NuCana announced on Thursday that its pre-planned initial analysis of the Phase II NuTide:323 trial indicated that NUC-3373 is unlikely to achieve the primary goal of superior progression-free survival (PFS) compared to a standard treatment regimen. This finding has led the company to halt the study. NUC-3373 is a derivative of 5-fluorouracil, a widely-used chemotherapy drug. The trial was assessing NUC-3373 in combination with leucovorin, irinotecan, and Avastin (bevacizumab) against a standard treatment that includes these same drugs with 5-fluorouracil.
NuCana mentioned that there were "prognostic imbalances favoring the control arm," although the company did not provide detailed explanations of these imbalances. CEO Hugh Griffith stated, "We gained valuable knowledge from the NuTide:323 study which will inform our ongoing development programmes." He added that the outcomes underline the difficulties in developing new treatments for complex and varied cancers like metastatic colorectal cancer.
In addition to the NuTide:323 trial, NuCana is also investigating NUC-3373 in the Phase I/II NuTide:303 trial. This study is exploring the candidate's combination with either Merck & Co.'s Keytruda (pembrolizumab) or the chemotherapy drug docetaxel in patients with lung cancer.
NuCana's development pipeline features another promising candidate, NUC-7738. This drug is a derivative of cordycepin, designed to have prolonged cytotoxic activity. The company plans to present data from the Phase II NuTide:701 study at the upcoming annual European Society for Medical Oncology (ESMO) meeting. This study examines NUC-7738 in combination with Keytruda in patients suffering from melanoma.
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