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In LUME-Lung 1, the key secondary endpoint of OS was analysed in a prespecified stepwise manner: first in patients with adenocarcinoma histology who had time since start of first-line therapy (TSFLT) of <9 months, then in all patients with adenocarcinoma histology and finally in the overall patient population.1 Adenocarcinoma patients with TSFLT <9 months in the nintedanib* arm of the study had an OS that was 3.0 months longer than patients in the placebo arm (p=0.0073).1
In the analysis of all patients with adenocarcinoma histology, the difference in OS between the two treatment groups was not statistically significant. Similarly, there was no significant difference in OS between treatment arms in the analysis of the overall patient population.1
There is a lack of validated clinical or molecular markers that can predict survival benefit from antiangiogenic treatment in NSCLC. Analysis of data from the LUME-Lung 2 trial was conducted to identify predictive and prognostic markers related to nintedanib* treatment; these were then validated using data from the LUME-Lung 1 trial.2 TSFLT was identified as a predictive clinical marker: Patients with a shorter TSFLT (<9 months) derived a greater clinical benefit from nintedanib vs placebo than patients TSFLT ≥9 months:
TSFLT could be used to guide treatment choice and select patients who are likely to derive the most benefit from nintedanib treatment.
Efficacy of nintedanib,* and in particular OS, was maintained in adenocarcinoma patients in LUME-Lung 1 regardless of whether patients had received first-line treatment with bevacizumab, pemetrexed or taxanes.3
Further analyses of the LUME-Lung 1 study population have identified further subgroups of adenocarcinoma patients who received significant survival benefit from nintedanib* treatment compared with placebo: patients with progressive disease as best response to first-line therapy (median OS difference of 3.5 months), and patients with time from end of first-line therapy (TEFLT) ≤6 months (median OS difference of 3.1 months).3
In an exploratory analysis of OS in European patients with adenocarcinoma, median OS was increased by 4.7 months in patients treated with nintedanib* compared with those treated with placebo.3
A 4.1 month improvement in median OS was observed in European patients with adenocarcinoma with TSFLT <9 months treated with nintedanib arm (HR 0.69; 95% CI 0.53–0.89; p=0.0049).
Tumour growth, as measured by the sum of longest diameter of target lesions (SLD), was analysed in the LUME-Lung 1 adenocarcinoma population.1 Treatment difference at 6 months significantly favoured nintedanib* compared with placebo, particularly for adenocarcinoma patients with a poor prognosis, defined as TSFLT <9 months or patients with progressive disease as best response to first-line therapy.
Patients included in this named patient use access programme had advanced lung adenocarcinoma, with progressive disease following at least one line of platinum-based doublet chemotherapy. Of the 390 patients included in the program, 11 had received immunotherapy prior to nintedanib/docetaxel. In these patients, median PFS with first-line chemotherapy was 3.3 months, with 4 patients progressing in under 3 months. Three patients then received nivolumab, four received pembrolizumab and four atezolizumab; the ORR on immunotherapy was 18% and median PFS was 2.3 months. Subsequent nintedanib/docetaxel treatment was associated with an ORR of 36% and a median PFS of 3.2 months.4
Reck M, et al. J Thorac Oncol 2015;10(9 Suppl 2):S324.
Gaschler-Markefski B, et al. ESMO Open 2017;11;2(1):e000102.
Gottfried M, et al. Target Oncol 2017 [Epub ahead of print]. doi:10.1007/s11523-017-0517-2. Accessed: July 2017.
Corral, J et al. Poster presented at WCLC 2017 (Poster P2.01-022).
*Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. For the full list of country-specific information please click here. Nintedanib is not approved in other oncology indications.
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