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 * FOR US HEALTHCARE PROFESSIONALS
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 * Important Safety Information
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    * IMFINZI Prescribing Information
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REACH
FOR MORE POSSIBILITIES WITH IMFINZI ALONE OR IN COMBINATION WITH IMJUDO


UNRESECTABLE STAGE III


NON-SMALL CELL LUNG CANCER


METASTATIC


NON-SMALL CELL LUNG CANCER


EXTENSIVE-STAGE


SMALL CELL LUNG CANCER

curve
NEW 4-YEAR* DATA


UNRESECTABLE


HEPATOCELLULAR CARCINOMA


LOCALLY ADVANCED OR METASTATIC


BILIARY TRACT CANCERS (BTCS)


SUPPORT & RESOURCES

Support and resources for HCPs and patients.


CONNECT WITH YOUR REP

Find your local IMFINZI representative.

*In the exploratory analysis, median duration of follow-up was 49.1 months
(range, 47.0-50.2) for IMFINZI + IMJUDO.




SEE FULL INDICATIONS

IMFINZI is indicated for the treatment of adult patients with unresectable Stage
III non-small cell lung cancer (NSCLC) whose disease has not progressed
following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is
indicated for the treatment of adult patients with metastatic NSCLC with no
sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic
lymphoma kinase (ALK) genomic tumor aberrations.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is
indicated for the first-line treatment of adult patients with extensive-stage
small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the
treatment of adult patients with locally advanced or metastatic biliary tract
cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult
patients with unresectable hepatocellular carcinoma (uHCC).

+


IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab) or IMJUDO®
(tremelimumab-actl).


INDICATIONS:

IMFINZI is indicated for the treatment of adult patients with unresectable Stage
III non-small cell lung cancer (NSCLC) whose disease has not


 


IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab) or IMJUDO®
(tremelimumab-actl).


SEVERE AND FATAL 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 clinical chemistries including liver
enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid
function at baseline and before each dose. 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 and IMJUDO depending on severity. See USPI Dosing and
Administration for specific details. In general, if IMFINZI and IMJUDO 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.


INDICATIONS:

IMFINZI is indicated for the treatment of adult patients with unresectable Stage
III non-small cell lung cancer (NSCLC) whose disease has not progressed
following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is
indicated for the treatment of adult patients with metastatic NSCLC with no
sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic
lymphoma kinase (ALK) genomic tumor aberrations.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is
indicated for the first-line treatment of adult patients with extensive-stage
small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the
treatment of adult patients with locally advanced or metastatic biliary tract
cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult
patients with unresectable hepatocellular carcinoma (uHCC).


IMMUNE-MEDIATED PNEUMONITIS

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal.
The incidence of pneumonitis is higher in patients who have received prior
thoracic radiation.

 * IMFINZI as a Single Agent
 * * 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 or BTC when
     given in combination with chemotherapy.
 * IMFINZI with IMJUDO
 * * Immune-mediated pneumonitis occurred in 1.3% (5/388) of patients receiving
     IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse
     reactions.
 * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
 * * Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving
     IMFINZI in combination with IMJUDO and platinum-based chemotherapy,
     including fatal (0.5%), and Grade 3 (1%) adverse reactions.


IMMUNE-MEDIATED COLITIS

IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated
colitis, which may be fatal.

IMFINZI and IMJUDO 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.

 * IMFINZI as a Single Agent
 * * Immune-mediated colitis occurred in 2% (37/1889) of patients receiving
     IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
 * IMFINZI with IMJUDO
 * * Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients
     receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
     Intestinal perforation has been observed in other studies of IMFINZI and
     IMJUDO.
 * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
 * * Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving
     IMFINZI in combination with IMJUDO and platinum-based chemotherapy
     including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal
     perforation and large intestine perforation were reported in 0.1% of
     patients.


IMMUNE-MEDIATED HEPATITIS

IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

 * IMFINZI as a Single Agent
 * * 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.
 * IMFINZI with IMJUDO
 * * Immune-mediated hepatitis occurred in 7.5% (29/388) of patients receiving
     IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3
     (4.1%) adverse reactions.
 * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
 * * Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving
     IMFINZI in combination with IMJUDO and platinum-based chemotherapy,
     including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.


