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Imfinzi

Generic Name: Durvalumab
Class: Antineoplastic Agents
CAS Number: 1428935-60-7

Medically reviewed on June 18, 2018

Introduction

Antineoplastic agent; recombinant fully human anti-programmed-death ligand-1 (anti-PD-L1) monoclonal antibody.1

Uses for Imfinzi

Urothelial Carcinoma

Treatment of locally advanced or metastatic urothelial carcinoma that has progressed during or following platinum-containing therapy for advanced disease or within 12 months of platinum-containing therapy in the neoadjuvant or adjuvant setting.1 5 6

Accelerated approval based on tumor response rate and duration of response; improvement in disease-related symptoms or increased survival not demonstrated.1 Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.1

Imfinzi Dosage and Administration

General

Restricted Distribution

  • Obtain durvalumab through a limited network of specialty distributors.3 4

  • Contact manufacturer at 844-275-23603 or consult the Imfinzi website ([Web]) for specific availability information.4

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.1

Durvalumab injection concentrate must be diluted prior to administration.1 (See Dilution under Dosage and Administration.) Immediate administration recommended.1 (See Storage under Stability.)

Do not infuse simultaneously through the same IV line with other drugs.1

Administer through a sterile, low-protein-binding 0.2- or 0.22-μm inline filter.1

Dilution

Undiluted solution should be clear to opalescent and colorless to slightly yellow.1 Do not use if cloudy or discolored or if particulate matter is present.1

Do not shake vial.1

Withdraw appropriate dose of durvalumab injection concentrate (containing 50 mg/mL) and dilute with appropriate volume of 0.9% sodium chloride or 5% dextrose injection to a final concentration of 1–15 mg/mL.1 Do not use any other diluent.1 Mix the diluted solution by gentle inversion; do not shake.1 Discard any partially used vials.1

Rate of Administration

Administer over 60 minutes.1

Dosage

Adults

Urothelial Carcinoma
IV

10 mg/kg every 2 weeks.1 Continue therapy until disease progression or unacceptable toxicity occurs.1

Therapy Interruption for Toxicity
Immune-mediated Pneumonitis
IV

If grade 2 immune-mediated pneumonitis occurs, interrupt therapy until toxicity resolves to grade 0 or 1.1 (See Immune-mediated Pneumonitis under Cautions.)

If grade 3 or 4 immune-mediated pneumonitis occurs, discontinue drug.1

Immune-mediated Hepatic Effects
IV

For serum ALT or AST elevations >3 times but ≤8 times the ULN or total bilirubin concentrations >1.5 times but ≤5 times the ULN, interrupt therapy until toxicity resolves to grade 0 or 1.1 (See Immune-mediated Hepatic Effects under Cautions.)

For ALT or AST elevations >8 times the ULN or total bilirubin concentrations >5 times the ULN, discontinue drug.1

For ALT or AST elevations >3 times the ULN and total bilirubin concentrations >2 times the ULN with no other cause, discontinue drug.1

Immune-mediated GI Effects
IV

If grade 2 immune-mediated colitis or diarrhea occurs, interrupt therapy until toxicity resolves to grade 0 or 1.1 (See Immune-mediated GI Effects under Cautions.)

If grade 3 or 4 immune-mediated colitis or diarrhea occurs, discontinue drug.1

Immune-mediated Endocrine Effects
IV

Manufacturer makes no specific dosage recommendations for patients with immune-mediated hypothyroidism.1

If grade 2–4 immune-mediated adrenal insufficiency, hyperthyroidism, hypophysitis, hypopituitarism, or type 1 diabetes mellitus occurs, interrupt therapy until patient is clinically stable.1 (See Immune-mediated Endocrine Effects under Cautions.)

Immune-mediated Renal Effects
IV

For Scr concentrations >1.5 times but ≤3 times the ULN (i.e., grade 2), interrupt therapy until toxicity resolves to grade 0 or 1.1 (See Immune-mediated Renal Effects under Cautions.)

