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 * Efficacy
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     PATIENT CHARACTERISTICS
 * Patient-Reported Outcomes
   * GLOBAL HEALTH STATUS/QoL AND
     FUNCTIONING SCALES
   * SYMPTOM SCALES
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   * ADVERSE REACTIONS
   * IMMUNE-MEDIATED ADVERSE REACTIONS
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Unresectable Stage III

Non-small Cell Lung Cancer

Extensive-Stage

Small Cell Lung Cancer

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GLOBAL HEALTH STATUS/QUALITY OF LIFE AND FUNCTIONING SCALES IN ES-SCLC

Patient-reported outcomes in prespecified analyses with IMFINZI + EP1

 * In the CASPIAN study, PROs were assessed at randomization, every 3 weeks
   during induction, every 4 weeks until disease progression, and every 8 weeks
   until secondary progression2
 * Time to deterioration of HRQoL/functioning and symptoms was the time from
   randomization until the first clinically meaningful confirmed deterioration2
 * Results should be interpreted based on the open-label study design and were
   not tested for statistical significance1
 * Compliance for PROs was >60% up to Cycle 23 for the IMFINZI + EP arm and up
   to Cycle 7 in the EP arm2

TIME TO DETERIORATION IN HRQOL AND FUNCTIONING SCALES2



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Health-related quality of life and functioning were assessed using EORTC
QLQ-C302

 * In the CASPIAN study, global health status/QoL and functioning scores at
   baseline were comparable between arms2
 * EORTC QLQ-C30 is an integrated questionnaire for assessing HRQoL of cancer
   patients participating in clinical trials using a scale of 0 to 100 with high
   scores representing high or healthy levels of functioning/high QoL3
 * Clinically meaningful deterioration in HRQoL/functioning was predefined as a
   decrease from baseline of ≥10 points2,4,5
 * The QLQ-C30 includes a global health status/QoL scale, 5 functional scales, 3
   symptom scales, and 6 single items3

ES-SCLC=extensive-stage small cell lung cancer; EP=etoposide and either
carboplatin or cisplatin; PROs=patient-reported outcomes; HRQoL=health-related
quality of life; EORTC QLQ=European Organisation for Research and Treatment of
Cancer Quality of Life Questionnaire; HR=hazard ratio; CI=confidence interval;
QoL=quality of life.

 


SYMPTOM SCALES IN ES-SCLC

Patient-reported outcomes in prespecified analyses with IMFINZI + EP1

 * In the CASPIAN study, PROs were assessed at randomization, every 3 weeks
   during induction, every 4 weeks until disease progression, and every 8 weeks
   until secondary progression2
 * Time to deterioration of HRQoL/functioning and symptoms was the time from
   randomization until the first clinically meaningful confirmed deterioration
 * Results should be interpreted based on the open-label study design and were
   not tested for statistical significance1
 * Compliance for PROs was >60% up to Cycle 23 for the IMFINZI + EP arm and up
   to Cycle 7 in the EP arm2

TIME TO DETERIORATION IN SYMPTOM SCALES2



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Symptoms were assessed using EORTC QLQ-C30 and QLQ-LC132

 * In the CASPIAN study, symptom scores at baseline were comparable between
   arms2
 * EORTC QLQ-LC13 is a supplementary questionnaire designed to evaluate symptoms
   and side effects specifically in lung cancer patients when used in
   conjunction with the QLQ-C303
 * The QLQ-LC13 and QLQ-C30 use the same 0 to 100 scale, but high scores
   represent a high level of symptom severity3
 * Clinically meaningful deterioration in symptoms was predefined as an increase
   from baseline of ≥10 points2,4,5

 



IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab).


INDICATION

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).


IMMUNE-MEDIATED ADVERSE REACTIONS

Important immune-mediated adverse reactions listed under Warnings and
Precautions may not include all possible severe and fatal immune-mediated
reactions. Immune-mediated adverse reactions, which may be severe or fatal, can
occur in any organ system or tissue. Immune-mediated adverse reactions can occur
at any time after starting treatment or after discontinuation. Monitor patients
closely for symptoms and signs that may be clinical manifestations of underlying
immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and
thyroid function at baseline and periodically during treatment. In cases of
suspected immune-mediated adverse reactions, initiate appropriate workup to
exclude alternative etiologies, including infection. Institute medical
management promptly, including specialty consultation as appropriate. Withhold
or permanently discontinue IMFINZI depending on severity. See Dosing and
Administration for specific details. In general, if IMFINZI requires
interruption or discontinuation, administer systemic corticosteroid therapy (1
mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or
less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Consider administration of other
systemic immunosuppressants in patients whose immune-mediated adverse reactions
are not controlled with corticosteroid therapy.


IMMUNE-MEDIATED ADVERSE REACTIONS

Important immune-mediated adverse reactions listed under Warnings and
Precautions may not include all possible severe and fatal immune-mediated
reactions. Immune-mediated adverse reactions, which may be severe or fatal, can
occur in any organ system or tissue. Immune-mediated adverse reactions can occur
at any time after starting treatment or after discontinuation. Monitor patients
closely for symptoms and signs that may be clinical manifestations of underlying
immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and
thyroid function at baseline and periodically during treatment. In cases of
suspected immune-mediated adverse reactions, initiate appropriate workup to
exclude alternative etiologies, including infection. Institute medical
management promptly, including specialty consultation as appropriate. Withhold
or permanently discontinue IMFINZI depending on severity. See Dosing and
Administration for specific details. In general, if IMFINZI requires
interruption or discontinuation, administer systemic corticosteroid therapy (1
mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or
less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Consider administration of other
systemic immunosuppressants in patients whose immune-mediated adverse reactions
are not controlled with corticosteroid therapy.


IMMUNE-MEDIATED PNEUMONITIS

IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is
higher in patients who have received prior thoracic radiation. In patients who
did not receive recent prior radiation, the incidence of immune-mediated
pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%)
adverse reactions. In patients who received recent prior radiation, the
incidence of pneumonitis (including radiation pneumonitis) in patients with
unresectable Stage III NSCLC following definitive chemoradiation within 42 days
prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients
receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the
patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3
adverse reactions. The frequency and severity of immune-mediated pneumonitis in
patients who did not receive definitive chemoradiation prior to IMFINZI were
similar in patients who received IMFINZI as a single agent or with ES-SCLC when
in combination with chemotherapy.


IMMUNE-MEDIATED COLITIS

IMFINZI can cause immune-mediated colitis that is frequently associated with
diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in
patients with corticosteroid-refractory immune-mediated colitis. In cases of
corticosteroid-refractory colitis, consider repeating infectious workup to
exclude alternative etiologies. Immune-mediated colitis occurred in 2% (37/1889)
of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%)
adverse reactions.


IMMUNE-MEDIATED HEPATITIS

IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred
in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4
(0.3%) and Grade 3 (1.4%) adverse reactions.


IMMUNE-MEDIATED ENDOCRINOPATHIES

 * Adrenal Insufficiency: IMFINZI can cause primary or secondary adrenal
   insufficiency. For Grade 2 or higher adrenal insufficiency, initiate
   symptomatic treatment, including hormone replacement as clinically indicated.
   Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients
   receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Hypophysitis: IMFINZI can cause immune-mediated hypophysitis. Hypophysitis
   can present with acute symptoms associated with mass effect such as headache,
   photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism.
   Initiate symptomatic treatment including hormone replacement as clinically
   indicated. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of
   patients who received IMFINZI.
 * Thyroid Disorders: IMFINZI can cause immune-mediated thyroid disorders.
   Thyroiditis can present with or without endocrinopathy. Hypothyroidism can
   follow hyperthyroidism. Initiate hormone replacement therapy for
   hypothyroidism or institute medical management of hyperthyroidism as
   clinically indicated.
 * Thyroiditis: Immune-mediated thyroiditis occurred in 0.5% (9/1889) of
   patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 2.1% (39/1889)
   of patients receiving IMFINZI.
 * Hypothyroidism: Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of
   patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis:
   Monitor patients for hyperglycemia or other signs and symptoms of diabetes.
   Initiate treatment with insulin as clinically indicated. Grade 3
   immune-mediated type 1 diabetes mellitus occurred in <0.1% (1/1889) of
   patients receiving IMFINZI.


