The non-interventional study ML22816 aimed at evaluating effectiveness and tolerability of 1L Erlotinib maintenance in clinical practice in patients with stable disease stage IIIB/IV NSCLC after 4 cycles of platinum-based chemotherapy.
The study included 272 unselected patients in 95 centers from 06/2010 to 05/2013. For each patient baseline characteristics, treatment regimen, effectiveness and safety data are documented. Data must be interpreted with caution as due to slow recruitment the study did not enroll 600 patients as planned. Primary endpoint was overall survival (OS). Sample size calculation was based on 1-year survival rate (SR).
Mean patient age was 65 years. 19% of patients were non-smokers, 49% ex-smokers, 29% current smokers. 104 patients were evaluated for presence of EGFR mutations: 20 patients (19%) were EGFR-mutation positive (EGFRmut+) and 84 (81%) EGFR-Wildtype. 62% of patients had confirmed adenocarcinoma, 27% squamous cell and 4% large-cell carcinoma. Median OS from Erlotinib treatment start (ITT population) was 10.4m (95%-CI: 8.8 - 12.5m), and thus slightly below the results of the phase III SATURN trial (12.0m). The mPFS of 4.8m (95%-CI: 3.9-5.5m) was a little longer than in the SATURN trial (12.3 weeks; approx. 3.1m). The 1-year SR (ITT population) was 46% (95%-CI: 38 - 54%). EGFRmut+ status was significantly associated with longer OS and PFS (Cox-Regr. p = 0.031 PFS, p = 0.038 OS). For EGFRmut+ vs. EGFR-Wildtype mPFS was 9.5m and 3.7m (log-rank p = 0.069), mOS was not reached and 7.8m (log-rank p = 0.611), respectively. 459 treatment-related adverse events (AE) were documented in 148 patients (54.4%), the most common rash (30.9%) and diarrhea (18.8%). 14 patients (5.1%) died due to a treatment-related AE. No new safety signals were detected.
Safety and effectiveness results of the study are in line with data of the SATURN trial. Improved PFS may be due to enrichment in EGFRmut+ patients. EGFRmut+ status was associated with improved PFS and OS. Of note, to reflect the findings of the IUNO trial (NCT01328951), the EU label of 1L Erlotinib maintenance was restricted in 01/2016 to patients with activating EGFR-mutations.
Clinical trial identification
Legal entity responsible for the study
Roche Pharma AG
Roche Pharma AG
P. Staib: Membership on an advisory board or board of directors: Roche, Celgene, Novartis, Amgen Corporate-sponsored research: Celgene, Roche, Novartis, Amgen. W. Brugger: Membership on an advisory board or board of directors: Roche, BI, Lilly, AstraZeneca, Novartis, Pfizer Other substantive relationships: Employee Astra Zeneca Cambridge since January 2016. All other authors have declared no conflicts of interest.