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Dear Healthcare Professional,

TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.¹

TAGRISSO + CT (pem/plat) provides you with an approved option for the first-line treatment of locally advanced or metastatic EGFRm NSCLC1

LEARN MORE ABOUT AN APPROVED INDICATION ❯

TAGRISSO + CT (pem/plat) significantly extended median PFS by ~9 months compared to TAGRISSO monotherapy1




	PROGRESSION-FREE SURVIVAL BY INVESTIGATOR ASSESSMENT1*†‡

HR=0.62

(95% CI: 0.49, 0.79); P<0.0001; N=557

SENSITIVITY ANALYSIS: PFS BY BLINDED
INDEPENDENT CENTRAL REVIEW ASSESSMENT2II

Median PFS, months (95% CI)

TAGRISSO + CT (pem/plat)

29.4 (25.1, NC)

TAGRISSO monotherapy

19.9 (16.6, 25.3)

HR (95% CI)

0.62 (0.48, 0.80)

•	PFS results by BICR were consistent with those reported via investigator assessment1
•	This sensitivity analysis was not powered to show statistical significance

SECOND INTERIM OVERALL SURVIVAL ANALYSIS¶#

HR=0.75

(95% CI: 0.57, 0.97); N=557

mOS for TAGRISSO + CT (pem/plat) was not reached (95% CI: 38.0, NC)

mOS for TAGRISSO monotherapy was 36.7 months (95% CI: 33.2, NC)

OS data were immature at this interim analysis (41% maturity). The final OS analysis has not yet been formally tested for statistical significance.

CT (pem/plat), pemetrexed plus platinum-based chemotherapy.

SAFETY DATA FROM THE FLAURA2 TRIAL1

•	Serious adverse reactions were reported in 38% of patients treated with TAGRISSO + CT (pem/plat). The most frequently reported serious adverse reactions (≥2%) were anemia (3.3%), COVID-19 (2.5%), pneumonia (2.5%), febrile neutropenia (2.2%), thrombocytopenia (2.2%), and pulmonary embolism (2.2%)

•	Fatal adverse reactions occurred in 7% of patients who received TAGRISSO + CT (pem/plat), including pulmonary embolism (1.1%), pneumonia (1.1%), and cardiomyopathy (1.1%)

•	Common adverse reactions occurring in greater than/equal to 20% of patients receiving TAGRISSO + CT (pem/plat) in FLAURA2 were rash (49%), diarrhea (43%), stomatitis (31%), nail toxicity (27%), and dry skin (24%)

•

Clinically relevant adverse reactions in <10% of patients receiving TAGRISSO + CT (pem/plat) were alopecia (9%), epistaxis (7%), palmar-plantar erythrodysesthesia syndrome (5%), interstitial lung disease (3.3%), QTc interval prolongation (1.8%), erythema multiforme (1.4%), urticaria (1.4%), and keratitis (0.7%). QTc interval prolongation represents the incidence of patients who had a QTcF prolongation >500 msec

•	ARs that resulted in permanent discontinuation of TAGRISSO occurred in 11% of patients treated with TAGRISSO + CT (pem/plat). ARs that resulted in permanent discontinuation in ≥1% of patients included ILD/pneumonitis (2.9%), pneumonia (1.4%), and decreased ejection fraction (1.1%)

•	ARs leading to dose reduction of TAGRISSO occurred in 10% of patients treated with TAGRISSO + CT (pem/plat). The most frequently reported adverse reactions leading to dose reduction in ≥1% of patients were diarrhea (1.1%) and rash (1.1%)

•	ARs leading to dose interruptions of TAGRISSO occurred in 44% of patients treated with TAGRISSO + CT (pem/plat). ARs which required dosage interruption in ≥2% of patients included anemia (4.7%), neutropenia (4.3%), diarrhea (3.6%), febrile neutropenia (3.3%), and thrombocytopenia (2.9%)

Please see Important Safety Information below. Please see complete Prescribing Information, including Patient Information for TAGRISSO.

FLAURA2 study design: Phase 3, open-label, randomized global trial in 557 patients with locally advanced or metastatic EGFRm (exon 19 deletions or exon 21 L858R mutations) NSCLC who had not received prior systemic treatment for advanced disease. Patients were randomized 1:1 to either TAGRISSO monotherapy (n=278) or TAGRISSO + CT (pem/plat) (n=279). Both arms of the trial were treated until disease progression or unacceptable toxicity. The primary endpoint of the study was PFS based on investigator assessment.^1,2

Primary endpoint in FLAURA2.¹

†

Overall PFS maturity by investigator analysis was 51%: TAGRISSO + CT (pem/plat), 43%; TAGRISSO monotherapy, 60%.²

‡

Median follow-up (censored patients) was 22.2 months (0, 33.1) in the TAGRISSO + CT (pem/plat) arm and 23.7 months (0, 33.1) in the TAGRISSO monotherapy arm.²

TAGRISSO + CT (pem/plat) dosing: In cycles 1-4, TAGRISSO 80 mg po qd + pemetrexed (500 mg/m2) q3w + cisplatin (75 mg/m2) or carboplatin (AUC 5) q3w; in cycles 5+, TAGRISSO 80 mg po qd + pemetrexed maintenance (500 mg/m2) q3w until disease progression or unacceptable toxicity. TAGRISSO monotherapy dosing: 80 mg po qd until disease progression or unacceptable toxicity.¹

Overall PFS maturity by BICR analysis was 43%.⁴

OS was a secondary endpoint in FLAURA2.¹

Median follow-up was 31.7 months (0.1, 43.3) in the TAGRISSO + CT (pem/plat) arm and 30.5 months (0.1, 43.0) in the TAGRISSO monotherapy arm.³

IMPORTANT SAFETY INFORMATION

•	There are no contraindications for TAGRISSO

•	TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy (CRT); 0.4% of cases were fatal. In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal. For patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed

•	TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia

•	TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO

•	Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist

•	Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed

•	Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity

•	Aplastic anemia has been reported in patients treated with TAGRISSO in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated

•	Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose

•	Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose

•	Most common (≥20%) adverse reactions, including laboratory abnormalities, were:

–

TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine

INDICATION

•

TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

Please see complete Prescribing Information, including Patient Information for TAGRISSO.

You may report side effects related to AstraZeneca products (opens new window).

ARs, adverse reactions; AUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; FDA, US Food and Drug Administration; HR, hazard ratio; ILD, interstitial lung disease; L858R, exon 21 leucine 858 arginine substitution; mOS, median overall survival; mPFS, median progression-free survival; NC, not calculable; NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; po, by mouth; q3w, once every 3 weeks; qd, once daily; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. N Engl J Med. 2023;389(21):1935-1948. 3. Valdiviezo N, Okamoto I, Hughes BGM, et al. First-line osimertinib ± platinum-pemetrexed in EGFRm advanced NSCLC: FLAURA2 post-progression outcomes [oral presentation]. Presented at: 2024 European Lung Cancer Congress; March 20-23, 2024; Prague, Czech Republic. 4. Jänne PA, Planchard D, Cheng Y, et al. Osimertinib with/without platinum-based chemotherapy as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA2) [oral presentation]. Presented at: ‌2‌0‌2‌3 World Conference on Lung Cancer; September 9-12, 2023; Singapore.



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