For Scr concentrations >3 times the ULN (i.e., grade 3 or 4), discontinue drug.1

Immune-mediated Dermatologic Effects
IV

If grade 2 immune-mediated rash or dermatitis occurs for >1 week or if grade 3 immune-mediated rash or dermatitis occurs, interrupt therapy until toxicity resolves to grade 0 or 1.1 (See Immune-mediated Dermatologic Effects under Cautions.)

If grade 4 immune-mediated rash or dermatitis occurs, discontinue drug.1

Immune-mediated Thrombocytopenic Purpura
IV

If grade 3 immune-mediated thrombocytopenic purpura occurs, interrupt therapy until toxicity resolves to grade 0 or 1.1 (See Immune-mediated Thrombocytopenic Purpura under Cautions.)

If grade 4 immune-mediated thrombocytopenic purpura occurs, discontinue drug.1

Other Immune-mediated Adverse Effects
IV

If any other grade 3 immune-mediated adverse effects occur, interrupt therapy until toxicity resolves to grade 0 or 1.1 (See Other Immune-mediated Effects under Cautions.)

If any other grade 4 immune-mediated adverse effects occur, discontinue drug.1

Infectious Complications
IV

If grade 3 or 4 infection occurs, interrupt therapy.1 (See Infectious Complications under Cautions.)

Infusion-related Reactions
IV

If grade 1 or 2 infusion-related reactions occur, decrease infusion rate or interrupt therapy.1 (See Infusion-related Reactions under Cautions.)

If grade 3 or 4 infusion-related reactions occur, discontinue drug.1

Special Populations

Hepatic Impairment

Mild hepatic impairment: No dosage adjustment required.2 (See Special Populations under Pharmacokinetics.)

Moderate or severe hepatic impairment: No dosage recommendations at this time.1

Renal Impairment

Mild or moderate renal impairment: No dosage adjustment required.2 (See Special Populations under Pharmacokinetics.)

Severe renal impairment: No dosage recommendations at this time.1

Geriatric Patients

No dosage adjustment required.2 (See Geriatric Use under Cautions.)

Cautions for Imfinzi

Contraindications

  • No known contraindications.1

Warnings/Precautions

Immune-mediated Pneumonitis

Immune-mediated pneumonitis or interstitial lung disease, sometimes fatal, reported.1 6

Monitor patients for manifestations of pneumonitis;1 evaluate those with suspected pneumonitis with radiographic imaging.1

If grade 2 immune-mediated pneumonitis occurs, interrupt durvalumab therapy and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1 If toxicity worsens or does not improve, consider dosage increase of corticosteroids and/or other systemic immunosuppressants.1 Once toxicity resolves to less than grade 1, taper corticosteroid dosage over ≥1 month.1

For toxicity not resulting in permanent drug discontinuance, resume durvalumab therapy when toxicity resolves to grade 0 or 1 and the corticosteroid dosage is reduced to <10 mg of prednisone daily (or equivalent).1

If grade 3 or 4 immune-mediated pneumonitis occurs, permanently discontinue durvalumab and initiate systemic corticosteroid (1–4 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Immune-mediated Hepatic Effects

Immune-mediated hepatitis, sometimes fatal, and liver function test abnormalities reported.1 6

Monitor liver function tests during each cycle of durvalumab therapy.1

If ALT or AST concentrations >3 to 8 times the ULN or total bilirubin concentrations >1.5 to 5 times the ULN occur, interrupt durvalumab therapy and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1 If toxicity worsens or does not improve, consider dosage increase of corticosteroids and/or other systemic immunosuppressants.1 Once toxicity resolves to less than grade 1, taper corticosteroid dosage over ≥1 month.1

For toxicity not resulting in permanent drug discontinuance, resume durvalumab therapy when toxicity resolves to grade 0 or 1 and the corticosteroid dosage is reduced to <10 mg of prednisone daily (or equivalent).1

