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Hutchmed looks for another fruquintinib use

Hutchmed’s quest to expand its VEGF inhibitor fruquintinib in China got a boost on Tuesday, with an apparent win in the phase 2/3 Frusica-2 trial in second-line renal cancer. Hutchmed only disclosed that the study met its primary endpoint, showing a progression-free survival benefit with fruquintinib plus Innovent’s PD-1 blocker Tyvyt, versus Inlyta or everolimus. Secondary endpoints including ORR and duration of response were also achieved, Hutchmed added, but the press release didn’t mention overall survival, another secondary outcome. Full results are due at a scientific conference. The fruquintinib/Tyvyt combination gained conditional Chinese approval in December for second-line MMR-proficient endometrial cancer. Fruquintinib monotherapy has been available in China since 2018 for third-line colorectal cancer, where it’s branded Elunate and is co-marketed by Lilly. The US FDA approved it for a similar use in 2023, where it’s known as Fruzaqla and Takeda has rights. However, things haven’t always gone smoothly, with China’s NMPA last year knocking back use in second-line gastric cancer, after the Frutiga trial failed to show a benefit on one of its co-primary endpoints, overall survival, despite hitting its other co-primary, PFS. Hutchmed will hope that history doesn’t repeat itself with Frusica-2.

 

Hutchmed-sponsored pivotal trials of fruquintinib

TrialSettingRegimenCountryOutcome
Fresco3rd-line CRCMonotherapy, vs placeboChinaChina approval (as Elunate) Sep 2018
Faluca3rd-line NSCLCMonotherapy, vs placeboChinaFailed Nov 2018
Fresco-23rd-line CRCMonotherapy, vs placeboGlobalFDA approval for 2nd-line CRC (as Fruzaqla) Nov 2023
Frutiga2nd-line gastric cancer+ paclitaxel, vs paclitaxelChinaFailed, rejected by China’s NMPA Aug 2024
Frusica-1 (ph1/2)2nd-line endometrial cancer+/- Tyvyt, uncontrolledChinaChina conditional approval Dec 2024
Frusica-22nd-line renal cancer+ Tyvyt, vs Inlyta/everolimusChinaToplined positive Mar 2025
2024-013-00CH12nd-line endometrial cancer+ Tyvyt, vs investigator's choice chemoChinaCompletes Jan 2029

Source: OncologyPipeline & clinicaltrials.gov.

Tags

Molecular Drug Targets