Company: NCNA
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0000950170-25-042709
Chunk: 143

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 4
Chunk 143
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 obtained significant tumor regression or stable disease when treated with Acelarin. Despite the heavily pre-treated nature of the patient populations in the early phase clinical trials, Acelarin has been well tolerated and showed anti-cancer activity in patients who were resistant to, or had progressed on, prior gemcitabine treatment.
 Acelarin: Completed Phase 1 clinical trial (PRO-001)
 In the Phase 1 trial, 68 patients with advanced solid tumors and metastatic disease who had exhausted all other standard treatment options received Acelarin as monotherapy at doses ranging from 375 mg/m 2 to 1,000 mg/m 2. All of these patients had rapidly progressing recurrent disease and had received on average 2.7 prior lines of chemotherapy. In a subset of 49 patients who received two or more cycles of Acelarin, equivalent to two or more months of therapy, and had at least one follow-up radiographic assessment to measure changes in tumor size. Five patients achieved a partial response, although not all of these five patients received a final confirmatory scan as technically required by the RECIST criteria for classification as a partial response. Another 33 patients were scored as having stable disease. This resulted in an overall disease control rate of 78% in the total 49-patient evaluable population.
 Acelarin: Completed Phase 1b clinical trial in combination with carboplatin (PRO-002)
 In the Phase 1b trial, 25 patients with recurrent ovarian cancer received Acelarin at doses from 500 mg/m2 to 750 mg/m2 in combination with carboplatin for a maximum of six treatment cycles lasting three weeks each. Patients had received on average four prior lines of chemotherapy. Of the 25 patients enrolled, 23 were evaluable and these patients were characterized by their platinum status: seven were platinum-refractory, 10 were platinum-resistant, three were partially platinum-sensitive and three were platinum-sensitive. The 23 evaluable patients had received one or more cycles of Acelarin in combination with carboplatin and had at least one follow-up radiographic assessment. Of the evaluable patients, one
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achieved a confirmed complete response and eight achieved a partial response (four confirmed). This resulted in an overall response rate of 39% (22% confirmed). Another 13 patients were scored as having stable disease. This resulted in a disease control rate of 96%. The median PFS duration was 6.2 months.
 Acelarin: Completed Phase