“Treatment with nintedanib plus pemetrexed and cisplatin improved progression-free survival (PFS) in the frontline setting by 3.7 months for chemotherapy-naive patients with malignant pleural mesothelioma (MPM), according to data reported at the 2017 ASCO Annual Meeting.
“In the phase II trial, known as LUME-Meso, the median PFS was 9.4 months with the nintedanib combination versus 5.7 months with pemetrexed and cisplatin alone (HR, 0.54; 95% CI, 0.33-0.87; P = .010). The median overall survival (OS) was 18.3 months with nintedanib versus 14.2 months with chemotherapy alone; however, this finding was not statistically significant (HR, 0.77; 95% CI, 0.46-1.29; P = .319).”
The gist: Lung cancer patients in the EU will now be able to take the drug Vargatef (aka nintedanib) in combination with the chemotherapy drug docetaxel. The treatment has been approved by the European Commission for adults with locally advanced, metastatic, or locally recurrent non-small cell lung cancer (NSCLC).
“The European Commission granted marketing authorisation for Vargatef (nintedanib) in combination with docetaxal for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) after first-line chemotherapy.
“Prof Klaus Dugi, Boehringer’s chief medical officer, said: ‘The approval of Vargatef expands our oncology portfolio, following last year’s approval of Giotrif (afatinib) for another specific type of lung cancer.’
“The launch of Giotrif/Gilotrif in 2013 as a treatment lung cancer patients who express epidermal growth factor receptor (EGFR) marked Boehringer’s entry onto the oncology market.
“The addition of Vargatef widens the potential patient base for the German company, allowing Boehringer to make sizeable inroads into lung cancer.”
The gist: People with early-stage HER-2-negative breast cancer might benefit from a new drug called nintedanib combined with standard chemotherapy. That insight came from a recently completed clinical trial—a research study with volunteer patients. 50% of the patients who took the new treatment in the trial had total remission of their tumors.
“The experimental drug nintedanib, combined with standard chemotherapy with paclitaxel, causes a total remission of tumours in 50% of patients suffering from early HER-2- negative breast cancer, the most common type of breast cancer. These are the conclusions of the Phase I Clinical Trial, sponsored by the Spanish National Cancer Research Centre (CNIO) and carried out by CNIO ́s Breast Cancer Clinical Research Unit. The study has been published today in British Journal of Cancer.
“According to Miguel Ángel Quintela, head of the Unit: ‘The drug combination of paclitaxel and nintedanib has turned out to be a complete success, given that it is proved to be safe and that the pathologic complete response [rate of complete recovery] was 50%, which doubles the response compared to patients treated with standard therapy with paclitaxel.’ The trial has also included 10 HER-2-negative breast cancer patients, all of them in early stages of the disease.
“In light of the results, the CNIO Breast Cancer Clinical Research Unit has already launched a large-scale Phase II Clinical Trial to validate the results in a large group of patients. These results, including biomarker studies that will facilitate advances in personalised medicine, will be released by early 2015.”
“The combination of nintedanib and docetaxel ‘is an effective second-line option’ for patients with advanced non–small cell lung cancer (NSCLC) who have received previous treatment with one line of platinum-based therapy, according to results from the phase III LUME-Lung 1 study published in The Lancet Oncology. The combination improved progression-free survival for patients with refractory NSCLC irrespective of histology when compared to docetaxel (Taxotere) plus placebo, and ‘significantly prolonged overall survival of patients with adenocarcinoma, including patients with poor prognosis (ie, those who had progressed within 9 months of start of first-line therapy),’ Martin Reck, MD, Lung Clinic Grosshansdorf, Germany, and colleagues reported for the LUME-Lung 1 Study Group.”
“A new oral angiogenesis inhibitor for the treatment of lung cancer could be edging closer to the market: Approval application for nintedanib (Boehringer Ingelheim) has been filed in Europe and is being prepared for the United States.
“The data for nintedanib come from the phase 3 trial known as LUME-Lung-1, recently published in the Lancet Oncology.”
Editor’s note: We previously posted a story about the potential benefits of the drug nintedanib for some patients with non-small cell lung cancer (NSCLC).
New clinical trial results suggest that adding the drug nintedanib (Vargatef) to second-line chemotherapy can improve survival for some patients with non-small cell lung cancer (NSCLC). Patients with advanced NSCLC whose cancer had progressed after first-line chemotherapy received either Vargatef and the chemotherapy drug docetaxel (Taxotere) or Taxotere alone. On the whole, Vargatef was associated with slightly longer times without worsening of the cancer (3.4 months vs 2.7 in the Taxotere-only group), but no improvement in overall survival. However, in patients with lung adenocarcinoma, a subtype of NSCLC, the addition of Vargatef improved overall survival by over 2 months (12.6 months vs 10.3 with Taxotere alone). Vargatef disrupts the formation of new blood vessels that feed growing tumors.
Corn PG, Wang F, McKeehen W, Navone N. Clinical Cancer Research. Sep 19, 2013.
“Advanced prostate cancer carries a poor prognosis and novel therapies are needed. Research has focused on identifying mechanisms that promote angiogenesis and cellular proliferation during prostate cancer progression from the primary tumor to bone-the principal site of prostate cancer metastases. One candidate pathway is the fibroblast growth factor (FGF) axis. Aberrant expression of FGF ligands and FGF receptors leads to constitutive activation of multiple downstream pathways involved in prostate cancer progression, including mitogen-activated protein kinase, phosphoinositide 3-kinase, and phospholipase Cγ. The involvement of FGF pathways in multiple mechanisms relevant to prostate tumorigenesis s provides a rationale for the therapeutic blockade of this pathway, and two small-molecule tyrosine kinase inhibitors-dovitinib and nintedanib-are currently in phase 2 clinical development for advanced prostate cancer. Preliminary results from these trials suggest that FGF pathway inhibition represents a promising new strategy to treat castrate-resistant disease.”
Patients treated with the new cancer drug nintedanib (Vargatef), in addition to second-line chemotherapy, experienced a longer delay before their lung cancer worsened, a recent phase III clinical trial showed. The study focused on patients with advanced non-small cell lung cancer (NSCLC) whose cancer had progressed after a first round of chemotherapy. Trial participants received the chemotherapy agent docetaxel (Taxotere) either with or without Vargatef. Those treated with Vargatef went an average of 3.4 months before their cancer started to grow again, compared to 2.7 in patients who were given Taxotere alone. There was also evidence that Vargatef may increase overall survival, especially in patients with lung adenocarcinoma, a subtype of NSCLC.