Filippo Pietrantonio, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, reports on a Phase I/II study (NCT05205330) which evaluated the safety and efficacy of CR6068 (an EP4 antagonist) in combination with balstilimab (an anti-PD-1 monoclonal antibody) in mismatch-repair-proficient and microsatellite stable (pMMR/MSS) chemorefractory metastatic colorectal cancer (mCRC). 28 patients received oral CR6086 (30, 90 or 180mg twice daily) plus balstilimab until disease progression, unacceptable toxicity or death. Primary endpoints were safety and tolerability, and disease control rate (DCR). The treatment was deemed to be well-tolerated: CR6086-related adverse events (AEs) were Grade 1, except for a Grade 4 duodenal ulcer; and balstilimab-related AEs were G2 and below. Objective response rate (ORR) was 11% and DCR was 50%. This interview took place at the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain.
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