On January 15, 2021 NuCana plc (NASDAQ: NCNA) reported interim data from the ongoing NuTide:302 study at the ASCO (Free ASCO Whitepaper) GI Conference, being held virtually January 15-17, 2021 (Press release, Nucana BioPharmaceuticals, JAN 15, 2021, View Source [SID1234574048]).

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NuTide:302 is a three-part study investigating NUC-3373, NuCana’s targeted thymidylate synthase inhibitor, in heavily pre-treated patients with metastatic colorectal cancer. The study is evaluating NUC-3373’s optimal dose and schedule in combination with agents commonly used to treat patients with colorectal cancer and is assessing safety, pharmacokinetics and anti-cancer activity. NUC-3373 has been designed to overcome the main challenges associated with 5-FU and capecitabine, including cancer-resistance mechanisms which limit efficacy, off-target toxicity and administration burdens.

The ASCO (Free ASCO Whitepaper) GI presentation highlighted data from 37 patients treated in Part I of the study who received NUC-3373 either as monotherapy or in combination with leucovorin. Ten patient case studies highlighted NUC-3373’s ability to stabilize disease and achieve prolonged durations of progression-free survival. Many patients achieved longer progression-free survival on NUC-3373 than they had on their prior line of therapy and five patients experienced tumor shrinkage. These patients included:

A fourth-line patient who achieved a Partial Response with a 40% reduction in tumor volume;

A third-line patient who achieved a 28% reduction in tumor volume after their disease rapidly progressed through all prior fluoropyrimidine-containing regimens.

Among the efficacy-evaluable population, a disease control rate of 62% was achieved.

In addition to these encouraging efficacy signals, the presentation compared the safety profile of NUC-3373 in Part I of the study with historical data for 5-FU and capecitabine in the front-line treatment of patients with colorectal cancer. NUC-3373 was well tolerated with no hand-foot-syndrome or neutropenia as well as lower rates of diarrhea, mucositis and stomatitis.

Dr. Andrew Coveler, Associate Professor at the University of Washington School of Medicine and Fred Hutchinson Cancer Research Center and an investigator in the NuTide:302 study, remarked: "I am encouraged by both the clinical activity and safety of NUC-3373. To observe this anti-cancer activity, including a Partial Response, in such a heavily pre-treated patient population is very promising. In addition, NUC-3373 has been well tolerated and its safety appears favorable when compared to 5-FU and capecitabine. As such, I look forward to advancing NUC-3373’s development in patients with colorectal cancer."

"We are very pleased with these additional data from Part I of the NuTide:302 study," said Hugh S. Griffith, NuCana’s Founder and CEO. "It was particularly encouraging to observe tumor shrinkages, prolonged disease stabilization and a favorable safety profile in a patient population that had received at least two prior fluoropyrimidine-containing regimens. We look forward to continuing Part II of the study in which NUC-3373 is being combined with leucovorin and either oxaliplatin or irinotecan. Our objective is to replace 5-FU and capecitabine with NUC-3373 as the backbone of treatment for patients with colorectal cancer."

Details of the poster presentation are as follows:

Title: A phase Ib study of NUC-3373 in combination with standard therapies in

advanced/metastatic colorectal cancer (NuTide:302)

Session: Colorectal Cancer

Abstract Number: 93