Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 150

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 150
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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 completed in July 2022. Its dual-primary endpoints were PFS and OS. The trial met the PFS endpoint at a statistically and clinically meaningful level. The OS endpoint was not statistically significant per the pre-specified statistical plan, although there was an improvement in median OS.

Results were presented orally at ASCO Plenary Series in February 2024. As of data cut-off on September 9, 2022, 703 patients were assigned 1:1 to either fruquintinib 4 mg OD 3 weeks on/1 week off and paclitaxel or placebo and paclitaxel. With a median follow-up of 31.7 months, patients on fruquintinib combined with paclitaxel achieved PFS of 5.6 months, vs 2.7 months in the control group on paclitaxel only with HR of 0.569 and p < 0.0001. There was an improvement in OS with median OS of 9.6 months vs. 8.4 months, however this was not statistically significant. There was an imbalance of patients receiving subsequent antitumor therapies across the two groups, with 52.7% in the fruquintinib plus paclitaxel group vs. 72.2% in the paclitaxel monotherapy group. In pre-specified sensitivity analysis, when excluding patients taking subsequent antitumor therapy, OS advantage becomes nominally statistically significant for the treatment arm at 6.9 months vs 4.8 months in control arm with HR of 0.72 and p=0.0422. Fruquintinib also demonstrated a statistically significant improvement in secondary endpoints including ORR, DCR and DoR. The safety profile of fruquintinib in FRUTIGA was consistent with previously reported studies.

In April 2023, the NDA in China was accepted for review by the NMPA. In August 2024, we voluntarily withdrawn the supplemental NDA in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroes