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 * Efficacy
   * OVERALL SURVIVAL
   * PROGRESSION-FREE SURVIVAL
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     PATIENT CHARACTERISTICS
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Unresectable Stage III

Non-small Cell Lung Cancer

Extensive-Stage

Small Cell Lung Cancer

Connect with your REP

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NEW APPROVAL


OVERALL SURVIVAL: 3-YEAR ANALYSIS

IMFINZI + EP: The only IO combination with 3-year overall survival in 1L
ES-SCLC1

SUPERIOR OVERALL SURVIVAL AT INTERIM ANALYSIS2*
(MEDIAN DURATION OF FOLLOW-UP 14.2 MONTHS)2,3





NEW DATA

OVERALL SURVIVAL AT 3-YEAR PLANNED EXPLORATORY ANALYSIS1†
(MEDIAN DURATION OF FOLLOW-UP 39.4 MONTHS)




 * 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

Durvalumab (IMFINZI®) + etoposide with either cisplatin or carboplatin is a
Category 1, preferred treatment option for first-line ES-SCLC3‡§

ES-SCLC=extensive-stage small cell lung cancer; EP=etoposide and either
carboplatin or cisplatin; IO=immuno-oncology; 1L=first line; 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).2,4

†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. OS rates at 12, 24, and 36 months are the estimated proportion of
patients alive based on the 3-year analysis.1

‡Preferred intervention=intervention that is based on superior efficacy, safety,
and evidence, and, when appropriate, affordability. Category 1=based upon
high-level evidence, there is uniform National Comprehensive Cancer Network®
(NCCN®) consensus that the intervention is appropriate. NCCN makes no warranties
of any kind whatsoever regarding their content, use, or application and
disclaims any responsibility for their application or use in any way. To view
the most recent and complete version of the guideline, go online to NCCN.org.



§See the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for
detailed recommendations, including other preferred treatment options.3

OS with IMFINZI + EP remained consistent across all subgroups with >3 years of
follow-up1

PRESPECIFIED SUBGROUP OVERALL SURVIVAL ANALYSIS1
(MEDIAN DURATION OF FOLLOW-UP 39.4 MONTHS)



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OS subgroup analysis was not powered to show differences between or within
individual subgroups, and was not formally tested for statistical significance.4

IMFINZI + EP was evaluated in key patient subgroups reflective of clinical
practice in ES-SCLC, including4-9:

 * Patients with brain/CNS metastases
 * Patients who received cisplatin or carboplatin
 * Patients over 65

ECOG=Eastern Cooperative Oncology Group; WHO=World Health Organization;
PS=performance status; CNS=central nervous system; AJCC=American Joint Committee
on Cancer.

 


PROGRESSION-FREE SURVIVAL

Landmark progression-free survival data for IMFINZI + EP with >2 years of median
follow-up4,10

Progression-free survival was not evaluated at the 3-year analysis.

PROGRESSION-FREE SURVIVAL AT 2-YEAR ANALYSIS10*
(MEDIAN DURATION OF FOLLOW-UP 25.1 MONTHS)







 * Median PFS at the interim analysis was 5.1 months (95% CI, 4.7-6.2) with
   IMFINZI + EP and 5.4 months (95% CI, 4.8-6.2) with EP alone (HR=0.78; 95% CI,
   0.65-0.94; 96% of total planned events)2
    * Median PFS did not change at the 2-year analysis2,10

 * PFS was not formally tested for statistical significance4,10
 * PFS rate at 12 months was a secondary endpoint at the interim and 2-year
   analyses4

PFS=progression-free survival.

*PFS rates at 12 and 24 months are the estimated proportion of patients alive
and progression free based on the 2-year analysis.10

 


OBJECTIVE RESPONSE RATE AND DURATION OF RESPONSE IN ES-SCLC

IMFINZI + EP provided a high response rate and demonstrated ongoing responses at
1 and 2 years10

Objective response rate and median duration of response were not evaluated at
the 3-year analysis.

CONFIRMED OBJECTIVE RESPONSE RATE
(POST-HOC ANALYSIS)10*
(MEDIAN DURATION OF FOLLOW-UP 25.1 MONTHS)




 * Complete responses: 3% with IMFINZI + EP and 1% with EP alone10
 * Partial responses: 65% with IMFINZI + EP and 57% with EP alone10

PERCENTAGE OF RESPONDERS WITH ONGOING RESPONSES (POST-HOC ANALYSIS)10 (MEDIAN
DURATION OF FOLLOW-UP 25.1 MONTHS)




 * Number of responders: 182 with IMFINZI + EP and 156 with EP alone10
 * Median duration of response: 5.1 months (95% CI, 4.9-5.3) with IMFINZI + EP
   and 5.1 months (95% CI, 4.8-5.3) for patients treated with EP alone10

RECIST=Response Evaluation Criteria in Solid Tumors.

*Investigator assessed per RECIST v1.1.

