Clinical Trials & Efficacy - LAURA - Tagrisso (osimertinib)

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Clinical Trials & Efficacy: LAURA

TAGRISSO is the first targeted treatment available for patients with unresectable Stage III EGFRM NSCLC (ex19del/L858R), after definitive CRT.¹

Efficacy

Clinical trial design

Study population

Clinical trial endpoints

Safety profile

LAURA was a global, Phase III study designed to investigate TAGRISSO in patients with unresectable Stage III EGFRm NSCLC who did not progress either during or following concurrent or sequential CRT.¹

TAGRISSO demonstrated a significant 7-fold increase in median PFS vs placebo arm¹

TAGRISSO 39.1 months median PFS (95% CI: 31.5–NC)

Placebo 5.6 months median PFS (95% CI: 3.7–7.4)

HR=0.16 (95% CI: 0.10–0.24); P<0.001

BICR analysis, primary endpoint

TAGRISSO selectively targets EGFR sensitising mutations to deliver clinically meaningful PFS benefits¹

Progression-free survival per BICR*

Primary Endpoint

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

*Primary endpoint in LAURA.¹

BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; NC, not calculated

Across all lesion sites, the incidence of new lesions was lower in patients on TAGRISSO (22%, n=32/143) than with placebo (68%, n=50/73 ) (p-value not tested)²

Patients in the TAGRISSO arm experienced lower rates of local progression and distant metastases vs placebo arm¹
Patients on TAGRISSO demonstrated similar patterns of local and distant progression vs placebo: 21% local progression on TAGRISSO vs 48% local progression on placebo; 16% distant metastases on TAGRISSO vs 37% distant metastases on placebo¹

Rate of new brain lesions in the LAURA trial^1,2

In the LAURA study, brain MRIs were required for all patients at baseline for the purpose of assessing CNS PFS.³

P-value not tested.²

Image showing the rate of new brain lesions in the LAURA trial for both study arms

*According to RECIST v1.1.²

†Patients could have more than one new lesion site. Data shown comprises all new lesions at any time, including those whose RECIST progression event has been censored.²

Clinical trial design chart for FLAURA2 trial - global phase 3 randomised TAGRISSO with chemotherapy vs TAGRISSO

Adapted from Lu S et al. N Engl J Med 2024 Supplementary Appendix and Lu S et al. N Engl J Med 2024 Protocol.^2,3

*Including at least 2 cycles of platinum-based chemotherapy and a total dose of radiation of 60 Gy±10% (54 to 66 Gy).³

After CRT completion, all patients underwent baseline magnetic resonance imaging (MRI) brain scans²
Only patients whose disease did not progress on or following CRT were eligible for randomisation¹
81% (50/62) patients in the control arm crossed over to open-label TAGRISSO after RECIST PD, and continuation on open-label TAGRISSO was available to patients in the TAGRISSO arm¹
Patients received concurrent or sequential standard-of-care CRT—including at least 2 cycles of platinum-based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy)—prior to randomisation³

CRT, chemoradiotherapy; EGFRm, epidermal growth factor receptor mutant; Gy, gray; NSCLC, non-small cell lung cancer; WHO, World Health Organization

LAURA included a generally well-balanced population of adult patients whose disease had not progressed following CRT.¹

Characteristics		TAGRISSO (n=143)	Placebo (n=73)
Sex	Male	37%	42%
Sex	Female	63%	58%
Age (years)	Median	62	64
Age (years)	Range	36–84	37–83
Smoking status	Smoker	29%	33%
Smoking status	Non-smoker	71%	67%
Race*	Asian	81%	85%
Race*	Non-Asian	19%	15%
WHO performance status^†	0	56%	42%
WHO performance status^†	1	44%	58%
AJCC/UICC staging at diagnosis (8th ed.)^‡	IIIA	36%	33%
	IIIB	47%	52%
	IIIC	17%	15%
Histology	Adenocarcinoma	97%	95%
Histology	Other	3%	6%
EGFRm at randomisation^II	ex19del	52%	59%
EGFRm at randomisation^II	L858R	48%	41%
Type of chemotherapy^¶	Concurrent	92%	85%
Type of chemotherapy^¶	Sequential	8%	15%
Response prior to CRT^#	CR	3%	4%
	PR	47%	37%
	SD	43%	51%
	NE**	8%	8%
Target lesion size^††	Median	33±18 mm	36±17 mm

