NuCana plc announced presentations from two ongoing clinical studies with NUC-3373 in colorectal cancer (CRC) at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2023 taking place October 11-15, 2023 in Boston, Massachusetts. For the first time, data has been presented from second-line patients with CRC. Previously, NuCana announced data on NUC-3373 both as a monotherapy (NuTide:301 study) and as part of combination therapy (NuTide:302 study Parts 1 & 2) in heavily pre-treated patients who had exhausted all available standard treatments.

In these studies, NUC-3373 demonstrated a favorable safety profile and encouraging signs of efficacy, including tumor volume reductions in patients who were refractory to prior fluoropyrimidine treatment. The NuTide:302 study is now in Part 3, where second-line patients with CRC are receiving either NUC-3373 in combination with leucovorin, irinotecan and bevacizumab (NUFIRI-bev) or NUC-3373 in combination with leucovorin, oxaliplatin and bevacizumab (NUFOX-bev). Data presented October 13, 2023 showed that both regimens had favorable tolerability profiles.

Furthermore, both NUFIRI-bev and NUFOX-bev demonstrated promising anti-tumor activity, including numerous patients with tumor volume reductions. Additionally, several patients achieved a longer progression-free survival (PFS) on NUC-3373-based regimens as compared to the PFS achieved in their first-line treatment with 5-FU-based therapy. The ongoing Phase 2 randomized NuTide:323 study is investigating NUFIRI-bev versus the global standard of care, 5-FU in combination with leucovorin, irinotecan and bevacizumab (FOLFIRI-bev), in 171 second-line patients with CRC.

The study is recruiting well and aggregated safety data from the first 40 patients enrolled showed no new safety signals.