Avelumab Plus Axitinib Demonstrates Promising Efficacy, Safety Among Previously Treated Patients With Advanced Gastrointestinal Stromal Tumors
According to results from the phase 2 AXAGIST study, avelumab plus axitinib demonstrated promising efficacy and safety among patients with advanced gastrointestinal stromal tumors (GISTs) after failure of standard tyrosine kinase inhibitor (TKI) therapy.
“Treatment options for patients with advanced [GISTs] after failure of standard therapies with tyrosine kinase inhibitors remain very limited,” stated Piotr Lukasz Rutkowski, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, and coauthors. “Given the favorable safety profile of axitinib and avelumab demonstrated in phase II/III studies in renal cell carcinoma, this combination was chosen for evaluation in GIST patients after failure of standard therapy.”
In this study, 56 patients received 10 mg/kg of avelumab once every 2 weeks plus 5 mg twice daily axitinib until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Key secondary end points included overall survival (OS), response, and safety.
At a median follow-up of 27.4 months, the 3-month PFS rate was 57.1%. Median PFS was 4.6 months, and median OS was 14.2 months. There were 5 partial responses, 34 patients with stable disease, and 17 patients with progressive disease. The median duration of response in patients with partial response was 18.5 months. Any-grade adverse events occurred in 94.6% of patients and grade ≥3 adverse events occurred in 30.4% of patients.
“The AXAGIST trial is the largest prospective study evaluating the efficacy of the combination of immune checkpoint inhibitor and a multikinase inhibitor in patients with advanced/metastatic GIST,” concluded Dr Rutkowski et al. “These results provide unique data on the activity of axitinib in GIST patients, which in combination with avelumab, resulted in long-term clinical benefit in a significant subset of patients.”
Source:
Rutkowski PL, Klimczak A, Teterycz P, et al. Avelumab plus axitinib in patients with advanced gastrointestinal stromal tumor. Eur J Cancer. Published online: June 6, 2025. doi: 10.1016/j.ejca.2025.115565
