This site uses cookies to improve your browsing experience. By using this site, you agree to their use. Cookie Information

Nintedanib in NSCLC: additional analyses

European patients: LUME-Lung 1​

In an exploratory analysis of overall survival (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.1

OS outcomes for European adenocarcinoma patients in LUME-Lung 1

LUME-Lung 1: figure for overall survival (OS) in European patients with nintedanib vs placebo

CI, confidence interval; HR, hazard ratio.

TSFLT as a clinical marker: LUME-Lung 1 and LUME-Lung 2

There is a lack of validated clinical or molecular markers that can predict survival benefit from anti-angiogenic treatment in non-small cell lung cancer. 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 Time since start of first-line therapy (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 who had TSFLT ≥9 months:

  • Median OS with TSFLT <9 months: 10.9 vs 7.9 months (HR=0.75 [95% CI: 0.60–0.92]; p=0.0073)
  • Median OS with TSFLT ≥9 months: 17.0 vs 15.1 months (HR=0.89 [95% CI: 0.66–1.19]; p=0.4239)

TSFLT could be used to guide treatment choice and select patients who are likely to derive the most benefit from nintedanib treatment.3

Prior treatment: LUME-Lung 1

The 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.4

OS outcomes by prior treatment in LUME-Lung 1 adenocarcinoma patients

LUME-Lung 1: figure for overall survival (OS) outcomes by prior treatment; nintedanib vs placebo

CI, confidence interval; HR, hazard ratio.

Fast-progressing tumours in adenocarcinoma patients: LUME-Lung 1

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).5

OS for adenocarcinoma patients with time from end of first-line therapy ≤6 months

LUME-Lung 1: figure for overall survival (OS) in adenocarcinoma patients with fast progressing tumours (TEFLT ≤6 months); nintedanib vs placebo

CI, confidence interval; HR, hazard ratio.

Tumour growth in adenocarcinoma patients with progressive disease as best response to first-line therapy

LUME-Lung 1: figure for adenocarcinoma patients with progressive disease as best response to FLT; nintedanib vs placebo

CI, confidence interval; HR, hazard ratio.

Tumour size: LUME-Lung 1

Effect of treatment on tumour growth, defined as the sum change in the longest diameter target lesions over time, was analysed in the LUME-Lung 1 adenocarcinoma population.6 Treatment difference at 6 months significantly favoured nintedanib compared with placebo, particularly for adenocarcinoma patients with a poor prognosis, defined as TSFLT <9 months and in patients with progressive disease as best response to first-line therapy.

Tumour growth in adenocarcinoma patients with time since start of first-line therapy <9 months

LUME-Lung 1: figure for tumour growth in adenocarcinoma patients with TSFLT less than 9 months; nintedanib vs placebo

SLD, sum of longest diameter; TSFLT, time since start of first-line therapy.

Tumour growth in adenocarcinoma patients with progressive disease as best response to first-line therapy

LUME-Lung 1: figure for tumour growth in patients with progressive disease as best response to FLT; nintedanib vs placebo

SLD, sum of longest diameter.

Did you find this information useful?

References

1

Gottfried M, et al. Target Oncol 2017;12(4):475–85.

2

Gaschler-Markefski B, et al. ESMO Open 2017;11;2(1):e000102.

3

Reck M, et al. Future Oncol 2019 Feb 13. doi: 10.2217/fon-2018-0948. [Epub ahead of print].

4

Heigener D, et al. J Thorac Oncol 2015;10(9 Suppl. 2):S323–S4.

5

Heigener D, et al. Ann Oncol 2016;27(Suppl. 6):1276P.

6

Reck M, et al. J Thorac Oncol 2015;10(9 Suppl. 2):S324.

*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.

 

Page last updated: March 2019