LUME-BioNIS clinical trial

LUME BioNIS: a Biomarker Study of Nintedanib in Patients With NSCLC

A non-interventional biomarker study in patients with non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology eligible for treatment with nintedanib* (Vargatef®) plus docetaxel according to the approved label.

 

Trial CT.gov-Identifier: NCT02671422

Patients

Patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma histology after failure of first-line chemotherapy

The study was not originally planned to include an immunotherapy pretreated subgroup. However, such patients were eligible and were enrolled as a result of changes in the treatment landscape

Nintedanib plus docetaxel is initiated and administered in accordance with the approved label

Available formalin-fixed and paraffin-embedded tumor tissue routinely obtained at diagnosis and/or at re-biopsy prior to first-line treatment initiation

N=295

Nintedanib 200 mg + Docetaxel 75 mg/m² Nintedanib 200 mg + Docetaxel 75 mg/m² ORAL TWICE DAILY (DAYS 2–21 OF EVERY 3-WEEK CYCLE) + INTRAVENOUS (DAY 1)

Endpoints

Primary outcome measure:

Overall survival (OS) in relation to exploratory biomarker assessment, including general expression profile, tumor genomic alterations and protein analysis.

Trial status

The LUME-BioNIS trial is a non-interventional biomarker study in patients who are eligible to receive nintedanib plus docetaxel as part of routine treatment and according to the approved label, i.e. have advanced adenocarcinoma NSCLC after failure of first-line chemotherapy. Mutation analysis of nintedanib target genes will be conducted, as well as evaluation of tumor protein expression and proliferation markers by immunohistochemistry. The study was conducted at 86 European sites and has finished recruitment.

 

Patients previously treated with immunotherapy: LUME-BioNIS

In a subgroup analysis of patients previously treated with immunotherapy and chemotherapy (n=67), patients treated with nintedanib plus docetaxel had a median PFS of 4.6 months and a median OS of 8.8 months. The majority of patients (n=57; 85.1%) received nintedanib plus docetaxel as third- or later-line treatment, with 47 (70.1%) patients receiving prior immunotherapy as second- or later- line therapy.

OS outcomes for patients previously treated with immunotherapy and chemotherapy (n=67) in LUME-BioNIS

OS outcomes for patients previously treated with immuno-therapy and chemo-therapy in LUME-BioNIS

CI, confidence interval; OS, overall survival.

PFS outcomes for patients previously treated with immunotherapy and chemotherapy (n=67) in LUME-BioNIS

PFS outcomes for patients previously treated with immuno-therapy and chemo-therapy in LUME-BioNIS

CI, confidence interval; PFS, progression-free survival.

Among 55 patients with available tumor response data, best response was partial response in 10 patients (18.2%) and stable disease in 33 patients (60.0%), providing a disease control rate of 78.2%.

Safety:

Safety findings were consistent with the known safety profile of nintedanib plus docetaxel in patients with advanced NSCLC. The most common reported adverse event was diarrhea in 32.3% (21/65) of patients.

 

Conclusion

This subgroup analysis suggests that, when used in line with the approved nintedanib label in routine practice, nintedanib plus docetaxel can be clinically effective in patients with adenocarcinoma NSCLC previously treated with chemotherapy and first- or later-line immunotherapy.

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References

1

Reck M, et al. Poster presented at ESMO I-O 2019 (Poster 80P).

2

Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT02671422 (Accessed: June 2020).

*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 tumor histology after first-line chemotherapy. For the full list of country-specific information, please click here. Nintedanib is not approved in other oncology indications.

 

© 2020 Boehringer Ingelheim International GmbH. All rights reserved.

 

Last updated: August 2020