Sanofi-Aventis has revealed positive results from a meta-analysis which reveal the survival benefit of regimens based on the firm’s Taxotere in patients with non small cell lung cancer.
The data from the meta-analysis of individual patient data, including 2,867 patients from seven clinical trials, has been presented at the 12th World Conference on Lung Cancer in Seoul, South Korea and have demonstrated a significant overall survival benefit of Taxotere (docetaxel) over vinca-alkaloid-based regimens in the treatment of first-line advanced NSCLC patients.
Taxotere was combined with a platinum compound in three trials, with gemcitabine in two and used as monotherapy in the other two studies, while vinorelbine-regimens were the comparators in six of the seven trials. The IPD meta-analysis, called DOCMA-LC, confirmed a 10% reduction of the risk of death with the drug and the pooled estimate for overall survival showed an improvement in favour of Taxotere whatever the data used, and Sanofi added that tolerability also favoured regimens based on its drug, which had second-quarter sales of 474 million euros, up 9%.
Benefits of Lovenox
Meantime, Sanofi announced at the European Society of Cardiology meeting in Vienna, Austria, that two long-term clinical studies – ExTRACT-TIMI 25 and STEEPLE – showed clear benefits for patients with acute coronary syndrome who are on Lovenox/Clexane (enoxaparin).
The ExTRACT-TIMI 25 trial showed that in patients with ST-segment elevation myocardial infarction (STEMI), treated with fibrinolysis, at one year, the primary endpoint of death or nonfatal myocardial infarction remained significantly in favour of enoxaparin versus unfractionnated heparin (15.8% versus 17.0%). Net clinical benefit was also significantly in favour of Lovenox through one year of follow-up (16.0% vs 17.3%).
"This was a very large trial with conclusive results at 30 days,” said Elliott Antman, senior investigator of the study and a professor at Harvard Medical School. “The persistence of significant net clinical benefit a full year after treatment is further evidence of the viability of the strategy of using enoxaparin as adjunctive anticoagulant therapy to fibrinolysis”.
Also, the STEEPLE trial found that there was no statistical significant difference in one-year death rates in patients taking Lovenox at levels of 0.5mg/kg or 0.75 mg/kg. Ischaemic events and major bleeding were found to be independent predictors of death at one year.