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Scientific Information
Erlotinib clinical trials
ENSURE phase III trial
- ENSURE: summary of safety data

ENSURE phase III trial

The superior efficacy of erlotinib over chemotherapy as first-line treatment for EGFR Mut+ NSCLC, observed in the OPTIMAL study, was confirmed in this broader Asian population. Erlotinib’s favourable safety profile was also confirmed.¹

Study design and endpoints¹

ENSURE was a randomised phase III trial that took place across 30 centres in Malaysia, China and the Philippines.
The trial compared erlotinib versus standard chemotherapy as first-line treatment for EGFR Mut+ NSCLC.

ECOG PS (Eastern Co-operative Oncology Group performance status)

Key Results

Efficacy¹

Patients who received erlotinib had significantly longer PFS than patients receiving chemotherapy.

Safety¹

Patients treated with erlotinib experienced fewer treatment-related severe AEs, fewer Grade ≥3 AEs and fewer dose modifications due to AEs, than patients treated with chemotherapy.

Please click here for further safety data

ENSURE: summary of safety data¹
ENSURE: common adverse events reported in the safety population (1/3)¹
ENSURE: common adverse events reported in the safety population (2/3)¹
ENSURE: common adverse events reported in the safety population (3/3)¹

References

Wu YL, et al. Ann Oncol 2015; 26:1883–9

ENSURE phase III trial

The superior efficacy of erlotinib over chemotherapy as first-line treatment for EGFR Mut+ NSCLC, observed in the OPTIMAL study, was confirmed in this broader Asian population. Erlotinib’s favourable safety profile was also confirmed.1

Key Results

The superior efficacy of erlotinib over chemotherapy as first-line treatment for EGFR Mut+ NSCLC, observed in the OPTIMAL study, was confirmed in this broader Asian population. Erlotinib’s favourable safety profile was also confirmed.¹