Results from the phase III OPTIMAL study have shown that first-line Erlotinib ( Tarceva ) extended the time people with a distinct form of lung cancer lived without their disease getting worse ( progression free survival, PFS ) to more than one year, which was almost three times longer than for patients who received traditional chemotherapy ( median 13.1 vs 4.6 months, HR=0.16, p less than 0.0001 ).
After one year over half ( 56% ) of all Erlotinib treated patients with advanced non small cell lung cancer ( NSCLC ) with epidermal growth factor receptor ( EGFR ) activating mutations were progression free compared to 1.7% of people who received chemotherapy. In addition, more than twice as many patients who received Erlotinib experienced shrinkage of their tumours compared to those who received chemotherapy ( 83% vs 36%; p less than 0.00001 ).
Data from the OPTIMAL study will be shared with the European Medicines Agency ( EMA ) to support the label extension currently under review for use of Tarceva as a first-line monotherapy treatment for people with advanced NSCLC with EGFR activating mutations.
Tarceva is the only EGFR inhibitor approved for use in maintenance and second-line treatment settings in patients with advanced or metastatic NSCLC irrespective of the presence of EGFR activating mutations.
OPTIMAL is a randomised, phase III study evaluating the efficacy of first-line Erlotinib versus Gemcitabine / Carboplatin chemotherapy in patients with advanced NSCLC with epidermal growth factor receptor ( EGFR ) activating mutations who have not received prior chemotherapy.
The study involving 165 patients was initiated by Tongji University, Shanghai, China.
The primary endpoint of the study was progression free survival. Secondary endpoints include overall survival, overall response rate, quality of life and safety.
Overall progression free survival was significantly prolonged with Erlotinib vs chemotherapy. People who received Erlotinib lived a median of 13.1 months without their disease getting worse, whereas those who received chemotherapy lived a median of 4.6 months ( HR=0.16, p less than 0.0001 ).
After one year 56% of all patients receiving Erlotinib were alive and progression free compared with only 1.7% of people in the chemotherapy group.
The objective response rate was significantly improved for people receiving Erlotinib compared to those receiving chemotherapy ( 83% vs 36%, p less than 0.00001 ).
Safety data confirm the favourable safety profile of Erlotinib with a lower incidence of adverse events and serious adverse events observed in patients receiving Erlotinib compared with those receiving chemotherapy. No unexpected safety signals were reported in either group. ( Xagena )
Source: 35th European Society for Medical Oncology ( ESMO ) Congress, 2010