July 26, 2016
By Alex Keown, BioSpace.com Breaking News Staff
INGELHEIM, Germany -- Boehringer Ingelheim was forced to halt two Phase III trials for lung cancer drug Gilotrif following the advice of a data monitoring committee, Pharma Times reported this morning.
The drug was being investigated for head and neck cancers in hopes of expanding the use of the drug. However, Pharma Times noted the company said the data monitoring committee realized the drug would not likely perform better than placebo. As a result, the company halted the LUX-Head and Neck 2 and 4 trials.
However, Boehringer Ingelheim is still running several other head and neck studies with Gilotrif that are expected to continue. The company will continue the LUX-Head and Neck 1 study, which has shown positive results in recurrent and/or metastatic head and neck cancer and the LUX-Head and Neck 3 trial in Asian patients, Pharma Times reported.
Gilotrif was approved for use in patients with advanced squamous carcinoma of the lung progressing after treatment with first-line chemotherapy in August 2015 by both the U.S. Food and Drug Administration (FDA) as well as the European Medicines Agency. Regulatory submissions were based on positive data from LUX-Lung 8 study that showed a significant delay in progression of lung cancer (progression-free survival, primary endpoint) and a significant improvement in overall survival for Gilotrif (afatinib) compared to Genentech ’s Tarceva (erlotinib), the company said.
In April, the FDA approved a supplemental New Drug Application (sNDA) for Gilotrif for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85 percent of lung cancer cases. Squamous cell lung cancer develops in the cells lining the airways and represents approximately 30 percent of NSCLC cases. SCC of the lung is associated with a poor prognosis and limited survival of about one year.
Non-small cell lung cancer is a popular area of research for many companies, including the aforementioned South San Francisco-based Genentech. Last year, Genentech revealed its investigational oral drug alectinib, an anaplastic lymphoma kinase (ALK) inhibitor, shrank tumors in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib. The two studies showed the tumors shrank by 50 percent and 47.8 percent, respectively. In December, the FDA granted accelerated approval to Alecensa (alectinib) for the treatment of NSCLC based on those trial results.
