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| Adverse reactions reported | CIOMS descriptor/ overall frequency (all CTCAE grades) | Frequency of CTCAE grade 3 or higher |
|---|---|---|
| Metabolism and nutrition disorders | ||
| Decreased appetite | Very common (19%) | 1.1% |
| Blood and lymphatic system disorders | ||
| Aplastic anaemia | Rare (0.07%) | 0.07% |
| Cardiac disorders | ||
| Cardiac failure | Uncommon (0.3%) | 0.1% |
| Respiratory, thoracic and mediastinal disorders | ||
| Epistaxis | Common (5%) | 0 |
| Interstitial lung disease | Common (3.8%) | 1.1% |
| Gastrointestinal disorders | ||
| Diarrhoea | Very common (47%) | 1.4% |
| Stomatitis | Very common (24%) | 0.5% |
| Eye disorders | ||
| Keratitis | Uncommon (0.7%) | 0.1% |
| Skin and subcutaneous tissue disorders | ||
| Rash | Very common (45%) | 0.7% |
| Dry skin | Very common (32%) | 0.1% |
| Paronychia | Very common (33%) | 0.4% |
| Pruritus | Very common (17%) | 0.1% |
| Palmar-plantar erythrodysaesthesia syndrome | Common (1.7%) | 0 |
| Skin hyperpigmentation | Uncommon (0.8%) | 0 |
| Alopecia | Common (4.6%) | 0 |
| Erythema multiforme | Uncommon (0.3%) | 0 |
| Stevens-Johnson syndrome | Rare (0.02%) | |
| Toxic epidermal necrolysis | Not Known | |
| Cutaneous vasculitis | Uncommon (0.3%) | 0 |
| Urticaria | Common (1.9%) | 0.1% |
| Investigations | ||
| QTc interval prolongation | Uncommon (0.8%) | |
| Blood creatine phosphokinase increased | Common (1.6%) | 0.3% |
| Left ventricular ejection fraction decreased | Common (3.2%) | |
| Musculoskeletal and connective tissue disorders | ||
| Myositis | Rare (0.07%) | |
| (Findings based on test results presented as CTCAE grade shifts) | ||
| Platelet count decreased | Very common (53%) | 1.2% |
| Leucocytes decreased | Very common (65%) | 1.2% |
| Lymphocytes decreased | Very common (62%) | 6% |
| Neutrophils decreased | Very common (33%) | 3.2% |
| Blood creatinine increased | Common (9%) | 0 |
GB-52084
Date of Preparation: February 2024
Primary endpoint: DFS in patients at 24 months with stage II-IIIA EGFRm NSCLC (n=470), HR =0.17 (99.06% CI, 0.11-0.26), p<0.001, median follow-up 22.1 months.3
In patients with Stage II-IIIA disease (primary endpoint subset, 5 year data):
reduction in risk of death1
HR=0.49
(95.03% CI 0.33-0.73);
ARR=12% at 60 months,
p=0.0004
reduction in risk of progression or death2
HR=0.23
(95% CI 0.18-0.30);
ARR=41% at 48 months;
p not provided*
Pre-specified exploratory analysis:
reduction in risk of CNS recurrence or death2
HR=0.24
(95% CI 0.14-0.42);
ARR=15% at 48 months;
p not provided
*Results from the interim analysis (released October 2020) showed a statistically significant DFS difference,3 however statistical analyses are not yet available for the 4-year data
The safety data from ADAURA (n=680) was consistent with Tagrisso's known safety profile, no new concerns reported. Diarrhoea was the most common AE in both treatment arms (47% vs 20% in osimertinib vs placebo).2