If ALT or AST elevations >8 times the ULN or total bilirubin concentrations >5 times the ULN occur or if ALT or AST concentrations >3 times the ULN occur with total bilirubin concentrations >2 times the ULN, permanently discontinue durvalumab and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Immune-mediated GI Effects

Diarrhea or colitis, including immune-mediated colitis, reported.1

Monitor patients for manifestations of colitis or diarrhea.1

If grade 2 immune-mediated colitis or diarrhea occurs, interrupt durvalumab therapy and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage;1 antidiarrheal agents also may be used.1 If toxicity worsens or does not improve, consider dosage increase of corticosteroids and/or other systemic immunosuppressants.1 Once toxicity resolves to less than grade 1, taper corticosteroid dosage over ≥1 month.1

For toxicity not resulting in permanent drug discontinuance, resume durvalumab therapy when toxicity resolves to grade 0 or 1 and the corticosteroid dosage is reduced to <10 mg of prednisone daily (or equivalent).1

If grade 3 or 4 immune-mediated diarrhea or colitis occurs, permanently discontinue durvalumab and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Immune-mediated Endocrine Effects

Immune-mediated endocrinopathies, such as thyroid dysfunction (i.e., hypothyroidism, hyperthyroidism), adrenal insufficiency, hypophysitis, hypopituitarism, and type 1 diabetes mellitus, reported.1

Thyroid Dysfunction

Evaluate thyroid function prior to initiation and periodically during therapy.1

If immune-mediated hypothyroidism occurs, initiate thyroid hormone replacement therapy.1

If immune-mediated hyperthyroidism occurs, initiate appropriate medical therapy and interrupt durvalumab therapy until patient is clinically stable.1

Adrenal Insufficiency

Monitor for signs and symptoms of adrenal insufficiency.1

If grade 2 or greater adrenal insufficiency occurs, initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage; initiate hormone replacement therapy as indicated.1 Interrupt durvalumab therapy until patient is clinically stable.1

Hypophysitis

Monitor for signs and symptoms of hypophysitis.1

If grade 2 or greater hypophysitis occurs, initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage; initiate hormone replacement therapy as indicated.1 Interrupt durvalumab therapy until patient is clinically stable.1

Hypopituitarism

Monitor for signs and symptoms of hypopituitarism.1

If grade 2 or greater hypopituitarism occurs, initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage; initiate hormone replacement therapy as indicated.1 Interrupt durvalumab therapy until patient is clinically stable.1

Diabetes Mellitus

Monitor for hyperglycemia or other manifestations of diabetes.1

If grade 2 or greater type 1 diabetes mellitus occurs, initiate insulin treatment as clinically indicated; interrupt durvalumab therapy until patient is clinically stable.1

Immune-mediated Renal Effects

Immune-mediated nephritis and elevated Scr concentrations reported.1 5

Evaluate renal function prior to initiation and periodically thereafter.1

If grade 2 elevations in Scr concentrations occur, interrupt durvalumab therapy and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1 If toxicity worsens or does not improve, consider dosage increase of corticosteroids and/or other systemic immunosuppressants.1 Once toxicity resolves to less than grade 1, taper corticosteroid dosage over ≥1 month.1

For toxicity not resulting in permanent drug discontinuance, resume durvalumab therapy when toxicity resolves to grade 0 or 1 and the corticosteroid dosage is reduced to <10 mg of prednisone daily (or equivalent).1

If grade 3 or 4 elevations in Scr concentrations occur, permanently discontinue durvalumab and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Immune-mediated Dermatologic Effects

Immune-mediated rash or dermatitis reported.1

Monitor patients for signs and symptoms of rash or dermatitis.1

If grade 2 rash or dermatitis occurs and persists >1 week or any grade 3 rash or dermatitis occurs, interrupt durvalumab therapy and consider initiating systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1 If toxicity worsens or does not improve, consider dosage increase of corticosteroids and/or other systemic immunosuppressants.1 Once toxicity resolves to less than grade 1, taper corticosteroid dosage over ≥1 month.1

