In This Article:
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In patients with non-small cell lung cancer (NSCLC) or melanoma who had acquired resistance to checkpoint inhibitors (CPIs), ATN-037 in combination with KEYTRUDA®(pembrolizumab) demonstrated an overall response rate (ORR) of 21.1% and a disease control rate (DCR) of 89.5%.
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Data from the Phase I dose escalation showed ATN-037's potential in reversing resistance to anti-PD-1 therapies.
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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.
BOSTON, Sept. 16, 2024 /PRNewswire/ -- Antennova, a clinical-stage biotech company focused on oncology today announced that it presented the latest data of CD73 small molecule inhibitor ATN-037 in a Mini Oral presentation at the 2024 European Society of Medical Oncology Congress (ESMO Congress 2024).
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
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ATN-037 is a highly potent oral small molecule inhibitor of CD73. The STAMINA-01 Phase I/II study was designed to evaluate the safety, pharmacokinetics and optimal dose of ATN-037 as a monotherapy or in combination with Merck's (known as MSD outside of the United States and Canada) 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.
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As of July 26, 2024, a total of 43 patients were enrolled and treated with ATN-037 monotherapy. 26 of these patients with acquired resistance to CPIs also received ATN-037 in combination with pembrolizumab. Since the beginning of the treatment (C1D1), 42 patients have received at least one tumor evaluation (1 patient was unevaluable).
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Efficacy data show that among the 42 evaluable patients who were on the monotherapy, 23 have achieved stable disease (SD).
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The 26 evaluable patients who received ATN-037 in combination with pembrolizumab include 9 patients with NSCLC and 10 patients with melanoma. 4 of these patients (2 with NSCLC and 2 with melanoma) have achieved confirmed partial response (PR). In the 19 patients with NSCLC or melanoma, the ORR was 21.1% (4/19) and the DCR was 89.5% (17/19).
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During the study, 43 (100%) patients experienced treatment-emergent adverse events (TEAEs); 62.3% were treatment-related). Among them, 16 patients experienced treatment-emergent serious adverse events (TE-SAEs), and 2 of them were treatment related; 18 patients experienced Grade 3 or higher TEAEs, and 4 of them were treatment-related. At 400 mg twice-daily (BID), the study observed one dose-limiting toxicity (DLT) of Grade 3 rash. No Grade 5 treatment-related adverse events (TRAEs) were reported.
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Preliminary data observed from Phase I dose escalation of STAMINA study has shown encouraging PR in patients treated with ATN-037 in combination with pembrolizumab with excellent safety profile. The combination of ATN-037 with Pembrolizumab may provide a new therapeutic option for CPI resistant NSCLC and melanoma patients.