Key clinical point: The combination of CXD101 and nivolumab at full individual doses was effective and well tolerated as a third-line and above treatment for patients with late-stage microsatellite stable colorectal cancer (MSS CRC).
Major finding: CXD101 and nivolumab combination was well tolerated, with neutropenia (18%) and anemia (7%) being the most common grade 3-4 adverse events. The median progression-free survival and overall survival were 2.1 (95% CI 1.4-3.9) and 7.0 (95% CI 5.13-10.22) months, respectively, with an immune disease control rate of 48% and an immune objective response rate of 9%.
Study details: The data comes from a phase 1b/2 trial including 55 heavily pretreated patients with biopsy-confirmed MSS CRC who received oral CXD101 and intravenous nivolumab.
Disclosures: The trial was supported by Celleron Therapeutics. This study was funded by The Oxford NIHR Comprehensive Biomedical Research Centre and a Cancer Research UK Advanced Clinician Scientist Fellowship. Some authors declared being employees of or holding shares or share options in Celleron Therapeutics.
Source: Saunders MP et al. CXD101 and nivolumab in patients with metastatic microsatellite-stable colorectal cancer (CAROSELL): A multicentre, open-label, single-arm, phase II trial. ESMO Open. 2022;7(6):100594 (Oct 27). Doi: 10.1016/j.esmoop.2022.100594