Company: NCNA
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0000950170-25-042709
Chunk: 138

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 4
Chunk 138
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 recommended Phase 2 dose for NUC-3373 as part of NUFIRI and NUFOX regimens has been established.
 
 In October 2023, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2023, we reported data from 14 patients with metastatic colorectal cancer who had received NUFIRI or NUFOX in combination with bevacizumab in Part 3 of the Phase 1b/2 NuTide:302 trial. NUC-3373 demonstrated a favorable safety profile when combined with irinotecan, leucovorin, and bevacizumab (NUFIRI + bev) and with oxaliplatin, leucovorin, and bevacizumab (NUFOX + bev). Additionally, as shown below, both regimens demonstrated encouraging signs of efficacy, including tumor volume reductions in patients who were refractory to or had progressed on prior fluoropyrimidine treatment.
 

 
Several patients achieved a longer PFS on NUFIRI + bev and NUFOX + bev as compared to the PFS achieved in their first-line treatment with 5-FU-based therapy.
 
 
NUC-3373: Discontinued Phase 2 clinical trial (NuTide:323).
 
In 2022, we initiated a randomized Phase 2 clinical trial of NUC-3373 in combination with NUFIRI + bev versus FOLFIRI + bev for the second-line treatment of patients with advanced colorectal cancer who have progressed on first-line FOLFOX. This trial included two NUC-3373 treatment arms to evaluate a weekly and a fortnightly, or alternate week, administration schedule.
 

In October 2023, we presented data from the NuTide:323 trial at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2023. The trial recruited well, and no new safety signals were observed from the aggregated safety data from the first 40 patients enrolled.
 In August 2024, we announced that we were discontinuing our NuTide:323 trial following a pre-planned initial analysis and recommendation from the NuTide:323 study Steering Committee. While there were prognostic imbalances favoring the control arm, the Steering Committee believed that NUFIRI + bev was unlikely to achieve the study’s primary objective of superior PFS compared to the control arm of FOLFIRI + bev in