IMMUNE-MEDIATED NEPHRITIS WITH RENAL DYSFUNCTION

IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred
in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%)
adverse reactions.


IMMUNE-MEDIATED DERMATOLOGY REACTIONS

IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis,
including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and
systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred
with PD-1/L-1 blocking antibodies. Topical emollients and/or topical
corticosteroids may be adequate to treat mild to moderate non-exfoliative
rashes. Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of
patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.


OTHER IMMUNE-MEDIATED ADVERSE REACTIONS

The following clinically significant, immune-mediated adverse reactions occurred
at an incidence of less than 1% each in patients who received IMFINZI or were
reported with the use of other PD-1/PD-L1 blocking antibodies.

 * Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
 * Nervous system: Meningitis, encephalitis, myelitis and demyelination,
   myasthenic syndrome/myasthenia gravis (including exacerbation),
   Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
 * Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur.
   Some cases can be associated with retinal detachment. Various grades of
   visual impairment to include blindness can occur. If uveitis occurs in
   combination with other immune-mediated adverse reactions, consider a
   Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with
   systemic steroids to reduce the risk of permanent vision loss.
 * Gastrointestinal: Pancreatitis including increases in serum amylase and
   lipase levels, gastritis, duodenitis.
 * Musculoskeletal and connective tissue disorders: Myositis/polymyositis,
   rhabdomyolysis and associated sequelae including renal failure, arthritis,
   polymyalgia rheumatic.
 * Endocrine: Hypoparathyroidism
 * Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic
   lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic
   necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune
   thrombocytopenia, solid organ transplant rejection.


INFUSION-RELATED REACTIONS

IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor
for signs and symptoms of infusion-related reactions. Interrupt, slow the rate
of, or permanently discontinue IMFINZI based on the severity. See Dosing and
Administration for specific details. For Grade 1 or 2 infusion-related
reactions, consider using pre-medications with subsequent doses.
Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving
IMFINZI, including Grade 3 (0.3%) adverse reactions.


COMPLICATIONS OF ALLOGENEIC HSCT AFTER IMFINZI

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. 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).
These complications may occur despite intervening therapy between PD-1/L-1
blockade and allogeneic HSCT. Follow patients closely for evidence of
transplant-related complications and intervene promptly. Consider the benefit
versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an
allogeneic HSCT.


EMBRYO-FETAL TOXICITY

Based on its mechanism of action and data from animal studies, IMFINZI can cause
fetal harm when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. 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.


LACTATION

There is no information regarding the presence of IMFINZI in human milk;
however, because of the potential for adverse reactions in breastfed infants
from IMFINZI, advise women not to breastfeed during treatment and for at least 3
months after the last dose.


ADVERSE REACTIONS

 * 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%). The most common
   Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%)
 * In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI
   plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions
   in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse
   reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy.
   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%). Fatal adverse
   reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy

The safety and effectiveness of IMFINZI have not been established in pediatric
patients.


INDICATION

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).

Please see complete Prescribing Information, including Medication Guide.

You may report side effects related to AstraZeneca products by clicking here.



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IMPORTANT SAFETY INFORMATION +

There are no contraindications for IMFINZI® (durvalumab).


IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab).


INDICATION+

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).

References: 1. 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): a randomised, controlled,
open-label, phase 3 trial. Lancet. 2019;394(10212):1929-1939. 2. Goldman JW,
Garassino MC, Chen Y, et al. Patient-reported outcomes with first-line
durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage
small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase
III study. Lung Cancer. 2020;149:46-52. 3. Fayers PM, Aaronson NK, Bjordal K, et
al. The EORTC QLQ-C30 Scoring Manual. 3rd ed. Brussels, Belgium: European
Organisation for Research and Treatment of Cancer; 2001. 4. Cocks K, King MT,
Velikova G, et al. Evidence-based guidelines for interpreting change scores for
the European Organisation for the Research and Treatment of Cancer Quality of
Life Questionnaire Core 30. Eur J Cancer. 2012;48(11):1713-1721. 5. Osoba D,
Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes
in health-related quality-of-life scores. J Clin Oncol. 1998;16(1):139-144.

 * Contact Us
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 * Legal Statement
 * Site Map

This product information is intended for US Healthcare Professionals only.

IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of
the AstraZeneca group of companies.

©2021 AstraZeneca. All rights reserved. US-33659; US-39734; US-44309; US-47522;
US-55480; US-55053 Last Updated 9/21





+


IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab).


IMMUNE-MEDIATED ADVERSE REACTIONS

Important immune-mediated adverse reactions listed under Warnings and
Precautions may not


INDICATION

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).

+


IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab).


IMMUNE-MEDIATED ADVERSE REACTIONS

Important immune-mediated adverse reactions listed under Warnings and
Precautions may not


INDICATION

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).


SEE FULL INDICATION

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).


IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab).


IMMUNE-MEDIATED ADVERSE REACTIONS

Important immune-mediated adverse reactions listed under Warnings and
Precautions may not include all possible severe and fatal immune-mediated
reactions. Immune-mediated adverse reactions, which may be severe or fatal, can
occur in any organ system or tissue. Immune-mediated adverse reactions can occur
at any time after starting treatment or after discontinuation. Monitor patients
closely for symptoms and signs that may be clinical manifestations of underlying
immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and
thyroid function at baseline and periodically during treatment. In cases of
suspected immune-mediated adverse reactions, initiate appropriate workup to
exclude alternative etiologies, including infection. Institute medical
management promptly, including specialty consultation as appropriate. Withhold
or permanently discontinue IMFINZI depending on severity. See Dosing and
Administration for specific details. In general, if IMFINZI requires
interruption or discontinuation, administer systemic corticosteroid therapy (1
mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or
less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Consider administration of other
systemic immunosuppressants in patients whose immune-mediated adverse reactions
are not controlled with corticosteroid therapy.


IMMUNE-MEDIATED PNEUMONITIS

IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is
higher in patients who have received prior thoracic radiation. In patients who
did not receive recent prior radiation, the incidence of immune-mediated
pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%)
adverse reactions. In patients who received recent prior radiation, the
incidence of pneumonitis (including radiation pneumonitis) in patients with
unresectable Stage III NSCLC following definitive chemoradiation within 42 days
prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients
receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the
patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3
adverse reactions. The frequency and severity of immune-mediated pneumonitis in
patients who did not receive definitive chemoradiation prior to IMFINZI were
similar in patients who received IMFINZI as a single agent or with ES-SCLC when
in combination with chemotherapy.


IMMUNE-MEDIATED COLITIS

IMFINZI can cause immune-mediated colitis that is frequently associated with
diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in
patients with corticosteroid-refractory immune-mediated colitis. In cases of
corticosteroid-refractory colitis, consider repeating infectious workup to
exclude alternative etiologies. Immune-mediated colitis occurred in 2% (37/1889)
of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%)
adverse reactions.


IMMUNE-MEDIATED HEPATITIS

IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred
in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4
(0.3%) and Grade 3 (1.4%) adverse reactions.


IMMUNE-MEDIATED ENDOCRINOPATHIES

 * Adrenal Insufficiency: IMFINZI can cause primary or secondary adrenal
   insufficiency. For Grade 2 or higher adrenal insufficiency, initiate
   symptomatic treatment, including hormone replacement as clinically indicated.
   Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients
   receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Hypophysitis: IMFINZI can cause immune-mediated hypophysitis. Hypophysitis
   can present with acute symptoms associated with mass effect such as headache,
   photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism.
   Initiate symptomatic treatment including hormone replacement as clinically
   indicated. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of
   patients who received IMFINZI.
 * Thyroid Disorders: IMFINZI can cause immune-mediated thyroid disorders.
   Thyroiditis can present with or without endocrinopathy. Hypothyroidism can
   follow hyperthyroidism. Initiate hormone replacement therapy for
   hypothyroidism or institute medical management of hyperthyroidism as
   clinically indicated.
 * Thyroiditis: Immune-mediated thyroiditis occurred in 0.5% (9/1889) of
   patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 2.1% (39/1889)
   of patients receiving IMFINZI.
 * Hypothyroidism: Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of
   patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis:
   Monitor patients for hyperglycemia or other signs and symptoms of diabetes.
   Initiate treatment with insulin as clinically indicated. Grade 3
   immune-mediated type 1 diabetes mellitus occurred in <0.1% (1/1889) of
   patients receiving IMFINZI.


IMMUNE-MEDIATED NEPHRITIS WITH RENAL DYSFUNCTION

IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred
in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%)
adverse reactions.


IMMUNE-MEDIATED DERMATOLOGY REACTIONS

IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis,
including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and
systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred
with PD-1/L-1 blocking antibodies. Topical emollients and/or topical
corticosteroids may be adequate to treat mild to moderate non-exfoliative
rashes. Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of
patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.


OTHER IMMUNE-MEDIATED ADVERSE REACTIONS

The following clinically significant, immune-mediated adverse reactions occurred
at an incidence of less than 1% each in patients who received IMFINZI or were
reported with the use of other PD-1/PD-L1 blocking antibodies.

 * Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
 * Nervous system: Meningitis, encephalitis, myelitis and demyelination,
   myasthenic syndrome/myasthenia gravis (including exacerbation),
   Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
 * Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur.
   Some cases can be associated with retinal detachment. Various grades of
   visual impairment to include blindness can occur. If uveitis occurs in
   combination with other immune-mediated adverse reactions, consider a
   Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with
   systemic steroids to reduce the risk of permanent vision loss.
 * Gastrointestinal: Pancreatitis including increases in serum amylase and
   lipase levels, gastritis, duodenitis.
 * Musculoskeletal and connective tissue disorders: Myositis/polymyositis,
   rhabdomyolysis and associated sequelae including renal failure, arthritis,
   polymyalgia rheumatic.
 * Endocrine: Hypoparathyroidism
 * Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic
   lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic
   necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune
   thrombocytopenic purpura, solid organ transplant rejection.


INFUSION-RELATED REACTIONS

IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor
for signs and symptoms of infusion-related reactions. Interrupt, slow the rate
of, or permanently discontinue IMFINZI based on the severity. See Dosing and
Administration for specific details. For Grade 1 or 2 infusion-related
reactions, consider using pre-medications with subsequent doses.
Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving
IMFINZI, including Grade 3 (0.3%) adverse reactions.


COMPLICATIONS OF ALLOGENEIC HSCT AFTER IMFINZI

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. 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).
These complications may occur despite intervening therapy between PD-1/L-1
blockade and allogeneic HSCT. Follow patients closely for evidence of
transplant-related complications and intervene promptly. Consider the benefit
versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an
allogeneic HSCT.


EMBRYO-FETAL TOXICITY

Based on its mechanism of action and data from animal studies, IMFINZI can cause
fetal harm when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. 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.


LACTATION

There is no information regarding the presence of IMFINZI in human milk;
however, because of the potential for adverse reactions in breastfed infants
from IMFINZI, advise women not to breastfeed during treatment and for at least 3
months after the last dose.


ADVERSE REACTIONS

 * 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%). The most common
   Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%)
 * In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI
   plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions
   in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse
   reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy.
   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%). Fatal adverse
   reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy

The safety and effectiveness of IMFINZI have not been established in pediatric
patients.


INDICATION

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).

Please see complete Prescribing Information, including Medication Guide.

Top

SCLC-POPUP

FOR US HEALTHCARE PROFESSIONALS

IMFINZI + EP for first-line ES-SCLC

NEW: UNPRECEDENTED 3-YEAR OVERALL SURVIVAL IN 1L ES-SCLC1

Superior overall survival at interim analysis2*





SEE THE NEW DATA

EP=etoposide and either carboplatin or cisplatin; 1L=first line;
ES-SCLC=extensive-stage small cell lung cancer; mOS=median overall survival;
HR=hazard ratio; CI=confidence interval; OS=overall survival.

