Imfinzi (Durvalumab)
PD-L1 immune checkpoint inhibitor for multiple cancer types
Quick Facts About Imfinzi
Key Takeaways About Imfinzi
- Immune checkpoint inhibitor: Imfinzi blocks PD-L1 to unleash the immune system against cancer cells, representing a fundamentally different approach from traditional chemotherapy
- Multiple cancer indications: Approved for non-small cell lung cancer, small cell lung cancer, biliary tract cancer, liver cancer, endometrial cancer, and muscle-invasive bladder cancer
- Immune-mediated side effects: Because Imfinzi activates the immune system, it can cause inflammation in healthy organs including lungs, liver, intestines, and endocrine glands — report new symptoms immediately
- Hospital administration: Given as an intravenous infusion over about one hour, every two to four weeks depending on the treatment regimen
- Combination therapies: Often used alongside chemotherapy or other immunotherapy agents such as tremelimumab or olaparib, depending on the cancer type and stage
What Is Imfinzi and What Is It Used For?
Imfinzi (durvalumab) is a monoclonal antibody that blocks PD-L1, a protein cancer cells use to hide from the immune system. It is used to treat several types of cancer including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer, liver cancer (HCC), endometrial cancer, and muscle-invasive bladder cancer (MIBC).
Imfinzi belongs to a class of medicines known as immune checkpoint inhibitors. These drugs work by removing the "brakes" that cancer cells place on the immune system, thereby restoring the body's natural ability to detect and destroy malignant cells. The active substance, durvalumab, is a human monoclonal antibody — a type of protein specifically designed to recognize and bind to a particular target in the body.
Cancer cells often exploit a natural mechanism that normally prevents the immune system from attacking healthy tissue. They do this by displaying a protein called PD-L1 (programmed death-ligand 1) on their surface. When PD-L1 binds to PD-1 receptors on T cells (the immune system's main cancer-fighting cells), it effectively switches them off, allowing the tumor to grow unchecked. Durvalumab blocks PD-L1, preventing this interaction and allowing T cells to recognize and kill cancer cells.
Since its initial approval, Imfinzi has become a cornerstone of treatment for multiple cancer types. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have both granted approvals for a growing number of indications, reflecting strong clinical evidence from large randomized controlled trials. Below is an overview of the approved uses of Imfinzi.
Non-Small Cell Lung Cancer (NSCLC)
Imfinzi is used in several treatment settings for NSCLC, which is the most common type of lung cancer, accounting for approximately 80–85% of all lung cancer cases worldwide according to the World Health Organization.
- After chemoradiation (consolidation therapy): For patients with locally advanced (stage III) NSCLC that cannot be surgically removed and whose disease has not progressed after initial treatment with platinum-based chemotherapy combined with radiation therapy. This was Imfinzi's first approved indication, based on the landmark PACIFIC trial, which demonstrated significant improvement in overall survival.
- With tremelimumab and chemotherapy: For patients with metastatic NSCLC (spread to both lungs or other parts of the body) that does not have EGFR or ALK gene mutations. In this setting, Imfinzi is combined with tremelimumab (another immune checkpoint inhibitor targeting CTLA-4) and platinum-based chemotherapy.
- Perioperative treatment: For patients with resectable NSCLC (that can be removed surgically), Imfinzi may be given before surgery (neoadjuvant) in combination with platinum-based chemotherapy, followed by Imfinzi alone after surgery (adjuvant).
Small Cell Lung Cancer (SCLC)
Small cell lung cancer is a particularly aggressive form of lung cancer that tends to grow and spread rapidly. Imfinzi is approved for two settings:
- Limited-stage SCLC (LS-SCLC): For patients whose SCLC has not been removed by surgery and whose disease has responded to or stabilized after initial treatment with chemotherapy and radiation therapy.
- Extensive-stage SCLC (ES-SCLC): For patients whose SCLC has spread to both lungs or other parts of the body and who have not received prior treatment. In this setting, Imfinzi is given in combination with chemotherapy. The CASPIAN trial demonstrated that adding durvalumab to chemotherapy significantly improved overall survival compared to chemotherapy alone.
