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Published on: July 21, 2018
Phase 2 trial of Linifanib (ABT-869) in patients with advanced non-small cell lung cancer
Eng-Huat Tan1, Glenwood D Goss, Ravi Salgia
1Medical Oncology, National Cancer Centre Singapore, Singapore. dmoteh@nccs.com.sg
Introduction:
This study assessed activity and safety of linifanib (ABT-869), a selective inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptors, in patients with locally advanced or metastatic non-small cell lung cancer.
Methods:
In this open-label trial (NCT00517790), patients who received one to two prior lines of systemic therapy were randomized to oral linifanib 0.10 mg/kg (low dose) or 0.25 mg/kg (high dose) once daily. Tumor responses were assessed by independent central imaging review every 8 weeks. The primary end point was progression-free rate at 16 weeks. Secondary end points included objective response rate, time to progression, progression-free survival, and overall survival. Safety was also assessed.
Results:
Between August 2007 and October 2008, 139 patients were enrolled; 60% had two or more prior regimens, and 88% had nonsquamous cell carcinoma. The objective response rate (low dose and high dose) was 5.0% (3.1 and 6.8%), progression-free rate at 16 weeks was 33.1% (32.3 and 33.8%), median time to progression was 3.6 months (3.6 and 3.7 months), median progression-free survival was 3.6 months (3.5 and 3.6 months), and median overall survival was 9.0 months (10.0 and 8.3 months). The most common linifanib-related adverse events were fatigue (42%), decreased appetite (38%), hypertension (37%), diarrhea (32%), nausea (27%), palmar-plantar erythrodysesthesia (24%), and proteinuria (22%). These events were more common in the high-dose group. The most common linifanib-related grade 3 or 4 adverse event was hypertension (14%).
Conclusions:
Linifanib is active in advanced non-small cell lung cancer as second- or third-line therapy. Increased adverse event rates were observed at the high dose of linifanib.
Insights
Linifanib shows activity in advanced non-small cell lung cancer treatment. Higher doses increased adverse events, suggesting careful dose selection is crucial for patient safety and efficacy.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Linifanib (ABT-869) is a targeted therapy inhibiting vascular endothelial growth factor and platelet-derived growth factor receptors.
- Non-small cell lung cancer (NSCLC) remains a significant challenge, necessitating novel therapeutic strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of linifanib in patients with advanced or metastatic non-small cell lung cancer.
- To compare the outcomes of low-dose versus high-dose linifanib administration.
Main Methods:
- An open-label, randomized clinical trial (NCT00517790) involving 139 patients with advanced NSCLC.
- Patients received either 0.10 mg/kg (low dose) or 0.25 mg/kg (high dose) of oral linifanib daily.
- Tumor response was assessed by independent central imaging, with progression-free rate at 16 weeks as the primary endpoint.
Main Results:
- The objective response rate was 5.0% (3.1% low dose, 6.8% high dose).
- Progression-free rate at 16 weeks was 33.1% (32.3% low dose, 33.8% high dose).
- Common adverse events included fatigue, decreased appetite, hypertension, and diarrhea, with higher incidence in the high-dose group.
Conclusions:
- Linifanib demonstrates activity as a second- or third-line treatment for advanced non-small cell lung cancer.
- The high dose of linifanib was associated with an increased rate of adverse events, particularly hypertension.
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