*Overall survival was the primary endpoint. At the time of the planned interim
overall survival analysis with a median duration of follow-up of 14.2 months,
mOS was 13 months (95% CI, 11.5-14.8) with IMFINZI + EP vs 10.3 months (95% CI,
9.3-11.2) with EP alone (HR=0.73; 95% CI, 0.59-0.91; P=0.0047).2,3

†The planned exploratory 3-year OS analysis was conducted at ~3 years after the
last patient was randomized, and was not formally tested for statistical
significance. At the time of the 3-year analysis, mOS was 12.9 months (95% CI,
11.3-14.7) with IMFINZI + EP vs 10.5 months (95% CI, 9.3-11.2) with EP alone
(HR=0.71; 95% CI, 0.60-0.86).1


IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab).


INDICATION

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).


IMMUNE-MEDIATED ADVERSE REACTIONS

Important immune-mediated adverse reactions listed under Warnings and
Precautions may not include all possible severe and fatal immune-mediated
reactions. Immune-mediated adverse reactions, which may be severe or fatal, can
occur in any organ system or tissue. Immune-mediated adverse reactions can occur
at any time after starting treatment or after discontinuation. Monitor patients
closely for symptoms and signs that may be clinical manifestations of underlying
immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and
thyroid function at baseline and periodically during treatment. In cases of
suspected immune-mediated adverse reactions, initiate appropriate workup to
exclude alternative etiologies, including infection. Institute medical
management promptly, including specialty consultation as appropriate. Withhold
or permanently discontinue IMFINZI depending on severity. See Dosing and
Administration for specific details. In general, if IMFINZI requires
interruption or discontinuation, administer systemic corticosteroid therapy (1
mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or
less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Consider administration of other
systemic immunosuppressants in patients whose immune-mediated adverse reactions
are not controlled with corticosteroid therapy.


IMMUNE-MEDIATED PNEUMONITIS

IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is
higher in patients who have received prior thoracic radiation. In patients who
did not receive recent prior radiation, the incidence of immune-mediated
pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%)
adverse reactions. In patients who received recent prior radiation, the
incidence of pneumonitis (including radiation pneumonitis) in patients with
unresectable Stage III NSCLC following definitive chemoradiation within 42 days
prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients
receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the
patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3
adverse reactions. The frequency and severity of immune-mediated pneumonitis in
patients who did not receive definitive chemoradiation prior to IMFINZI were
similar in patients who received IMFINZI as a single agent or with ES-SCLC when
in combination with chemotherapy.


IMMUNE-MEDIATED COLITIS

IMFINZI can cause immune-mediated colitis that is frequently associated with
diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in
patients with corticosteroid-refractory immune-mediated colitis. In cases of
corticosteroid-refractory colitis, consider repeating infectious workup to
exclude alternative etiologies. Immune-mediated colitis occurred in 2% (37/1889)
of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%)
adverse reactions.


IMMUNE-MEDIATED HEPATITIS

IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred
in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4
(0.3%) and Grade 3 (1.4%) adverse reactions.


IMMUNE-MEDIATED ENDOCRINOPATHIES

 * Adrenal Insufficiency: IMFINZI can cause primary or secondary adrenal
   insufficiency. For Grade 2 or higher adrenal insufficiency, initiate
   symptomatic treatment, including hormone replacement as clinically indicated.
   Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients
   receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Hypophysitis: IMFINZI can cause immune-mediated hypophysitis. Hypophysitis
   can present with acute symptoms associated with mass effect such as headache,
   photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism.
   Initiate symptomatic treatment including hormone replacement as clinically
   indicated. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of
   patients who received IMFINZI.
 * Thyroid Disorders: IMFINZI can cause immune-mediated thyroid disorders.
   Thyroiditis can present with or without endocrinopathy. Hypothyroidism can
   follow hyperthyroidism. Initiate hormone replacement therapy for
   hypothyroidism or institute medical management of hyperthyroidism as
   clinically indicated.
 * Thyroiditis: Immune-mediated thyroiditis occurred in 0.5% (9/1889) of
   patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 2.1% (39/1889)
   of patients receiving IMFINZI.
 * Hypothyroidism: Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of
   patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis:
   Monitor patients for hyperglycemia or other signs and symptoms of diabetes.
   Initiate treatment with insulin as clinically indicated. Grade 3
   immune-mediated type 1 diabetes mellitus occurred in <0.1% (1/1889) of
   patients receiving IMFINZI.