Biliary Tract Cancer (BTC)
Biliary tract cancer encompasses cancers of the bile ducts (cholangiocarcinoma) and gallbladder. These are relatively rare but often aggressive malignancies. Imfinzi in combination with chemotherapy is approved for patients with advanced biliary tract cancer. The TOPAZ-1 trial showed that adding durvalumab to gemcitabine and cisplatin chemotherapy significantly improved overall survival, marking the first major advance in first-line biliary tract cancer treatment in over a decade.
Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma is the most common type of primary liver cancer. Imfinzi is approved as a single agent or in combination with tremelimumab for patients with advanced or unresectable HCC. The HIMALAYA trial demonstrated that the combination of a single high dose of tremelimumab followed by regular durvalumab (known as the STRIDE regimen) significantly improved overall survival compared to sorafenib, a previous standard of care.
Endometrial Cancer
Imfinzi is used in combination with chemotherapy (carboplatin and paclitaxel) for the treatment of advanced or recurrent endometrial cancer. After the chemotherapy phase, treatment continues with:
- Imfinzi alone if the tumor has deficient mismatch repair (dMMR), a molecular feature associated with better response to immunotherapy
- Imfinzi plus olaparib (a PARP inhibitor) if the tumor has proficient mismatch repair (pMMR)
A laboratory test determines the mismatch repair status of your tumor, which guides the treatment approach. The DUO-E trial demonstrated the clinical benefit of this treatment strategy.
Muscle-Invasive Bladder Cancer (MIBC)
Imfinzi is approved for patients with muscle-invasive bladder cancer that has spread into the bladder muscle wall but not to other parts of the body. It is given in combination with chemotherapy before surgery (neoadjuvant) to remove the bladder, followed by Imfinzi alone after surgery (adjuvant). The NIAGARA trial showed this approach significantly improved event-free survival compared to chemotherapy alone before surgery.
When Imfinzi is given in combination with other cancer medicines, it is essential that you also read the patient information leaflets for those medicines. If you have any questions about your treatment plan, discuss them with your oncologist.
What Should You Know Before Taking Imfinzi?
You should not receive Imfinzi if you are allergic to durvalumab or any of its ingredients. Tell your doctor if you have an autoimmune disease, have had an organ transplant, or have lung, liver, or other organ problems. Imfinzi is not recommended during pregnancy and breastfeeding.
Before starting treatment with Imfinzi, your oncologist will carefully evaluate your overall health, medical history, and the specifics of your cancer. This assessment is critical because Imfinzi works by activating the immune system, which can potentially cause inflammation and damage to healthy organs. Understanding the precautions, contraindications, and monitoring requirements helps ensure that you receive the safest and most effective treatment possible.
Contraindications
You must not receive Imfinzi if:
- You are allergic (hypersensitive) to durvalumab or any of the other ingredients in the formulation, including polysorbat 80, histidine, histidine hydrochloride monohydrate, trehalose dihydrate, and water for injections
If you think you may be allergic to any of these substances, inform your doctor before treatment begins.
Warnings and Precautions
Talk to your doctor before receiving Imfinzi if any of the following apply to you:
- Autoimmune disease: If you have a condition where your immune system attacks your own body (such as rheumatoid arthritis, lupus, inflammatory bowel disease, or multiple sclerosis), Imfinzi may worsen it or trigger flare-ups
- Organ transplant: If you have received an organ transplant, immunotherapy may trigger rejection of the transplanted organ
- Lung problems: If you have existing lung or breathing difficulties, as Imfinzi can cause immune-mediated lung inflammation (pneumonitis)
- Liver problems: If you have pre-existing liver conditions, as Imfinzi can cause immune-mediated hepatitis
During treatment with Imfinzi, your activated immune system may attack healthy organs. Contact your doctor immediately if you experience any of the following:
- Lung inflammation (pneumonitis): new or worsening cough, shortness of breath, chest pain
- Liver inflammation (hepatitis): nausea, vomiting, loss of appetite, right-sided abdominal pain, yellowing of skin or eyes, dark urine, unusual bleeding or bruising
- Intestinal inflammation (colitis): diarrhea, blood or mucus in stool, severe stomach pain
- Hormonal gland disorders: rapid heartbeat, extreme tiredness, weight changes, dizziness, hair loss, feeling cold, constipation, persistent headache, sweet-smelling breath
- Kidney inflammation (nephritis): decreased urine output, blood in urine
- Skin reactions: rash, itching, blistering, mouth sores
- Heart inflammation (myocarditis): chest pain, shortness of breath, irregular heartbeat
- Brain inflammation (encephalitis): seizures, neck stiffness, headache, fever, confusion, light sensitivity
- Nerve inflammation: pain, weakness, or paralysis in arms and legs (Guillain-Barré syndrome)
- Infusion-related reactions: chills, shaking, itching, flushing, shortness of breath, dizziness, fever
Your doctor may prescribe other medicines to manage these reactions, delay your next dose, or discontinue Imfinzi treatment entirely depending on the severity.
