600TiP A randomized blinded phase II study of ompenaclid (RGX-202-01) vs placebo in combination with FOLFIRI plus bevacizumab (BEV) in patients (pts) with previously treated RAS mutated (RASmt) advanced/metastatic colorectal cancer (mCRC)

Elez Fernandez, M.E.;Rosello Keranen, S.;Paez, D.;Jiménez Castro, J.;Tabernero, J.;et.al.
(2024) the ESMO Gastrointestinal Cancers Congress 2024 — Location: (Germany) Munich (26.June.2024)

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Authors
  • Elez Fernandez, M.E.
    Author
  • Rosello Keranen, S.
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  • Paez, D.
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  • Jiménez Castro, J.
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  • Van den Eynde, MarcUCLouvain
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  • Tabernero, J.
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Abstract
Background : Pts with RASmt mCRC have a short median progression-free survival (PFS) of ∼5–6 months and median overall survival (OS) of ∼1 year after failing first-line (1L) therapy. Novel therapies with modes of action distinct from these established agents are urgently needed to improve on patient outcomes. Creatine metabolism was found to be activated in RASmt mCRC as a mechanism to fuel the increased energy demands of RASmt tumors. Ompenaclid is a first-in-class small molecule inhibitor of the creatine transporter SLC6A8 that prevents import of creatine and the high energy metabolite phosphocreatine, which results in depletion of intracellular ATP levels, leading to tumor cell apoptosis. In an open-label single arm study (RGX-202-001) as 2L treatment in pts with RASmt mCRC, ompenaclid at 2400 mg and 3000 mg orally twice-daily (BID) in combination with FOLFIRI/BEV was shown to have potential clinical benefit with a tolerable safety profile (ESMO 2023, abstract 646P). [...]
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Elez Fernandez, M. E., Rosello Keranen, S., Paez, D., Jiménez Castro, J., Rivera Herrero, F., Ruiz-Casado, A., Riesco Martinez, M. C., Montagut Viladot, C., Coupez, D., Ducreux, M. P., Loly, C., Martin-Babau, J., Prenen, H., Van den Eynde, M., Borg, C., Cuyle, P.-J., de Haar-Holleman, A., Raimbourg, J., Bechar, N., & Tabernero, J. (2024). 600TiP A randomized blinded phase II study of ompenaclid (RGX-202-01) vs placebo in combination with FOLFIRI plus bevacizumab (BEV) in patients (pts) with previously treated RAS mutated (RASmt) advanced/metastatic colorectal cancer (mCRC). Annals of Oncology, 35(Suppl 1), S480-S481. https://doi.org/10.1016/j.annonc.2024.08.669 (Original work published 2024)