Boehringer Ingelheim is in the process of drawing up regulatory filings for its Giotrif product in squamous cell carcinoma of the lung (SCC) after reporting positive phase III data.
The German pharma company reports that Giotrif (afatinib) was more effective than Roche’s Tarceva (erlotinib) in extending the lives of previously treated SCC patients in the study, which has just been published in The Lancet Oncology.
Giotrif and Tarceva both target the epidermal growth factor receptor (EGFR) tyrosine kinase pathway and the LUX-Lung 8 trial is the largest comparative study ever conducted in this drug class, according to Boehringer.
SCC is a subgroup of non-small cell lung cancer (NSCLC), the most common form of cancer affecting the lung. It develops from cells lining the airways and is often associated with smoking, so its incidence tends to be in decline in countries where smoking is also becoming less common.
Treatment options for SCC of the lung are limited, however, and this type of lung cancer is associated with a particularly poor prognosis with less than 5% of patients with advanced disease surviving for five years or more.
The new overall survival (OS) data from LUX-Lung 8 show that patients on Giotrif lived for a median of 7.9 months, compared to 6.8 months with Tarceva, while updated progression-free survival (PFS) was 2.6 months and 1.9 months respectively.
“The broader and irreversible … blockade of afatinib may explain the superiority shown in LUX-Lung 8 over erlotinib, an EGFR inhibitor already approved in this setting,” commented Dr. Mehdi Shahidi, who leads Boehringer’s solid tumour oncology unit.
The data will help Boehringer differentiate Giotrif in an increasingly crowded EGFR inhibitor marketplace in lung cancer. In addition to Tarceva it also competes with Iressa (gefitinib) from AstraZeneca (AZ) in some markets, with other compounds also coming through development.
Giotrif was approved for NSCLC in 2013 and was the first cancer drug to emerge from Boehringer’s R&D push into cancer in 2006. It has since been joined by triple angiokinase inhibitor Vargatef (nintedanib), another drug for lung cancer approved last year.