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Afatinib in advanced squamous cell carcinoma of the lung: Added benefit not proven

The comparisons presented were unsuitable for the benefit assessment

Date:
August 18, 2016
Source:
Institute for Quality and Efficiency in Health Care
Summary:
Considering Afatinib in advanced squamous cell carcinoma of the lung, neither the direct nor the indirect comparison conducted by the drug manufacturer allows conclusions on advantages or disadvantages in comparison with the appropriate comparator therapy.
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Afatinib (trade name: Giotrif) has been approved since April 2016 for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) of squamous histology who have already received chemotherapy. In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether in these patients this drug offers advantages over the appropriate comparator therapy. According to the findings, an added benefit of afatinib for these patients is not proven.

Requirements for comparator therapy not met

The Federal Joint Committee (G-BA) specified docetaxel or -- if no further chemotherapy is indicated for the patients -- best supportive care as appropriate comparator therapy. The drug manufacturer presented no data for this second research question.

For the first research question -- i.e. patients who can receive further chemotherapy -- the manufacturer cited the study LUX-Lung 8. In this study, however, afatinib was not compared with docetaxel, but with erlotinib. The manufacturer did not sufficiently justify the therapeutic equivalence of these two drugs in the treatment of patients with squamous cell carcinoma. IQWiG therefore concluded that there was no comparison with the appropriate comparator therapy that could be assessed.

Indirect comparison without informative value

In addition, the manufacturer conducted an indirect comparison with erlotinib as common comparator, using the LUX-Lung 8 study on the afatinib side, and the TAILOR study on the docetaxel side. However, the manufacturer did not attempt to derive an added benefit from this comparison. The information on study design and on the participants in the TAILOR study was actually inadequate to assess whether both studies were sufficiently similar. In addition, the dosage of docetaxel did not exactly comply with the Summary of Product Characteristics, and only results on overall survival were reported under patient-relevant outcomes.

Hence also from the indirect comparison no conclusion on advantages or disadvantages of afatinib could be derived. IQWiG therefore concluded that an added benefit of afatinib in comparison with the appropriate comparator therapy is not proven.


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Materials provided by Institute for Quality and Efficiency in Health Care. Note: Content may be edited for style and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Afatinib in advanced squamous cell carcinoma of the lung: Added benefit not proven: The comparisons presented were unsuitable for the benefit assessment." ScienceDaily. ScienceDaily, 18 August 2016. <www.sciencedaily.com/releases/2016/08/160818131515.htm>.
Institute for Quality and Efficiency in Health Care. (2016, August 18). Afatinib in advanced squamous cell carcinoma of the lung: Added benefit not proven: The comparisons presented were unsuitable for the benefit assessment. ScienceDaily. Retrieved May 26, 2017 from www.sciencedaily.com/releases/2016/08/160818131515.htm
Institute for Quality and Efficiency in Health Care. "Afatinib in advanced squamous cell carcinoma of the lung: Added benefit not proven: The comparisons presented were unsuitable for the benefit assessment." ScienceDaily. www.sciencedaily.com/releases/2016/08/160818131515.htm (accessed May 26, 2017).

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