Abstract 1342P
Background
In ALTER-L004 (NCT03736837), anlotinib (A) plus icotinib (T) showed encouraging efficacy and good tolerability. Here, we reported the updated results and further evaluated the efficacy based on genetic profile of the study.
Methods
Patients with EGFR-mutated locally advanced and/or metastatic stage IIIb-IV non-squamous NSCLC were enrolled. The regimen consists of A (12 mg p.o, qd, day 1 to 14 every 21-day cycle) and T (125mg p.o, tid). The efficacy including efficacy objective response rate (ORR), disease control rate (DCR) and early-tumor shrinkage (ETS) based on genetic profile was investigated.
Results
Between Jul 2018 and 29 Apr 2020, 40 patients were enrolled and 34 had received at least one tumor assessment. The median follow-up time reached 9.65 months. Among 34 evaluable patients, there was 1 complete response (CR), 23 partial response, 9 stable disease and 1 disease progression, resulting in the ORR 70.6% and DCR 97.1%. 61.8% (21/34) of patients experienced ≥30% reduction by the first evaluation, which defined ETS. Patients with concomitant mutation or pathogenic concomitant mutation achieved ORR more than 80%, DCR 100% and ETS greater than 65% (Table). It is worth mentioning that the patient resulted in CR was with concomitant but nonpathogenic mutation. At present, there are 6 patients (28.6%) with concomitant mutations have already exceeded the progression-free survival (PFS) of 10 months, and still under treatment. The most common Grade 3 or 4 adverse events were hypertension and hypertriglyceridemia. Table: 1342P
| Variable | No. (%) | ORR No. (%) | DCR No. (%) | ETS No. (%) |
| EGFR status Exon 19 | 17(50%) | 13(76.47%) | 17(100%) | 12(70.59%) |
| deletion Exon 21 L858R | 17(50%) | 11(64.71%) | 16(94.12%) | 10(58.82%) |
| Concomitant mutations Yes No | 21(80.77%) 5(19.23%) | 17(80.95%) 2(40%) | 21(100%) 5(100%) | 14(66.67%) 2(40%) |
| Pathogenic concomitant mutations Yes No | 20(76.92%) 6(23.08%) | 16(80%) 3(50%) | 20(100%) 6(100%) | 13(65%) 3(50%) |
Conclusions
This updated analysis has confirmed that A plus T showed encouraging efficacy for previously untreated, EGFR-mutated advanced NSCLC patients. The combination may represent a new first-line treatment option for patients with concomitant mutations.
Clinical trial identification
NCT03736837, December 1, 2018.
Editorial acknowledgement
Legal entity responsible for the study
Dingzhi Huang.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.