Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 146

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 146
---
06584032)

FRUSICA-3 is a China Phase III randomized, open-label, active-controlled confirmatory study of fruquintinib in combination with Tyvyt versus paclitaxel or doxorubicin for 2L EMC with pMMR. The primary endpoints are OS and PFS. The study enrolled its first patient in December 2024 and targets recruitment of about 400 patients.

Table of Contents

FRUSICA-2: Phase II/III study of fruquintinib in combination with Tyvyt in 2L RCC (NCT05522231)

In first-line clear-cell renal cell carcinoma, clinical benefits have been demonstrated for the combination of antiangiogenic therapy and immunotherapy. However, there is limited evidence on the benefits of this combination in the second-line setting. FRUSICA-2 is a China Phase II/III randomized, open-label, active-controlled study in 2L advanced or metastatic RCC patients treated with fruquintinib in combination with Tyvyt, versus axitinib or everolimus monotherapy. The trial started in October 2022 and completed recruitment of 234 patients in December 2023. Primary endpoint of PFS was met in March 2025 and we are preparing a NDA submission to NMPA.

FRUSICA-2 was preceded by a China Phase Ib/II basket study (NCT03903705) evaluating 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 RCC open-label, single-arm, dose expansion cohort, data was presented at ASCO 2023 and published in Targeted Oncologyin January 2025. From September 9, 2020, to the data cut-off of March 31, 2023, for 1L patients (22), PFS was not reached and 18-month PFS rate was 59.4%. OS was not reached and 36-month OS rate was 72.4%. Confirmed ORR was 68.2%; DCR was 95.5% and DoR rate at ≥18 months was 73.4%. For 2L patients (20), which was the focus on subsequent FRUSICA-2 trial (NCT05522231), PFS was 15.