
Avelumab Plus Axitinib Shows Promise in Advanced GIST
METHODOLOGY:
Researchers conducted a phase 2 trial to evaluate the safety and efficacy of avelumab in combination with axitinib among 56 patients with unresectable/metastatic GIST (median age, 60 years) after the failure of standard therapy.
Participants received avelumab 10 mg/kg intravenously every 2 weeks combined with axitinib 5 mg orally twice daily.
The primary endpoint was the 3-month PFS rate; key secondary endpoints included overall survival, disease control rate, duration of response, and adverse events (AEs).
The median follow-up duration was 27.4 months.
TAKEAWAY:
The PFS rate at 3 months was 57.1%, the median PFS was 4.6 months, and the median overall survival was 14.2 months.
A partial response was achieved in 8.9% of patients, and the median duration of response was 18.5 months.
Stable disease was observed in 60.7% of patients, corresponding to a disease control rate of 69.6%.
AEs occurred in 94.6% of patients, with 30.4% experiencing grade 3 or higher events. The most common treatment-related AEs were diarrhoea (33.9%), thyroid dysfunction (30.4%), hypertension (25%), palmar-plantar erythrodysesthesia (23.2%), myalgia (17.9%), and dysphonia (17.9%).
IN PRACTICE:
"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. 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," the authors wrote.
SOURCE:
This study was led by Piotr Lukasz Rutkowski, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland. It was published online on June 06, 2025, in the European Journal of Cancer .
LIMITATIONS:
This study lacked a comparator arm, which made it impossible to conclude whether the addition of avelumab improves the antitumour activity of axitinib.
DISCLOSURES:
This research and drug supply were financially supported by Pfizer, as part of an alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc. Several authors declared receiving honoraria or having other ties with various sources.
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Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information Analyst coverage H.C. Wainwright & Co Yi Chen New York, views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ Disclaimer The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 Non-audited figure 2 Antiglaucoma Drug Market Size, Trends, Growth Report 2034; Glaucoma Therapeutics Market Report by Drug Class (Prostaglandin Analogs, Beta Blockers, Alpha Adrenergic Agonists, Carbonic Anhydrase Inhibitors, Combination Drugs, and Others), Indication (Open Angle Glaucoma, Angle Closure Glaucoma, and Others); Glaucoma Therapeutics Market Size, Growth, Analysis - 20313 World Glaucoma Association website: World Glaucoma Association » What is glaucoma? Attachment EN_NCX470KowaGlobalLicenseJuly2025_PR_FINAL