Boehringer Ingelheim took another step forward in its quest to build an oncology division, reporting positive--though slim--progression-free and overall survival data for nintedanib in a population of patients with advanced non-small cell lung cancer.
The PFS data in the drug/docetaxel arm--an angiogenesis inhibitor designed to eliminate the blood vessels that feed tumor growth--was 3.4 months compared to 2.7 months in the docetaxel-only group. The median OS data, a secondary endpoint, was 10.1 months for nintedanib and 9.1 months for docetaxel, but significantly there was a 2.3 month advantage for patients with adenocarcinoma histology--reflecting a key advantage over the squamous cell group in the study.
Non-small cell lung cancer is particularly tough disease target, and Boehringer is happy to see that its drug showed an improvement in a field littered with setbacks and trial failures.
"No one has shown an overall survival benefit for angiogenesis second-line" in non-small cell lung cancer, says Bill Goeckeler, director of oncology medical affairs at Boehringer. "The fact that it was shown is important."
Boehringer recruited 1,314 patients around the world for its LUME-Lung 1 trial. This is the company's second most advanced cancer drug in the clinic, with a Phase III trial in ovarian cancer about to wrap up. Last year at ASCO Boehringer announced upbeat results for afatinib for non-small cell lung cancer for patients with EGFR mutations.
The orphan therapy has been given priority review status at the FDA and faces a third-quarter PDUFA date.
Boehringer's third Phase III cancer drug is volasertib, which is being studied for acute myeloid leukemia.
All of Boehringer's oncology programs have been homegrown, says Goeckeler, noting that the company created a cancer research division in Vienna 17 years ago. Now with the first set of products facing regulatory reviews, Boehringer plans to flesh out a marketing program to spearhead its sales effort in oncology.
- here's the press release