Chinese biopharma Hutchmed is eyeing approval for renal cell carcinoma (RCC) drug, fruquintinib, on home soil following a successful Phase III trial.
In the FRUSCIA-2 study (NCT05522231), a combination of fruquintinib and Eli Lilly & Innovent Biologics’ Tyvyt (sintilimab) offered a statistically significant 15.3-month boost to progression-free survival (PFS), as per an abstract released ahead of the European Medical Society of Oncology (ESMO) Congress 2025 held from 17-21 October in Berlin, Germany.
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The 15.3-month PFS data was on top of the PFS of 6.9 months seen in the Inlyta (axitinib) and Afinitor (everolimus) patient arms, respectively, meaning patients randomised to fruquintinib-Tyvyt experienced a PFS of 22.2 months.
The combination also significantly bolstered objective response rates (ORR), with 60.5% of patients experiencing a treatment response as opposed to the 24.3% seen in the control arm.
Though the overall survival (OS) data for this study is yet to mature, Hutchmed noted that the efficacy benefits of fruquintinib-Tyvyt were seen across all prognostic risk groups, suggesting the combination’s broad potential across the RCC indication.
Meanwhile, the drugs were found to be safe and tolerable when used as a pair, though more treatment-emergent adverse events (TEAEs) were seen in patients who received the combination rather than Inlyta or Afinitor. There were also 8% more discontinuations associated with the duo compared with both Inlyta or Afinitor.
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By GlobalDataThe combination works through a dual mechanism, with Tyvyt acting as a programmed cell death protein 1 (PD-1) blocker, and fruquintinib functioning as a vascular endothelial growth factor (VEGF) inhibitor.
Hutchmed will present further details from the FRUSCIA-2 study on 17 October 2025 at the ESMO congress in Berlin.
The combination’s future potential
According to the trial’s co-leading principal investigator, Prof Zhisong He, the results of the FRUSCIA-2 study spotlight fruquintinib-Tyvyt’s potential to play a “meaningful role” in the second-line treatment of advanced RCC.
“These results point to the combination’s potential to enhance clinical outcomes, providing a new option for managing this challenging disease,” He stated in a 13 October press release.
Moving forward, Hutchmed will submit a new drug application (NDA) to the Chinese National Medical Products Association (NMPA) for the combination, which was previously awarded breakthrough therapy designation, in second-line RCC.
Fruquintinib, which is known as Elunate in China, will now have three indications under its belt in the region, as it previously received the NMPA go-ahead in advanced endometrial and metastatic colorectal cancer.
The drug is also available on the US market through licensee Takeda Pharmaceuticals – which has branded the drug under the name Fruzaqla – for colorectal cancer.
Meanwhile, Tyvyt is not approved in the US, despite Innovent and partner Eli Lilly’s efforts to get the drug to market in non-small cell lung cancer (NSCLC). This is due to the agency’s requirement for an additional, multiregional pivotal study involving the therapy, which would have to be conducted with OS as the primary endpoint.
Elsewhere in the oncology sector, companies like Akeso and Summit Therapeutics have developed PD-1-VEGF bispecific antibody Idafang (ivonescimab), which combine the mechanisms of fruquintinib and Tyvyt in one drug.
Thus far, the therapy has shown significant potential in the oncology space, outcompeting MSD’s blockbuster seller, Keytruda (pembrolizumab) in a Phase III study in NSCLC and meeting its primary endpoint in another trial within the indication.
Idafang has already got the green light from the NMPA in first-line NSCLC, but now Akeso and Summit are looking to get the drug to the US market.
