I am a Healthcare Professional outside the US and UK

I am a Healthcare Professional outside the US and UK

Click here for international medical scientific information about Oncology for Healthcare Professionals.

I am not a Healthcare Professional and I am outside the US and the UK

I am not a Healthcare Professional and I am outside the US and the UK

Click here for general international information for patients, caregivers and the general public.

Country-specific medical scientific information

Country-specific medical scientific information

Country-specific medical scientific information for Healthcare Professionals.

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

InOncology.com

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