Tagrisso (osimertinib) | FLAURA Clinical Trial

Click on the animation below for a full overview of the FLAURA trial

Background

The FLAURA trial was a double-blind, phase 3 trial involving patients with previously untreated advanced NSCLC (non-small cell lung cancer) with EGFR mutations that compared the efficacy and safety profiles of osimertinib with that of two other EGFR-TKIs, gefitinib or erlotinib.

Conclusion

Among patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib (n=279) had longer overall survival (median OS 38.6 months), than those who received a comparator EGFR-TKI (n=277; median OS 31.8 months; p=0.046).¹ The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group.

Overall survival was a secondary endpoint. The primary endpoint was PFS; the median PFS was 18.9 months with osimertinib vs 10.2 months with comparator EGFR-TKI (p<0.001).²

References

Ramalingam et al. N Engl J Med 2020; 382:41-50
Soria et al. N Engl J Med 2018;378:113-125

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%