Pierre Fabre Medicament has launched two phase III trials of its new cytotoxic agent Javlor in the treatment of non-small cell lung cancer and bladder cancer.
The non-small cell lung cancer trial is a second-line single agent study, which randomizes Javlor (320 mg/m2 every 3 weeks) versus docetaxel. It will include around 550 patients with locally advanced non-small cell lung cancer previously treated with a platinum containing regimen. The patients will come from 80 different centers, mainly in Europe, South Africa, Singapore and Mexico. The primary objective is to compare the progression free survival of the treatments. Secondary evaluation criteria are survival, quality of life, tolerance, and clinical benefit. The first patient inclusion occurred on June 23rd, 2003, and the study inclusions are planned to be over by the end of 2004.
The bladder cancer study will include 330 patients who have either not responded to treatment with platinum derivative association, or relapsed afterwards. These patients will be drawn from 90 centers coming from 18 countries including most countries in Europe, as well as Mexico, Argentina and South Africa. Considering that no standard treatment is available in second line, Javlor will be compared with best supporting care (i.e. without chemotherapy), using type a 2:1 randomization protocol (vinflunine + best supporting care / vs. best supporting care). The main criterion used for the evaluation will be overall survival, and, as secondary aims, quality of life, and clinical benefit. The inclusions are expected to finish by the end of 2004.
"These two trials are an important milestone in the development of Javlor," says Patrick Hurteloup, director of Pierre Fabre Oncologie. "They should allow us to confirm the significant clinical efficacy observed in phase II studies, observed in 2nd line advanced bladder cancer, where the medical need is important, and in non-small cell lung cancer. The patients eligible for these phase III trials show resistance to usual treatments, and conducting trials in such population should reveal how useful Javlor can be in the therapeutic strategy".
Originated at the Pierre Fabre Research Center, Javlor (vinflunine ditartrate) is the first vinca-alkaloid derivative ever obtained by the use of super acidic chemistry. Such strategy enabled the selective introduction of two fluorine atoms in a part of the scaffold previously inaccessible by classic chemistry, thereby leading to a new generation of Vinca alkaloids. In addition, Javlor exhibits unique pharmalogical properties, and is also devoid of any unpredictable acute toxicity.