NuCana discontinues Phase II NuTide:323 colorectal cancer study

 Scotland-based biotech NuCana has announced that it is discontinuing its NuTide:323 study (NCT05678257).

NuTide:323 was an open-label, dose/schedule optimisation study evaluating the efficacy of NuCana’s NUC-3373 ProTide in combination with leucovorin, irinotecan and bevacizumab (NUFIRI+bev).

The ProTide was being evaluated versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) in patients with previously treated unresectable metastatic colorectal cancer.

NuCana’s ProTides are developed through a phosphoramidate chemistry approach and aim to overcome the limitations of traditional nucleoside analogs used in chemotherapy to generate higher concentrations of anti-cancer metabolites in cancer cells.

NuTide:323’s Study Steering Committee recommended cancelling the study after determining that NUFIRI+bev was unlikely to achieve the study’s primary objective of superior progression-free survival (PFS) compared to the control arm of FOLFIRI-bev.

Study Steering Committee chair, Professor Josep Tabernero, revealed that the study’s aim was to develop NUC-3373 as a replacement for 5-FU, with the goal based on robust clinical and non-clinical data.

“We gained valuable knowledge from the NuTide:323 study which will inform our ongoing development programs,” said NuCana founder and CEO Hugh S. Griffith.

Griffith continued: “These results highlight the challenges associated with developing new medicines for patients with complex and heterogenous cancers such as metastatic colorectal cancer. We will leverage insights from these data to identify future potential development options for NUC-3373 in colorectal cancer.”

Griffith added that the outcome of NuTide:323 would not impact NuCana’s ongoing NuTide:303 study (NCT05714553), in which NUC-3373 is being combined with docetaxel in patients with lung cancer and with Keytruda (pembrolizumab) in solid tumours.

This week, MSD discontinued two of its own Phase III Keytruda trials – KEYNOTE-867 (NCT03924869) and KEYNOTE-630 trial (NCT03833167) – after they failed to meet the primary and secondary endpoints.

According to GlobalData’s pharmaceutical database, Keytruda generated global sales of around $25m in 2023, with sales forecast to peak in 2027 at around $34.3m.

GlobalData’s pharmaceutical database shows that NuCana has 13 ProTides in its drug development pipeline, in indications including ovarian cancer, non-small cell lung cancer, and acute lymphocytic leukaemia. GlobalData is the parent company of Clinical Trials Arena.

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