October 4th, 2012

Xalkori Superior to Standard Chemotherapy in ALK-Positive Lung Cancer


The targeted therapy Xalkori® (crizotinib) is superior to standard chemotherapy for the treatment of patients with advanced, ALK-positive non-small cell lung cancer, according to the results of a phase III trial presented at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.

Lung cancer is the leading cause of cancer death in the U.S. and around the world, highlighting the importance of developing effective new approaches to treatment.

Up to 7% of non-small cell lung cancers (NSCLC) have an abnormal version of the anaplastic lymphoma kinase (ALK) gene. Lung cancers with this abnormality typically occur in non-smokers. The abnormal gene contributes to the growth and development of cancer cells.

Xalkori is a targeted oral medication that blocks the protein produced by the ALK gene. It works by works by binding with and inhibiting the action of the enzyme that is produced by the mutated gene.

This randomized, phase III study was designed to compare the safety and efficacy of Xalkori with standard chemotherapy. The study included 347 patients with ALK-positive lung cancer who had already been treated with chemotherapy. Patients were randomized to receive Xalkori or standard chemotherapy with pemetrexed or docetaxel.

The results indicated that Xalkori prolonged progression-free survival to a median of 7.7 months compared to 3.0 months among those patients who received the chemotherapy. What’s more—the overall response rate was also significantly higher in patients treated with Xalkori: 65 percent compared to 20 percent in the chemotherapy patients.

Thus far, researchers have not observed a statistically significant difference in overall survival; however, the interim analysis is still immature. It could be difficult to determine an overall survival benefit because there was significant crossover in the study—patients in the chemotherapy arm who experienced disease progression were allowed to crossover to receive Xalkori. The majority of patients in the chemotherapy arm did eventually receive Xalkori.

Xalkori was associated with more adverse events than chemotherapy; however, patients reported improved quality of life with Xalkori compared with chemotherapy.

Based on these results, the researchers concluded that Xalkori may be the new standard of care for patients with ALK-positive NSCLC.


Shaw AT, Kim DW, Nakagawa K, et al. Phase III study of crizotinib versus pemetrexed or docetaxel chemotherapy in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) (PROFILE 1007). Presented at the 37th Congress of the European Society for Medical Oncology (ESMO), Vienna, Austria, September 28-October 2, 2012. Abstract LBA1.

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Tags: Lung Cancer - Non-Small Cell, News, Recurrent Lung Cancer - Non-Small Cell, Stages IIIB-IV Lung Cancer - Non-Small Cell, Uncategorized