Safety profile and side effects - ADAURA

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Safety Profile and Side Effects: ADAURA

In the ADAURA study, most adverse events were mild to moderate.¹

Quality of life was maintained with adjuvant TAGRISSO in ADAURA despite prolonged treatment.^2,3

At time of safety analysis, zero deaths had been reported as an adverse event outcome in the TAGRISSO arm compared with one death in the placebo arm^2,3
AE leading to a dose reduction occurred in 12% (42) of patients in the TAGRISSO arm vs 1% (3) in the placebo arm; an AE leading to dose interruption occurred in 27% (91) patients in the TAGRISSO arm vs 13% (43) in the placebo arm; an AE leading to discontinuation in 12% (42) patients in the TAGRISSO arm vs. 3% (9) in the placebo arm.¹
ILD (grouped term) was reported in 11 (3%) of patients in the TAGRISSO arm (all Grade 1/2)¹
QTc prolongation was reported in 30 (9%) of patients in the TAGRISSO arm and 8 (2%) of patients in the placebo arm¹

TAGRISSO adverse events: ADAURA trial (in ≥10% of patients)¹

Characteristics	TAGRISSO (n=337)		Placebo (n=343)
	Overall frequency (all grades)	Grade ≥3	Overall frequency (all grades)	Grade >3
Diarrhoea	47%	3%	20%	1(<1)
Paronychia	27%	1%	1%	0
Dry skin	25%	<1%	7%	0
Pruritus	21%	0%	9%	0
Cough	20%	0%	18%	0
Stomatitis	18%	2%	4%	0
Nasopharyngitis	15%	0%	10%	0
URTI	16%	1%	11%	0
Decreased appetite	14%	1%	4%	0
Mouth ulceration	12%	0%	3%	0
Dermatitis acneiform	12%	0%	5%	0
Nausea	10%	<1%	6%	0
Weight decrease	10%	1%	3%	0
Arthralgia	7%	0	11%	0

Adapted from Tsuboi M et al. ESMO congress 2022.¹

Mean total duration of exposure: TAGRISSO 35.8 months (range 0 to 38) and placebo 25.1 months (range 0 to 39)

URTI, upper respiratory tract infection

TAGRISSO Safety Considerations^2,3

Please refer to product labelling for more information.

Patients with acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) should have their treatment interrupted while investigations are performed to exclude ILD. If ILD is diagnosed, TAGRISSO should be discontinued and appropriate treatment initiated as necessary. Reintroduction should be considered only after careful consideration of the individual patient’s benefits and risk.

QTc interval prolongation occurs in patients treated with TAGRISSO. QTc interval prolongation may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death. When possible, TAGRISSO should be avoided in patients with congenital long QT syndrome. Periodic monitoring with electrocardiograms and electrolytes should be considered in patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval. Treatment should be withheld in patients who develop a QTc interval greater than 500 msec on at least 2 separate ECGs until the QTc interval is less than 481 msec or recovery to baseline if the QTc interval is greater than or equal to 481 msec then resume TAGRISSO at a reduced dose. TAGRISSO should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia.

Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye should be referred promptly to an ophthalmology specialist.

Rare cases of aplastic anaemia, including fatal events, have been reported in association with TAGRISSO treatment. Before initiating treatment, patients should be advised of signs and symptoms of aplastic anaemia including, but not limited, to persistent fever, bruising, bleeding, pallor, infection and fatigue. If signs and symptoms suggestive of aplastic anaemia develop, close patient monitoring and drug interruption or discontinuation of TAGRISSO should be considered. TAGRISSO should be discontinued in patients with confirmed aplastic anaemia.

Before initiating treatment, patients should be advised of signs and symptoms of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If signs and symptoms suggestive of SJS or TEN appear, TAGRISSO should be interrupted. TAGRISSO should be discontinued immediately if SJS or TEN are diagnosed.

In an adjuvant placebo-controlled study (ADAURA), 1.5% (5/325) of patients treated with TAGRISSO and 1.5% (5/331) of patients treated with placebo experienced LVEF decreases ≥ 10% and a drop to less than 50%. In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered. In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.

For the latest recommendations on cardiovascular monitoring, please refer to the 2022 ESC guidelines on cardio-oncology.⁴

Advise patients Hepatitis B Virus (HBV) reactivation can occur if treated with TAGRISSO, and in some cases, may result in fulminant hepatitis, hepatic failure, and death. Patients with evidence of positive HBV serology should be monitored for clinical and laboratory signs of HBV reactivation while receiving TAGRISSO. In patients who develop reactivation of HBV while on TAGRISSO, treatment with TAGRISSO should be withheld and they should be managed according to local institutional guidelines.

Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher. Close monitoring is recommended in these patients.

There are no or limited data from the use of TAGRISSO in pregnant women; studies in animals have shown reproductive toxicity (embryolethality, reduced foetal growth and neonatal death). TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with TAGRISSO.

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ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; ESC, European Society of Cardiology; ILD, interstitial lung disease; LVEF, left ventricular ejection fraction; MOA, mode of action; NSCLC, non-small cell lung cancer; QTc, corrected QT interval; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis; URTI, upper respiratory tract infection

Tsuboi M, et al. Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA nonsmall cell lung cancer (NSCLC): Updated results from ADAURA. Presented at ESMO Congress, 9th–13th September 2022, Paris.
TAGRISSO (osimertinib) 40 mg Summary of Product Characteristics.
TAGRISSO (osimertinib) 80 mg Summary of Product Characteristics.
Lyon A et al. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS): Developed by the task force on cardio-oncology of the European Society of Cardiology (ESC). Eur Heart J. 2022 Nov 1;43(41):4229–361.

GB-71908 | DOP: December 2025

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling ‌‌‌0‌‌‌8‌‌‌‌‌0‌‌‌‌0‌‌‌ ‌‌7‌‌‌‌‌‌8‌‌‌3‌‌‌ ‌‌0‌‌‌‌‌0‌‌‌‌3‌‌‌‌3‌‌‌.

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Safety Profile and Side Effects: ADAURA

Quality of life was maintained with adjuvant TAGRISSO in ADAURA despite prolonged treatment.2,3

TAGRISSO adverse events: ADAURA trial (in ≥10% of patients)1

TAGRISSO Safety Considerations2,3

Interstitial lung disease

QTc interval prolongation

Keratitis

Aplastic anaemia

Stevens-Johnson syndrome

Changes in cardiac contractility

Hepatitis B Virus (HBV) reactivation

Age and body weight

Pregnancy and lactation

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Abbreviations and References

Quality of life was maintained with adjuvant TAGRISSO in ADAURA despite prolonged treatment.^2,3

TAGRISSO adverse events: ADAURA trial (in ≥10% of patients)¹

TAGRISSO Safety Considerations^2,3