On September 8, 2024 Antennova, a clinical-stage biotech company focused on oncology reported that it will present the latest data of CD73 small molecule inhibitor ATN-037 in a Mini Oral presentation at the 2024 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO Congress 2024), taking place from September 13th to September 17th at the Fira Barcelona Gran Via in Barcelona, Spain (Press release, Antennova, SEP 8, 2024, View Source [SID1234646411]).
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Details of the Presentation:
ATN-037 (also known as ATG-037, CD73 Oral Small Molecule Inhibitor)
Title: A First-In-Human Phase I/Ib study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Advanced Solid Tumours – STAMINA-01
Abstract: 6067
Presentation Number: 997MO
Date: September 16, 2024
Time:
10:50 AM – 10:55 AM (Central European Summer Time)
4:50 AM – 4:55 AM (US Eastern Time)
ATN-037 is a highly potent oral small molecule inhibitor of CD73. The STAMINA-01 Phase I/II study is investigating the safety, pharmacokinetics and optimal dose of ATN-037 as a monotherapy or in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with refractory/relapsed solid tumors. Antennova has initiated the dose optimization and dose expansion portion of the Phase II STAMINA trial of ATN-037 in Australia and plans to initiate the study in China at the end of October 2024.
As of February 29, 2024, 32 patients have been enrolled, receiving doses ranging from 20mg BID to 600mg BID. 20 of these patients who acquired checkpoint inhibitor (CPI) resistance were treated with combination therapy.
Efficacy data showed that in the 32 patients in the monotherapy group who were all evaluable, 14 achieved stable disease (SD) with a 43.8% disease control rate (DCR). In the 15 evaluable patients among the 20 patients in the combination therapy group, 3 patients (2 with melanoma and 1 with NSCLC) achieved confirmed partial response (PR) and 1 patient with non-small cell lung cancer (NSCLC) achieved unconfirmed PR with an overall response rate (ORR) of 20.0%. Additionally, 9 patients achieved SD, contributing to a 65.0% DCR.
40.6% of patients on monotherapy and 25.0% on combination therapy reported treatment-related adverse events (TRAEs). Only one patient receiving combination therapy experienced a dose-limiting toxicity grade 3 rash, while all other TRAEs were grades 1-2.
The updated results as of July 26, 2024 will be presented in the Mini Oral Session of ESMO (Free ESMO Whitepaper) Congress 2024, scheduled on September 16.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merk & Co., Inc., Rahway, NJ, USA.