Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 15

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 15
---
3 [0.8 – 90.6]
     
    20.0 [6.8 – 40.7]
     
    16.0 [4.5 – 36.1]

Note: A hyphen (-) indicates no events were reported. n = number
of patients with an event; N = number of patients; NR = non-resectable. Percentages are based on the number of patients. CR = complete
response; PR = partial remission; SD = stable disease; PD = progressive disease; ORR = objective response rate (CR and PR); DCR = disease
control rate (CR, PR, and SD).

The clinical response was assessed by recurrence-free survival
after re-operation (RFS) (in the 107 CFU/mL resectable group), time-to-progression (TTP), progression free survival
(PFS), and overall survival (OS). In the patients who underwent tumor resection (107 CFU/mL resectable group), disease
progression occurred only in Patient 01-17 with an RFS of 1.8. Patient 01-14 was censored with an RFS of 20.9 months.
The results for TTP and PFS were identical, with an overall median of 2.7 months and range of 1.2 to 13.8 months in the non-resected patients
(Total NR group). The median OS in the Total NR group was 11.1 months (95% CI: 8.5 – 15.1) with a range of 3.8 to
38.2 months. At the time of database lock, 1 patient in the 107 CFU/mL resectable group was alive and had stable
disease without post-resection recurrence, while 3 patients in the 107 CFU/mL non-resectable group were alive
with progressive disease in longterm follow-up.

VXM01 phase I/II clinical trial — Immune response

The effect of VXM01 plus avelumab was explored by evaluating the VEGFR-2 specific
T cell response and frequency of immune cells in peripheral blood, and by staining of immune- and biomarkers in tumor tissue obtained
during resection.

ELISpot assay was used to measure the number of these