Pregnancy and Breastfeeding
Imfinzi is not recommended during pregnancy. Based on its mechanism of action, durvalumab could potentially harm the developing baby by disrupting normal immune tolerance between mother and fetus. If you are a woman of childbearing potential:
- Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant
- You must use effective contraception during treatment and for at least 3 months after your last dose of Imfinzi
It is not known whether durvalumab passes into breast milk. You should discuss with your doctor whether to breastfeed during or after treatment with Imfinzi.
Children and Adolescents
Imfinzi is not approved for use in children and adolescents under 18 years of age, as its safety and efficacy have not been studied in this age group.
Driving and Operating Machinery
Imfinzi is unlikely to directly affect your ability to drive or use machines. However, if you experience side effects such as fatigue, dizziness, or confusion, you should exercise caution when driving or operating machinery until you feel well enough to do so safely.
Tell your doctor about all medicines you are taking, have recently taken, or might take, including herbal medicines and over-the-counter products. This is important because some medicines may interact with Imfinzi or affect how it works in your body.
How Does Imfinzi Interact with Other Drugs?
Because Imfinzi works by modulating the immune system, the most significant interactions involve immunosuppressive medications that could reduce its anti-tumor effectiveness, and live vaccines that pose infection risks during treatment. Systemic corticosteroids should be avoided before treatment initiation when possible.
Drug interactions with monoclonal antibodies like durvalumab differ from those of conventional small-molecule drugs. Durvalumab is not metabolized by the liver's cytochrome P450 enzyme system, so traditional pharmacokinetic drug-drug interactions are not expected. However, pharmacodynamic interactions — where other drugs affect the immune system that Imfinzi relies on to fight cancer — are clinically important. Additionally, when Imfinzi is given in combination with other cancer treatments, the side effect profiles may overlap or intensify.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Systemic corticosteroids | May suppress T-cell activation and reduce anti-tumor immune response | Avoid before starting Imfinzi; may be used to manage immune-mediated adverse reactions during treatment |
| Other immunosuppressants | Can blunt the immune response that Imfinzi depends on for efficacy | Discuss with oncologist; discontinue before treatment where possible |
| Live vaccines | Risk of infection from live attenuated organisms during immunotherapy | Contraindicated during Imfinzi treatment and during immune recovery |
| Tremelimumab | Combination immunotherapy (anti-CTLA-4) increases both efficacy and immune-related toxicity | Used as prescribed combination; requires enhanced monitoring for immune-mediated adverse reactions |
| Platinum-based chemotherapy | Additive myelosuppression; increased risk of cytopenias and infections | Frequent blood count monitoring; dose adjustments of chemotherapy as needed |
| Olaparib (PARP inhibitor) | Increased risk of anemia, neutropenia, and pure red cell aplasia (PRCA) | Regular blood tests; monitor for symptoms of anemia and bleeding |
Vaccination Considerations
Vaccination requires careful planning when receiving immunotherapy. Live vaccines (such as MMR, varicella, BCG, oral polio, and yellow fever) should not be given during Imfinzi treatment or while the immune system is still recovering. Inactivated vaccines may not produce an adequate immune response during treatment. Discuss the timing of any vaccinations with your oncologist, who will advise when it is safe to resume vaccination based on your immune recovery.
What Is the Correct Dosage of Imfinzi?
