES-SCLC enrolled in the CASPIAN study. Imfinzi is administered as an intravenous infusion over 60 minutes. Imfinzi can cause immune-mediated pneumonitis. Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity (ADCC). These complications can be serious and can lead to death. The pharmacokinetics of durvalumab is similar when assessed as a single agent and when in combination with chemotherapy. Cancer Immunotherapy. Immune-Mediated Nephritis with Renal Dysfunction. You may report side effects to FDA at 1-800-FDA-1088. Imfinzi’s mechanism of action. The efficacy of Imfinzi was evaluated in the PACIFIC study (NCT02125461), a multicenter, randomized, double-blind, placebo-controlled study in patients with unresectable Stage III NSCLC who completed at least 2 cycles of concurrent platinum-based chemotherapy and definitive radiation within 42 days prior to initiation of the study drug and had a WHO performance status of 0 or 1. The recommended dosages for Imfinzi as a single agent and Imfinzi in combination with chemotherapy are presented in Table 1 [see Clinical Studies (14)]. For additional information regarding Imfinzi or advanced or metastatic urothelial carcinoma and non-small cell lung cancer, please visit https://www.imfinzi.com/, 300 N. Washington St., Suite 200, Falls Church, VA 22046, USA, Phone 617.948.5100 – Toll free 866.219.3440, Copyright © 2021. AstraZeneca’s Imfinzi (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard … he world has finally taken a major step in ending the COVID-19 pandemic — a vaccine has been approved and there are at least two more that appear to be at least 90 percent effective in additi… Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving Imfinzi, including Grade 3 (0.3%) adverse reactions. Due to the potential for serious … Thyroiditis can present with or without endocrinopathy. Of 201 patients in the CASPIAN study who received Imfinzi 1500 mg every 3 weeks in combination with chemotherapy for four doses followed by Imfinzi 1500 mg every 4 weeks no patients tested positive for treatment-emergent ADA. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In mouse allogeneic pregnancy models, disruption of PD-L1 signaling was shown to result in an increase in fetal loss. Cardiac/vascular: Myocarditis, pericarditis, vasculitis. Design, CMS, Hosting & Web Development :: ePublishing, Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges, MAGI's Clinical Research vConference — Spring 2021, Regenerative Medicine: Steps to Accelerate Development, Clinical Trial Agreements: A Guide to Key Words and Phrases, Mid-Study Updates Delay Trials At Least a Month, CSDD Report Finds, Real-Time Data Helped Sponsors Respond to Sites’ Needs During the Pandemic, Increasing Protocol Complexity Requires Adapting Quality Metrics Tools, Ask the Experts: Participant Reimbursement, Compensation and Incentives. (durvalumab) Figure 2. Imfinzi is a registered trademark of AstraZeneca group of companies. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC).IMFINZI may be used when your NSCLC has not spread outside your chest, … Additional efficacy outcome measures included ORR and DoR assessed by BICR. The major efficacy outcome measures were confirmed Objective Response Rate (ORR) according to RECIST v1.1 as assessed by Blinded Independent Central Review (BICR), and duration of response (DoR). Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy. 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 16.6% (79/475) in patients receiving Imfinzi and 13.2% (31/234) in patients receiving placebo. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Advise pregnant women of the potential risk to a fetus. IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can …

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