This section highlights FDA-related milestones and regulatory updates for drugs developed by NuCana (NCNA).
Over the past two years, NuCana has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NUC-3373, NUC-7738, and NuTide:323. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NUC-3373 (NuTide:301) - FDA Regulatory Timeline and Events
NUC-3373 (NuTide:301) is a drug developed by NuCana for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NUC-3373 (NuTide:301)
- Announced Date:
- November 25, 2024
- Indication:
- Solid tumors
Announcement
NuCana plc provided clinical updates
AI Summary
At ESMO Congress 2024, NuCana plc shared new clinical updates on its anti-cancer medicines. The company presented encouraging Phase 2 results from the NuTide:701 study, where 9 out of 12 patients with PD-1 inhibitor-resistant melanoma achieved disease control when treated with NUC-7738 in combination with pembrolizumab. Notably, one patient experienced a 55% reduction in tumor volume, and the median progression-free survival extended to over five months compared to the usual two to three months with standard care.
NuCana also announced initial findings from the Phase 1b/2 NuTide:303 study for NUC-3373. The early data shows that when paired with pembrolizumab or docetaxel, NUC-3373 may enhance the body's immune response while leading to significant tumor reductions in patients with advanced solid tumors and lung cancer. These results underline the potential of the company's innovative pipeline.
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NUC-7738 (NuTide:701) - FDA Regulatory Timeline and Events
NUC-7738 (NuTide:701) is a drug developed by NuCana for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NUC-7738 (NuTide:701)
- Announced Date:
- March 20, 2025
- Indication:
- Solid tumors
Announcement
NuCana plc provided an update on its clinical development program with its two lead anti-cancer medicines.
AI Summary
NuCana plc provided an update on its clinical development program for its two lead anti-cancer medicines, NUC-7738 and NUC-3373. NUC-7738 is being studied in combination with pembrolizumab for patients with PD-1 inhibitor-resistant melanoma. In the NuTide:701 study, early data showed promising results, including disease control in 75% of patients, with several experiencing tumor reductions and partial responses. These encouraging findings have led to plans to initiate an expansion study later this year to further assess NUC-7738’s potential and support discussions with the FDA regarding its regulatory strategy.
NUC-3373, a targeted thymidylate synthase inhibitor with immune modulating properties, is also under clinical evaluation in a Phase 1b/2 study. Early results from this program indicate significant tumor volume reductions and prolonged progression free survival in patients with advanced solid tumors.
Read Announcement- Drug:
- NUC-7738 (NuTide:701)
- Announced Date:
- March 20, 2025
- Indication:
- Solid tumors
Announcement
NuCana plc provided an update on its clinical development program with its two lead anti-cancer medicines.
AI Summary
NuCana plc has provided an update on its clinical development program for its two lead anti-cancer candidates: NUC-7738 and NUC-3373. NUC-7738, designed to impact gene expression and target the tumor microenvironment, has shown promise in early studies. When combined with pembrolizumab, early data indicate that NUC-7738 may help reduce tumor size and extend progression-free survival in patients with PD-1 inhibitor-resistant melanoma. In the NuTide:701 study, a significant number of patients experienced disease control, with some achieving partial responses and notable tumor reductions. Based on these encouraging results, NuCana plans to launch an expansion study and will provide further updates later this year. Additionally, the company is actively seeking FDA guidance on the optimal path to advance NUC-7738 toward potential approval. Meanwhile, initial findings from the NUC-3373 program in a Phase 1b/2 study also look promising.
Read Announcement- Drug:
- NUC-7738 (NuTide:701)
- Announced Date:
- November 25, 2024
- Indication:
- Solid tumors
Announcement
NuCana plc provided clinical updates
AI Summary
NuCana plc recently provided an update on its clinical development program at the European Society for Medical Oncology (ESMO) Congress 2024. The company presented encouraging Phase 2 data on NUC-7738, a novel anti-cancer agent that affects gene expression and targets different parts of the tumor microenvironment. In a study of patients with PD-1 inhibitor-resistant melanoma, 9 out of 12 participants achieved disease control when treated with NUC-7738 in combination with pembrolizumab. One patient, who had already received two lines of treatment, saw a 55% reduction in tumor volume. Notably, the median progression-free survival for patients receiving this combination was over five months, compared to the usual two to three months seen with current therapies. These promising results highlight NUC-7738's potential to improve treatment outcomes for patients with difficult-to-treat melanoma.