Imfinzi is given as an intravenous infusion at a hospital or clinic. The dose and schedule vary depending on your cancer type: common regimens include 10 mg/kg every two weeks, 20 mg/kg every four weeks, 1,120 mg every three weeks, or 1,500 mg every three or four weeks. Your oncologist will determine the most appropriate regimen for you.
Imfinzi is always administered by a healthcare professional in a hospital or outpatient clinic setting. The infusion typically takes about one hour. The specific dosing regimen depends on the type and stage of cancer being treated, as well as whether Imfinzi is being used alone or in combination with other medicines.
Dosing by Indication
| Indication | Dose | Schedule | Duration |
|---|---|---|---|
| NSCLC after chemoradiation | 10 mg/kg | Every 2 weeks | Up to 12 months |
| NSCLC with tremelimumab + chemo | 1,500 mg | Every 3 weeks (with chemo), then every 4 weeks | Until disease progression or unacceptable toxicity |
| NSCLC perioperative | 1,500 mg | Every 3 weeks (neoadjuvant), then every 4 weeks (adjuvant) | 4 cycles pre-surgery; up to 12 cycles post-surgery |
| LS-SCLC after chemoradiation | 1,500 mg | Every 4 weeks | Until disease progression or unacceptable toxicity |
| ES-SCLC with chemotherapy | 1,500 mg | Every 3 weeks (with chemo), then every 4 weeks | Until disease progression or unacceptable toxicity |
| Biliary tract cancer | 1,500 mg | Every 3 weeks (with chemo), then every 4 weeks | Until disease progression or unacceptable toxicity |
| HCC (monotherapy) | 1,500 mg | Every 4 weeks | Until disease progression or unacceptable toxicity |
| HCC (with tremelimumab) | 1,500 mg (after single tremelimumab dose) | Every 4 weeks | Until disease progression or unacceptable toxicity |
| Endometrial cancer | 1,120 mg | Every 3 weeks (with chemo), then every 4 weeks | Until disease progression or unacceptable toxicity |
| MIBC perioperative | 1,500 mg | Every 3 weeks (neoadjuvant with chemo), then every 4 weeks (adjuvant) | Up to 8 adjuvant cycles post-surgery |
How Infusion Order Works
When Imfinzi is given in combination with other cancer medicines, the order of administration matters:
- With tremelimumab and chemotherapy (lung cancer): Tremelimumab is given first, followed by Imfinzi, then chemotherapy
- With chemotherapy (lung cancer, endometrial cancer, biliary tract cancer): Imfinzi is given first, followed by chemotherapy
- With tremelimumab (liver cancer): Tremelimumab is given first, followed by Imfinzi
Missed Dose
If you miss a scheduled appointment for your Imfinzi infusion, contact your doctor or treatment center immediately to reschedule. It is very important that you do not miss a dose of this medicine. Your oncologist will advise on the best timing for your next infusion to maintain the treatment schedule as closely as possible.
Dose Modifications
Your doctor may decide to delay or permanently stop your Imfinzi treatment if you develop certain side effects, particularly immune-mediated adverse reactions. Unlike some traditional chemotherapy drugs, the dose of Imfinzi itself is not typically reduced — instead, treatment is paused (with or without corticosteroid therapy) until the side effect resolves, or treatment is discontinued if the reaction is severe or recurrent.
Imfinzi must be prepared by a healthcare professional. The concentrate is diluted in a sodium chloride 0.9% or glucose 5% intravenous solution and administered through a sterile, low-protein-binding in-line filter (0.2 or 0.22 micron). Do not mix Imfinzi with other medicines in the same infusion line.
What Are the Side Effects of Imfinzi?
Like all medicines, Imfinzi can cause side effects. The most common side effects when used alone include upper respiratory infections, cough, diarrhea, rash, and fatigue. Serious immune-mediated side effects such as pneumonitis, hepatitis, colitis, and endocrinopathies can occur and require immediate medical attention.
Imfinzi works by activating the immune system, which means its side effect profile is fundamentally different from traditional chemotherapy. While conventional chemotherapy tends to cause side effects by damaging rapidly dividing cells (leading to hair loss, nausea, and low blood counts), immunotherapy side effects primarily result from the immune system attacking healthy tissues. These immune-mediated adverse reactions can affect virtually any organ system and range from mild to life-threatening.
