Safety profile and side effects - LAURA

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Safety Profile and Side Effects: LAURA

Safety results were consistent with the known profiles for both TAGRISSO and chemoradiation¹

Consistent safety results

TAGRISSO adverse events: LAURA trial¹

AEs with an incidence of ≥10% in either arm are shown. Patients with multiple events in the same category were counted only once in that category. Patients with events in more than one category were counted once in each of those categories. Includes AEs with an onset date on or after the date of first dose and up to and including 28 days following the discontinuation of study treatment and before starting subsequent cancer therapy.

Characteristics	TAGRISSO (n=143)		Placebo (n=73)
	Overall frequency (all grades)	Grade ≥3	Overall frequency (all grades)	Grade >3
Radiation pneumonitis	48%	2%	38%	0%
Diarrhoea	36%	2%	14%	0%
Rash	24%	0%	14%	0%
COVID-19	20%	1%	8%	0%
Paronychia	17%	0%	1%	0%
Cough	16%	0%	10%	0%
Decreased appetite	15%	1%	5%	0%
Dry skin	13%	1%	5%	0%
Pruritus	13%	0%	7%	0%
Decreased white-cell count	12%	1%	3%	0%
Stomatitis	12%	0%	3%	0%
Pneumonia	11%	2%	8%	4%
Anaemia	10%	1%	4%	0%

Adapted from Lu S et al. N Engl J Med 2024.¹

*One patient in the group that received TAGRISSO plus platinum-pemetrexed died from COVID-19¹

ALT, alanine aminotransferase; AST, aspartate transferase; ILD, Interstitial lung disease

13% (n=18) of patients discontinued treatment in the TAGRISSO arm and 5% (n=4) of patients discontinued treatment in the placebo arm¹
The impact of dose modification on treatment exposure time was minimal (23.7 months actual median exposure to TAGRISSO vs 24.0 months total median exposure)¹
The median duration of exposure to TAGRISSO was 24.0 months vs 8.3 months in the placebo arm. Median duration of investigator follow-up was 22.2 months in the TAGRISSO arm and 5.7 months in the placebo arm^1,2

TAGRISSO Safety Considerations^3,4

Please refer to product labelling for more information.

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.

LVEF decreases ≥10% and a drop to less than 50% occurred in 4.2% (65/1557) of TAGRISSO-treated patients who had baseline and at least one follow-up LVEF assessment. 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.

Radiation pneumonitis events were experienced by 48% of patients treated with TAGRISSO (68/143) vs 38% with placebo (28/73) in the LAURA trial.²

In the TAGRISSO arm (N=143), the majority of patients who experienced radiation pneumonitis had Grade 1 (21/143) or Grade 2 (44/143) events, with three Grade 3 events and no Grade 4/5 events.²

Please refer to the Summary of Product Characteristics for information about dose modification and management of these adverse events.^3,4

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.

ILD-related (interstitial lung disease, pneumonitis, and pulmonary fibrosis) adverse reactions were reported in 8% of patients (11/143) who received TAGRISSO and 1% of patients (1/73) who received placebo in the LAURA study.¹ One patient (1%) in the TAGRISSO group reported a fatal event of pneumonitis (grade 5).²

Please refer to the Summary of Product Characteristics for information about dose modification and management of these adverse events.^3,4

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Take a look at real patient case studies: LAURA trial 

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Learn more about how TAGRISSO works

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AE, adverse event; ILD, interstitial lung disease; MOA, mode of action

Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024 Aug 15;391(7):585-97.
Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. (Supplementary Appendix) N Engl J Med. 2024 Aug 15;391(7):585-97.
TAGRISSO (osimertinib) 40 mg Summary of Product Characteristics.
TAGRISSO (osimertinib) 80 mg Summary of Product Characteristics.

GB-71911 | 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: LAURA

Consistent safety results

TAGRISSO adverse events: LAURA trial1

TAGRISSO Safety Considerations3,4

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

AEs related to radiation pneumonitis

AEs related to ILD

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Abbreviations and References

TAGRISSO adverse events: LAURA trial¹

TAGRISSO Safety Considerations^3,4