Boehringer Ingelheim's nintedanib has become the first drug in more than 10 years to improve survival in lung cancer patients whose disease had progressed despite chemotherapy.
The results of the LUME-Lung 1 trial, presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago, showed that the drug extended survival by 2.3 months compared to placebo when added to docetaxel therapy in non-small cell lung cancer (NSCLC) patients with adenocarcinomas.
The orally-active drug was unable to improve overall survival for the entire NSCLC patient population enrolled into the study, which also included patients with squamous-type tumours, although there was a trend towards a benefit.
The primary clinical measure in the study was progression-free survival (PFS), and on this endpoint the combination of nintedanib and docetaxel had a modest effect, delaying progression by three weeks compared to docetaxel and placebo, which was a statistically significant difference.
The effect on PFS was seen in both squamous and adeno NSCLC patients, but the effect was much stronger in the latter group with an improvement compared to placebo of 1.2 months.
Nintedanib is an investigational triple angiokinase inhibitor that targets three of the receptor tyrosine kinases (FGFR, PDGFR, and VEGFR) involved in the formation of new blood vessels (angiogenesis) in tumour tissue.
"This is the first time an anti-angiogenic treatment has shown a real benefit for NSCLC patients after initial chemotherapy has failed," commented Martin Reck of the Lung Clinic Grosshansdorf in Germany, who was the principal investigator in the trial and presented the data at ASCO.
Adenocarcinoma is the most common form of NSCLC – accounting for around 40 per cent of cases – while squamous cell carcinomas make up 25 to 30 per cent, according to the American Cancer Society. Other types include large cell carcinoma (10 to 15 per cent of NSCLC cases) and rarer forms such as adenosquamous carcinoma and sarcomatoid carcinoma.
Meanwhile, a combination study looking at nintedanib in combination with Lilly's Alimta (pemetrexed) in non-squamous NSCLC, called LUME-Lung 2, was also presented as a poster at ASCO.
This trial was stopped prematurely after an interim analysis suggested no benefit. However, after it was unblinded the data showed that the combination had in fact met the primary objective of improving PFS compared to Alimta alone when given second-line after chemotherapy failure.
Nintedanib also is in phase III testing for ovarian cancer and idiopathic pulmonary fibrosis (IPF), and is in earlier-stage clinical testing for liver, kidney and colorectal cancer.
It is one of one of three cancer drugs Boehringer is ushering through clinical development after it entered the cancer area in 2006. The others are ErbB inhibitor afatinib, which has already been filed for approval in NSCLC, and polo-like kinase 1 (Plk1) inhibitor volasertib, which is being developed to treat acute myeloid leukaemia.
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