New late-stage data on Boehringer Ingelheim's lung cancer drug nintedanib and its benefit to overall survival in some patients has caused a stir at the American Society of Clinical Oncology meeting in Chicago.
The German drugmaker presented results from the LUME-Lung 1 Phase III trial looking at the addition of nintedanib, to docetaxel as a second-line treatment in patients with advanced non-small cell lung cancer (NSCLC) compared to chemotherapy alone. The primary endpoint was progression-free survival and the results showed patients treated with the combination lived for a median of 3.4 months before their tumour started to grow again, versus 2.7 months with the chemotherapy alone.
Of more note was the secondary endpoint of overall survival. In all patients there was no statistically significant difference but the results for those with adenocarcinoma, the most common type of NSCLC, were more striking.
For the latter sub-group, the median overall survival, which Boehringer notes is "the gold standard measure of success in lung cancer treatment", was 12.6 months in the nintedanib combo arm versus 10.3 months with docetaxel alone. The most common adverse events - gastrointestinal side effects and liver enzyme elevations - were manageable.
Presenting the data at ASCO, Martin Reck of the Lung Clinic Grosshansdorf, Germany, and principal investigator of the trial, said that given the long history of negative trials in this field, the results "are particularly exciting because we have not seen any advances in overall survival for NSCLC patients receiving second-line treatment in nearly ten years". He added that "this is the first time an anti-angiogenic treatment has shown a real benefit for NSCLC patients after initial chemotherapy has failed".
The data comes after another trial, LUME-Lung 2, of nintedanib combined with another chemotherapy, pemetrexed, was halted based on an interim futility analysis. However, highly unusually, once the study was then unblinded, increased progression-free survival was indeed seen with that combo compared to pemetrexed alone.
Boehringer has high hopes for its oncology pipeline, an area in which it is a newcomer. As well as NSCLC, nintedanib, a triple angiokinase inhibitor, is also being investigated for ovarian, liver, kidney and colorectal cancer, as well as idiopathic pulmonary fibrosis. The company also has another lung cancer drug, afatinib, in late-stage development.