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NICE recommends Giotrif (afatinib) for first line treatment of EGFR mutation positive advanced lung cancer

Lung cancer patients in the UK are closer to gaining access to a new targeted treatment Giotrif® (afatinib), the first oncology treatment to be developed by Boehringer Ingelheim. The National Institute for Health and Care Excellence (NICE) has issued the Final Appraisal Determination (FAD) recommending afatinib as a first line treatment “for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small cell lung cancer”.1 Afatinib is only the second oncology drug to be approved by NICE in the past fourteen months2 and is the only epidermal growth factor receptor mutation tyrosine kinase inhibitor (EGFR TKI) in lung cancer to go straight to FAD based on the strength of the clinical and cost-effectiveness evidence.1,3,4

Dr Riyaz Shah, Consultant Medical Oncolgist at Kent Oncology Centre, Maidstone Hospital, commented: “This is a welcomed approval from NICE and it is encouraging to hear that afatinib will be made available for patients in England with advanced NSCLC harbouring an EGFR mutation. Around 40,000 people in the UK are diagnosed with lung cancer every year so the approval of afatinib is an encouraging step forward in providing lung cancer patients with more targeted treatment options that not only prolong survival, but also offer an improved quality of life.”

In the UK about 42,000 people are diagnosed with lung cancer5 and there are around 35,000 deaths per year, which is more than breast cancer and prostate cancer combined (22,354).6

Lung cancer is still seen mainly as a smoker’s disease however, lung cancer in people who have never smoked is on the increase.7 In fact, one in eight cases of lung cancer are not linked with smoking and lung cancer patients who have never smoked are more likely to have a mutation change in the EGFR.7

Afatinib is a new, once-daily, tablet which targets the entire ErbB family of receptors which are known to play a critical role in helping cancer cells grow. 8-11

Data submitted to NICE included the key studies LUX-Lung 3 and LUX- Lung 6 conducted in EGFR mutation positive patients with advanced lung cancer. In the two phase III studies, patients receiving afatinib lived for longer without their tumour growing (known as progression free survival, PFS) compared to chemotherapy.12,13

LUX-Lung 3, the largest global phase III trial in patients with EGFR mutation positive advanced lung cancer, showed that patients taking afatinib as a first line treatment lived for an average of 11.1 months without their tumour growing (PFS) versus 6.9 months for those treated with pemetrexed/cisplatin (HR 0.58; p<0.001). Side-effects seen with afatinib were manageable through dose reductions and supportive care, with 8% of patients discontinuing due to afatinib related side effects, compared to 12% in the chemotherapy arm. The most common side effect was diarrhoea with 1.3% of patients discontinuing treatment due to this.12

In the companion trial in Asian patients – LUX-Lung 6, EGFR mutation positive patients with advanced lung cancer taking afatinib as a first line treatment, lived for an average of 11.0 months without their tumour growing (PFS), versus 5.6 months for those treated with gemcitabine/cisplatin (HR 0.28; p<0.0001).13

“We are very pleased that NICE has recommended afatinib as a clinically and cost effective treatment. It’s great to see that Giotrif® will provide oncologists with a new therapeutic option for the management of EGFR mutation positive patients with advanced lung cancer,” commented Zinta Krumins, Managing Director Boehringer Ingelheim UK.

Source

1 Final Appraisal Determination. Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small small- cell lung cancer. [Online] Available at: http://www.nice.org.uk/nicemedia/live/14070/66933/66933.pdf Last Accessed March 2014

2 NICE. Published technology appraisals. [Online] Available at: http://www.nice.org.uk/guidance/ta/published/index.jsp?p=off. Last Accessed: February 2014

3 NICE. Press releases. [Online] Available at: http://www.nice.org.uk/newsroom/pressreleases/ErlotinibLungCancerACD.jsp. Last Accessed: February 2014

4 NICE. Press releases. [Online] Available at: http://www.nice.org.uk/newsroom/pressreleases/2010061gefitinib.jsp. Last Accessed: February 2014

5 NHS Choices. Lung cancer: are you at risk? [Online] Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170525/. Last Accessed: February 2014

6 New Cancer Research UK. Lung Cancer – UK incidence statistics. [Online] Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/lung/incidence/. Last Accessed: February 2014

7 Cancer Research UK, UK Cancer Incidence (2010) by Country Summary, April 2013. [Online] Last Accessed: February 2014

8 GIOTRIF® 20mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

9 GIOTRIF® 30mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

10 GIOTRIF® 40mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

11 GIOTRIF® 50mg film–coated tablets. Summary of Product Characteristics 2013. Boehringer Ingelheim.

12 Sequist LV, Yang JC, Yamamoto N et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013; 31(27):3327-3334

13 Wu YL, Zhou C, Hu CP et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014; 15(2):213-222

14 Solca F, Dahl G, Zoephel A et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther. 2012;343:342-50

15 Reid A, Vidal L, Shaw H et al. Dual inhibition of ErbB1 (EGFR/HER1) and ErbB2 (HER2/neu). Eur J Cancer. 2007; 43:481-489

16 Cancer Research UK. Cancer incidence for common cancers. [Online]. Last Accessed: February 2014

17 Cancer Research UK. Cancer mortality for common cancers. [Online]. Last Accessed: February 2014.

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