On October 13, 2023 NuCana plc (NASDAQ: NCNA) reported presentations from two ongoing clinical studies with NUC-3373 in colorectal cancer (CRC) at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2023 taking place October 11-15, 2023 in Boston, Massachusetts (Press release, Nucana BioPharmaceuticals, OCT 13, 2023, View Source [SID1234635951]).

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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 today 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.

Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer, said: "We are delighted to have been able to showcase these data. For the first time, we have presented data from our lead program of NUC-3373 in second-line colorectal cancer from the NuTide:302 study, which has shown encouraging signs of efficacy and continues to demonstrate a favorable safety profile. Four out of seven patients who received fluoropyrimidine plus oxaliplatin-based therapy as a first-line treatment achieved a longer PFS on NUFIRI-bev in the second-line setting where PFS is typically five months shorter. This result gives us further confidence in our ongoing randomized Phase 2 NuTide:323 study."

Mr. Griffith continued: "We also shared an update from NuTide:323 which is recruiting well with no new safety signals observed. We remain on track to fully enroll the study in the coming months and we look forward to sharing further updates from this study."