“Afatinib (Giotrif, EU; Gilotrif, US) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with advanced squamous cell non–small cell lung cancer (NSCLC) following progression on platinum-based chemotherapy, according to Boehringer Ingelheim, the manufacturer of the irreversible EGFR inhibitor.
“The CHMP opinion, which recommends that the treatment should gain approval from the European Medicines Agency in this setting, is based on data from the phase III LUX-Lung 8 trial. In the study, second-line afatinib reduced the risk of both disease progression and death by 19%, compared with erlotinib (Tarceva) in patients with advanced squamous cell carcinoma of the lung.”
“The team behind the Lung Cancer Master Protocol (Lung-MAP), a groundbreaking clinical trial for patients with advanced squamous cell lung cancer, is announcing exciting new changes and enrolling more patients as it adapts to the latest science and treatments. The nation-wide precision medicine trial now includes nivolumab, the immunotherapy treatment recently approved by the U.S. Food and Drug Administration
“Lung-MAP tests several new treatments for patients with advanced stage squamous cell lung cancer. In advanced stage squamous patients, cancer has usually spread from the lungs to other organs. The trial is for these patients, whose cancer has continued to grow – even after being treated with standard therapy.
“Lung-MAP gives these patients access to innovative therapies. The trial design allows several drugs to be tested simultaneously. Currently, the trial has four trial options for patients. Here’s how it works. All qualifying patients enrolled in Lung-MAP get free genomic profiling. Based on results of that DNA tumor tissue test, patients can be assigned to one of three biomarker-driven sub-studies, each evaluating a promising new drug. If there is no genomic match, patients can enroll in a fourth sub-study, which is testing the FDA-approved nivolumab, an immunotherapy made by Bristol Myers Squibb, against a nivolumab combination therapy. Regardless of their genomic profile, all Lung-MAP patients receive a treatment – not a placebo.”
“Nedaplatin plus docetaxel conferred significantly improved OS rates compared with cisplatin plus docetaxel in patients with advanced or relapsed squamous cell lung carcinoma, according to the results of a phase 3 study presented at the ASCO Annual Meeting.
“ ‘Limited progress has been made for the treatment of advanced squamous cell lung cancer compared with non-squamous non–small cell lung cancer,’ Takehito Shukuya, MD, of the department of respiratory medicine at Juntendo University in Tokyo, said during a presentation. ‘Cisplatin plus docetaxel is the current standard of care in patients with advanced squamous cell lung cancer.’ “
“Nedaplatin (Aqupla, Shionogi Co) is a second-generation platinum compound that produces a reduced rate of certain adverse events — including nausea, vomiting and nephrotoxicity — compared with cisplatin. A previous phase 2 study of nedaplatin plus docetaxel demonstrated encouraging outcomes with acceptable toxicity for patients with advanced squamous cell lung carcinoma, according to study background.”