IMMUNE-MEDIATED ENDOCRINOPATHIES

 * Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary
   adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate
   symptomatic treatment, including hormone replacement as clinically indicated.
 * * IMFINZI as a Single Agent
   * * Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of
       patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
   * IMFINZI with IMJUDO
   * * Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of
       patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse
       reactions.
   * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
   * * Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of
       patients receiving IMFINZI in combination with IMJUDO and platinum-based
       chemotherapy, including Grade 3 (0.8%) adverse reactions.
 * Hypophysitis: IMFINZI and IMJUDO 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.
 * * IMFINZI as a Single Agent
   * * Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of
       patients who received IMFINZI.
   * IMFINZI with IMJUDO
   * * Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of
       patients receiving IMFINZI and IMJUDO.
   * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
   * * Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients
       receiving IMFINZI in combination with IMJUDO and platinum-based
       chemotherapy, including Grade 3 (0.5%) adverse reactions.
 * Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI
   and IMJUDO 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.
 * * IMFINZI as a Single Agent
   * * Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients
       receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
     * Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients
       receiving IMFINZI.
     * Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients
       receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
   * IMFINZI with IMJUDO
   * * Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients
       receiving IMFINZI and IMJUDO.
     * Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients
       receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
     * Immune-mediated hypothyroidism occurred in 11% (42/388) of patients
       receiving IMFINZI and IMJUDO.
   * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
   * * Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients
       receiving IMFINZI in combination with IMJUDO and platinum-based
       chemotherapy.
     * Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients
       receiving IMFINZI in combination with IMJUDO and platinum-based
       chemotherapy, including Grade 3 (0.2%) adverse reactions.
     * Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients
       receiving IMFINZI in combination with IMJUDO and platinum-based
       chemotherapy, including Grade 3 (0.5%) 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.
 * * IMFINZI as a Single Agent
   * * Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1%
       (1/1889) of patients receiving IMFINZI.
   * IMFINZI with IMJUDO
   * * Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin
       therapy that had not resolved at last follow-up.
   * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
   * * Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of
       patients receiving IMFINZI in combination with IMJUDO and platinum-based
       chemotherapy including Grade 3 (0.3%) adverse reactions.


IMMUNE-MEDIATED NEPHRITIS WITH RENAL DYSFUNCTION

IMFINZI and IMJUDO can cause immune-mediated nephritis.

 * IMFINZI as a Single Agent
 * * Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving
     IMFINZI, including Grade 3 (<0.1%) adverse reactions.
 * IMFINZI with IMJUDO
 * * Immune-mediated nephritis occurred in 1% (4/388) of patients receiving
     IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
 * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
 * * Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving
     IMFINZI in combination with IMJUDO and platinum-based chemotherapy,
     including Grade 3 (0.2%) adverse reactions.


IMMUNE-MEDIATED DERMATOLOGY REACTIONS

IMFINZI and IMJUDO 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), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical
emollients and/or topical corticosteroids may be adequate to treat mild to
moderate non-exfoliative rashes.

 * IMFINZI as a Single Agent
 * * Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients
     receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
 * IMFINZI with IMJUDO
 * * Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients
     receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%)
     adverse reactions.
 * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
 * * Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients
     receiving IMFINZI in combination with IMJUDO and platinum-based
     chemotherapy, including Grade 3 (0.3%) adverse reactions.


IMMUNE-MEDIATED PANCREATITIS

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis.
Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving
IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) 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 and IMJUDO
or were reported with the use of other immune-checkpoint inhibitors.

 * 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 and IMJUDO 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 and IMJUDO based
on the severity. See USPI Dosing and Administration for specific details. For
Grade 1 or 2 infusion-related reactions, consider using pre-medications with
subsequent doses.

