For ALK-Positive Lung Cancer, Phase III Trial Shows Crizotinib Superior To Single-Agent Chemotherapy

Date: Sep-30-2012The results of a new phase III trial show that crizotinib, a targeted therapy, is a more effective treatment than standard chemotherapy for patients with advanced, ALK-positive lung cancer, researchers said at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.

Rearrangements of the anaplastic lymphoma kinase (ALK) gene are found in about 5% of all lung cancers. In previous uncontrolled studies, crizotinib has been shown to induce significant clinical responses in patients with advanced ALK-positive lung cancer.

"This study is the first head-to-head comparison of crizotinib with standard chemotherapy in this patient group," said lead study author Dr Alice Shaw from Massachusetts General Hospital Cancer Center in Boston, USA. "In ALK-positive patients who have been previously treated with first-line, platinum-based chemotherapy, crizotinib is superior to standard single-agent chemotherapy in terms of response, progression-free survival and quality of life. These results establish crizotinib as the standard of care for patients with advanced, previously treated, ALK-positive lung cancer."

The current global randomized phase III study compared the efficacy and safety of crizotinib with standard chemotherapy with pemetrexed or docetaxel, in 347 patients with ALK-positive lung cancer who had already been treated with chemotherapy.

The study showed that crizotinib prolonged progression-free survival to a median of 7.7 months compared to 3.0 months among those patients who received the chemotherapy (HR 0.49; 95% CI 0.37-.64 ; P
Ganetespib in combination with docetaxel is well tolerated by patients with advanced non-small cell lung cancer:

Results of the randomized Phase IIB/III Galaxy trial shows promising signals of activity in pre-specified patient populations. Commenting on the data, Dr Enriqueta Felip said: "The results of the GALAXY trial are potentially important because they may represent a new paradigm in the treatment of patients with lung cancer who no longer benefitted from first-line chemotherapy. In this study comparing the standard second-line treatment, docetaxel, with docetaxel plus ganetespib the investigators stated that they found early signs of activity.

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