Boehringer cancer drug impresses
pharmafile | October 1, 2013 | News story | Research and Development, Sales and Marketing |Â Â Boehringer, NSCLC, nintedanibÂ
Boehringer Ingelheim has shown off its impressive oncology treatment nintedanib at the European Cancer Congress (ECC) in Amsterdam.
The oral triple angiokinase inhibitor has been shown to extend life when added to chemotherapy in adenocarcinoma patients after prior first-line chemotherapy.
Adenocarcinoma is the most common form of non-small cell lung cancer (NSCLC) – and as most patients with an advanced stage of the disease will get worse after initial therapy, second-line treatments which are effective will form a key part of treatment.
The Phase III LUME-Lung 1 trial showed that nintedanib plus docetaxel lengthened overall survival (OS) by 2.3 months for advanced NSCLC patients versus placebo and docetaxel.
Median OS rose from 10.3 months in the placebo arm to 12.6 months in the nintedanib arm – and the earlier that adenocarcinoma patients failed first line chemotherapy, the more benefit they got from nintedanib.
Patients who progressed within nine months after the start of their first-line treatment had a larger median OS of three months – 10.9 months versus 7.9 months.
Adenocarcinoma accounts for almost half of all NSCLC but this is a hard-to-treat group, and the LUME-Lung 1 results are the first promising findings in almost a decade in terms of OS for patients where initial chemotherapy has failed.
Dr Anders Mellemgaard from the Department of Oncology at Copenhagen’s Herlev University Hospital called the drug ‘an important milestone’.
But the sheer size of the potential patient population also makes this a competitive therapy area: Roche has also presented data at ECC which suggests its own early-stage oncology treatment MPDL3280A, designed to work by interfering with the PD-L1 (Programmed Death-Ligand 1), has shown encouraging results in smokers with NSCLC.
Lung cancer accounts for 1.6 million new cancer cases annually, but prognosis is poor: 1.38 million deaths each year are attributable to the disease, with smoking the main cause.
However, nintedanib blocks three growth factor receptors: vascular endothelial (VEGFR 1-3), platelet-derived (PDGFR alpha and beta) and fibroblast (FGFR 1-3) – a range which could put it ahead of the field and may give it applications in other therapy areas.
The investigational drug is currently being looked at in patients with various solid tumours including advanced NSCLC, ovarian cancer, liver cancer (hepatic cell carcinoma), kidney cancer (renal cell carcinoma) and colorectal cancer.
Boehringer has also been testing nintedanib in the fatal respiratory disease idiopathic pulmonary fibrosis (IPF), an indication for which the FDA has already awarded the drug orphan designation.
The Phase II TOMORROW trial demonstrated a positive trend in reducing lung function decline in IPF patients treated with 150 mg of nintedanib twice-daily compared to placebo.
Adam Hill
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