Abstract 1242P
Background
Anti-angiogenic monoclonal antibodies combined with EGFR-TKI has shown excellent efficacy and prolong PFS in patients(pts) with EGFR mutations. Anlotinib, an oral and multi-target tyrosine kinase inhibitor, has significantly improved OS and PFS in advanced NSCLC pts in the ALTER0303 study. This is the first trial evaluating anlotinib plus gefitinib in treatment-naive advanced NSCLC pts.
Methods
This is a prospective, single-arm clinical trial. Pts with previously untreated, EGFR mutation–positive (exon 19 deletion or L858R) advanced NSCLC were enrolled. Eligible pts received anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) and gefitinib (at a dose of 250 mg once daily) until disease progression or treatment intolerance. The primary endpoint is PFS. Secondary endpoints are ORR, DCR and OS and safety.
Results
From May 2019 to Feb 2021, a total of 21 pts were enrolled. As of March 18, 2021, median follow-up was 7.6 months. Among all pts, 13 pts achieved PR, 8 pts achieved SD. ORR was 61.9%, DCR was 100%. Median PFS was not reached. 16 pts are still receiving treatment and the longest exposure was 22.9 months. 10 (77%) of 13 pts with exon 19 deletions and 3 (38%) of 8 pts with L858R mutations achieved an objective response. The most common Grade 3 TRAE were hypertension (14.3 %), rash (9.5%) and hand and foot skin reaction (9.5%), and no grade 4/5 observation.
Conclusions
The combination of anlotinib and gefitinib showed a promising efficacy for previously untreated, EGFR mutation–positive advanced NSCLC pts, and with a manageable safety profile. The PFS and OS outcomes need further evaluation.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.