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ES-SCLC iPub


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1CHAPTER 1: Introduction and ES-SCLC Background2CHAPTER 2: CASPIAN Study Design
and Overall Survival3CHAPTER 3: CASPIAN Secondary Endpoints4CHAPTER 4: CASPIAN
Safety Data and Study Summary

CHAPTER 1: Introduction and ES-SCLC Background

CHAPTER 2: CASPIAN Study Design and Overall Survival

CHAPTER 3: CASPIAN Secondary Endpoints

CHAPTER 4: CASPIAN Safety Data and Study Summary

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 2.0% (28/1414), 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 16.6% (79/475) in patients
receiving IMFINZI and 13.2% (31/234) in patients receiving placebo. Of the 79
patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 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 1.6%
(31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3
(0.3%) adverse reactions.

IMMUNE-MEDIATED HEPATITIS

IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred
in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and
Grade 3 (0.6%) 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 0.4% (7/1889) 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 0.4% (7/1889) of
   patients receiving IMFINZI.
 * Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 1.4% (27/1889)
   of patients receiving IMFINZI.
 * Hypothyroidism: Immune-mediated hypothyroidism occurred in 7.3% (137/1889) 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 0.3% (5/1889) 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 1.6% (30/1889) 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 patient 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.

MOST COMMON ADVERSE REACTIONS

 * In patients with extensive-stage SCLC in the CASPIAN study (n=265), the most
   common adverse reactions (≥20%) were nausea, fatigue/asthenia, and alopecia.
   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 (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.

INDICATIONS

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.

Please see complete Prescribing Information, including Medication Guide.


MEET THE SPEAKER

Mark Socinski, MD

AdventHealth Cancer Institute
Orlando, FL

US-46856 Last Updated 12/20






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