Nintedanib in lung cancer: Added benefit depends on disease severity

In continuation of my update on Nintedanib

According to the findings, there is an indication of a minor added benefit of nintedanib in combination with docetaxel in patients without brain metastases. However, in patients with brain metastases, the new drug has more disadvantages than chemotherapy with docetaxel alone. This results in a hint of a lesser benefit of nintedanib with the extent "considerable."

Findings from the only study are biased: at most indications can be derived

In its dossier the drug manufacturer compares treatment comprising nintedanib plus docetaxel with treatment comprising placebo plus docetaxel. As the treatment period in the nintedanib arm was longer than in the placebo arm (median: 4.3 versus 3 months), the observation periods for the study arms differed. Except for overall survival, the results are therefore uncertain for all outcomes.

In principle, at most an indication of an added benefit can be derived from the results of the only study included in the manufacturer dossier. As the analysis of the data shows, the advantages or disadvantages of nintedanib in combination with docetaxel primarily depend on whether patients already had brain metastases at the start of the study or not.

Patients without brain metastases live longer

Patients without brain metastases who received nintedanib in combination with docetaxel lived longer than study participants who were only treated with docetaxel (median: 13.5 versus 10.3 months). This results in an indication of a minor added benefit of nintedanib.

Although diarrhoea was more frequent in patients receiving nintedanib, this disadvantage does not challenge the survival advantage. Therefore, overall an indication remains of a minor added benefit for patients without brain metastases.

More symptoms in patients with brain metastases

Nintedanib in lung cancer: Added benefit depends on disease severity  

LUME-Lung 1 shows QoL, symptoms benefits

LUME-Lung 1 (Nintedanib + docetaxel) trial patients’ reports of symptoms and health-related quality of life (HRQoL) support the use of second-line nintedanib for the treatment of advanced non-small-cell lung cancer (NSCLC).

Initial findings from the phase III trial demonstrated that the angiokinase inhibitor plus docetaxel offered significantly better progression-free survival for patients with advanced NSCLC, including subpopulations with adenocarcinoma, than placebo plus docetaxel, explain Silvia Novello (University of Turin, Italy) and co-authors in theEuropean Journal of Cancer.

For the current study, the team used a battery of tests to compare patient-reported outcomes on day 1 of each 21-day treatment cycle, at the end of treatment and at the first follow-up visit for the two treatment groups.

Over 80% of the 655 nintedanib-treated patients and 659 of controls completed the European Organisation for Research and Treatment of Cancer Core QoL Questionnaire and its lung cancer supplement, with 70% doing so at the end of treatment.

Baseline health and QoL were comparable for the nintedanib and placebo groups with relatively good scores and a low burden of lung cancer-specific symptoms, such as cough and pain.

The patient groups also had comparable time to deterioration for cough, pain and dyspnoea, although patients given nintedanib had a significantly shorter time to development of the gastrointestinal symptoms of nausea, vomiting, diarrhoea and decreased appetite.

Similarly, the 322 patients with adenocarcinoma histology given nintedanib alongside docetaxel had a similar time to deterioration of lung cancer symptoms as the 336 given placebo, with a small benefit in global health and QoL with nintedanib detected but this did not reach significance.

Ref : http://www.ejcancer.com/article/S0959-8049(14)01139-3/fulltext

LUME-Lung 1 shows QoL, symptoms benefits

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

In continuation of update on nintedanib

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

In continuation of update on nintedanib

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

Nintedanib drug to treat NSCLC is submitted for approval from European Medicines Agency

In continuation of my update on NSCLC (non-small cell lung carcinoma)

We know that, Nintedanib (see structure, formerly BIBF 1120; trade name Vargatef) is a small molecule of angiokinase inhibitor class inhibiting vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet derived growth factor receptor(PDGFR) being developed by Boehringer Ingelheim for use as an anti-vascular anti-cancer agent.

"We are proud that nintedanib, a compound out of our innovative oncology research programme, is the second compound in our portfolio to be filed with the European Medicines Agency."

Nintedanib drug to treat NSCLC is submitted for approval from European Medicines Agency