Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 147

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 147
---
9 months and 18-month PFS rate was 40.0%. OS was not reached and 36-month OS rate was 58.3%. Confirmed ORR was 60.0%; DCR was 85.0% and DoR rate at ≥18 months was 33.3%. Grade ≥3 TRAEs occurred in 52.4% of patients, including hypertension (27.3% in 1L, 15.0% in 2L), increased amylase (0.0% in 1L, 15.0% in 2L), proteinuria (9.1% in 1L, 10.0% in 2L), hypertriglyceridemia (9.1% in 1L, 20.0% in 2L) and hand-foot syndrome (9.1% in 1L, 0.0% in 2L). TRAEs led to discontinuation of fruquintinib in 11.9% of patients and discontinuation of Tyvyt in 7.1% of patients.

Phase Ib/II basket study of fruquintinib in combination with Tyvyt (NCT03903705)

The China Phase Ib/II basket study (NCT03903705) evaluated the combination of fruquintinib and Tyvyt in a dose-escalation phase covering various solid tumors, followed by a dose-expansion phase on CRC, HCC, RCC, EMC, CC, NSCLC and GC.

For the GC Phase II single-arm cohort, 27 GC patients with PD-L1 status of CPS≥1 were enrolled between September 9, 2021 and July 31, 2023. Results were presented at ESMO 2023. 18 1L patients and 6 ≥2L patients were evaluable for efficacy, with PFS of 11.0 months and 10.5 months, respectively. OS was not mature while 15-month OS rates were 56.7% and 66.7%, for 1L and ≥2L patients, respectively. Confirmed ORRs were 72.2% and 33.3%; DCRs were 100% and 83.3% while DoR was 10.3 months and not reached, for 1L and ≥2L patients, respectively. There was no obvious difference of clinical