LUX-Lung 7 infographicV9 - Boehringer Ingelheim · Afatinib significantly increased compared with...
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0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 LUX-LUNG 7 CO-PRIMARY ENDPOINTS: • PFS by independent review • OS • TTF Afatinib significantly increased median PFS vs gefitinib; 11.0 months vs 10.9 months (p=0.017). The increase in PFS became more pronounced over time, showing a greater long-term benefit with afatinib vs gefitinib. Median OS was increased with afatinib compared with gefitinib (27.9 vs 24.5 months) but the difference did not reach statistical significance. Afatinib significantly increased TTF vs gefitinib; 13.7 months vs 11.5 months (p=0.0073). Improvements in efficacy endpoints with afatinib vs gefitinib were reported consistently across prespecified subgroups including EGFR mutation type, age, gender, and race. Gefitinib – 250 mg oral, once daily PFS: All patients TTF: All patients Tumour Response 1,4 100 80 60 40 20 0 Estimated probability of being on treatment (%) Time (months) 0 ORR (%) ORR 1 Long-term responders 4 12% of patients treated with afatinib responded to treatment for ≥3 years compared with 4% of patients treated with gefitinib Median duration of response 1 A global, randomised, open-label trial comparing two EGFR-directed therapies (afatinib* vs gefitinib) head-to-head in the first-line treatment of EGFR-positive NSCLC. p=0.0083 Stratified by: • Mutation type (Del19/L858R) • Brain metastases (present/absent) Trial Sites 2§ EGFR mutation positive (Del19 or L858R) adenocarcinoma of the lung (stage IIIB/IV) No prior treatment for advanced/metastatic disease Stable brain metastases at baseline permitted ECOG PS 0–1 1 1 N=319 RANDOMISEDn=160 n=159 Afatinib – 40 mg oral, once daily Trial Results 1,3 Trial Design 1 Safety Profile 1 AEs were consistent with the known safety profiles of both treatments Treatment with either monotherapy was generally tolerable, with an equally low rate of treatment-related discontinuation in both arms (6%) *Afatinib is approved in more than 70 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. § Australia, Canada, China, France, Germany, Hong Kong, Ireland, Republic of Korea, Norway, Singapore, Spain, Sweden, Taiwan, UK. Abbreviations: AE, adverse event; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; HR, hazard ratio; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PS, performance status; TTF, time to treatment failure; vs, versus. 1. Park K, et al. Lancet Oncol 2016;17(5):577–89; 2. Clinicaltrials.gov.NCT01466660 https://clinicaltrials.gov/ct2/show/NCT01466660 (Accessed: August 2017); 3. Paz-Ares L, et al. Ann Oncol. 2017;28(2):270–277. 4. Schuler M, et al. Eur J Cancer 2017;72 (Suppl 1):S176-S7. This information is from an international website which is intended for healthcare professionals not located in the United States of America (US) and the United Kingdom (UK). Afatinib is subject to country-specific regulations and the approved product label may vary from country to country. Information on this website is derived from the approved European Summary of Product Characteristics. Please refer to your local product label for full details. © Boehringer Ingelheim International GmbH 2017. This document and its contents are property of Boehringer Ingelheim (third party sources are indicated) and are, inter alia, protected by copyright law. Complete or partial passing on to third parties as well as copying, reproduction, publication or any other use by third parties is not permitted. Last updated: August 2017. Procedure ID: 6048 Risk of progression reduced by 27% with afatinib vs gefitinib (HR=0.73; 95% CI: 0.57–0.95) Risk of treatment failure reduced by 27% with afatinib vs gefitinib (HR=0.73; 95% CI: 0.58–0.92) 10 20 30 40 50 60 70 80 70 56 Afatinib Gefitinib In this global study, 57% of patients were of Asian ethnicity 100 80 60 40 20 0 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 PFS (%) Time (months) Afatinib: 10.1 months Gefitinib: 8.4 months Afatinib Gefitinib
Transcript of LUX-Lung 7 infographicV9 - Boehringer Ingelheim · Afatinib significantly increased compared with...
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LUX-LUNG 7
CO-PRIMARY ENDPOINTS: • PFS by independent review • OS • TTF
Afatinib significantly increased median PFSvs gefitinib; 11.0 monthsvs 10.9 months (p=0.017).
The increase in PFS became more pronounced over time, showing a greater long-term benefit with afatinib vs gefitinib.
Median OS was increasedwith afatinib compared withgefitinib (27.9 vs 24.5 months) but the di�erence did not reach statistical significance.
Afatinib significantly increased TTF vs gefitinib; 13.7 months vs 11.5 months (p=0.0073).
Improvements in e�cacy endpoints with afatinib vs gefitinib were reported consistently across prespecified subgroups including EGFR mutation type, age, gender, and race.
