Efficacy and safety of first-line anlotinib-based combinations for advanced non-small cell lung cancer: a three-armed
Tianqing Chu1, Wei Zhang1, Bo Zhang1
1Department of Respiratory, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.
Background:
The evidence of combined therapies of multi-target agents in first-line treatment of advanced non-small cell lung cancer (NSCLC) was limited. This study aimed to evaluate the safety and efficacy of anlotinib combined with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), chemotherapy, or immune checkpoint inhibitor (ICI) in advanced NSCLC.
Methods:
This open-label, three-arm, prospective study (NCT03628521) enrolled untreated locally advanced/metastatic NSCLC patients. Patients with EGFR mutation NSCLC received anlotinib and erlotinib (cohort A). Patients without EGFR/ALK/ROS1 mutation received anlotinib combined with carboplatin plus pemetrexed/gemcitabine (cohort B), or sintilimab (cohort C). The primary outcomes were safety and objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), disease control rate (DCR), and overall survival (OS). Treatments were performed for at least 2 cycles and efficacy was evaluated every 2 cycles using RECIST version 1.1. Safety was assessed throughout the study.
Results:
A total of 30, 30, and 22 patients were enrolled in cohorts A, B, and C, respectively. There were 3 patients did not complete the treatment in cohort A. In cohorts A and B, ≥ grade 3 treatment-related adverse events (TRAEs) occurred in 77.3% and 60.0% of patients, respectively. The most common TRAEs were rash (10.0%) and decreased platelet count (30.0%) in cohorts A and B, respectively. The ORRs were 92.9% and 60.0% in cohorts A and B, respectively, and DCRs were 96.4% and 96.7%, respectively. The ORR and incidence of ≥ grade 3 TRAEs of cohort C were, which 72.7% and 54.5%, which had been published previously. Median PFSs [95% confidence interval (CI)] were 21.6 (15.6 to 24.9), 13.0 [10.5 to not estimated (NE)], and 15.6 (12.9 to NE) months in cohorts A, B, and C, respectively. Median OS was 28.1 (95% CI: 21.82 to NE) months in cohort B. The 24-month OS rates in cohorts A and C were 87.1% and 83.9%, respectively.
Conclusions:
Anlotinib-based combinations with EGFR-TKI, chemotherapy, and ICI are well-tolerated and encouraging as first-line therapies for advanced NSCLC, which could be verified in future studies. Anlotinib-based combination might provide multiple choices for first-line treatment in patients with advanced NSCLC.
Insights
Anlotinib combined with EGFR-TKI, chemotherapy, or ICI shows promising safety and efficacy for advanced non-small cell lung cancer (NSCLC) first-line treatment. These combinations offer well-tolerated options for patients with advanced NSCLC.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Limited evidence exists for combined therapies using multi-target agents in first-line treatment for advanced non-small cell lung cancer (NSCLC).
- This study evaluates anlotinib combined with EGFR-TKI, chemotherapy, or ICI in advanced NSCLC patients.
Purpose of the Study:
- To assess the safety and efficacy of anlotinib-based combination therapies as a first-line treatment for advanced NSCLC.
- To explore anlotinib's potential in combination with different treatment modalities for NSCLC.
Main Methods:
- An open-label, three-arm prospective study enrolled untreated advanced/metastatic NSCLC patients.
- Cohort A: anlotinib + erlotinib (EGFR mutation+). Cohort B: anlotinib + chemotherapy (EGFR/ALK/ROS1 mutation-). Cohort C: anlotinib + sintilimab (ICI).
- Primary outcomes: safety and objective response rate (ORR); secondary: progression-free survival (PFS), disease control rate (DCR), overall survival (OS).
Main Results:
- Objective response rates (ORRs) were 92.9% (Cohort A) and 60.0% (Cohort B).
- Median PFS: 21.6 months (A), 13.0 months (B), 15.6 months (C).
- High disease control rates (≥96.4%) and encouraging 24-month OS rates (87.1% in A, 83.9% in C) were observed.
Conclusions:
- Anlotinib-based combinations with EGFR-TKI, chemotherapy, and ICI are well-tolerated and effective first-line therapies for advanced NSCLC.
- These combinations provide valuable therapeutic options for advanced NSCLC patients, warranting further investigation.
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