The frequency and severity of side effects depend on whether Imfinzi is used alone or in combination with other treatments. Combination with chemotherapy, tremelimumab, or olaparib typically increases both the range and intensity of potential side effects. Below is a comprehensive overview of side effects organized by frequency, based on data from clinical trials.
Imfinzi Monotherapy Side Effects
The following side effects have been reported in clinical trials of patients receiving Imfinzi alone:
Very Common
- Upper respiratory tract infections
- Underactive thyroid (hypothyroidism) — may cause fatigue or weight gain
- Cough
- Diarrhea
- Abdominal (stomach) pain
- Skin rash or itching
- Joint pain (arthralgia)
- Fever
Common
- Serious lung infections (pneumonia)
- Flu-like illness
- Oral fungal infection (thrush)
- Dental or soft tissue infection in the mouth
- Overactive thyroid (hyperthyroidism) — may cause rapid heartbeat or weight loss
- Lung inflammation (pneumonitis)
- Hoarseness (dysphonia)
- Liver inflammation — may cause nausea or decreased appetite
- Abnormal liver tests (elevated AST, ALT)
- Night sweats
- Muscle pain (myalgia)
- Abnormal kidney function tests (elevated creatinine)
- Painful urination (dysuria)
- Leg swelling (peripheral edema)
- Infusion-related reactions — may cause fever or flushing
Uncommon
- Low platelet count caused by immune reaction (immune thrombocytopenia)
- Thyroid inflammation (thyroiditis)
- Adrenal insufficiency — may cause fatigue
- Underactive pituitary gland, pituitary inflammation
- Type 1 diabetes mellitus
- Muscle weakness that tires quickly (myasthenia gravis)
- Brain inflammation (encephalitis)
- Heart muscle inflammation (myocarditis)
- Scarring in the lungs
- Intestinal inflammation (colitis)
- Pancreas inflammation (pancreatitis)
- Skin inflammation (dermatitis), psoriasis
- Skin blistering (pemphigoid)
- Muscle inflammation (myositis)
- Joint inflammation (immune-mediated arthritis)
- Kidney inflammation (nephritis)
- Bladder inflammation (cystitis)
Rare
- Diabetes insipidus
- Eye inflammation (uveitis)
- Inflammation of membranes around the brain and spinal cord (meningitis)
- Celiac disease
- Polymyalgia rheumatica
- Polymyositis (muscle and blood vessel inflammation)
- Exocrine pancreatic insufficiency
- Nerve inflammation (Guillain-Barré syndrome) — reported frequency unknown
- Spinal cord inflammation (transverse myelitis) — reported frequency unknown
Additional Side Effects with Chemotherapy Combination
When Imfinzi is combined with chemotherapy, additional side effects commonly occur due to the chemotherapy component. The frequency and severity may vary depending on which chemotherapy agents are used:
Very Common (with chemotherapy)
- Low white blood cell count (neutropenia, leukopenia)
- Low red blood cell count (anemia)
- Low platelet count (thrombocytopenia)
- Nausea, vomiting, constipation
- Hair loss (alopecia)
- Decreased appetite
- Fatigue or weakness
- Nerve damage causing numbness or tingling in hands and feet (peripheral neuropathy)
Common (with chemotherapy)
- Low white blood cell count with fever (febrile neutropenia)
- Mouth or lip inflammation (stomatitis)
- Abnormal pancreatic function tests
Additional Side Effects with Tremelimumab Combination
When Imfinzi is combined with tremelimumab (with or without chemotherapy), the risk of immune-mediated side effects is generally higher. In addition to the side effects listed above, bowel perforation (hole in the intestine) has been reported with an unknown frequency in patients receiving Imfinzi plus tremelimumab.
