Tarceva set for first line treatment
pharmafile | January 31, 2011 | News story | Sales and Marketing | Iressa, NSCLC, Roche, Tarceva
Roche’s lung cancer treatment Tarceva has been shown to help patients as a first line treatment.
An independent data monitoring committee has recommended that a phase III trial of Tarceva be stopped early because it met its primary endpoint of extending progression free survival in NSCLC patients.
The EURTAC study evaluated the first line use of Tarceva (erlotinib) versus platinum-based chemotherapy in patients with advanced NSCLC with EGFR activating mutations.
Tarceva is currently licensed for either second line treatment or maintenance therapy for metastatic non-small cell lung cancer (NSCLC) irrespective of EGFR status.
AstraZeneca’s rival product Iressa (gefitinib) is currently the only approved oral first line treatment, in combination with a doublet chemotherapy regime, for EGFR patients.
The EGFR (epidermal growth factor receptor) mutation is only present in a subgroup of non-small cell lung cancer patients, estimated to be around 10% of the Western population with NSCLC, and around 30% in Asia.
This is the first phase III study of Tarceva in a Western population with this form of lung cancer, with a similar study (OPTIMAL) carried out in an Asian population.
Roche has already submitted its filing for Tarceva as a first line treatment, making its application to the EMA in June last year.
Roche and its partner OSI Pharmaceuticals say they will now use the EURTAC data to discuss similar updates to the Tarceva label with the FDA.
Hal Barron M.D., chief medical officer and head, global product development, Roche said: “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.
“We are encouraged by these results and look forward to discussing them with health authorities around the world.”
As a maintenance therapy, Tarceva has shown it can extend progression free survival by an average of 3.3 months.
A 2010 study of Iressa published in the New England Journal of Medicine showed that it achieved a median progression-free survival of 10.8 months compared with 5.4 months from standard chemotherapy regimens.
Ben Adams
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