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IMFINZI SAFETY

Testing

In the PACIFIC study, IMFINZI was generally well tolerated1,2,6

The most common adverse events (≥20%) for IMFINZI were cough, fatigue, rash, dyspnoea and radiation pneumonitis1

ADVERSE EVENTS REPORTED IN ≥10% OF PATIENTS (VERY COMMON)1,3

The following are adverse reactions reported in ≥10% of patients (very common): rash, pruritus, cough/productive cough, pneumonitis, upper respiratory tract infections, pneumonia, hypothyroidism, pyrexia, diarrhoea, and abdominal pain.
The following are adverse reactions reported in ≥10% of patients (very common): rash, pruritus, cough/productive cough, pneumonitis, upper respiratory tract infections, pneumonia, hypothyroidism, pyrexia, diarrhoea, and abdominal pain.

Grade 3 pneumonitis or radiation pneumonitis occurred in 3.4% of patients on IMFINZI and 3.0% on placebo.1

Grade 5 adverse events of any cause occurred in 4.4% of patients on IMFINZI vs 6.4% on placebo.6

Overall, the safety profile of durvalumab in the PD-L1 ≥1% subgroup was consistent with the ITT population, as was the PD-L1 <1% subgroup.1

*Fatal pneumonitis and fatal pneumonia were reported at similar rates between the IMFINZI and placebo groups in the PACIFIC study.1

Testing

In the PACIFIC study, comparable safety profile with respect to Grade 3 or 4 imAEs4

Overall Grade 3/4 imAEs occurred at similar rates with IMFINZI vs placebo (3.4% vs 2.6%)4

IMMUNE-MEDIATED ADVERSE EVENTS IN THE PACIFIC STUDY INCLUDE5

Immune-mediated adverse reactions in the PACIFIC study include pneumonitis, hypothyroidism, hyperthyroidism, rash or dermatitis, colitis or diarrhoea, select hepatic events, and any imAR.
Immune-mediated adverse reactions in the PACIFIC study include pneumonitis, hypothyroidism, hyperthyroidism, rash or dermatitis, colitis or diarrhoea, select hepatic events, and any imAR.

*Grade 5 immune-mediated pneumonitis: 0.8% with IMFINZI vs 1.3% with placebo.1

IMFINZI is most commonly associated with immune-mediated adverse events.Routine monitoring of patients for signs and symptoms is advised

The use of systemic corticosteroids or immunosuppressants before starting durvalumab, except physiological dose of systemic corticosteroids (≤10 mg/day prednisone or equivalent), is not recommended because of their potential interference with the pharmacodynamic activity and efficacy of durvalumab. However, systemic corticosteroids or other immunosuppressants can be used after starting durvalumab to treat immune-related adverse reactions.

Discontinuation rate due to adverse events, regardless of causality, was 15.4% with IMFINZI vs 9.8% with placebo2

imAE: immune-mediated adverse event

Testing

Recommended imAE management for IMFINZI

withhold
withhold

Corticosteroids and other medicines may also be required. Most imAEs, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of IMFINZI.1

Please see Summary of Product Characteristics for additional information on treatment modifications and management specific to immune-mediated adverse events.

No dose escalation or reduction of IMFINZI is recommended for the management of adverse events. However, dose withholding or discontinuation may be required based on individual safety and tolerability.1

ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal

*Common Terminology Criteria for Adverse Events, version 4.03.1
If no improvement within 3 to 5 days despite corticosteroids, promptly start additional immunosuppressive therapy. Upon resolution (Grade 0), corticosteroid taper should be initiated and continued over at least 1 month, after which IMFINZI can be resumed based on clinical judgment.1
Permanently discontinue IMFINZI if adverse reaction does not resolve to ≤Grade 1 within 30 days or if there are signs of respiratory insufficiency.1

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References: 1. IMFINZI - UK Summary of Product Characteristics. Date: September 2020. 2. Antonia SJ, Villegas A, Daniel D, et al. PACIFIC investigators. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. [published online September 25,2018]. N Engl J Med. 2018;379(24):2342-2350 3. Data on File, REF-41250, AstraZeneca Pharmaceuticals LP. 4. Antonia SJ, Villegas. A, Daniel. D, et al; PACIFIC investigators Durvalumab after Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer. N Engl J Med. 2017;377(20):1919-1929. 5. Data on File, REF-41144, AstraZeneca Pharmaceuticals LP. 6. Antonia SJ, Villegas A, Daniel D, et al. PACIFIC investigators. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. [published online September 25,2018]. N Engl J Med. 2018;379(24):2342-2350. Supplementary Appendix.