IMMUNE-MEDIATED NEPHRITIS WITH RENAL DYSFUNCTION

IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred
in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%)
adverse reactions.


IMMUNE-MEDIATED DERMATOLOGY REACTIONS

IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis,
including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and
systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred
with PD-1/L-1 blocking antibodies. Topical emollients and/or topical
corticosteroids may be adequate to treat mild to moderate non-exfoliative
rashes. Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of
patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.


OTHER IMMUNE-MEDIATED ADVERSE REACTIONS

The following clinically significant, immune-mediated adverse reactions occurred
at an incidence of less than 1% each in patients who received IMFINZI or were
reported with the use of other PD-1/PD-L1 blocking antibodies.

 * Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
 * Nervous system: Meningitis, encephalitis, myelitis and demyelination,
   myasthenic syndrome/myasthenia gravis (including exacerbation),
   Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
 * Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur.
   Some cases can be associated with retinal detachment. Various grades of
   visual impairment to include blindness can occur. If uveitis occurs in
   combination with other immune-mediated adverse reactions, consider a
   Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with
   systemic steroids to reduce the risk of permanent vision loss.
 * Gastrointestinal: Pancreatitis including increases in serum amylase and
   lipase levels, gastritis, duodenitis.
 * Musculoskeletal and connective tissue disorders: Myositis/polymyositis,
   rhabdomyolysis and associated sequelae including renal failure, arthritis,
   polymyalgia rheumatic.
 * Endocrine: Hypoparathyroidism
 * Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic
   lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic
   necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune
   thrombocytopenia, solid organ transplant rejection.


INFUSION-RELATED REACTIONS

IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor
for signs and symptoms of infusion-related reactions. Interrupt, slow the rate
of, or permanently discontinue IMFINZI based on the severity. See Dosing and
Administration for specific details. For Grade 1 or 2 infusion-related
reactions, consider using pre-medications with subsequent doses.
Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving
IMFINZI, including Grade 3 (0.3%) adverse reactions.


COMPLICATIONS OF ALLOGENEIC HSCT AFTER IMFINZI

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. 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).
These complications may occur despite intervening therapy between PD-1/L-1
blockade and allogeneic HSCT. Follow patients closely for evidence of
transplant-related complications and intervene promptly. Consider the benefit
versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an
allogeneic HSCT.


EMBRYO-FETAL TOXICITY

Based on its mechanism of action and data from animal studies, IMFINZI can cause
fetal harm when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. 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.


LACTATION

There is no information regarding the presence of IMFINZI in human milk;
however, because of the potential for adverse reactions in breastfed infants
from IMFINZI, advise women not to breastfeed during treatment and for at least 3
months after the last dose.


ADVERSE REACTIONS

 * 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%). The most common
   Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%)
 * In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI
   plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions
   in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse
   reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy.
   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%). Fatal adverse
   reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy

The safety and effectiveness of IMFINZI have not been established in pediatric
patients.


INDICATION

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).

Please see complete Prescribing Information, including Medication Guide.

You may report side effects related to AstraZeneca products by clicking here.

References: 1. Paz-Ares L, Chen Y, Reinmuth N, et al. Durvalumab ± tremelimumab
+ platinum-etoposide in first-line extensive-stage SCLC (ES-SCLC): 3-year
overall survival update from the phase 3 CASPIAN study [presentation]. Presented
at: European Society for Medical Oncology (ESMO) Virtual Annual Meeting;
September 17-21, 2021. 2. IMFINZI® (durvalumab) [Prescribing Information].
Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021. 3. 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): a
randomised, controlled, open-label, phase 3 trial. Lancet.
2019;394(10212):1929-1939.

IMFINZI is a registered trademark of the AstraZeneca group of companies.

©2021 AstraZeneca. All rights reserved. US-54776 Last Updated 9/21