Tarceva in NSCLC setback
OSI Pharmaceuticals and Roche have revealed that two first-line Phase III studies (called TRIBUTE in the U.S. and TALENT outside of the U.S.) of Tarceva (erlotinib HCl) plus standard chemotherapy in metastatic non-small cell lung cancer (NSCLC) did not meet their primary endpoints of improving overall survival.
OSI Pharmaceuticals and Roche have revealed that two first-line Phase III studies (called TRIBUTE in the U.S. and TALENT outside of the U.S.) of Tarceva (erlotinib HCl) plus standard chemotherapy in metastatic non-small cell lung cancer (NSCLC) did not meet their primary endpoints of improving overall survival.
In the TRIBUTE study, one of the secondary endpoints, time to symptomatic progression, did achieve statistical significance, but this did not translate into improvements in overall survival or time to disease progression. These results do not affect Genentech's previous earnings per share growth projections for the current or future years.
The studies, conducted by Genentech in the United States and Roche in countries outside of the United States, evaluated Tarceva at 150 mg/day in combination with standard chemotherapy. Tarceva is a small molecule oral therapy designed to inhibit the tyrosine kinase activity of the HER1/EGFR signaling pathway inside the cell, which may block tumor growth.
'We are disappointed, but not completely surprised based on previously announced failures of EGFR inhibitors in this setting, that Tarceva in combination with chemotherapy did not improve overall survival as a first-line therapy in these studies. We believe that further work is needed to provide more insight into the role of EGFR inhibitors in this setting, either as a single agent or in combination with other targeted agents or chemotherapy,' said Dr Susan Hellmann, Genentech's executive vice president, development and product operations, and chief medical officer. 'In order to optimise the therapeutic potential of EGFR inhibition in NSCLC, we will use clinical data and conduct pre-specified analyses of tumour biopsy material to identify potential subsets of patients who may be more likely to benefit from treatment with Tarceva in combination with chemotherapy. The alliance of Genentech, OSI and Roche remains on track with our clinical development program and believes Tarceva may have utility in treating a variety of cancers.'