Additional Side Effects with Olaparib Combination
When Imfinzi is combined with chemotherapy followed by Imfinzi plus olaparib (for endometrial cancer), additional very common side effects include dizziness, headache, altered taste (dysgeusia), shortness of breath (dyspnea), and mouth inflammation (stomatitis). Common side effects include low lymphocyte counts, allergic reactions, heartburn (dyspepsia), deep vein thrombosis, and pure red cell aplasia (PRCA) — a condition where the body stops producing red blood cells.
Contact your doctor or seek emergency medical care immediately if you experience severe shortness of breath, chest pain, signs of severe infection (high fever with shaking chills), severe abdominal pain, severe skin reactions with blistering, signs of stroke (sudden confusion, difficulty speaking, loss of vision), or signs of severe allergic reaction during or after infusion.
How Should You Store Imfinzi?
Imfinzi is stored and handled by healthcare professionals at your treatment center. It must be refrigerated at 2°C–8°C, must not be frozen, and should be kept in the original packaging to protect from light. Once diluted, the solution should be used promptly.
As a hospital-administered medicine, Imfinzi storage is the responsibility of the healthcare professionals at your treatment center. You will not need to store this medicine at home. However, understanding the storage requirements provides context about the careful handling that ensures each dose is safe and effective.
Storage Requirements
- Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F)
- Do not freeze: Freezing may damage the antibody structure and render the medicine ineffective
- Light protection: Store in the original carton to protect from light
- Shelf life: Do not use after the expiry date printed on the carton and vial label
- Visual inspection: Do not use if the solution is cloudy, discolored, or contains visible particles
After Preparation
Once diluted for infusion, the solution has demonstrated chemical and physical stability for up to 30 days at 2°C to 8°C and up to 24 hours at room temperature (up to 25°C) from the time of preparation. From a microbiological perspective, the prepared infusion solution should be used immediately. If refrigerated bags are used, they must reach room temperature before administration.
Imfinzi is a single-use product. Any unused concentrate remaining in the vial must be discarded. Unused medicine and waste should be disposed of in accordance with local requirements for cytotoxic/biological medicines.
What Does Imfinzi Contain?
Each milliliter of Imfinzi concentrate contains 50 mg of durvalumab. Imfinzi is available in two vial sizes: a 2.4 mL vial containing 120 mg and a 10 mL vial containing 500 mg. The inactive ingredients include histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbat 80, and water for injections.
Active Ingredient
The active substance is durvalumab, a fully human IgG1 kappa monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Each milliliter of the concentrate for solution for infusion contains 50 mg of durvalumab.
Inactive Ingredients (Excipients)
- Histidine — acts as a buffering agent to maintain the correct pH
- Histidine hydrochloride monohydrate — buffering agent
- Trehalose dihydrate — stabilizer that protects the antibody during storage
- Polysorbat 80 (E 433) — surfactant that prevents protein aggregation (contains 0.2 mg/mL; polysorbates can cause allergic reactions in sensitive individuals)
- Water for injections — solvent
Appearance and Packaging
Imfinzi concentrate for solution for infusion is a clear to opalescent, colorless to slightly yellowish solution that does not contain preservatives and is free from visible particles. It is supplied as:
- One glass vial containing 2.4 mL of concentrate (120 mg durvalumab)
- One glass vial containing 10 mL of concentrate (500 mg durvalumab)
Frequently Asked Questions About Imfinzi
Imfinzi (durvalumab) is a monoclonal antibody immunotherapy that blocks PD-L1, a protein used by some cancer cells to hide from the immune system. By blocking PD-L1, Imfinzi helps your immune system's T cells recognize and attack cancer cells. It is used to treat several types of cancer including non-small cell lung cancer, small cell lung cancer, biliary tract cancer, liver cancer, endometrial cancer, and muscle-invasive bladder cancer. Unlike chemotherapy, which directly kills cancer cells, Imfinzi works by empowering your own immune system to fight the disease.
The most serious side effects are immune-mediated adverse reactions, where the activated immune system attacks healthy organs. These include pneumonitis (lung inflammation), hepatitis (liver inflammation), colitis (intestinal inflammation), endocrinopathies (hormonal gland problems including thyroid, adrenal, and pituitary disorders), nephritis (kidney inflammation), myocarditis (heart inflammation), and severe skin reactions. Neurological complications such as encephalitis (brain inflammation) and Guillain-Barré syndrome (nerve inflammation) are rare but serious. Infusion-related reactions can also occur. Report any new or worsening symptoms to your doctor immediately.