 


CASPIAN STUDY DESIGN AND PATIENT CHARACTERISTICS

The Phase III CASPIAN study compared IMFINZI + EP vs EP and was designed to
reflect real-world clinical practice4,5

A large, randomized, open-label, multicenter study of IMFINZI + etoposide and
platinum-based chemotherapy (EP) vs EP alone2,4



PRIMARY ENDPOINT2,4

Overall survival

KEY SECONDARY ENDPOINTS2,4

 * PFS§
 * ORR (unconfirmed)§
 * OS at 18 months
 * PFS at 6 and 12 months
 * HRQoL patient-reported outcomes

CASPIAN ALLOWED FOR

Investigator’s choice of platinum-based chemotherapy4||

THE CONTROL ARM ALLOWED FOR

Up to 6 cycles of EP. 57% of patients received 6 cycles2

PCI per investigator’s discretion2,4

Patients with asymptomatic or treated brain metastases participated in the
CASPIAN study4¶

Baseline patient characteristics were well balanced between the IMFINZI + EP and
EP arms4

PATIENT CHARACTERISTICS4



IMFINZI + EP
(n=268) EP alone
(n=269) Median age (years) (range) 62 (58-68) 63 (57-68) Gender Male 71% 68%
Female 29% 32% ECOG/WHO PS 0 37% 33% 1 63% 67% Stage III 10% 9% IV 90% 91%
Smoking history Current smoker/former smoker 92% 94% Never smoker 8% 6% Brain or
CNS metastases 10% 10% Liver metastases 40% 39%

Q3W=once every 3 weeks; Q4W=once every 4 weeks; PCI=prophylactic cranial
irradiation; ORR=objective response rate; HRQoL=health-related quality of life;
AUC=area under the curve; CT=computed tomography; MRI=magnetic resonance
imaging.

*IMFINZI 1500 mg + either carboplatin (AUC 5 mg/mL/min or 6 mg/mL/min) or
cisplatin (75 mg/m2-80 mg/m2) on Day 1 and etoposide (80 mg/m2-100 mg/m2)
intravenously on Days 1, 2, and 3 of each 21-day cycle for 4 cycles, followed by
IMFINZI 1500 mg every 4 weeks until disease progression or unacceptable
toxicity.2,4

†Either carboplatin (AUC 5 mg/mL/min or 6 mg/mL/min) or cisplatin (75 mg/m2-80
mg/m2) on Day 1 and etoposide (80 mg/m2-100 mg/m2) intravenously on Days 1, 2,
and 3 of each 21-day cycle for 4 to 6 cycles.2,4

‡8% of patients who were treated with EP alone received PCI post-EP.2,4

§Assessed using investigator assessments according to RECIST v1.1.4

||78% received carboplatin and 25% received cisplatin in the IMFINZI + EP arm;
78% received carboplatin and 25% received cisplatin in the EP alone arm.4

¶Patients with confirmed brain metastases had to be treated and stable off
steroids and anticonvulsants for at least 1 month prior to study treatment.
Patients with suspected brain metastases at screening should have a CT/MRI of
the brain prior to study entry.4

 



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, 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. Referenced with
permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Small Cell Lung Cancer V.1.2022. ©National Comprehensive Cancer
Network, Inc. 2021. All rights reserved. Published August 9, 2021. Accessed
August 16, 2021. To view the most recent and complete version of the guideline,
go online to NCCN.org. 4. 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. 5. Rudin CM,
Ismaila N, Hann CL, et al. Treatment of small-cell lung cancer: American Society
of Clinical Oncology endorsement of the American College of Chest Physicians
Guideline. J Clin Oncol. 2015;33(34):4106-4111. 6. Foster NR, Renfro LA, Schild
SE, et al. Multitrial evaluation of progression-free survival as a surrogate end
point for overall survival in first-line extensive-stage small-cell lung cancer.
J Thorac Oncol. 2015;10(7):1099-1106. 7. Wang S, Zimmermann S, Parikh K,
Mansfield AS, Adjei AA. Current diagnosis and management of small-cell lung
cancer. Mayo Clin Proc. 2019;94(8):1599-1622. 8. Seute T, Leffers P, Wilmink JT,
ten Velde GP, Twijnstra A. Response of asymptomatic brain metastases from
small-cell lung cancer to systemic first-line chemotherapy. J Clin Oncol.
2006;24(13):2079-2083. 9. Parsons HM, Harlan LC, Stevens JL, Ullmann CD.
Treatment of small cell lung cancer in academic and community settings: factors
associated with receiving standard therapy and survival. Cancer J.
2014;20(2):97-104. 10. Goldman JW, Dvorkin M, Chen Y, et al. Durvalumab, with or
without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in
first-line treatment of extensive-stage small-cell lung cancer (CASPIAN):
updated results from a randomised, controlled, open-label, phase 3 trial. Lancet
Oncol. 2021;22(1):51-65.

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This product information is intended for US Healthcare Professionals only.

IMFINZI is a registered trademark and AstraZeneca Access 360 is a trademark of
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©2021 AstraZeneca. All rights reserved. US-33659; US-40509; US-39734; US-44309;
US-47522; US-55480; US-55053; US-56977 Last Updated 10/21





+


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