Data Readout

NuCana's NUC-7738 melanoma data due in H2 2026 after early partial responses

NuCana plans final Phase 2 data on NUC-7738 plus pembrolizumab in PD-1-resistant melanoma later in 2026, building on two partial responses and one complete metabolic response shown so far.

By AppliedXLJuly 13, 2026Trial NCT03829254

Executive Summary

NuCana has narrowed the window for final data from its melanoma combination study to the second half of 2026, following interim results that already showed tumor responses in a PD-1-resistant population with no approved standard treatment.
The sponsor tightened its own guidance from a full-year 2026 timeframe to the second half of the year, a refinement rather than a delay, and tied the eventual data to a planned regulatory conversation about a registrational path.
Because no direct competitor trial in this exact resistant-melanoma setting is available for comparison, the expansion cohort's own interim signal, a confirmed partial response and a complete metabolic response, becomes the benchmark the final data must extend or contradict.
A readout that confirms the interim pattern would support NuCana's plan to seek FDA guidance on registration; a readout that reverts toward background response rates would undercut that plan without an established alternative mechanism in this setting.

The catalyst

NuCana plc said it expects to announce final data from the Phase 2 NuTide:701 expansion study of NUC-7738 combined with pembrolizumab later in 2026, tightening earlier full-year 2026 guidance to a second-half window running from July through December. The study is registered as NCT03829254, a Phase 1/2 trial testing NUC-7738 across advanced solid tumors and lymphoma, with a specific melanoma expansion cohort added to test the combination in patients whose disease progressed on PD-1 inhibitor therapy. NuCana+1

What the interim data showed

NuCana's chief executive, Hugh S. Griffith, said the company presented data from the study at the 2025 European Society for Medical Oncology Immuno-Oncology Congress showing "a favorable safety profile and evidence of clinical activity, including two partial responses, one of which was confirmed, and multiple cases of stable disease, including one patient whose disease converted to a complete metabolic response with no detectable active disease". That interim readout, not the final data, is what is currently on record; the second-half 2026 announcement is meant to report on the completed expansion cohort. NuCana

Trial mechanics

The registry record for NCT03829254 lists a primary completion date of June 2024 and an enrollment target of 94 patients, both set when the trial's design predated the melanoma expansion cohort that generated the 2025 interim data. NuCana said it expects to complete enrollment in the expansion study in the first half of 2026, ahead of the final data readout later in the year. The trial's registry-amendment history shows no additional protocol changes beyond what supports this enrollment expansion. NCT03829254+1

The regulatory link

NuCana has tied the melanoma readout to a regulatory step: Griffith said the company plans to obtain FDA guidance on a potential registrational pathway for NUC-7738 in melanoma. That places weight on what the final expansion-cohort data show, since the response pattern reported at the 2025 congress, rather than a formal statistical hypothesis test, is the evidence base management has pointed to ahead of that regulatory conversation. NuCana

Competitive context

No competitor trial sharing NUC-7738's target or mechanism class is available for comparison in PD-1 inhibitor-resistant metastatic melanoma, and no historical outcome data specific to this drug-indication pairing exists to benchmark against. That leaves the interim signal, a confirmed partial response and a complete metabolic response in a small expansion cohort, as the reference point the final data will extend or fail to reproduce, in a post-PD-1 resistant setting where treatment options remain limited. NuCana

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.