Read Announcement- Drug:
- NUC-7738 (NuTide:701)
- Announced Date:
- September 14, 2024
- Indication:
- Solid tumors
Announcement
NuCana plc presented final data from the Phase 2 NuTide:701 study at the ESMO Congress on NUC-7738 in combination with pembrolizumab for patients with metastatic melanoma who were refractory to or had relapsed on prior PD-1 inhibitor therapy.
AI Summary
NuCana plc presented final data from its Phase 2 NuTide:701 study at the ESMO Congress. The study looked at the combination of NUC-7738 and pembrolizumab for patients with metastatic melanoma who did not respond to or had relapsed after previous PD-1 inhibitor treatments.
In a cohort of 12 patients, 75% achieved disease control. Two patients saw partial responses, including one with a 55% tumor reduction after failing multiple prior therapies. Notably, seven patients experienced progression-free survival longer than five months, which is unusual given this group’s typically short survival times. The combination was also well tolerated, showing a favorable safety profile. Researchers believe NUC-7738 works by disrupting RNA processes in cancer cells, which may help re-sensitize tumors to PD-1 inhibitors, potentially offering a new option for managing resistant melanoma cases.
Read Announcement- Drug:
- NUC-7738 (NuTide:701)
- Announced Date:
- April 9, 2024
- Indication:
- Solid tumors
Announcement
NuCana plc announced two posters being presented today at the American Association of Cancer Research (AACR) Annual Meeting.
AI Summary
NuCana plc today announced that it will present two posters at the American Association of Cancer Research (AACR) Annual Meeting. One poster, titled "Exposing the Heterogeneity of the Lipidome in the TME of Cutaneous Melanoma Following Treatment with NUC-7738 in Combination with anti-PD-1 Therapy" (Abstract 6222), highlights research showing that NUC-7738 alters tumor lipid metabolism. The study found that the drug increases levels of polyunsaturated fatty acids—linked to less aggressive tumors—and reduces monounsaturated fatty acids associated with malignancy and chemotherapy resistance.
The second poster, "RNA Regulatory Disruption by 3'-dATP: A Novel Approach to Inhibit Ribosome Biogenesis in Cancer" (Abstract 5650), demonstrates how NUC-7738 modulates RNA and protein regulators needed for ribosome biogenesis, a process critical for cancer cell growth. Together, these findings help clarify the drug’s multi-faceted mechanisms and support its potential use both alone and in combination with other cancer therapies.
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NuTide:323 - FDA Regulatory Timeline and Events
NuTide:323 is a drug developed by NuCana for the following indication: The nucleoside analog 5-fluorouracil, a widely used chemotherapy agent.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NuTide:323
- Announced Date:
- August 29, 2024
- Indication:
- The nucleoside analog 5-fluorouracil, a widely used chemotherapy agent
Announcement
NuCana plc announced that the NuTide:323 study is being discontinued following a pre-planned initial analysis and recommendation from the NuTide:323 Study Steering Committee.
AI Summary
NuCana plc announced that the NuTide:323 study is being discontinued after a pre-planned initial analysis and recommendation from the study’s Steering Committee. The analysis revealed that the experimental treatment, NUC-3373 combined with leucovorin, irinotecan, and bevacizumab (NUFIRI+bev), was unlikely to achieve the primary goal of improved progression-free survival compared to the control arm receiving the standard FOLFIRI+bev regimen.
The Steering Committee noted prognostic imbalances favoring the control arm, leading to the decision to stop the study. NuCana’s CEO expressed disappointment with the outcome but emphasized that valuable insights were gained that will help guide future research. While the overall safety profile remained favorable with only a few participants discontinuing due to side effects, the company remains committed to developing new treatment options to improve survival outcomes for cancer patients.
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