Company: IMCR
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001671927-25-000006
Chunk: 27

Company: Immunocore Holdings plc
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 27
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 control arm of either nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The trial was designed based on our analysis of the ongoing Phase 1 data in previously treated CM which demonstrated monotherapy clinical activity including partial responses ("PR"), durable tumor reduction, disease control (PR and stable disease), PFS and circulating tumor DNA ("ctDNA") reduction (consistent with prior reported data for brenetafusp and tebentafusp). Additional rationale includes safety in combination with checkpoints (from the ongoing Phase 1 data and prior experience with tebentafusp) and evidence from across the platform for increased clinical activity in earlier line patients compared to later line. The first patient was randomized in this trial in June 2024.

•Brenetafusp is also being tested in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer ("PROC") and with bevacizumab or with platinum chemotherapy in earlier lines of platinum sensitive ovarian cancer ("PSOC"). In the same trial, we continue signal detection in metastatic non-small cell lung cancer ("NSCLC") cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC and additional solid tumors. 

We presented updated clinical data from the Phase 1/2 trial:

◦in patients with late-line CM, at the 2024 American Society of Clinical Oncology annual meeting, showing promising brenetafusp monotherapy disease control (partial response and stable disease), PFS, and ctDNA molecular response. In PRAME positive patients, the disease control rate ("DCR") was 58% and median PFS was 4.2 months. This analysis of the initial 18 uveal and cutaneous melanoma patients was an update of the initial data set presented at the 2022 European Society for Medical Oncology (“ESMO”) Congress, which continued to show promising durability of the clinical activity (range of duration of patient response from 6 months to 17 months).

◦in patients with heavily pre-treated platinum-resistant high grade serous ovarian cancer, at the 2024 ESMO Congress, showing signals of activity in heavily pretreated, platinum-resistant patients. DCR was 58% in monotherapy patients and 69% for combination patients. Overall survival ("OS") was still maturing (73% 6 months OS rate in the