Abstract 1219P
Background
In ALTER-L004 (NCT03736837), anlotinib plus icotinib showed encouraging efficacy and good tolerability. Here, we reported the updated results.
Methods
Patients with EGFR-mutated locally advanced and/or metastatic stage IIIb-IV non-squamous NSCLC were enrolled. The regimen consists of anlotinib (12 mg qd, day 1 to 14 every 21-day cycle) and icotinib (125mg, tid). The primary endpoint is PFS. Secondary endpoints are OS, ORR, DCR and safety.
Results
Between Jul 2018 and Dec 2020, 60 patients were enrolled and 56 had received at least one tumor assessment. By Apr 30, 2021 data cutoff, patients were followed up for a median of 18.2 months. The mPFS was 15.100 months (95%CI: 11.309-18.891). The ORR was 67.9% and DCR was 98.2%. 58.9% of patients experienced ≥30% reduction by the first evaluation, which defined ETS. The mPFS was 15.600 months (95%CI: 10.407-20.793) and 14.900 months (95%CI: 9.089-20.711) of patients with concomitant mutation and pathogenic concomitant mutation, respectively. Patients with concomitant mutation or pathogenic concomitant mutation achieved ORR more than 80%, DCR 100% and ETS greater than 70%. 23 patients are still receiving treatment and the longest exposure was 30 cycles. Upon analyses, adverse events (AEs) occurred in 100% of the patients and the incidence of grade 3/4 AEs was 40%. The most common AEs were hypertriglyceridemia, diarrhea, hypercholesteremia, hypertension, rash, proteinuria, hand and foot skin reaction, increased ALT, hypothyroidism, increased thyroid-stimulating hormone, increased AST, urine occult blood. The most common grade 3/4 AEs were hypertension and diarrhea. There was 1 drug-related serious AE due to acute coronary syndrome. 26.7% of patients had to adjust treatment dosage.
Conclusions
This updated analysis has confirmed that anlotinib plus icotinib showed encouraging efficacy for untreated, EGFR-mutated advanced NSCLC patients and may represent a new treatment option for patients with concomitant mutations. The combination was well tolerated and the AEs were manageable.
Clinical trial identification
NCT03736837; 9 November 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.