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New analysis showed dose adjustment of Giotrif® (afatinib) improved tolerability without an apparent impact on efficacy in patients with EGFR mutation-positive non-small cell lung cancer

Results from a new post-hoc analysis of two large Phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Giotrif® (afatinib* ) in patients with advanced non-small cell lung cancer (NSCLC) were published in Annals of Oncology. The analysis suggests specific dose reductions, as described in SmPC / prescribing information, led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy.

“Afatinib’s efficacy and safety profile in the first-line treatment of patients with EGFR mutation-positive NSCLC has been well established in multiple large trials. This further analysis suggests that dosing of afatinib can be adjusted to help manage a patient’s treatment-related adverse events, without any apparent reduction in efficacy. This may provide physicians and their patients with confidence and allows physicians to help address adverse events,” commented principal investigator and lead author James Chih-Hsin Yang, Director, Department of Oncology, National Taiwan University Hospital, and Director, Graduate Institute of Oncology, National Taiwan University Cancer Center, Taiwan.

Afatinib-treated patients from the LUX-Lung 3 [NCT00949650 ] (n=229) and LUX-Lung 6 [NCT01121393 ] (n=239) trials were included in the analysis. Dose reductions** took place in 53.3% (n=122) and 28% (n=67) of patients in each study, respectively, most within the first six months of treatment. Dose reductions were associated with decreases in the incidence and severity of treatment-related AEs, while median progression-free survival (PFS) was similar in patients who dose-reduced within the first six months of treatment versus those who did not (LUX-Lung 3, 11.3 vs 11 months; LUX-Lung 6, 12.3 vs 11 months).

Mehdi Shahidi, M.D., Global Head of Medicine, Oncology, Boehringer Ingelheim said, “Afatinib has demonstrated significant treatment benefits compared to chemotherapy in the LUX-Lung 3 and 6 trials. These additional data on dose modification add to the robust body of evidence for afatinib. Adjusting the dose where needed provides healthcare professionals with increased flexibility in the appropriate use of afatinib.”

LUX-Lung 3 and LUX-Lung 6 are multicentre, randomised, open-label, Phase III trials of afatinib versus chemotherapy (pemetrexed / cisplatin and gemcitabine / cisplatin, respectively) as first-line treatment for patients with EGFR mutation-positive, advanced and metastatic NSCLC. Both trials met their primary endpoint of PFS with afatinib significantly delaying tumour growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to have shown an overall survival (OS) benefit for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy. This was coupled with improvements in lung cancer-related symptoms (cough, shortness of breath, pain) and quality of life with afatinib treatment when compared with chemotherapy in the overall study population.

Afatinib is approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC*. Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial.

*Afatinib is approved in the EU under the brand name Giotrif ® for the first-line treatment of tyrosine kinase inhibitor naïve adult patients with advanced EGFR mutation-positive NSCLC and in the US under the brand name Gilotrif ® for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Registration conditions differ internationally, please refer to locally approved prescribing information.

**In case of the following treatment-related AEs: any grade ≥3 AE, prolonged grade 2 diarrhoea, grade 2 nausea or vomiting for ≥7 days despite supportive care, or grade ≥2 worsening renal function, treatment was interrupted for up to 14 days until severity reduced to grade 1 or baseline, and then resumed at a lower dose (10 mg decrements to a minimum of 20 mg).

Afatinib should be initiated at the approved dose of 40 mg/day; tolerability-guided dose adjustments can then be made to reduce afatinib-related AEs without an apparent impact on therapeutic efficacy.

Intended audiences:

This press release is issued from our corporate headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

For references and notes to editors, please visit:

http://www.boehringer-ingelheim.com/press-release/new-analysis-showed-dose-adjustment-giotrif-afatinib-improved-tolerability

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