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Anlotinib Combined with EGFR-TKIs Shows Promise in Extending Progression-Free Survival in Advanced NSCLC

A phase 2 trial, CTONG-1803/ALTER-LOO1, has demonstrated that combining anlotinib with EGFR-tyrosine kinase inhibitors (EGFR-TKIs) significantly extends progression-free survival (PFS) in patients with advanced non-small cell lung cancer (NSCLC) who have shown gradual, oligo, or potential progression after previous EGFR-TKI treatment. The study reported a median PFS of 9.1 months and a 12-month PFS rate of 38.8%, suggesting a feasible and effective treatment strategy for this patient population.

Anlotinib Combined with EGFR-TKIs Shows Promise in Extending Progression-Free Survival in Advanced NSCLC

The single-arm phase 2 CTONG-1803/ALTER-LOO1 trial (NCT04007835) has evaluated the efficacy of anlotinib in combination with EGFR-tyrosine kinase inhibitors (EGFR-TKIs) for patients with advanced non-small cell lung cancer (NSCLC) who have experienced gradual, oligo, or potential progression after previous EGFR-TKI treatment. Published in the Journal of Hematology and Oncology, the findings reveal significant improvements in progression-free survival (PFS).

Key Findings

  • Median PFS: 9.1 months (95% CI, 6.8-11.7) among all evaluable patients (n = 120).
  • 6- and 12-month PFS rates: 68.5% (95% CI, 58.7%-76.4%) and 38.8% (95% CI, 28.4%-49.0%), respectively.
  • Overall Survival (OS): 12-month OS rate of 81.1% (95% CI, 71.8%-87.5%), though data remain immature.

Study Design and Patient Demographics

Conducted between July 8, 2019, and December 15, 2022, the trial screened 140 patients, with 120 meeting the inclusion criteria. Patients received 12 mg of oral anlotinib daily for 2 weeks, followed by an off-week period, in 3-week cycles until disease progression or intolerable toxicities.
  • Patient Characteristics: Predominantly women (59.2%), median age of 57.5 years (range, 29-75 years), with the majority having adenocarcinoma (96.7%).
  • Previous Treatments: 71.7% had frontline first- or second-generation EGFR-TKIs, and 26.7% had third-generation EGFR-TKI exposure.

Efficacy and Safety

  • Disease Control Rate (DCR): 87.5% (95% CI, 80.2%-92.8%) at a median follow-up of 17.9 months.
  • Lesion Size Reduction: 63.3% of patients experienced a reduction from baseline.
  • Safety: Treatment-emergent adverse events (TEAEs) were observed in 96.7% of patients, with 52.5% experiencing grade 3 or higher TEAEs. Common TEAEs included diarrhea (53.3%), hypertension (50.0%), and proteinuria (39.2%).

Conclusion

Dr. Hua-Jun Chen, the lead investigator, emphasized the feasibility of combining EGFR-TKIs with anlotinib, highlighting its potential to extend the clinical benefits of original EGFR-TKIs. The study advocates for further research with larger sample sizes and randomized controlled designs to validate these findings.
Reference: Chen HJ, Tu HY, Hu Y, et al. A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001). J Hematol Oncol. 2025;18(1):3. doi:10.1186/s13045-024-01656-0
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Reference News

[1]
Anlotinib Prolongs EGFR-TKI Clinical Benefit in Advanced NSCLC - Cancer Network
cancernetwork.com · Jan 21, 2025

The CTONG-1803/ALTER-LOO1 trial showed anlotinib combined with EGFR-TKIs achieved a median PFS of 9.1 months in advanced...

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