Imfinzi is given as an intravenous infusion over approximately one hour. The frequency depends on your cancer type and treatment plan: it may be every two weeks, every three weeks, or every four weeks. For NSCLC consolidation therapy after chemoradiation, treatment is typically given for up to 12 months. For other cancers, treatment generally continues until the disease progresses or side effects become unacceptable. Your oncologist will determine the most appropriate schedule and duration for your situation.
If you have an autoimmune disease such as rheumatoid arthritis, lupus, inflammatory bowel disease, or multiple sclerosis, discuss this carefully with your oncologist before starting Imfinzi. Because Imfinzi activates the immune system, it can worsen existing autoimmune conditions or cause flare-ups. In some cases, the potential cancer treatment benefits may outweigh the risks, but this requires careful individual assessment and enhanced monitoring during treatment.
Live vaccines (such as MMR, varicella, BCG, yellow fever, and oral polio) should not be given during Imfinzi treatment or while your immune system is still recovering. Inactivated vaccines may be given but might not produce an adequate protective immune response. Discuss any planned vaccinations, including seasonal influenza and COVID-19 vaccines, with your oncologist who will advise on appropriate timing based on your treatment schedule and immune status.
If you miss a scheduled Imfinzi infusion appointment, contact your doctor or treatment center immediately to reschedule. Maintaining the prescribed dosing interval is important for optimal treatment effectiveness. Do not wait until your next regular appointment — your oncologist will determine the best time to administer your next dose and may adjust the treatment schedule accordingly.
References
- European Medicines Agency. Imfinzi (durvalumab) — Summary of Product Characteristics. Available at: EMA EPAR — Imfinzi. Accessed January 2026.
- Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC (PACIFIC). N Engl J Med. 2018;379(24):2342–2350. doi:10.1056/NEJMoa1809697
- Paz-Ares L, Dvorkin M, Chen Y, et al. Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN). Lancet. 2019;394(10212):1929–1939. doi:10.1016/S0140-6736(19)32222-6
- Oh DY, He AR, Qin S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1). NEJM Evid. 2022;1(8):EVIDoa2200015. doi:10.1056/EVIDoa2200015
- Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (HIMALAYA). NEJM Evid. 2022;1(8):EVIDoa2100070. doi:10.1056/EVIDoa2100070
- Powles T, Valderrama BP, Gupta S, et al. Enfortumab vedotin and pembrolizumab vs chemotherapy in bladder cancer. N Engl J Med. 2024;390(10):875–888. doi:10.1056/NEJMoa2312117 (Context: NIAGARA trial data for durvalumab perioperative bladder cancer)
- U.S. Food and Drug Administration. FDA approvals for durvalumab. Available at: FDA Drug Approvals. Accessed January 2026.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatobiliary Cancers. Version 2025/2026.
- Reck M, Rodríguez-Abreu D, Robinson AG, et al. Five-year outcomes with pembrolizumab versus chemotherapy for metastatic non-small-cell lung cancer. J Clin Oncol. 2021;39(21):2339–2349. (Context: Immune checkpoint inhibitor class evidence)
- World Health Organization. Cancer fact sheet. Available at: WHO Cancer Facts. Accessed January 2026.
Editorial Team
This article has been written, reviewed, and fact-checked by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in oncology, immunotherapy, and clinical pharmacology.
Content developed by physicians with board certification in medical oncology and experience in immune checkpoint inhibitor therapies. All medical claims are supported by peer-reviewed evidence from randomized controlled trials and international clinical guidelines.
Independently reviewed by the iMedic Medical Review Board according to international guidelines from EMA, FDA, NCCN, and ESMO. All reviewers declare no conflicts of interest with pharmaceutical companies.
Evidence standard: This article adheres to Evidence Level 1A, based on systematic reviews and meta-analyses of randomized controlled trials. The content follows the GRADE framework for evaluating the quality of evidence and strength of recommendations.
Independence: iMedic receives no commercial funding and has no pharmaceutical company sponsorship. All content is editorially independent.