For toxicity not resulting in permanent drug discontinuance, resume durvalumab therapy when toxicity resolves to grade 0 or 1 and the corticosteroid dosage is reduced to <10 mg of prednisone daily (or equivalent).1

If grade 4 rash or dermatitis occurs, permanently discontinue durvalumab and consider initiating systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Immune-mediated Thrombocytopenic Purpura

Immune-mediated thrombocytopenic purpura, sometimes fatal, reported.1

Monitor patients for signs and symptoms of thrombocytopenic purpura.1

If grade 3 immune-mediated thrombocytopenic purpura occurs, interrupt durvalumab therapy and initiate symptomatic management.1 If corticosteroids are administered and there is worsening or no improvement of toxicity, consider dosage increase of corticosteroids and/or other systemic immunosuppressants.1 Once toxicity resolves to less than grade 1, taper corticosteroid dosage over ≥1 month.1

For toxicity not resulting in permanent drug discontinuance, resume durvalumab therapy when toxicity resolves to grade 0 or 1 and the corticosteroid dosage is reduced to <10 mg of prednisone daily (or equivalent).1

If grade 4 immune-mediated thrombocytopenic purpura occurs, permanently discontinue durvalumab and consider initiating systemic corticosteroid therapy (1–4 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Other Immune-mediated Effects

Other immune-mediated adverse effects, including aseptic meningitis, hemolytic anemia, myocarditis, myositis, ocular inflammatory toxicity (e.g., uveitis, keratitis) reported.1

If grade 3 immune-mediated toxicity occurs, interrupt durvalumab therapy and initiate symptomatic management.1 If corticosteroids are administered and there is worsening or no improvement of toxicity, consider dosage increase of corticosteroids and/or other systemic immunosuppressants.1 Once toxicity resolves to less than grade 1, taper corticosteroid dosage over ≥1 month.1

For toxicity not resulting in permanent drug discontinuance, resume durvalumab therapy when toxicity resolves to grade 0 or 1 and the corticosteroid dosage is reduced to <10 mg of prednisone daily (or equivalent).1

If grade 4 immune-mediated adverse effects occur, permanently discontinue durvalumab and consider initiating systemic corticosteroid therapy (1–4 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Infectious Complications

Severe infections (e.g., sepsis, necrotizing fasciitis, osteomyelitis) reported.1

Monitor for signs and symptoms of infection and treat suspected or confirmed infection with anti-infectives.1

If grade 3 or greater infection occurs, interrupt therapy.1

Infusion-related Reactions

Severe infusion-related reactions reported.1

Monitor for signs and symptoms of infusion-related reactions.1

If grade 1 or 2 infusion-related reactions occur, interrupt therapy or decrease infusion rate.1 Consider use of appropriate premedications (e.g., corticosteroids) with subsequent infusions.1

If grade 3 or 4 infusion-related reactions occur, discontinue drug.1

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.1 May disrupt maternal immune tolerance to the fetus and increase risk of fetal loss (abortion, stillbirth); also may increase risk of immune-mediated disorders.1

Avoid pregnancy during therapy.1 Advise women of childbearing potential to use an effective contraceptive method while receiving durvalumab and for ≥3 months after drug is discontinued.1 If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.1

Immunogenicity

Potential for immunogenicity.1 Development of anti-drug antibodies to durvalumab reported but incidence in patients receiving the drug not fully determined.1 Clinical importance of anti-durvalumab antibodies unknown.1

Specific Populations

Pregnancy

May cause fetal harm.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether durvalumab is distributed into milk.1 Discontinue nursing during therapy and for ≥3 months after drug discontinuance.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

Use with caution in patients ≥65 years of age, particularly those ≥75 years of age.1

Hepatic Impairment

Systemic exposure and clearance not affected by mild hepatic impairment.1 2 Data lacking in patients with moderate or severe hepatic impairment.1 (See Special Populations under Pharmacokinetics.)