Gefitinib – 250 mg oral, once daily
PFS: All patients
TTF: All patients
Tumour Response1,4
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ORR1
Long-term responders4
12% of patients treated with afatinibresponded to treatment for ≥3 yearscompared with 4% of patients treatedwith gefitinib
Median duration of response1
A global, randomised, open-label trial comparing two EGFR-directed therapies (afatinib* vs gefitinib) head-to-head in the first-line treatment of EGFR-positive NSCLC.
p=0.0083
Stratified by: • Mutation type (Del19/L858R)• Brain metastases (present/absent)
Trial Sites2§
EGFR mutation positive(Del19 or L858R) adenocarcinoma of the lung (stage IIIB/IV)
No prior treatment for advanced/metastatic disease
Stable brain metastases at baseline permitted
ECOG PS 0–1
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N=319
RANDOMISED
n=160
n=159
Afatinib – 40 mg oral, once daily
Trial Results1,3
Trial Design1
Safety Profile1
AEs were consistent with the known safety profiles of bothtreatments
Treatment with either monotherapy was generally tolerable, withan equally low rate of treatment-related discontinuation in botharms (6%)
*Afatinib is approved in more than 70 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here.§Australia, Canada, China, France, Germany, Hong Kong, Ireland, Republic of Korea, Norway, Singapore, Spain, Sweden, Taiwan, UK.
Abbreviations: AE, adverse event; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; HR, hazard ratio; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival;PFS, progression-free survival; PS, performance status; TTF, time to treatment failure; vs, versus.
1. Park K, et al. Lancet Oncol 2016;17(5):577–89; 2. Clinicaltrials.gov.NCT01466660 https://clinicaltrials.gov/ct2/show/NCT01466660 (Accessed: August 2017); 3. Paz-Ares L, et al. Ann Oncol. 2017;28(2):270–277. 4. Schuler M, et al. Eur J Cancer2017;72 (Suppl 1):S176-S7.
This information is from an international website which is intended for healthcare professionals not located in the United States of America (US) and the United Kingdom (UK). Afatinib is subject to country-specific regulations and the approved product labelmay vary from country to country. Information on this website is derived from the approved European Summary of Product Characteristics. Please refer toyour local product label for full details.© Boehringer Ingelheim International GmbH 2017. This document and its contents are property of Boehringer Ingelheim (third party sources are indicated)and are, inter alia, protected by copyright law. Complete or partial passing on to third parties as well as copying, reproduction, publication or any other useby third parties is not permitted. Last updated: August 2017. Procedure ID: 6048
Risk of progression reduced by27% with afatinib vs gefitinib(HR=0.73; 95% CI: 0.57–0.95)
Risk of treatment failure reducedby 27% with afatinib vs gefitinib(HR=0.73; 95% CI: 0.58–0.92)
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Afatinib Gefitinib
In this global study, 57% of patients were of Asianethnicity
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Afatinib Gefitinib
LUX-LUNG 7Abbreviated EU SmPC:
EGFR M+ NSCLC and sqNSCLCGIOTRIF®: Irreversible ErbB family blocker. Active substance: Afatinib. Indications: GIOTRIF is indicated as monotherapy for (1) patients with locally advanced or metastatic NSCLC with activating EGFR mutations not previously treated with EGFR TKIs, (2) patients with NSCLC of squamous histology progressing on or after platinum-based chemotherapy. Posology: The recommended dose is 40 mg once daily, orally. Not recommended in patientswith an eGFR <15ml/min and severe hepatic impairment. Contraindications: Hypersensitivity to afatinib or any of the excipients. Interactions: Potent P-gp inhibitors may lead to increased afatinib exposure, concomitant treatment with potent P-gp inducers may lead to a reduction in afatinib exposure. Afatinibis not an inhibitor or inducer of CYP enzymes. Undesirable e�ects: Paronychia, cystitis, decreased appetite, dehydration, hypokalaemia, dysgeusia,conjunctivitis, dry eye, epistaxis, rhinorrhoea, diarrhoea, stomatitis, nausea, vomiting, cheilitis, dyspepsia, alanine aminotransferase increased, aspartate aminotransferase increased, rash, acneiform dermatitis, pruritus, dry skin, palmar-plantar erythrodysaesthesia syndrome, nail disorders, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle spasms, renal impairment/renal failure, pyrexia, weight decreased, interstitial lung disease, keratitis, pancreatitis. Presentations: 20 mg, 30 mg, 40 mg, and 50 mg film-coated tablets. For detailed information, please refer to the published Prescribing Information.
Supply classification: POM.
This medicine is subject to additional monitoring.
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
eGFR, estimated glomerular filtration rate; EGFR M+, epidermal growth factor receptor mutation positive; NSCLC, non-small cell lung cancer; POM, prescription only medicine; sqNSCLC, non-small cell lung cancer of squamous histology;TKI, tyrosine kinase inhibitor.
Date of text revision: July 2017
