Abstract 15P
Background
Furmonertinib is a novel third-generation EGFR-TKI with high brain penetration, wide therapeutic range and minimal toxicity. Anlotinib is an oral multi-targeted tyrosine kinase inhibitor for tumor angiogenesis. There is limited data of third-generation TKI combined with anlotinib in the naïve patients with EGFR-mutated NSCLC. For the L858R population, associated with a worse prognosis, combining a third-generation TKI with an anti-angiogenic drug could offer a potential strategy to enhance efficacy in this population.
Methods
FOCUS-A study is a prospective multicenter phase II trial, enrolled 40 patients who were locally advanced or metastatic NSCLC with EGFR-sensitive mutations. Patients with stable brain metastasis can be enrolled. The regimen is consisting of furmonertinib (80mg, qd) and anlotinib (10 mg qd, day 1 to 14 every 21-days /cycle). The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), safety, etc.
Results
Until Data Cut-Off 2023.12.21, 40 patients have been fully enrolled, with 22 of them having the L858R mutation. For L858R subgroup, efficacy were all completed with at least 2 time assessment and median follow-up was 13.96 months. The baseline characteristics were as follows: the median age was 62.5 years (range 50-71), female (63.6%), never smokers (86.4%), stage IV adenocarcinoma (90.9%) and CNS metastases (36.4%). The ORR was 95.45%（95%CI, 77.2-99.9）assessed by the investigator with RECIST1.1 criteria, with 21 patients achieved partial response (PR) and 1 patient stable disease (SD), DCR was 100%. Median Depth of response (DpR) was 42.0%. Grade≥3 TRAEs were experienced by 5 (22.7%) patients the most common adverse reactions were hypertension and elevation of creatinine. The follow-up remains ongoing.
Conclusions
FOCUS-A study demonstrated that furmonertinib plus anlotinib as first-line treatment for advanced EGFR L858R mutant NSCLC had an outstanding efficacy with manageable safety.
Clinical trial identification
NCT04895930.
Legal entity responsible for the study
The authors.
Funding
Shanghai Allist Pharmaceuticals.
Disclosure
All authors have declared no conflicts of interest.