Renal Impairment

Clearance not affected by mild or moderate renal impairment.1 2 Limited data available in patients with severe renal impairment.1 (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Fatigue,1 5 6 musculoskeletal pain,1 constipation,1 decreased appetite/hypophagia,1 nausea,1 peripheral edema,1 urinary tract infection,1 abdominal pain,1 pyrexia/tumor-associated fever,1 diarrhea/colitis,1 dyspnea/exertional dyspnea,1 rash,1 cough/productive cough,1 hyponatremia,1 lymphopenia.1

Interactions for Imfinzi

No formal drug interaction studies to date.1

Imfinzi Pharmacokinetics

Absorption

Bioavailability

Steady-state concentrations achieved within approximately 16 weeks.1

Systemic exposure is dose proportional over dosage range of 3–20 mg/kg.1

Distribution

Extent

Not known whether durvalumab is distributed into milk.1

Elimination

Half-life

Approximately 17 days.1

Special Populations

Mild hepatic impairment (total bilirubin concentrations not exceeding the ULN with AST concentrations exceeding the ULN, or total bilirubin concentrations >1 to 1.5 times the ULN with any AST concentrations): Clearance similar to that in patients with normal hepatic function.1 2

Moderate or severe hepatic impairment (total bilirubin concentrations >1.5 times the ULN with any AST concentrations): Data not available.1

Mild or moderate renal impairment (Clcr 30–89 mL/minute per 1.73 m2): Clearance similar to that in patients with normal renal function.1 2

Severe renal impairment (Clcr 15–29 mL/minute per 1.73 m2): Data not available.1

Age (range: 19–96 years), body weight (34–149 kg), gender, race, albumin concentrations, LDH concentrations, Scr, PD-L1 expression, and ECOG performance status do not have meaningful effects on pharmacokinetics of durvalumab.1

Stability

Storage

Parenteral

Injection

2–8°C in original carton.1 Do not freeze; protect from light.1

Diluted solution may be stored at room temperature for up to 4 hours from time of preparation (including infusion time) or 2–8°C for up to 24 hours.1 Do not freeze.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible

Dextrose 5% in water1

Sodium chloride 0.9%1

Actions

  • IgG1 kappa immunoglobulin that binds to PD-L1.1

  • Overexpression of programmed-death receptor-1 (PD-1) ligands on surface of tumor cells results in activation of PD-1 and CD80 (i.e., B7.1) and suppression of cytotoxic T-cell activity, T-cell proliferation, and cytokine production.1 8

  • Blocks interaction between PD-L1 and the receptors PD-1 and CD80, resulting in activation of antitumor immune response without inducing antibody-dependent cell-mediated cytotoxicity (ADCC).1 8 10

Advice to Patients

  • Importance of advising patients to read the manufacturer's medication guide.1

  • Risk of immune-mediated pneumonitis.1 Importance of informing clinician immediately if new or worsening cough, chest pain, or shortness of breath occurs.1

  • Risk of immune-mediated hepatitis.1 Importance of informing clinician immediately if signs and symptoms of liver damage (e.g., jaundice, severe nausea or vomiting, abdominal pain [particularly in right upper quadrant], lethargy, easy bruising or bleeding) occur.1

  • Risk of immune-mediated colitis.1 Importance of informing clinician immediately if diarrhea, severe abdominal pain, or changes in stool occur.1

  • Risk of immune-mediated endocrine effects.1 Importance of informing clinician immediately if manifestations of hypophysitis, hyperthyroidism, hypothyroidism, adrenal insufficiency, or type 1 diabetes mellitus occur.1

