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Efficacy and Safety of Firmonertinib Plus Anlotinib as First-Line Treatment for Advanced NSCLC With EGFR Mutations: A
Huiyang Shi1, Haohua Zhu1, Le Tang1
1Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Background:
This single-arm, phase I/II trial aimed to evaluate the efficacy and safety of firmonertinib plus anlotinib as first-line treatment for patients with non small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations.
Methods:
We enrolled patients aged 18 years or older and had locally advanced or metastatic NSCLC harboring EGFR sensitive mutation. Patients were treated with oral firmonertinib 80 mg once daily combined with oral anlotinib (days 1-14 in 21-day cycle). The primary endpoint was objective response rate (ORR).
Results:
Between March, 19th, 2022 and July, 27th, 2023, 36 patients were enrolled. In dose-exploration phase, 2 patients were treated with anlotinib 8 mg, 3 were treated with anlotinib 10 mg and 3 were treated with anlotinib 12 mg combined with firmonertinib 80 mg. In dose-expansion phase, 5 were treated with 10 mg anlotinib and 23 were treated with anlotinib 12 mg combined with firmonertinib 80 mg. The median follow-up time was 19.4 months. ORR was 63.9% and disease control rate (DCR) was 100.0%. Median progression free survival (PFS) was 19.6 months (95% CI 16.9-22.3). Median duration of response (DoR) was 23.0 months (95% CI 12.1-34.0). Concurrent pathogenic TP53 mutation was an independent prognostic factor (HR 2.38, 95% CI 0.90-6.30, P = .07). Diarrhea and hypertension were the most common TRAEs. ≥Grade 3 TRAEs occured in 36.1% patients. 47.2% patients experienced dose reduction and 33.3% patients experienced treatment discontinuation.
Conclusion:
Firmonertinib plus anlotinib demonstrated preliminary efficacy and manageable safety as first-line treatment among patients with NSCLC harboring EGFR mutations.
Insights
Firmonertinib and anlotinib show promising results as a first-line treatment for non-small cell lung cancer (NSCLC) with EGFR mutations. This combination therapy achieved a high objective response rate and manageable safety profile in early-phase trials.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Non-small cell lung cancer (NSCLC) remains a leading cause of cancer-related deaths worldwide.
- Epidermal growth factor receptor (EGFR) mutations are key drivers in a subset of NSCLC patients.
- Novel therapeutic strategies are needed for first-line treatment of EGFR-mutated NSCLC.
Purpose of the Study:
- To evaluate the efficacy and safety of firmonertinib plus anlotinib as a first-line treatment for NSCLC patients with EGFR mutations.
- To determine the objective response rate (ORR) as the primary endpoint.
- To assess progression-free survival (PFS) and duration of response (DoR).
Main Methods:
- A single-arm, phase I/II clinical trial was conducted.
- Patients with locally advanced or metastatic NSCLC harboring EGFR sensitive mutations were enrolled.
- Treatment consisted of oral firmonertinib (80 mg daily) combined with oral anlotinib (10-12 mg on days 1-14 of a 21-day cycle).
Main Results:
- 36 patients were enrolled between March 2022 and July 2023.
- The objective response rate (ORR) was 63.9%, with a disease control rate (DCR) of 100.0%.
- Median PFS was 19.6 months, and median DoR was 23.0 months. Common adverse events included diarrhea and hypertension; 36.1% experienced Grade 3+ adverse events.
Conclusions:
- Firmonertinib plus anlotinib demonstrated preliminary efficacy in first-line treatment for NSCLC patients with EGFR mutations.
- The combination therapy showed a manageable safety profile.
- Further investigation in larger trials is warranted.
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