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Tarceva® (erlotinib) may be a viable alternative to platinum-based chemotherapy in newly diagnosed non-small cell lung cancer (NSCLC) patients with EGFR activating mutations, research suggests.
Naoki Okamura, chief executive officer, OSI Pharmaceuticals, made the statement after the first Phase III study of erlotinib treatment of NSCLC with epidermal growth factor receptor (EGFR) activating mutations in a Western population was stopped early because it met its primary endpoint.
A planned interim analysis showed that Tarceva significantly extended progression-free survival of people with newly diagnosed advanced NSCLC with EGFR-activating mutations, compared with platinum-based chemotherapy, Genentech and OSI Pharmaceuticals announced.
The findings also indicate that testing for EGFR activating mutations could identify good candidates for Tarceva treatment.
A preliminary safety analysis showed the safety profile was consistent with previous studies of Tarceva. Data will be submitted for presentation at a future medical meeting.
The European Randomized Trial of Tarceva vs. Chemotherapy (EURTAC) was designed and sponsored by the Spanish Lung Cancer Group (SLCG) and conducted together with investigators from France and Italy, in cooperation with Roche.
While it is the first Phase III study in a Western population with this distinct form of lung cancer, a similar study (OPTIMAL) has been carried out in an Asian population.
“The EURTAC study demonstrates that testing for EGFR activating mutations can identify people who may be candidates to receive Tarceva as their initial treatment for advanced lung cancer,” said Hal Barron, M.D., chief medical officer and head, Global Product Development, Roche.
“We are encouraged by these results and look forward to discussing them with health authorities around the world.”
“We are pleased that the EURTAC study so quickly revealed Tarceva may be a viable alternative to platinum-based chemotherapy in newly diagnosed NSCLC patients with EGFR activating mutations,” said Naoki Okamura, chief executive officer, OSI Pharmaceuticals.