 * IMFINZI as a Single Agent
 * * Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving
     IMFINZI, including Grade 3 (0.3%) adverse reactions.
 * IMFINZI with IMJUDO
 * * Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI
     and IMJUDO.
 * IMFINZI with IMJUDO and Platinum-Based Chemotherapy
 * * Infusion-related reactions occurred in 2.9% (17/596) of patients receiving
     IMFINZI in combination with IMJUDO and platinum-based chemotherapy,
     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 their mechanism of action and data from animal studies, IMFINZI and
IMJUDO can cause fetal harm when administered to a pregnant woman. Advise
pregnant women of the potential risk to a fetus. In females of reproductive
potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and
advise them to use effective contraception during treatment with IMFINZI and
IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.


LACTATION

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


ADVERSE REACTIONS

 * In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI
   (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue
   (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract
   infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4
   adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation
   pneumonitis (3.4%).
 * In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI
   (n=475), discontinuation due to adverse reactions occurred in 15% of patients
   in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients
   receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were
   pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal
   pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of
   patients and were similar across arms.
 * In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO
   plus platinum-based chemotherapy (n=330), the most common adverse reactions
   (occurring in ≥20% of patients) were nausea (42%), fatigue (36%),
   musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and
   diarrhea (22%).
 * In patients with mNSCLC in the POSEIDON study receiving IMFINZI in
   combination with IMJUDO and platinum-based chemotherapy (n=330), permanent
   discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in
   17% of patients. Serious adverse reactions occurred in 44% of patients, with
   the most frequent serious adverse reactions reported in at least 2% of
   patients being pneumonia (11%), anemia (5%), diarrhea (2.4%),
   thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%).
   Fatal adverse reactions occurred in a total of 4.2% of patients.
 * 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.
 * In patients with locally advanced or metastatic BTC in the TOPAZ-1 study
   receiving IMFINZI (n=338), the most common adverse reactions (occurring in
   ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%),
   decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia
   (20%).
 * In patients with locally advanced or metastatic BTC in the TOPAZ-1 study
   receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred
   in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse
   reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy.
   The most frequent serious adverse reactions reported in at least 2% of
   patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%)
   and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of
   patients receiving IMFINZI plus chemotherapy. These include ischemic or
   hemorrhagic stroke (4 patients), sepsis (2 patients), and upper
   gastrointestinal hemorrhage (2 patients).
 * In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and
   IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of
   patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%),
   musculoskeletal pain (22%), and abdominal pain (20%).
 * In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and
   IMJUDO (n=388), serious adverse reactions occurred in 41% of patients.
   Serious adverse reactions in >1% of patients included hemorrhage (6%),
   diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%),
   acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions
   occurred in 8% of patients who received IMJUDO in combination with
   durvalumab, including death (1%), hemorrhage intracranial (0.5%), cardiac
   arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and
   immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment
   regimen due to an adverse reaction occurred in 14% of patients.

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


INDICATIONS:

IMFINZI is indicated for the treatment of adult patients with unresectable Stage
III non-small cell lung cancer (NSCLC) whose disease has not progressed
following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is
indicated for the treatment of adult patients with metastatic NSCLC with no
sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic
lymphoma kinase (ALK) genomic tumor aberrations.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is
indicated for the first-line treatment of adult patients with extensive-stage
small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the
treatment of adult patients with locally advanced or metastatic biliary tract
cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult
patients with unresectable hepatocellular carcinoma (uHCC).

Please see Full Prescribing Information including Medication Guide for IMFINZI
and IMJUDO.

Click here for more information on IMJUDO.

You may report side effects related to AstraZeneca products.

References: 1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE:
AstraZeneca Pharmaceuticals LP; 2023. 2. IMJUDO® (tremelimumab-actl)
[Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2023.
3. Sangro B, Chan SL, Kelley RK, et al. Four-year overall survival update from
the phase 3 HIMALAYA study of tremelimumab plus durvalumab in unresectable
hepatocellular carcinoma [presentation]. Presented at: 25th ESMO World Congress
on Gastrointestinal Cancer; June 28-July 1, 2023; Barcelona, Spain.
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This product information is intended for US Healthcare Professionals only.

IMFINZI and IMJUDO are registered trademarks and AstraZeneca Access 360 is a
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Updated 10/23