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

*Race was reported by the investigators.¹

†WHO performance status scores range from 0 to 5, with higher numbers indicating greater disability.¹

‡Disease stages are classified according to the eighth edition of the AJCC–UICC Cancer Staging Manual and are summarised on the basis of data entered in the electronic case-report form.¹

§This category included two patients with adenosquamous histologic characteristics and one patient with adenosquamous carcinoma histologic characteristics. Classification was made on the basis of data entered in the electronic case-report form.¹

IIOne patient in the osimertinib group underwent randomisation without an approved positive local or central EGFR test result.¹

¶The type of chemoradiotherapy was summarised on the basis of data entered in the electronic case-report form.

#Responses were assessed by the investigator.¹

**Target lesions that were not evaluable did not meet progressive disease criteria and were not measurable after chemoradiotherapy.¹

††Target-lesion size was determined by independent central reviewers who were unaware of trial-group assignments.¹

AJCC, American Joint Committee on Cancer; CR, complete response; NE, not evaluable; PR, partial response; SD, stable disease; UICC, Union for International Cancer Control; WHO, World Health Organization

Primary endpoint: Progression-free survival as assessed by BICR (blinded independent central review).¹
Key secondary endpoints: Overall survival, CNS progression-free survival.¹

Explore TAGRISSO’s results

Navigate the safety profile: LAURA trial 

Explore safety profile

Take a closer look at how TAGRISSO is administered: LAURA trial

Explore dosing and administration

Learn more about how TAGRISSO works

Explore MOA

AJCC, American Joint Committee on Cancer; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CR, complete response; CRT, chemoradiotherapy; ECG, electrocardiogram; EGFRm, epidermal growth factor receptor mutant; Gy, gray; HR, hazard ratio; ILD, interstitial lung disease; NC, not calculated; NSCLC, non-small cell lung cancer; mNSCLC, metastatic non-small cell lung cancer; MOA, mode of action; mPFS, median progression-free survival; MRI, magnetic resonance imaging; NE, not evaluable; PD, progressive disease; PFS, progression-free survival; PR, partial response; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; UICC, Union for International Cancer Control; WHO, World Health Organization

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.
Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. (Protocol) N Engl J Med. 2024 Aug 15;391(7):585-97.

GB-63984 | DOP: July 2025

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Clinical Trials & Efficacy: LAURA

LAURA was a global, Phase III study designed to investigate TAGRISSO in patients with unresectable Stage III EGFRm NSCLC who did not progress either during or following concurrent or sequential CRT.1

TAGRISSO demonstrated a significant 7-fold increase in median PFS vs placebo arm1

~7x mPFS benefit

TAGRISSO selectively targets EGFR sensitising mutations to deliver clinically meaningful PFS benefits1

Progression-free survival per BICR*

Primary Endpoint

LAURA efficacy: local and distant progression

Rate of new brain lesions in the LAURA trial1,2

LAURA clinical trial design2,3

LAURA study population

LAURA clinical trial endpoints

Explore TAGRISSO’s results

Abbreviations and References

LAURA was a global, Phase III study designed to investigate TAGRISSO in patients with unresectable Stage III EGFRm NSCLC who did not progress either during or following concurrent or sequential CRT.¹

TAGRISSO demonstrated a significant 7-fold increase in median PFS vs placebo arm¹

TAGRISSO selectively targets EGFR sensitising mutations to deliver clinically meaningful PFS benefits¹

Rate of new brain lesions in the LAURA trial^1,2