Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 406

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 406
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/II dose-escalation plus dose-expansion cohorts, 44 CRC patients were enrolled between April 26, 2019 and December 30, 2021. Results were presented at ASCO 2021 and published in European Journal of Cancer in March 2023. There were 30 2L patients and 13 ≥3L patients. 22 patients received fruquintinib 3mg OD + sintilimab Q3W while another 22 patients on 5mg OD 2 weeks on/1 week off, with the latter becoming the recommended dosing regimen. Among 43 efficacy evaluable patients, PFS was 5.6 months (6.9 months in 5mg OD regimen); OS was 14.3 months (14.8 months in 5mg regimen); ORR was 20.9% (23.8% in 5mg OD regimen); DCR was 88.4% (100% in 5mg OD regimen) and DoR was 8.3 months (9.7 months in 5mg OD regimen). Within the 22 patients on 5mg OD regimen, Grade ≥3 TRAEs occurred in 36.4% of patients, mainly hypertension (13.6%) and hand-foot syndrome (9.1%).
Fruquintinib Combination - Gastric Cancer
Advanced gastric cancer is a major medical need, particularly in Asian populations, with limited treatment options for patients who have failed first-line standard chemotherapy with 5-fluorouracil and platinum doublets.

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Treatment                       Trial Name, Patient Focus       Sites       Phase       Status/Plan                                  NCT #      
Fruquintinib + paclitaxel       FRUTIGA: 2L GC              ​   China   ​   III     ​   Supplemental NDA withdrawn in Aug 2024   ​   NCT03223376
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FRUTIGA: Phase III study of fruquintinib in combination with paclitaxel in 2L GC (NCT03223376)
FRUTIGA is a China Phase III randomized, double-blind active-controlled study of fruquintinib in combination with paclitaxel compared with paclitaxel monotherapy, for 2L GC. Enrollment was