NuCana Stock Plunges On Colorectal Combo Therapy Trial Setback, Ends Mid-Stage Study After Disappointing Data

Thursday, NuCana plc NCNA announced that the NuTide:323 study is being discontinued 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 the combination of NUC-3373 with leucovorin, irinotecan, and bevacizumab (NUFIRI+bev) was unlikely to achieve the study’s primary objective of superior Progression-Free Survival compared to the control arm of 5-FU, leucovorin, irinotecan, and bevacizumab (FOLFIRI+bev) in the final analysis.

NuTide:323 is a Phase 2 study comparing NUC-3373/NUFIRI-bev to FOLFIRI-bev for unresectable metastatic colorectal cancer.

In all three arms, the treatment regimens were observed to have a favorable safety profile and to be generally well tolerated, with only 12 of the 175 patients (four patients in each arm) discontinuing treatment due to adverse events.

Mr. Griffith continued: “The results of the NuTide:323 study do not impact the ongoing NuTide:303 study, in which NUC-3373 is being combined with either pembrolizumab in solid tumors or docetaxel in patients with lung cancer. Furthermore, we are excited about the potential of NUC-7738, a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. We look forward to sharing the latest data from the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with pembrolizumab in patients with melanoma at the ESMO annual conference in September 2024.”

William Blair has downgraded the stock to Market Perform, saying, “Given this was the first controlled trial with NUC-3373, we believe it will be difficult to regain investor interest in the program in other ongoing studies.”

As of June 30, 2024, NuCana had cash and cash equivalents of $15.3 million (11.6 million pounds), which is expected to provide a cash runway into the first quarter of 2025.

Price Action: At last check on Friday, NCNA stock was down 52.3% to $3.69 during the premarket session.

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