  • Risk of other immune-mediated adverse effects.1 Importance of informing clinician immediately if manifestations of rash, nephritis, aseptic meningitis, thrombocytopenic purpura, myocarditis, hemolytic anemia, myositis, uveitis, or keratitis occur.1

  • Risk of infections.1 Importance of informing clinician if fever, flu-like symptoms, cough, or painful or frequent urination occurs.1

  • Risk of infusion-related reactions.1 Importance of informing clinician if signs and symptoms of such reactions, including dizziness, chills, fever, breathing difficulty (e.g., shortness of breath, wheezing), pruritus, flushing, feeling of faintness, back or neck pain, or angioedema, occur.1

  • Risk of fetal harm.1 Necessity of advising women of childbearing potential to use an effective method of contraception while receiving the drug and for at least 3 months after discontinuance of therapy.1 Importance of women informing clinicians if they are or plan to become pregnant.1 If pregnancy occurs, advise pregnant women of potential risk to the fetus.1

  • Importance of advising women to avoid breast-feeding while receiving the drug and for at least 3 months after discontinuance of therapy.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., autoimmune disorders, history of organ transplantation, liver damage, pulmonary disorders).1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of durvalumab is restricted.3 4 (See Restricted Distribution under Dosage and Administration.)

Durvalumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Concentrate, for injection, for IV infusion

50 mg/mL (120 and 500 mg)

Imfinzi

AstraZeneca

AHFS DI Essentials. © Copyright 2018, Selected Revisions June 18, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. AstraZeneca. Imfinzi (durvalumab) injection for intravenous infusion prescribing information. Wilmington, DE; 2017 May.

2. Food and Drug Administration. Center for Drug Evaluation and Research. Application number 761069Orig1s000: Summary review(s). From FDA website. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761069Orig1s000SumR.pdf

3. AstraZeneca. Imfinzi (durvalumab) access and reimbursement guide. From AstraZeneca website. Accessed 2017 Sep 21. https://www.imfinzi.com/content/dam/website-services/us/434-imfinzi-com/hcp/pdf/how_to_order_IMFINZI.pdf

4. AstraZeneca. Imfinzi distribution. From AstraZeneca website. Accessed 2017 Sep 21. https://www.imfinzi.com/hcp/urothelial-carcinoma/how-to-order-imfinzi.html#how-to-order

5. Massard C, Gordon MS, Sharma S et al. Safety and Efficacy of Durvalumab (MEDI4736), an Anti-Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Urothelial Bladder Cancer. J Clin Oncol. 2016; 34:3119-25. http://www.ncbi.nlm.nih.gov/pubmed/27269937?dopt=AbstractPlus

6. Powles T, O'Donnell PH, Massard C et al. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017; 3:e172411. http://www.ncbi.nlm.nih.gov/pubmed/28817753?dopt=AbstractPlus

7. Bellmunt J, Powles T, Vogelzang NJ. A review on the evolution of PD-1/PD-L1 immunotherapy for bladder cancer: The future is now. Cancer Treat Rev. 2017; 54:58-67. http://www.ncbi.nlm.nih.gov/pubmed/28214651?dopt=AbstractPlus

8. Lee HT, Lee JY, Lim H et al. Molecular mechanism of PD-1/PD-L1 blockade via anti-PD-L1 antibodies atezolizumab and durvalumab. Sci Rep. 2017; 7:5532. http://www.ncbi.nlm.nih.gov/pubmed/28717238?dopt=AbstractPlus

9. Stewart R, Morrow M, Hammond SA et al. Identification and Characterization of MEDI4736, an Antagonistic Anti-PD-L1 Monoclonal Antibody. Cancer Immunol Res. 2015; 3:1052-62. http://www.ncbi.nlm.nih.gov/pubmed/25943534?dopt=AbstractPlus

10. Syed YY. Durvalumab: First Global Approval. Drugs. 2017; 77:1369-1376. http://www.ncbi.nlm.nih.gov/pubmed/28643244?dopt=AbstractPlus

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