Antennova will present the latest data from the Phase I/Ib STAMINA-01 trial of ATN-037, an oral small molecule CD73 inhibitor, at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. The presentation, scheduled for September 16, will detail the drug's safety, pharmacokinetics, and optimal dosing as a monotherapy and in combination with Merck's anti-PD-1 therapy, pembrolizumab (KEYTRUDA®), in patients with refractory/relapsed solid tumors.
STAMINA-01 Trial Details
The STAMINA-01 trial is a Phase I/Ib study designed to evaluate ATN-037 in patients with advanced solid tumors. As of February 29, 2024, 32 patients were enrolled, receiving doses of ATN-037 ranging from 20mg BID to 600mg BID. Twenty of these patients, who had acquired checkpoint inhibitor (CPI) resistance, were treated with the combination therapy.
Efficacy and Safety Results
Preliminary efficacy data from the trial indicated that in the 32 patients treated with ATN-037 monotherapy, 14 achieved stable disease (SD), resulting in a 43.8% disease control rate (DCR). Among the 15 evaluable patients in the combination therapy group, 3 (2 with melanoma and 1 with NSCLC) achieved confirmed partial responses (PR), and 1 patient with non-small cell lung cancer (NSCLC) achieved unconfirmed PR, yielding an overall response rate (ORR) of 20.0%. Additionally, 9 patients in the combination arm achieved SD, contributing to a 65.0% DCR.
The treatment was generally well-tolerated. Treatment-related adverse events (TRAEs) were reported in 40.6% of patients on monotherapy and 25.0% on combination therapy. Only one patient receiving combination therapy experienced a dose-limiting toxicity, a grade 3 rash, while all other TRAEs were grades 1-2.
Ongoing Development
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. The updated results as of July 26, 2024, will be presented at the ESMO Congress 2024.
