Tagrisso (osimertinib) | ADAURA Clinical Trial

Click on the infographic below for a full overview of the ADAURA trial and updated 5-year data

Background

The ADAURA trial was a double-blind, phase 3 trial which randomly assigned patients with completely resected EGFRm NSCLC to receive either Tagrisso (osimertinib) or placebo for 3 years.

Conclusion

Adjuvant TAGRISSO demonstrated a statistically significant and clinically meaningful improvement in OS vs. placebo in the recent 5-year readout of ADAURA, reiterating its long-term efficacy. In patients with stage II-IIIA disease (primary endpoint subset), the relative reduction in risk of death was 51%, HR: 0.49, 95.03% CI 0.33-0.73; P=0.0004, ARR: 12%.

Further information on ADAURA Trial

ADAURA Trial: 4 year DFS update

Dr Yvonne Summers, Consultant Medical Oncologist, Christie NHS Foundation Trust

Please click here for TAGRISSO UK prescribing information

ADAURA Trial: CNS recurrence data

Dr John Conibear, Consultant Clinical Oncologist, Barts Health NHS Trust

Please click here for TAGRISSO UK prescribing information

ADAURA Trial: Evolving UK clinical practice for EGFRm+ NSCLC

Dr Yvonne Summers, Consultant Medical Oncologist, Christie NHS Foundation Trust

Dr Shobhit Baijal, Consultant Medical Oncologist, Birmingham University Hospitals NHS Foundation Trust

Please click here for TAGRISSO UK prescribing information

References

Tsuboi M, et al. Abstract LBA47. Presented at ESMO Congress, 9th–13th September 2022, Paris

Adverse reactions reported	TAGRISSO		TAGRISSO with pemetrexed and platinum-based chemotherapy
Adverse reactions reported	CIOMS descriptor/ overall frequency (all CTCAE grades)	Frequency of CTCAE grade 3 or higher	CIOMS descriptor/ overall frequency (all CTCAE grades)	Frequency of CTCAE grade 3 or higher
Blood and lymphatic system disorders
Aplastic anaemia	Rare (0.06%)	0.06%	0%	0%
Leukopenia	Common (5.4%)	0.4%	Very common (12.7%)	2.9%
Lymphopenia	Common (1.7%)	0.2%	Common (2.5%)	1.1%
Thrombocytopenia	Common (7.6%)	0.6%	Very common (18.5%)	6.9%
Neutropenia	Common (6%)	0.9%	Very common (24.6%)	13.4%
Metabolism and nutrition disorders
Decreased appetite	Very common (19%)	1.2%	Very common (31%)	2.9%
Eye disorders
Keratitis	Uncommon (0.6%)	0.06%	Uncommon (0.7%)	0%
Cardiac disorders
Cardiac failure	Uncommon (0.5%)	0.2%	Common (1.8%)	1.1%
Respiratory, thoracic and mediastinal disorders
Epistaxis	Common (6%)	0%	Common (7%)	0.4%
Interstitial lung disease	Common (4.0%)	1.4%	Common (3.3%)	0.7%
Gastrointestinal disorders
Diarrhoea	Very common (47%)	1.4%	Very common (43%)	2.9%
Stomatitis	Very common (24%)	0.4%	Very common (31%)	0.4%
Skin and subcutaneous tissue disorders
Rash	Very common (46%)	0.8%	Very common (49%)	2.5%
Paronychia	Very common (34%)	0.4%	Very common (27%)	0.7%
Dry skin	Very common (32%)	0.1%	Very common (24%)	0%
Pruritus	Very common (17%)	0.06%	Common (8%)	0%
Alopecia	Common (5%)	0%	Common (9%)	0%
Palmar-plantar erythrodysaesthesia syndrome	Common (2.1%)	0%	Common (5%)	0%
Urticaria	Common (1.9%)	0.1%	Common (1.4%)	0.4%
Skin hyperpigmentation	Common (1.0%)	0%	Common (2.5%)	0%
Erythema multiforme	Uncommon (0.3%)	0%	Common (1.4%)	0.7%
Cutaneous vasculitis	Uncommon (0.2%)		0%	0%
Stevens-Johnson syndrome	Rare (0.02%)		0%	0%
Toxic Epidermal Necrolysis	Not known		0%	0%
Investigations
Left ventricular ejection fraction decreased	Common (4.2%)		Common (8%)
QTc interval prolongation	Common (1.1%)		Common (1.8%)
Blood creatine phosphokinase increased	Common (1.9%)	0.3%	Common (3.3%)	1.1%
Investigations (Findings based on test results presented as CTCAE grade shifts)
Leucocytes decreased	Very common (65%)	1.8%	Very common (88%)	20%
Lymphocytes decreased	Very common (64%)	8%	Very common (78%)	16%
Platelet count decreased	Very common (53%)	1.3%	Very common (85%)	16%
Neutrophils decreased	Very common (36%)	4.0%	Very common (85%)	36%
Blood creatinine increased	Common (9%)	0.2%	Very common (22%)	0.4%
Musculoskeletal and connective tissue disorders
Myositis	Uncommon (0.2%)	0%	0%	0%